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CTP-Supported Tobacco Regulatory Research Projects (TEST)

Research supported by FDA’s Center for Tobacco Products (CTP) informs regulatory and public education efforts aimed at improving the overall health of the public and may also provide data about the impact of these efforts. 

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04/15/2022

Systematic Identification of Cardiotoxic E-Cigarette Flavorants

The goal of this study is to examine how individual flavorants in e-cigarettes modify the effects of e-cigarette aerosol exposures on the electrical activities of the heart (i.e., cardiac electrophysiology), leading to heart arrhythmias and functional remodeling. Researchers will identify short-term and long-term effects of flavorant exposure on cardiac electrophysiology in mice by using various state-of-the-art analytical approaches. Study aims are: (1) to identify the short-term effects of flavored e-cigarette aerosol inhalation on cardiac electrophysiology; (2) to examine the direct impact of flavorants on cardiac electrophysiology by examining cardiac myocyte function; and (3) to clarify the impacts of individual flavorants on the short- and long-term impacts of e-cigarette aerosol exposures on cardiac electrophysiology, structure, and function. This study will provide new data on the cardiac toxicity of e-cigarette flavorants.

Alex Carll and Matthew Nystoriak Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01HL163818-01
Institution: University of Louisville
03/30/2022

Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-Cigarettes Among Current Menthol Smokers

The goal of this study is to model the impact of different menthol regulatory scenarios on real-world smoking behavior. Study aims are: (1) to examine the impact of banning menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) to investigate whether outcomes differ by race to understand the impact of menthol ban policies on Black (vs. non-Black) individuals, given high rates of menthol cigarette use in this population. Researchers will recruit 150 adults (ages 21+) who currently smoke menthol cigarettes and will provide them with cigarette and e-cigarette products to use for 8 weeks; subjects will be randomized to one of three study conditions in which they will receive products as follows: (1) no menthol ban (menthol cigarettes and menthol flavored e-cigarettes), (2) menthol ban on cigarettes only (non-menthol cigarettes and menthol flavored e-cigarettes), or (3) menthol ban on both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco flavored e-cigarettes). A follow-up survey at 12 weeks will assess changes in the number of cigarettes smoked per day (the primary study outcome) as well as percent days smoke-free, changes in nicotine dependence, and motivation, confidence, and intention to quit smoking. Findings may inform regulatory activities related to menthol. 

Krysten Bold Funding Mechanism: National Institutes of Health – Grant 
ID Number: 1R01DA054993-01A1
Institution: Yale University
 
03/28/2022

Novel "Tobacco-Free" Oral Nicotine Pouches: The Impact of Product Features and Marketing Influences on Abuse Liability, Perceptions, and Use Behavior in Smokers and Non-Nicotine Users

A novel class of oral nicotine pouches that contain a nicotine powder instead of tobacco leaves has recently emerged; these pouches often contain non-tobacco flavors (e.g., fruit) with known appeal to youth. The goal of this study is to describe nicotine pouch product features and marketing tactics that may drive initiation and continued use among smokers and non-nicotine users, including youth. Study aims are: (1) to examine how pouch flavors and nicotine doses impact pharmacokinetics (PK), or how nicotine moves through the body, and pharmacodynamics (PD), or the effects a person feels after using a drug, in cigarette smokers; (2) to characterize nicotine pouch marketing tactics in advertisements and examine the influence of these tactics on cigarette smokers’ and youth non-nicotine users’ product perceptions; and (3) to examine how a common marketing tactic (e.g., “tobacco-free” descriptors) impacts use behaviors and PK/PD effects in cigarette smokers and non-nicotine users. To achieve Aim 1, 28 smokers (ages 21+) will use pouches of different flavors (tobacco, mint, fruit) and nicotine doses (low, high), and their own brand of cigarettes over seven laboratory sessions, and PK and PD effects (e.g., subjective abuse liability, tobacco withdrawal) will be assessed. In Aim 2, researchers will review nicotine pouch advertisements over 5 years to identify/monitor marketing tactics and examine, via web-based experiments, how common tactics influence product perceptions (i.e., perceived harm, addictiveness, appeal) and use intentions among 2,500 adult (ages 21+) cigarette smokers and 2,500 youth (ages 13-20) non-nicotine users. In Aim 3, researchers will conduct a second laboratory study with 60 smokers and 60 non-nicotine users (ages 21+) to determine how a common marketing tactic identified from the Aim 2 marketing analysis (“tobacco-free” descriptors) impacts pouch use behaviors and PK/PD effects. Findings may inform future regulatory activities related to novel oral nicotine pouches. 

Tory Spindle and Meghan Moran Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA055962-01
Institution: Johns Hopkins University
03/22/2022

The Effect of Menthol on ENDS Users' Dependence, Respiratory, and Toxicants Emission Outcomes

The goal of this study is to clarify how menthol affects electronic nicotine delivery system (ENDS) users' experience and puffing patterns, which in turn affect dependence, exposure to toxicants, and clinical outcomes. In this study, 200 current/past month closed-system ENDS users (ages 21-35) will attend two laboratory sessions and use their ENDS once with menthol flavor and once with tobacco flavor. Study aims are: (1) to test the effects of menthol vs. tobacco flavor on subjective, puffing, and respiratory outcomes including pre-post-use assessment of craving, withdrawal, satisfaction, harm perception, intention to quit or use, respiratory functions, and symptoms (e.g., dry mouth, irritation, cough, palpitation, nausea); and (2) to use a smoking robot to measure the effects of menthol vs. tobacco flavor on ENDS emissions of 14 aldehydes. Findings may inform future regulatory activities related to the use of menthol flavor in ENDS. 

Wasim Maziak Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA055937-01
Institution: Florida International University
03/18/2022

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

More information about the impact of menthol-flavored e-cigarettes in enabling menthol cigarette smokers to switch to e-cigarettes would be useful. The goal of this study is to compare the efficacy of menthol-flavored versus tobacco-flavored e-cigarettes in facilitating switching from combustible cigarettes to e-cigarettes among adult menthol smokers. Researchers will randomize 800 menthol smokers (≥ age 21) into a 12-week trial comparing menthol-flavored and tobacco-flavored e-cigarettes, with follow-up at week 26. Study aims are: (1) to compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching (measured by cigarette and e-cigarette use patterns) at week 12; (2) to compare tobacco harm reduction of menthol versus tobacco e-cigarettes (measured by self-reported health-related quality of life, expired carbon monoxide, respiratory measures, and blood pressure) at week 12; (3) to compare the acceptability of menthol versus tobacco e-cigarettes (measured by product use; effects on withdrawal, craving, and dependence; and subjective and sensory effects) at week 12; and (4) to examine the long-term use of menthol versus tobacco e-cigarettes at week 26. Findings may inform future regulatory activities related to menthol flavoring in e-cigarettes. 

Nicole Nollen Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA055999-01
Institution: University of Kansas Medical Center
10/31/2021

Nicotine Flux, A Potentially Powerful Tool for Regulating Nicotine Delivery from Electronic Cigarettes: Significance of Nicotine Flux to the Rate of Nicotine Delivery and Subjective Effects

The rate at which electronic nicotine delivery systems (ENDS) emit nicotine (“nicotine flux”) can be predicted based on knowledge of a few device design and operating variables. The goal of this study is to provide empirical evidence demonstrating the relationship between nicotine flux and nicotine delivery and between nicotine flux and the physiological and subjective effects that support nicotine dependence. Study aims are: (1) to examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery, and (2) to assess the relationship between nicotine flux, nicotine form, and subjective effects. To achieve Aim 1, participants will puff on ENDS devices under conditions that differ by flux and form while arterial blood is sampled for nicotine levels; the outcome will indicate the degree to which nicotine flux and form determine the speed and dose of ENDS nicotine delivery, and thus, abuse liability. To achieve Aim 2, participants will use ENDS devices with varying nicotine fluxes and forms, and dependency measures such as urge to smoke, craving, and abstinence will be assessed; the outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and toxicant exposure. Findings may provide evidence for using nicotine flux to inform possible regulatory activities. 

Soha Talih Principal Investigator
Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA052565-01A1
Institution: American University of Beirut
10/15/2021

CTP Supplement to Parent Grant: Chronic Hookah (Waterpipe) Smoking, Vascular Dysfunction, Inflammation and Oxidative Stress


As a supplement to a parent grant, this study will further examine the long-term health effects of hookah smoking by evaluating autonomic nervous system regulations of the heart and identifying additional biomarkers of harm that could be used to evaluate and monitor the effects of chronic hookah smoking on cardiovascular health. In a group of generally 34 healthy chronic hookah smokers ages 21-49 who do not smoke cigarettes -- matched with 34 cigarette smokers and 34 nonsmokers -- researchers will examine: (1) cardiac sympathetic nerve activity measured by heart rate variability; and (2) biological markers of inflammation and oxidative stress, including: (a) interleukin-6 and tumor necrosis factor-a; (b) free polyunsaturated fatty acids and oxidized metabolites, assessed by mass spectrometry; and (c) concentrations of glutathione, bilirubin, heme oxygenase-1, and functional activity of paraoxonase1, determined by colorimetric and enzymatic assays. Findings will provide new information about the cardiovascular effects of hookah smoking.

Mary Rezk-Hanna Funding Mechanism: National Institutes of Health - Grant
ID Number: 3R01HL152435-02S1
Institution: University of California, Los Angeles
10/12/2021

Determinants and Health Effects of Dynamic Changes in E-Cigarette use Before, During, and After Pregnancy

The goal of this secondary data analysis is to examine changes in maternal e-cigarette use before, during, and after pregnancy, determinants of these changes, and their effects on maternal and infant health. Study aims are: (1) to examine determinants of changes in e-cigarette use before, during, and after pregnancy; and (2) to assess health outcomes associated with changes in e-cigarette use (discontinuing, switching, and relapsing) before, during, and after pregnancy.  Researchers will analyze data from two large U.S. national studies: the Pregnancy Risk Assessment Monitoring System (PRAMS) with N=153,336 existing mothers during 2016-2019 plus new mothers in 2020-2021, and the Population Assessment of Tobacco and Health (PATH) Study with N=4,392 existing pregnancies in waves 1-4 during 2013-2017 plus new pregnancies in wave 5 during 2018-2019 and the adult telephone survey in 2020. Potential determinants of e-cigarette use changes to be evaluated will include socio-demographics, pregnancy intention and characteristics, baseline e-cigarette use and product features, risk perception of e-cigarette use, concurrent substance use, and time of survey. Prenatal outcomes will include gestational weight gain and gestational duration. Neonatal outcomes will include small-for-gestational-age birth, mode of delivery, and length of infant hospital stay. Postpartum outcomes will include breastfeeding and postpartum depression. Findings will provide new information about changes in e-cigarette use and its effects on maternal and child health.

Xiaozhong Wen Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21DA053638-01A1
Institution: State University of New York at Buffalo
09/30/2021

Can Machine Generated Nicotine Yield Predict Human Nicotine Exposure from ENDS?

The goal of this study is to examine whether machine-generated nicotine yield from electronic nicotine delivery systems (ENDS) can predict human exposure to nicotine. Study aims are: (1) to determine whether nicotine yields generated from machine-vaped ENDS are associated with human nicotine exposure following prescribed or ad libitum ENDS use, and (2) to determine which machine-vaping regimes (e.g., CORESTA, intense, playback of human puff topography), if any, are most effective for estimating human exposure to nicotine. Researchers will also investigate how changes in ENDS nicotine yield may affect nicotine pharmacokinetics, pharmacodynamics, non-nicotine HPHC exposure, subjective effects, and puff topography. In this randomized study, 32 current ENDS users (ages 21-65) will complete four experimental visits during which they will use an ENDS containing one of four e-liquid nicotine concentrations (i.e., very low, low, medium, high) under prescribed and ad libitum use conditions; researchers will then measure nicotine pharmacokinetic parameters (e.g., maximum plasma nicotine concentration) to determine nicotine exposure and compare it to machine-generated yields. Results will help determine whether nicotine yield data can be used to estimate human exposure to nicotine from ENDS, whether these data can be used to draw inferences regarding ENDS abuse liability, and whether certain machine-puffing regimens are most suitable for estimating human nicotine exposure from ENDS.

Wallace Pickworth (CTP Contact: Marzena Hiler and Arit Harvanko) Funding Mechanism: Research Contract
ID Number: HHSF22320170040I
Institution: Battelle
09/23/2021

Strengthening Cigar Warnings to Prevent Adolescent Use

In 2016, the Food and Drug Administration (FDA) mandated six rotating text-only warning statements to be placed on little cigar and cigarillo (LCC) packaging. The goal of this study is to advance the science on LCC warnings that are effective for youth ages 15-20 who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. Study aims are: (1) to identify the most effective images to pair with FDA-mandated LCC text-only warning statements using a youth advisory board and a quantitative online survey delivered to 500 youth; (2) to examine whether LCC warning size (30% vs 50% on the LCC package principle display panels) and type (text-only vs. text+image) affect perceived message effectiveness of LCC warnings among an online sample of 500 youth; and (3) to conduct a randomized controlled trial with 900 youth to test whether the most effective LCC warnings from Aim 2 reduce willingness to use LCCs (compared to the text-only 30% size FDA-mandated LCC warnings and a control condition). Findings may inform regulatory activities related to LCC warnings.

Leah Ranney and Jennifer Cornacchione Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01CA260822-01A1
Institution: University of North Carolina at Chapel Hill
09/23/2021

Effect of Tobacco Use Patterns on Toxicant Exposure and Successful Cessation: A Longitudinal Study among US Adult Cigarette Smokers

Researchers will analyze data from Waves 1-5 of the Population Assessment of Tobacco and Health (PATH) Study to identify groups of adult smokers defined by their toxicant exposure and investigate how levels of nicotine dependence and patterns of tobacco use could impact adults’ ability to achieve successful smoking cessation (smoking abstinence ≥3 months). Study aims are: (1) to analyze data on biomarkers of exposure to tobacco chemicals (i.e., nicotine, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, volatile organic compounds) in 8,000 adult current cigarette smokers and group those smokers based on toxicant concentrations detected in urine; researchers will examine whether groups differ by personal characteristics, smoking behaviors (e.g., menthol vs. non-menthol smoking; cigarette smoking only or polytobacco use), and level of nicotine dependence; and (2) to describe trends in nicotine dependence and smoking behaviors to identify characteristics and behaviors of adults who achieved successful smoking cessation. Findings may inform regulatory and research activities that address tobacco-related toxicant exposure and will shed light on barriers and facilitators to achieving successful smoking cessation in adults. 

Ban Majeed Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21CA267932-01
Institution: Augusta University
09/23/2021

Development of Biomarkers of Exposure and Effects for Electronic Cigarette vs. Combustible Cigarette Use

E-cigarette use has been associated with a variety of diseases, including cancer. The goal of this study is to detect genetic and epigenetic (i.e., behavioral, environmental) alterations in key genes in the oral and blood cells of 45 healthy adult vapers and 45 healthy adult smokers in comparison to a control group (45 nonsmokers/non-vapers) matched for age, sex, and race. Study aims are: (1) to screen for the deregulation (i.e., functional impairment) of disease-related genes in oral and blood cells of vapers and smokers as compared to controls; (2) after identifying the deregulated genes, to employ targeted next-generation sequencing (a method of analyzing DNA) to detect genetic changes in the deregulated genes; and (3) to employ targeted next-generation sequencing to detect epigenetic modifications to the deregulated genes. As a secondary goal, researchers will identify correlations between the identified genetic changes and subjects’ tobacco product use patterns and product characteristics (e.g., e-cigarette device features; e-liquid content; cigarette brand, type, and chemical constituents); this will clarify the impact of vaping/smoking dose and product characteristics on the biological effects of e-cigarette use vs. cigarette smoking. Study findings will identify gene changes that can serve as biomarkers to differentiate among vapers, smokers, and nonsmokers/non-vapers, thereby indicating the health risks and/or potential benefits of e-cigarette use relative to smoking.

Ahmad Besaratinia Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21CA268197-01
Institution: University of Southern California
 
09/21/2021

Pulmonary Toxicological Evaluation and Chemical Interactions of Menthol, Mint, and Tobacco Flavored E-Cigarette Products

Menthol/mint and tobacco flavors contain harmful chemicals that can cause adverse cellular and molecular changes in lung tissue. The goal of this study is to identify constituents of menthol/cooling and tobacco flavors and their pulmonary toxicity and to determine potential biomarkers of disease. Study aims are: (1) to identify the chemistry of menthol, menthol-like (cooling), and tobacco flavors, including flavoring chemicals and secondary products formed upon aerosolization; (2) to determine the in vitro and in vivo toxicity and health effects of menthol, menthol-like, and tobacco-flavored electronic nicotine delivery systems (ENDS) in EpiAirway 3D tissues (tissues constructed of human tracheal/bronchial epithelial cells) and in mice under normal and pre-existing respiratory conditions (chronic obstructive pulmonary disease and asthma) (3) to determine in vitro and in vivo toxicity and health effects of exposure to responsible flavoring chemicals identified in Aim1 using EpiAirway 3D tissues and mice under normal and pre-existing respiratory conditions. Findings will provide new information about lung toxicity caused by menthol and tobacco flavored e-cigs, identify disease processes of asthma and COPD upon switching to menthol and tobacco flavors from combustible cigarettes, and identify the culprits in these flavored e-cigs causing lung disease and exacerbations, thus, providing critical information for regulation of constituents of these ENDS.

Thivanka Muthumalage Funding Mechanism: National Institutes of Health - Grant
ID Number: 1K99ES033835-01
Institution: University of Rochester
09/21/2021

Impact Analysis of Flavor Restrictions and Tobacco 21 Policies on Youth Tobacco Use

Sixteen states and the District of Columbia enacted state-wide tobacco 21 (T21) policies prior to passage of the federal T21 law in December 2019, and seven states have recently enacted bans on flavored tobacco products. The goal of this study is to examine the impact of state flavor restrictions and state and federal T21 policies on disparities in tobacco use among youth and young adults aged 14-24 years. Researchers will analyze data from two surveys: the Behavior Risk Factor Surveillance System (BRFSS), an annual national phone-based survey of health-related behaviors among adults aged 18+; and the Youth Risk Behavior Survey (YRBS), a biennial school-based survey of health-related behaviors in 44 states. Study aims are: (1) to evaluate the impact of flavor restrictions and T21 policies on tobacco use (cigarettes, ENDS, smokeless tobacco) across age (18-20 vs. 21-24) and examine the impact of both policies on tobacco use across socio-demographic strata, using BRFSS data; (2) to evaluate the impact of flavor restrictions and T21 policies on tobacco use (cigarettes, ENDS, smokeless tobacco, cigars) across age (14-17 vs. 18) and examine the impact of both policies on tobacco use across socio-demographic strata, using YRBS data; and (3) to examine the impact of Covid-19 state closures and re-openings on tobacco use overall, by age, and across sociodemographic strata, using data from both surveys. Findings may inform future regulatory activities related to youth and young adult tobacco use.

Summer Hawkins Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21CA268199-01
Institution: Boston College
09/21/2021

Countering E-cigarette Marketing in the Retail Environment among Adolescents and Young Adults

Many adolescents and young adults directly purchase e-cigarettes from brick-and mortar retail stores. The goal of this study is to identify appealing and influential characteristics of e-cigarette marketing in the retail environment that impact adolescent (ages 11-18) and young adult (ages 19-21) e-cigarette purchase and use. Study aims are: (1) to examine adolescent and young adult descriptions of e-cigarette marketing in the retail environment and its influence on their e-cigarette purchase and use behavior; (2) to identify the most appealing characteristics of e-cigarette retail marketing that influence purchase and use; and (3) to develop and evaluate the effectiveness of an e-cigarette counter-marketing lesson to reduce adolescents’ intent to use and actual use of e-cigarettes. To achieve Aim 1, researchers will conduct focus group discussions with adolescents and young adults who have either never used e-cigarettes or have ever used or currently use e-cigarettes; the study will include a separate focus group for youth peer advocates working on e-cigarette prevention (total participants = 72). To achieve Aim 2, researchers will survey 2,250 adolescents and young adults to identify how and which e-cigarette marketing characteristics influence e-cigarette purchase and use; the survey will include a discrete choice experiment. Aim 3 will involve a randomized controlled trial that will assign 950 adolescents to one of two conditions: (1) a newly-developed online counter-marketing lesson about e-cigarette marketing in the retail environment, or (2) an existing online e-cigarette overview lesson to assess influence on intent to use and actual use of e-cigarettes. Findings may inform future educational and regulatory activities related to e-cigarette retail marketing. 

Shivani Gaiha Funding Mechanism: National Institutes of Health - Grant
ID Number: 1K99CA267477-01
Institution: Stanford University
 
09/20/2021

Personal Factors, Product Characteristics, and Changes in Biomarkers of Exposure among Cigarette Smokers Who Switch to Noncombustible Tobacco Products

The goal of this study is to evaluate the factors associated with transitioning from cigarettes to noncombustible tobacco products (e.g., smokeless tobacco, e-cigarettes) and assess the potential of noncombustibles as a harm reduction strategy. Researchers will evaluate four possible trajectories -- continued smoking (least optimal outcome), complete cessation (most optimal outcome), exclusive noncombustible use (possible harm reduction) or dual/poly tobacco use (unlikely harm reduction) -- through an analysis of Population Assessment of Tobacco and Health Study data. Study aims are: (1) to identify personal characteristics (e.g., sociodemographic characteristics, smoking history, harm perceptions, exposure to messaging) associated with switching from cigarettes to noncombustibles; (2) to describe product characteristics (e.g., cigarette characteristics, noncombustible characteristics such as flavor and nicotine content) associated with switching; and (3) to examine health outcomes and exposure biomarkers in smokers who have switched. Findings will provide new information related to switching from cigarettes to noncombustible tobacco products. 

Nicholas Felicione Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21CA268198-01
Institution: Roswell Park Cancer Institute Corporation
09/14/2021

Modeling the Impact of Tobacco Regulations on US Future Trends of Chronic Obstructive Pulmonary Disease

The objective of this research project is to build a chronic obstructive pulmonary disease (COPD) model based on individual cigarette smoking histories that will be used to predict the long-term population impact of two FDA tobacco regulatory scenarios on COPD disease burden. Study aims are: (1) to analyze data from a database of US adults with COPD (the COPDGene Study) to determine the impact of smoking behavior changes on lung function decline and COPD mortality; (2) to develop a COPD simulation that estimates future COPD incidence, prevalence and COPD-associated respiratory and lung cancer deaths based on individual smoking histories; and (3) to predict possible future trends in COPD morbidity and mortality under two FDA tobacco regulatory scenarios: cigarette pack and advertisement graphic health warnings (implementation of a Final Rule) and a menthol cigarette ban (planned). Findings will provide new information about the impact of tobacco control policies on COPD trends.
 

Luz Maria Sanchez-Romero Funding Mechanism: National Institutes of Health - Grant
ID Number: 1K01CA260378-01A1
Institution: Georgetown University
08/20/2021

CTP Supplement to Parent Grant: Impact of Flavor on Youth & Young Adults Use Intention, Abuse Liability and Perceptions of Cigarillos

The goal of this project supplement to the parent grant is to determine how the removal of flavors from cigarillos could impact co-use of cigarillos and cannabis, and whether that impact is related to perceptions of appeal or harm. Specific aims are: (1) to analyze parent study data on 361 young adult (ages 21-28) cigarillo users to determine the relationship between use of flavored cigarillos and co-use with cannabis (including blunts), and (2) to conduct one-on-one interviews with a subset of 38 participants to expand findings from the parent study, including understanding flavor appeal, perceived harm, and product substitution, and to assess these factors in the context of co-use with cannabis. Findings will provide new information about the influence of flavor on young adult co-use of cannabis and cigarillos.

Erika Trapl Funding Mechanism: National Institutes of Health - Grant
ID Number: 3R01DA048529-03S1
Institution: Case Western Reserve University 
08/18/2021

Evaluation and Comparison of Impacts of Flavored Waterpipe Tobacco and Electronic Waterpipe E-Liquid Formulation Variations on Toxicant Yields and Particle Size Distribution in Mainstream Emissions

The popularity of flavored waterpipe (WP) smoking has expanded in recent years to flavored tobacco-free alternatives, including electronic WP (EWP). EWP replaces the traditional WP bowl and heat source with an electronic head filled with flavored, nicotine-containing liquid (e-liquid), turning the WP into an electronic nicotine delivery system (ENDS). The goal of this study is to compare the impact of variations in flavor profiles, humectants, sugar levels, and heating temperature in a variety of commercially available WP tobaccos and EWP e-liquids on hazardous and potentially hazardous constituents (HPHCs) and other toxicant yields as well as particle size distribution in mainstream WP emissions. Specific aims are: (1) to characterize variations in formulations of a variety of commercially available WP tobaccos and EWP e-liquids by determining the flavor profiles and humectant and sugar content; (2) to determine HPHC and other toxicant yields and particle size distribution in mainstream emissions generated by machine-smoking the WPTs using a research-grade electric heater operating at a high and low temperature; and (3) to determine HPHC and other toxicant yields and particle size distribution in mainstream emissions generated by machine smoking the e-liquids at a high and low EWP power setting. To achieve Aim 1, nine WP tobaccos and nine e-liquid flavors within popular flavor categories will be selected and chemically analyzed using established methods. To achieve Aim 2, WP tobaccos selected in Aim 1 will be machine-smoked using a human-derived smoking regimen; mainstream emissions will be analyzed for volatile and semivolatile HPHCs, particle size distribution, and other toxicants. The heater and tobacco temperature will be monitored and recorded. To achieve Aim 3, EWP e-liquids selected in Aim 1 will be machine-smoked as in Aim 2 but using an EWP head with variable power. Findings may inform future regulatory actions related to WP and EWP.

Stephanie Buehler Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01ES033016-01
Institution: Battelle Centers Public Health Research and Evaluation
07/22/2021

Survey of Risk Factors of Lithium Ion Batteries Used in ENDS

Electronic nicotine delivery system (ENDS) lithium-ion battery-related overheat, fire, and explosion (O/F/E) incidents have increased in recent years, but limited information is available about ENDS-related O/F/E risk factors. Efforts to understand causes of ENDS-related O/F/E incidents suggest that specific products and certain user practices may increase the risk of ENDS-related O/F/E incidents. The goals of this project are to collect data from a representative sample of 6,000 U.S. adult ENDS users via an online survey to identify user practices, ENDS devices, and batteries that may increase the risk of ENDS-related O/F/E incidents, and to estimate the prevalence of O/F/E incidents. Findings may inform future regulatory activities related to ENDS.

Jessica Pepper (CTP Contact: Azieb Kidanu) Funding Mechanism: Research Contract
ID Number: 75F40120A00017
Institution: Research Triangle Institute (RTI) International
06/30/2021

Multi-Parameter Investigation of Factors Controlling Carbonyl Emissions from Electronic Cigarettes

Carbonyl compounds, such as formaldehyde, a known human carcinogen, are among the hazardous and potentially hazardous constituents (HPHCs) found in e-cigarette aerosols. Researchers have reported numerous factors that influence e-cigarette carbonyl production (e.g., e-cigarette type, power, coil material, e-cigarette liquid (e-liquid) composition, topography), but differences in sampling methodology and testing protocols and a limited number of parameters investigated in individual studies have contributed to controversy regarding carbonyl levels in e-cigarette aerosols and the role individual factors play in their production. The goal of this study is to resolve some of the outstanding questions regarding e-cigarette carbonyl emissions by performing comprehensive testing of popular devices that are representative of three e-cigarette types (a cig-a-like, a sub-Ohm “mod”, and a “pod” type) under a variety of use patterns. Study aims are: (1) to test different carbonyl collection methods using a NIST-traceable formaldehyde standard and e-cigarette aerosols containing different amounts of liquid particulates, and select the best method for subsequent tests; (2) to investigate interactions between the main flavoring compound classes with e-cigarettes that have fresh and aged coils at different temperatures and e-liquid formulations; and (3) to investigate how different combinations of power, puff topography, and e-liquid viscosity affect carbonyl emissions of the e-cigarette types. Findings will help determine the optimal sampling methodology for carbonyls in e-cigarette aerosols and may inform future regulatory activities related to e-cigarettes. 

Andrey Khylstov Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01ES033390-01
Institution: Desert Research Institute
06/15/2021

Receipt and Use of Prohibited Free Samples of Tobacco Products Among Adult Cigarette, Cigar, and/or Smokeless Tobacco Users, 2020

On March 19, 2010, FDA finalized regulations restricting the distribution of free samples of cigarettes, roll-your-own cigarette products, and smokeless tobacco in the U.S. (excepting free samples of smokeless tobacco distributed in “qualified adult-only facilities”). This ban was extended to cover all tobacco products, including e-cigarettes and cigars, when the Deeming Rule went into effect on August 8, 2016. More information about tobacco product free samples distribution since the regulations went into effect would be useful. Using data from the National Panel of Tobacco Consumer Studies (TCS Panel), which includes approximately 4,000 U.S. adult current cigarette, cigar, and/or smokeless tobacco users, this study will report on free samples receipt and use behavior for cigarettes, cigars, smokeless, and e-cigarette products; locations where free samples are received; top brands received; and demographic and behavioral characteristics of recipients. If sample sizes are large enough, the following may also be examined: how and/or where tobacco users receive free samples, including vouchers to exchange for free samples; types of products and top brands received; how often tobacco users received free samples; whether recipients used the free samples; whether users of the free samples like and consider purchasing products that they received as free samples; and significant predictors or factors associated with receipt. Findings will provide new information on outcomes related to the tobacco free samples ban.

Brett Loomis (CTP Contact: Naa Inyang) Funding Mechanism: Research Contract
ID Number: HHSF223201510002B-HHSF22317005
Institution: Research Triangle Institute (RTI) International
06/15/2021

Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers

More research would be useful regarding how electronic nicotine delivery system (ENDS) uptake affects tobacco use and associated toxicity among African American (AA) cigarette smokers, particularly those who smoke menthol cigarettes. The goal of this study is to evaluate how future ENDS flavor regulations may impact African American menthol smokers. The study will evaluate whether ENDS menthol flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers (N=210, ages ≥21) by performing a six-week clinical trial of ENDS provision with follow-up to 30 days. Specific aims are: (1) to compare the effect of ENDS flavor availability on patterns of tobacco use behavior; (2) to quantify the effect of ENDS flavor availability on biomarkers of cigarette/ENDS exposure (expired air carbon monoxide, urine cotinine/NNAL, and urine propylene glycol; and (3) to test the effect of ENDS flavor availability on addiction/abuse liability using validated behavioral economic instruments at multiple time points during the trial. Researchers will provide subjects with JUUL devices with compatible cartridges at 5% nicotine and will randomize them to one of three groups that differ by potential FDA regulations related to ENDS flavor availability: (1) the current market where only menthol- and tobacco-flavored ENDS cartridges are available; (2) a market where only tobacco-flavored ENDS are available, and (3) a market where only unflavored cartridges are available. Study visits will occur weekly beginning one week prior to randomization with daily tobacco use monitoring throughout and biomarker/self-report data collection at each in-person visit. Study results may clarify the impact on AA menthol smokers of moving from the current regulatory market where menthol/tobacco-flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available.

Andrew Barnes and Caroline Cobb Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA050996-01A1
Institution: Virginia Commonwealth University
05/28/2021

The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults

Data on the impact of sweet flavoring on combustible cigarillo use is important for understanding their health impact among young adults. The study aim is to determine whether the subjective rewarding value, the relative reinforcing value, and the absolute reinforcing value of sweet-flavored cigarillos are greater than that of non-flavored cigarillos among young adults. Researchers will investigate these aims in three separate laboratory visits among 86 young adults (ages 18-24 years) who have smoked at least 10 cigarillos in their lifetime. Participants will complete various validated scale measurements, a behavioral choice task, and an ad-libitum smoking procedure. Researchers will examine whether indices of abuse liability remain significant while controlling for other factors that may underlie the preference for flavoring. Results may inform future regulatory activities related to cigarillos. 

Janet Audrain-McGovern Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21DA050789-01A1
Institution: University of Pennsylvania 
05/27/2021

The Effects of IQOS Use on Cigarette Smoking Behavior

In 2019, the Food and Drug Administration (FDA) authorized the sale of IQOS, and more data on the impact of IQOS use on cigarette smoking behaviors would be useful. This study addresses two aims: (1) to evaluate the effects of IQOS use on cigarette smoking behaviors; and (2) to examine which subjective and objective effects of IQOS predict cigarette smoking. Researchers will recruit 100 combustible cigarette smokers ages (18-65) to a 21-day study. Baseline smoking rate will be established during days 1-5. After overnight cigarette smoking abstinence, laboratory visits on days 6 and 7 will assess IQOS-associated craving relief, withdrawal relief, risk perceptions, subjective reward, and the reinforcing value of IQOS relative to combustible cigarettes. Participants will switch from cigarette smoking to IQOS use for the following 14 days (days 8-21). Participants will collect their spent cigarette filters and their used IQOS HeatSticks daily to enable researchers to assess consumption of cigarettes and tobacco sticks per day. The primary outcome is the daily count of cigarettes from baseline to day 21, and the secondary outcome is changes in motivation to quit smoking from baseline to day 21. Findings may inform future regulatory activities related to heated tobacco products. 

Janet Audrain-McGovern Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01CA260448-01
Institution: University of Pennsylvania
05/24/2021

The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users

This study will assess the effectiveness of cigarillo warnings by extending previous research in which the researchers developed pictorial warnings for cigarillos. Study aims are: (1) to examine the impact of a pictorial cigarillo warning policy on young adult cigarillo smokers’ purchasing behaviors using a behavioral economics framework; and (2) to examine the impact of repeated exposure to pictorial versus text cigarillo warnings on cigarillo smoking intentions and behaviors. Participants will be young adult frequent cigarillo users ages 21-34. An estimated 1,282 subjects (635 Black/African American and 647 White) will complete an online shopping task using the Experimental Tobacco Marketplace; researchers will then examine the impact of different cigarillo warning manipulations (pictorial, FDA text-only, Surgeon General text-only) on cigarillo purchasing, cigarillo demand, and substitution of other tobacco products. Researchers will then recruit another sample of 600 young adult frequent cigarillo users (300 Black/African American and 300 White) to participate in a 6-week randomized control trial where they will be exposed to cigarillo warnings weekly to examine the impact of the warnings on intentions to continue cigarillo smoking and cigarillo smoking behaviors. Study results may reveal how to effectively communicate the risks of cigarillo smoking to young adults, including Black/African Americans, and may inform regulatory decision-making related to cigarillo warnings.

Jennifer Cornacchione (Ross) Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01CA260460-01
Institution: Wake Forest University Health Sciences
05/18/2021

Exosomal Epigenetic Biomarkers Associated with Flavored Electronic Cigarette Use in Adults

More information about the health risks, especially long-term health risks, of flavored e-cigarette use would be useful. The goal of this study is to identify exosomal epigenetic biomarkers (including microRNAs and long non-coding RNAs) associated with flavored e-cigarettes. Study aims are: (1) to examine blood and urinary exosomal epigenetic biomarkers and associated biological pathways related to flavored (such as fruit-flavored) e-cigarette use; and (2) to evaluate within-subject alterations in exosomal epigenetic biomarkers and associated biological pathways during e-cigarette initiation and cessation. Researchers will analyze blood and urine specimens from the Population Assessment of Tobacco and Health (PATH) Study biorepositories. After identifying key biomarkers, researchers will expose them to primary human bronchial epithelial cells and small airway epithelial cells from non-smoker adults to determine their toxicity/inflammatory response. Findings may inform future regulatory activities related to flavored e-cigarettes.

Dongmei Li and Ifran Rahman Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21ES032159-01A1
Institution: University of Rochester
 
05/10/2021

Impact of E-Cigarette Characteristics and Marketing on Tobacco Use and Health: A Longitudinal Study Among U.S. Youth and Adults

More information about the impact of e-cigarette characteristics and marketing on tobacco use among youth and adults would be useful. Researchers will analyze longitudinal data (Waves 1-4) from the Population Assessment of Tobacco and Health (PATH) Study to accomplish three study aims: (1) to identify the impact of e-cigarette flavors (non-tobacco and non-menthol flavors vs. tobacco and menthol flavors) and types (open vs. closed system) on e-cigarette use among youth (12-17 years), young adults (18-34 years), and older adults (35 years and older); (2) to determine the impact of e-cigarette advertising exposure on e-cigarette initiation, use frequency, and susceptibility, as well as the mediating effect of harm and addiction perceptions; and (3) to identify the effect of e-cigarette use on cardiovascular, respiratory, and periodontal health, and compare the effects among different types of tobacco users (e.g., exclusive e-cigarette users, never cigarette smokers, exclusive e-cigarette users, former cigarette smokers, dual users, cigarette-only smokers). Findings may impact future regulatory activities related to e-cigarettes. 

Nan Jiang Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21CA260423-01
Institution: New York University School of Medicine
04/28/2021

The Effects of Branded and Influencer Social Media Promotion of Flavored Tobacco Products (FTP) on FTP Use Among Youth and Young Adults

This study will examine the impact of exposure to social media marketing of flavored tobacco products (FTPs). Study aims are: (1) to identify and characterize social media message content related to FTPs by source (e.g., brand, influencer/community, regular consumer) and major themes (e.g., new-user targeting, health risks, flavor-type); (2) to examine the impact of exposure to commercial and influencer FTP content on product sales and on youth and young adult awareness, risk perceptions, intentions to use, initiation, and patterns of use of FTP products; and (3) to study whether/to what extent FTP regulatory policies modify the impact of exposure to social media content on FTP product sales and youth and young adult awareness, risk perceptions, intentions to use, initiation, and patterns of use of FTP products. These aims will be accomplished by analyzing social media data from Twitter and Instagram; individual-level data on exposure to tobacco marketing, tobacco attitudes, and tobacco use from the Population Assessment of Tobacco and Health (PATH) Study; FTP sales volume data from Nielsen store scanner data; and state/local FTP policy data collected by the National Opinion Research Center. Findings from this study may inform future regulatory activities related to social media marketing of FTPs. 

Sherry Emery and Ganna Kostygina Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA051000-01A1
Institution: National Opinion Research Center
04/20/2021

Racial Disparities in Biomarkers, Tobacco Cessation, and Smoking Relapse in Association with Electronic Cigarette Use

Biomarkers can play an important role in assessing the potential health effects of tobacco products. However, evidence on the racial disparities related to biomarker outcomes of e-cigarette use is scarce. The goal of this study is to examine the racial disparities in biomarkers of exposure and toxicants in association with e-cigarette use by analyzing Population Assessment of Tobacco and Health (PATH) Wave 1-4 biomarker data. Study aims are: (1) to assess racial disparities in biomarkers of tobacco exposure and toxicants; and (2) to develop a bio-socio-psycho risk score in prediction of cessation, relapse, and health outcomes. To achieve Aim 1, researchers will link the biomarker data with the PATH adult surveys to identify the between-person and within-person differences in biomarkers by use of different vaping products, flavors, and transitions between e-cigarettes and combustible cigarettes across different waves. To achieve Aim 2, researchers will then use machine learning algorithms to develop a composite bio(biomarker)-socio(socio-demographics)-psycho(psychosocial factors) risk index score for each racial/ethnic group to predict subsequent abstinence from cigarette smoking and relapse to cigarette smoking. Study findings will provide new information related to racial disparities in e-cigarette health effects.

Hongying Dai Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21DA054818-01
Institution: University of Nebraska Medical Center
04/20/2021

Electronic Cigarette Use During Pregnancy and the Impact on Newborn Metabolic Profile and Perinatal Health Outcomes

More information about the effects of e-cigarette use by pregnant women would be useful.  The goal of this study is to evaluate the potential adverse effects of e-cigarettes on pregnant women and their developing fetuses. Specific study aims are: (1) to determine the pattern of women's smoking from preconception to the perinatal period; (2) to determine the pattern of women’s smoking from 2016 to 2018; (3) to determine whether pregnancy e-cigarette use is associated with pregnancy, perinatal, and infant-related adverse outcomes; and (4) to determine whether pregnancy e-cigarette use is associated with an imbalanced metabolic profile in infants measured at birth. Researchers will conduct a surveillance study of women who had live births between 2016-2018 and participated in the Pregnancy Risk Assessment Monitoring System (PRAMS) survey. Data analyzed will include detailed smoking information, including conventional cigarette and e-cigarette use during preconception, third trimester of pregnancy, and post-delivery; researchers will also link PRAMS subjects from Tennessee and Iowa to newborn metabolic screening data to identify and validate metabolic profiles measured at birth that are associated with secondhand in utero e-cigarette and conventional cigarette exposure. Study findings may inform future regulatory activities that impact pregnant e-cigarette users.

Pingsheng Wu Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21DA052026-01A1
Institution: Vanderbilt University Medical Center
04/20/2021

Assessing the Impacts of the Four 2019/2020 US Federal-Level Tobacco Control Actions: Flavors, Youth Marketing, Youth Access, and Tobacco 21

Four key federal-level tobacco control actions were taken in the U.S. in December 2019/January 2020 to reduce electronic nicotine delivery system (ENDS)/tobacco use appeal and access, particularly among young people. These four actions were: (1) ENDS Flavors/Device Guidance, in which FDA prioritized enforcement against “any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product),” (2) ENDS Marketing Guidance, in which FDA prioritized enforcement against “any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors,” (3) ENDS Access Guidance, in which FDA prioritized enforcement against “all other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access,” and (4) Federal T21, in which the federal minimum age of sale of tobacco products was raised from 18 to 21 years. Around the same time, two national public health events occurred that likely also contributed to population-level changes in ENDS/tobacco use behaviors: an outbreak of ENDS/vaping-associated lung injury (EVALI) was identified by CDC in August 2019, and the spread of a novel coronavirus in the US in January 2020 (COVID19). The shared historical timing of these actions and events requires innovative methods to assess the specific impacts of each federal action. Researchers will use a theoretically grounded mediational model to disentangle overall impacts into action-specific impacts. They will conduct secondary data analyses using the following sources: two complementary nationally-representative data sources, which each assess key measures of appeal and access and together include over 61,000 participants; the Population Assessment of Tobacco and Health (PATH) Study youth and adult surveys (2017-2021); and the U.S. arm of the International Tobacco Control (ITC) Project youth and adult surveys (2018-2021). Study findings will contribute to an understanding of the impacts of each action on Americans’ ENDS/tobacco use behaviors. 

Karin Kasza Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R21DA053614-01
Institution: Roswell Park Cancer Institute Corporation
04/16/2021

Testing the Effect of Anti-Tobacco Message Framing on Polytobacco Use in Lesbian, Gay, Bisexual, and Transgender Young Adults

Polytobacco use, defined as concurrent use of more than one tobacco product including electronic nicotine delivery systems (ENDS), is rising in lesbian, gay, bisexual, and transgender (LGBT) young adults. More information about how to effectively frame polytobacco risk communications for this population would be useful. The goal of this study is to test the effect of polytobacco message framing on risk perceptions and polytobacco use in LGBT young adults. Study aims are: (1) to identify polytobacco risk messages that effectively communicate absolute and relative risks to young adults; (2) to determine the effects of cultural targeting on LGBT young adult polytobacco users’ attention to messages and perceived effectiveness; (3a) to assess the feasibility of polytobacco risk messages developed in Aims 1 and 2 to LGBT young adults via text; and (3b) to estimate the effect sizes of exposure to messages on risk perceptions and tobacco use over time. Researchers will develop 48 messages and will conduct an online survey study with 2400 young adults (ages 18-35, estimated 50% LGBT) in which each participant will view and rate eight polytobacco education messages. Researchers will also conduct an in-laboratory study and focus groups (108 and 24-32 participants, respectively) and a Phase I randomized controlled trial (300 participants) to determine the message framing and targeting most effective for LGBT young adults. Findings may inform future tobacco education campaigns targeted to LGBT young adults. 
 

Joanne G. Patterson Funding Mechanism: National Institutes of Health - Grant
ID Number: 1K99CA260718-01
Institution: The Ohio State University 
01/26/2021

Pharmacokinetic Bridging Study for the Inhalation of Nicotine in Saline in Male Sprague-Dawley Rats

Additional information on nicotine pharmacokinetics (PK) following inhalation will be useful in accurately predicting its PK across species (i.e., rodents, non-human primates, and humans). The CTP-NCTR InhaleCore Group has recently completed studies evaluating nicotine PK profiles in rats following a single dose administration by inhalation, oral gavage, and intravenous injection (E07607.01 and E07716.01). In these studies, the dose formulations for inhalation exposure consisted of nicotine in propylene glycol and water. Due to possible unknown inhalation toxicities of propylene glycol and its potential to impact the lungs, propylene glycol is probably not an appropriate vehicle for investigating nicotine inhalation toxicity in planned subacute and subchronic inhalation toxicology studies. In this study, the InhaleCore Group will assess the applicability of the previously collected PK data (nicotine in propylene glycol and water) to the PK profiles for new nicotine formulations (nicotine in saline) that will be used in the planned studies. Results from these studies will provide useful information for the development of physiologically-based pharmacokinetic (PBPK) modeling to characterize the PK of nicotine and its metabolites (cotinine and 3-hydroxycotinine) in rodents across different routes of exposure.

Qiangen Wu (CTP Contact: Prabha Kc) Funding Mechanism: FDA Internal
ID Number: E07763.01
Institution: National Center for Toxicological Research (NCTR)
12/22/2020

Uptake and Patterns of Use of the IQOS Heated Tobacco System by US Smokers

More information about the U.S. population health impact of IQOS, a heated tobacco system, would be useful. The goal of this project is to provide postmarket data evaluating the sociodemographic and tobacco use patterns of IQOS initiators, including the extent to which adult smokers are completely stopping use of all tobacco products, switching to exclusive IQOS use, dual-using cigarettes and IQOS, or rejecting IQOS and continuing smoking, as well as differing perceptions and use of IQOS by sociodemographic variables relevant to tobacco disparities. Study aims are: (1) to examine the sociodemographic and tobacco use characteristics, decision-making processes, and marketing exposure among adult initiators of IQOS; and (2) to examine the longitudinal determinants of long-term tobacco use outcomes among adult cigarette smokers who purchased and initiated use of IQOS. The study will involve an initial survey of 1000 adult (ages ≥18) IQOS initial purchasers and follow-up surveys of 600 cigarette smokers initially surveyed; follow-up will occur at 1 month, 6 months, and 12 months. A subsequent focus group study of 20 survey participants who had either switched to exclusive IQOS use or were dual-using IQOS and cigarettes will be conducted to obtain a deeper understanding of the quantitative findings. Findings will reveal important information about heated tobacco product use in the U.S.

Scott Weaver Funding Mechanism: National Institutes of Health - Grant
ID Number: 1R01DA051002-01A1
Institution: Georgia State University
12/01/2020

Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Product

A single standardized smoking machine adaptor for cigars, ENDS, and heated tobacco products does not exist, making it difficult to accurately quantify the aerosol and smoke physical properties and hazardous and potentially hazardous constituent (HPHC) levels produced by these products. This design project has four aims: (1) to develop a single universal adaptor, or standardized family of adaptors, for the attachment of ENDS, cigars, and heated tobacco products to existing smoking machines originally designed for use with cigarettes; (2) to ensure that the adaptor(s) have high repeatability and reproducibility; (3) to coordinate and administer a study that tests repeatability and device validation while comparing the newly designed adaptor(s) to currently available adaptors; and (4) to provide tobacco product stakeholders with continued adaptor product support and improvement. A well-validated standardized smoking machine adaptor will ensure that accurate data are being used by stakeholders in their efforts to protect the public from tobacco-related death and disease.

Marielle Brinkman (CTP Contact: Raymond Williamson) Funding Mechanism: Research Contract
ID Number: 1UC2FD007229-01
Institution: The Ohio State University
09/15/2020

Waterpipe Tobacco Additives and Their Effect on Human Puffing Behavior, Toxicant Exposures, Pulmonary Function and Appeal

Sweetened waterpipe (WP) tobacco may increase WP smoking appeal for first-time users; furthermore, high levels of sweet additives produce harmful and potentially harmful constituents (HPHCs) in WP smoke. The goal of this study is to define the effects of WP tobacco’s primary chemical additives with respect to sweet perception, appeal, toxicant exposure, addictiveness, harm and health risk perceptions, and lung function. Study aims are: (1) to characterize the HPHC and sugar content of four WP tobaccos (one brand prepared four different ways to vary glycerol and sugars); (2) to characterize the HPHC and sugar yields in mainstream smoke generated from machine smoking the four WP tobacco preparations using a research-grade waterpipe and a standardized WP puffing regimen; (3) to determine how WP tobacco content impacts puffing behaviors, a carbon monoxide biomarker, pulmonary function, nicotine uptake, and perceived sensory attributes and appeal of WP smoking, based on data gathered from 50 experienced WP smokers (ages 21-50) who will smoke the four different WP tobacco preparations in four different laboratory sessions; and (4) to determine the HPHC exposure ranges from the average puffing behaviors measured under Aim 2 for each WP tobacco preparation. Findings will provide new information about the impact of chemical additives in WP tobacco.

Marielle Brinkman and Theodore Lee Wagener Funding Mechanism: National Institutes of Health – Grant 
ID number: 1R01CA255563-01
Institution: Ohio State University
09/10/2020

Understanding Uncontrolled Vaping Among Vulnerable Populations

E-cigarettes differ from combustible cigarettes in ways that may make it harder to control vaping.  For example, e-cigarettes lack many of the same stopping cues as cigarettes, indoor bans are less common, and discreet use is easy. The goal of this study is to understand uncontrolled vaping and vaping restraint strategies. Study aims are: (1) to develop measures of uncontrolled vaping and restraint strategies; (2) to assess prevalence of and factors related to both uncontrolled vaping and restraint strategies; and (3) to establish the long-term impact of vaping restraint on uncontrolled vaping. To achieve Aim 1, researchers will conduct phone interviews with 8 adolescent (ages 13-17), 8 young adult (ages 18-25), and 8 adult (ages 26 and older) current e-cigarette users to understand how they describe uncontrolled use and vaping restraint and will then develop survey measures. To achieve Aim 2, researchers will survey 1,050 current e-cigarette users (300 adolescents, 300 young adults, and 450 adults) and evaluate the usefulness of the new measures. Researchers will then estimate uncontrolled use and vaping restraint strategies for the nation and examine whether these outcomes are more common among vulnerable populations, certain device type users, and dual users. To achieve Aim 3, researchers will conduct a follow-up online survey with approximately 700 e-cigarette users from the Aim 2 sample to examine how baseline vaping restraint related to uncontrolled vaping and smoking behavior one year later. Findings may inform regulatory activities related to e-cigarettes.

Noel Todd Brewer Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01CA246606-01A1
Institution: University of North Carolina 
09/10/2020

The Impact of Cigar Pack Quantity on Tobacco Use Behaviors

The goal of the proposed analyses is to clarify the relationship between cigar pack quantity and tobacco use behaviors. Study aims are: (1) to determine whether cigar pack quantity is associated with between- or within-person changes in cigar use and assess whether changes vary by sociodemographic characteristics (age, sex, race, ethnicity, income, and educational attainment); (2) to evaluate the impact of minimum cigar pack quantity laws on tobacco use and assess whether the impact of these laws varies by sociodemographic characteristics; (3) to evaluate the impact of minimum cigar pack quantity laws on cigar sales and assess whether the impact of these laws varies by county characteristics; and (4) to characterize differences in implementation and enforcement of minimum cigar pack quantity laws through qualitative interviews with key implementation personnel. The researcher will analyze data from national datasets, including the Population Assessment of Tobacco and Health (PATH) Study, the Tobacco Use Supplement to the Current Population Survey (TUS-CPS), the Youth Risk Behavior Surveillance System (YRBSS), and Nielsen retail scanner data. Study findings may inform future regulatory activities related to cigar pack quantity.

Jessica Lynn King
 
Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01CA253235-01
Institution: University of Utah
09/09/2020

Designing and Evaluating Communication for Dual Users of E-cigarettes and Combustible Cigarettes

People who use both cigarettes and e-cigarettes (“dual users”) may not be adequately informed of their continued risk from smoking combustible cigarettes as well as the known harms of e-cigarettes. The goal of this project is to develop communication campaign messages for dual users that increase their knowledge of the high health risk of dual use and increase their intent to quit combustible cigarettes and ultimately e-cigarettes. Study aims are: (1) to develop effective campaign messages by investigating how dual users think about their identity, motivations for tobacco product use, and the barriers to quitting combustible cigarettes; (2) to determine whether campaign ads are more engaging if they focus on quitting combustible cigarettes only, sequentially quitting cigarettes and e-cigarettes, or simultaneously quitting cigarettes and e-cigarettes; and (3) to pilot test the effectiveness of texted campaign ads in changing real-world combustible cigarette and e-cigarette quit intention among dual users. To achieve Aim 1, the research team will conduct six focus groups (8-10 adult dual users ages 18+ per group) to better understand dual use and gather concepts for messages, draft 50-75 potential campaign messages for dual users to encourage them to quit, and conduct a national survey with 1,008 adult dual users to select the most promising campaign message themes. To achieve Aim 2, the team will create visual ads for the messages from Aim 1 and use an eye-tracking experiment to determine how the different conditions affect attention among dual users. To achieve Aim 3, the team will conduct a five-week experiment with 90 adult dual users randomized to receive the most effective ads from Aim 2 or control ads in order to determine subsequent quit intentions and behaviors. Study findings may inform the development of communication campaign messages specifically for dual cigarette and e-cigarette users.

M. Justin Byron Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01CA253234-01
Institution: University of North Carolina
09/16/2020

Patterns of Use and Health Effects of “Premium Cigars” and Priority Research

Patterns of use can vary widely across cigar subtypes both by frequency of use and the population subgroups most likely to use them. Some research indicates that “premium” cigar smokers (versus smokers of other cigar subtypes) are significantly less likely to use cigars regularly (daily or monthly) or report current cigarette smoking. Still, all cigars pose serious negative health risks and premium cigars are used by youth and young adults. The goal of this study is to conduct an in-depth evaluation of the public health issues related to premium cigars (defined in this study as large cigars that contain tightly rolled tobacco wrapped in a tobacco leaf) as well as the health effects of premium cigars compared to other cigars and other tobacco products. This study will involve a comprehensive and systematic review and assessment of the scientific literature related to premium cigars. Topics evaluated will include patterns of use of premium cigars; how use patterns differ among cigar subtypes and other tobacco products and among different populations (types of tobacco users, age groups, and other demographics); and the short- and long-term health effects of premium cigar use. Findings may inform future regulatory activities related to premium cigars. 

Stuart Nightingale and Caroline Hagedorn (CTP Contact: Lisa Lagasse) Funding Mechanism: Research Contract
ID Number: 75F40120S90019
Institution: National Academics of Sciences, Engineering, and Medicine (NASEM)
09/14/2020

Chronic Hookah (Waterpipe) Smoking, Vascular Dysfunction, Inflammation and Oxidative Stress

The goal of this research is to clarify the long-term health effects of hookah (waterpipe) smoking on endothelial (artery lining) and vascular (blood vessel) function and identify biomarkers of harm that are associated with the effects of chronic hookah smoking on vascular health. Study aims are: (1) to evaluate the chronic effects of hookah smoking on peripheral endothelial function; (2) to study the chronic effects of hookah smoking on central artery stiffness; and (3) to evaluate the chronic effects of hookah smoking on biological markers of oxidative stress and inflammation. In 34 healthy chronic hookah smokers (ages 21-49 years) who never smoked cigarettes, matched for age and sex with 34 cigarette smokers and 34 non/never-smokers, researchers will measure: (a) endothelial function (measured by brachial artery flow-mediated dilation); and (b) vascular stiffness (measured by carotid-femoral pulse wave velocity and aortic augmentation index). Biological markers of inflammation (high sensitivity C-reactive protein, 8-iso-prostaglandin F2a, fibrinogen) and oxidative stress (pro-oxidant high density lipoprotein oxidant index and total antioxidant capacity) will be collected. Findings will provide new information about the chronic effects of hookah smoking and provide a foundation for future long-term studies of the effects of hookah smoking.  

Mary Rezk-Hanna Funding Mechanism: National Institutes of Health – Grant 
ID number: 1R01HL152435-01A1
Institution: UCLA
09/10/2020

The Effect of Switching on or off Menthol Use on Cigarette Consumption, Dependence, Nicotine Exposure and Quitting Success

More information about menthol use among subpopulations would be useful. Researchers will analyze data from the adult (ages 18+) sample of cigarette smokers in Waves 1-4 of the Population Assessment of Tobacco and Health (PATH) Study using a technique called propensity score matching. They will study two groups of adult smokers: smokers who switched from menthol to non-menthol cigarettes and later attempted to quit smoking, and smokers who switched from non-menthol to menthol cigarettes and later attempted to quit smoking. Study aims are: (1) to compare quitting success between quit attempters who switched from menthol to non-menthol cigarettes and those who switched from non-menthol to menthol cigarettes; (2) to compare consumption, nicotine exposure, and dependence between adult smokers who did not successfully quit after either switching from menthol to non-menthol cigarettes or switching from non-menthol to menthol cigarettes; and (3) to assess whether race, sex or age modify the effect of switching from menthol to non-menthol cigarettes or from non-menthol to menthol cigarettes on 30-day cigarette abstinence, 12-month cigarette abstinence, consumption, dependence, and nicotine exposure. Study findings may inform future regulatory activities related to menthol.

Eric Leas Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051356-01
Institution: University of California, San Diego
09/01/2020

Distinguishing Exposure to Secondhand and Thirdhand Tobacco Smoke and Electronic Cigarettes among U.S. Children Based on Multiple Biomarker Profiles

Currently, tobacco smoke exposure biomarkers that differentiate exposure to thirdhand smoke (THS) from exposure to secondhand smoke (SHS) or e-cigarette aerosol exposure are lacking. The goal of this project is to examine existing tobacco-specific and nonspecific biomarkers to assess children’s exposure to diverse tobacco/nicotine products. Researchers will analyze National Health and Nutrition Examination Survey (NHANES) 2013-2016 data to examine the prevalence and health risks of exposure to SHS and THS among children presumed to be unexposed to any tobacco smoke and among children exposed to e-cigarette aerosol only. This project has three study aims. Aim 1 is to compare tobacco-specific biomarkers of exposure (e.g., cotinine, total nicotine equivalents, tobacco-specific nitrosamines) with self-reported smoking and tobacco smoke exposure to categorize children into one of four groups: (a) mixed SHS and THS group (MEG): lives with nonsmokers or smokers of combustible products only, reported SHS; (b) THS group (TEG): lives with nonsmokers or smokers, no reported SHS; (c) e-cigarette group (ECG): lives with e-cigarette only users, reported e-cigarette aerosol exposure; and (d) no/minimal exposure group (NEG): lives with nonsmokers, no reported SHS. Aim 2 is to examine multiple tobacco-nonspecific (i.e., polyaromatic hydrocarbons, volatile organic compounds) and tobacco-specific biomarkers and biomarker ratios (e.g., NNAL/cotinine, 2-hydroxyfluorene/cotinine) to assess which combination of biomarker profiles further differentiates children by exposure type. Aim 3 is to examine the associations between exposure type and demographics, exposure-related symptoms, diagnoses, and healthcare utilization patterns in the MEG, TEG, and ECG compared with the NEG. Study findings will provide insight into the different health effects children experience depending on type of tobacco product exposure. 

Ashley Merianos Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21ES032161-01
Institution: University of Cincinnati 
08/24/2020

CTP Supplement to Parent Grant: Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine, and Other Constituents (YCSTP) (TCORS 2.0)

This supplement project will measure the effects of e-cigarette use and abstinence on the adolescent brain and behavior by testing biomarkers to assess short- and long-term e-cigarette effects. This project will add neuroimaging and neurocognitive testing to an existing clinical trial of an e-cigarette cessation intervention in adolescents (Yale’s Adolescent Brain Cognitive Development [ABCD] study); it will use ABCD neuroimaging and neurocognitive testing protocols to investigate how critical domains of function (i.e., reward processing, impulsivity and impulse control, working memory, emotion regulation) differ among adolescent e-cigarette users and change with abstinence. All youth in the trial (N=100; ages 13-20) will complete the ABCD neurocognitive battery, and 30 youth in the trial and 30 age/sex-matched controls will complete the ABCD neuroimaging protocol. Specific aims are: (1) to test for baseline brain and behavioral differences in critical domains of function between youth e-cigarette users and non-users; (2) to compare changes in brain and behavioral measures of critical domains of function between youth e-cigarette users and non-users; and (3) to test the relationship between changes in critical domains of function and e-cigarette abstinence among youth users. Findings will provide some of the first measures of the impact of e-cigarette use and abstinence on brain and behavior biomarkers of addiction among adolescents.

Stephanie O’Malley and Suchitra Krishnan-Sarin Principal Investigator
Funding Mechanism: National Institutes of Health - Grant
ID Number: 3U54DA036151-08S3
Institution: Yale University
08/21/2020

Center for the Study of Tobacco Products: Respiratory Effects of THC and Nicotine E-Cigarettes: A Prospective Study

E-cigarette/vaping-associated lung injury (EVALI) is a new disease that is not well-understood, in part because of the differences among e-cigarette devices and liquids used; however, it has been linked to tetrahydrocannabinol (THC) liquid use and vitamin E acetate inhalation. Importantly, computed tomography (CT) scans of the lungs of EVALI patients uniformly reveal “ground-glass opacities” (GGOs), which indicates partial displacement of air within the lung; the appearance of GGOs in e-cigarette users is a potential EVALI biomarker. Researchers at the Center for the Study of Tobacco Products (CSTP) will perform CT scans and pulmonary function tests and analyze the devices and liquids from healthy e-cigarette users aged 18-45 years. They will track participants’ respiratory health for two years and then conduct a second set of CTs and pulmonary function tests. Study aims are: (1) to perform CT scans and pulmonary function tests at baseline and after two years on 45 exclusive nicotine e-cigarette users, 45 exclusive THC e-cigarette users, and 45 nicotine+THC e-cigarette users, as well as an additional 45 non-e-cigarette users as controls; (2) to identify e-cigarette devices and analyze e-cigarette liquids used by each participant; and (3) to track respiratory health over two years using quarterly online surveys assessing respiratory and gastrointestinal symptoms. Study findings may provide more information about EVALI and may inform future regulatory activities related to e-cigarettes. 

Thomas Eissenberg Funding Mechanism: National Institutes of Health – Grant
ID number: 3U54DA036105-08S1
Institution: Virginia Commonwealth University
08/20/2020

Pilot Study to Determine Health Effects of E-cigarettes in Healthy Young Adults

In this CTP supplement to a parent grant (Integrated Translational Health Research Institute of Virginia (iThriv): Using Data to Improve Health), researchers will conduct studies to assess early changes in human lungs due to e-cigarette use. This study will use a new magnetic resonance imaging technique called 3-dimensional hyperpolarized xenon-129 MRI. It is anticipated that this new MRI technique will help detect possible early changes in the lungs of healthy young people who use e-cigarettes. Study aims are: (1) to determine effects of e-cigarette use on healthy young adults (ages 21-30) who have never smoked cigarettes, and (2) to develop research methods to perform a larger clinical trial to determine whether e-cigarettes cause lung disease, and if so, what kind. To achieve the first aim, researchers will study ten e-cigarette users with normal lung function tests and ten healthy non-users. Researchers will perform MRI tests and collect exhaled breath, blood, and urine for testing. To achieve the second aim, researchers will develop study methods for performing MRIs at two locations, the University of Virginia and Duke University, in preparation for a multi-center clinical trial to conclusively determine if there are harmful health effects of e-cigarettes. Study results will provide new knowledge on the impact of e-cigarettes on human lung health. 

Karen Johnston Funding Mechanism: National Institutes of Health – Grant
ID number: 5UL1TR003015-02S4
Institution: University of Virginia
08/19/2020

Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents

To reduce the risk of e-cigarette/vaping acute lung injury (EVALI), several states have banned flavored e-cigarette sales and one temporarily banned all vaping product sales. In this CTP supplement to a parent grant (Yale Center for the Study of Tobacco Product Use and Addiction), researchers will use new data from e-cigarette/vaping acute lung injury (EVALI) case reports by state and by month to estimate how smoking and vaping rates shifted in response to these policies as well as to the EVALI outbreak itself. Study aims are: (1) to clarify how state variation in behaviors and policies may have contributed to EVALI’s geographic distribution; (2) to quantify changes in vaping and smoking rates in response to the EVALI outbreak; and (3) to estimate how states’ policy responses to EVALI affected vaping and smoking. To address Aim 1, researchers will conduct analyses to characterize states’ 2019 EVALI prevalence by their pre-outbreak rates of vaping and marijuana use as well as marijuana legalization policies. To address Aim 2, researchers will analyze how adults’ smoking and vaping behavior shifted following changes in their state’s reported EVALI prevalence. To address Aim 3, researchers will estimate how banning flavored e-cigarette sales and all vaping product sales affected smoking and vaping rates (before and after policy implementation and compared to states that did not adopt policies). Study findings may inform state regulatory activities related to e-cigarettes.

Suchitra Krishnan-Sarin Funding Mechanism: National Institutes of Health – Grant
ID number: 3U54DA036151-08S2
Institution: Yale University
08/14/2020

Secondhand E-cigarette Exposure and Lung Function in Children

In this CTP Supplement to a parent grant about how lifetime environmental exposures impact health (the HERCULES Exposome Research Center), researchers will describe secondhand e-cigarette aerosol exposure and measures of lung function in children (ages 6-12) who reside with daily vapers. Study aims are: (1) to examine associations between secondhand e-cigarette aerosol chemical exposures and salivary metabolic profiles and pathways, and (2) to examine associations of secondhand e-cigarette chemical exposure and salivary metabolic profiles with markers of lung function. To achieve Aim 1, researchers will measure nicotine, benzene, and toluene exposure in 30 children of daily vapers and 30 children of non-vapers/non-smokers who will wear wristband air samplers for 120 hours (5 days). Researchers will collect saliva samples and analyze them to identify altered metabolic profiles and pathways; they will also examine associations of nicotine, benzene, and toluene with salivary metabolic profiles. To achieve Aim 2, researchers will examine associations between nicotine, benzene, and toluene exposure data and metabolomics data (from Aim 1) and lung function measures including fractional exhaled nitric oxide (FeNO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), mid-expiration forced expiratory flow rate (FEF 25-75%), and parent report of recurrent/chronic respiratory symptoms. Study findings may inform future regulatory activities related to e-cigarettes. 

Carmen Marsit Funding Mechanism: National Institutes of Health – Grant
ID number: 3P30ES019776-08S1
Institution: Emory University
08/11/2020

Understanding the Influence of E-cigarette Advertisement Features

The goal of this study is to examine the influence of four e-cigarette advertisement features (flavors, models, marketing claims, and price promotions) on young adult (ages 18-29) non-tobacco users who are susceptible to e-cigarette use. Study aims are: (1) to identify key features of e-cigarette advertisements that lead to greater attention; (2) to examine the associations between key features of e-cigarette advertisements and positive neurocognitive responses; and (3) to determine whether edited advertisements without key features lead to reduced positive e-cigarette perceptions and behavioral intentions compared to original advertisements. To address Aim 1, researchers will use eye-tracking technology to identify key e-cigarette advertisement features that receive attention (gaze duration and fixation frequency) in 70 young adults. To address Aim 2, researchers will use electroencephalogram (EEG) technology to evaluate the associations between key e-cigarette advertisement features and sustained cognitive processing and emotional arousal in 120 young adults. To address Aim 3, researchers will conduct a randomized comparative study among 900 young adults to determine whether an intervention group that receives e-cigarette advertisements without key features has lower levels of positive e-cigarette perceptions and behavioral intentions than a control group that receives original unaltered advertisements. Findings will provide information about the potential impact of specific e-cigarette advertising characteristics on the initiation and progression of e-cigarette use among young adults. 

Julia Cen Chen-Sankey Funding Mechanism: National Institutes of Health - Grant
ID number: 1K99CA242589-01A1
Institution: National Institute on Minority Health and Health Disparities
08/07/2020

The Relationship Between Nicotine Metabolism and Nicotine Concentrations in E-cigarettes on Smoking Behavior and Toxicant Exposure in African American and White Smokers

African Americans are particularly vulnerable to smoking-related diseases and are less successful at smoking cessation. The goal of this study is to investigate the use of e-cigarettes for smoking reduction in African American and White smokers. Study aims are: (1) to investigate the impact of nicotine metabolism on nicotine pharmacokinetics and the subjective effects of nicotine concentrations in e-cigarettes, and (2) to elucidate the relationship between nicotine metabolism and nicotine concentrations in e-cigarettes and the impact on smoking behavior and toxicant exposure. To address Aim 1, 56 smokers (28 African American subjects and 28 White subjects ages 18 and older) will receive e-cigarettes with their preferred flavor (menthol or tobacco) and 10mg/ml and 50mg/ml of nicotine during two sessions (one concentration per session). To address Aim 2, one week after the completion of Aim 1, subjects will receive preferred-flavor e-cigarettes with 10mg/ml or 50mg/ml of nicotine to take home for two weeks. Outcomes (and associated race differences) for these study aims will include nicotine metabolite rate, plasma nicotine levels, carbon monoxide, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), cigarette craving, nicotine withdrawal, nicotine dependence, cardiovascular and lung function, volatile organic compounds, self-reports of combustible tobacco product use, e-cigarette use, and amount of e-liquid used. Study findings will help elucidate the relationship between nicotine metabolism and e-cigarette nicotine concentration and its impact on smoking behavior and toxicant exposure in African American and White smokers. 

Asti Jackson Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01DA051882-01
Institution: Yale University
08/05/2020

Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users

The goal of this study is to identify neurobehavioral markers of nicotine use escalation and cigarette smoking initiation among young adult electronic nicotine delivery systems (ENDS) users.  Study aims are: (1) to identify neural and behavioral markers of ENDS escalation and smoking initiation; (2) to determine whether neural markers add predictive utility beyond traditional measures; and (3) to determine the efficacy of public service announcements (PSAs) and identify neural predictors of PSA efficacy. At baseline, the researcher will measure traditional behavioral and novel brain responses using functional MRI in 180 non-smoking young adult (age 18-20) ENDS users to identify salient predictors of nicotine use escalation and smoking initiation; the researcher will quantify responses to smoking stimuli, vaping stimuli, and associated food stimuli in brain systems associated with cognitive control, emotion, and salience. Responses in the same brain networks will be assessed in response to existing tobacco control education PSAs and PSAs addressing ENDS flavors. Over the following six months, participants will receive weekly PSAs and bi-weekly PSA evaluations via emails and texts. In addition to evaluating the PSAs, participants will report all tobacco product use during the past two weeks. In-person visits at 3, 6, 9 and 12 months will include breath carbon monoxide and urine cotinine tests. Outcomes will include cigarettes smoked, exhaled carbon monoxide levels, urine cotinine levels, and ENDS and tobacco use outcomes. Study findings may inform future regulatory activities related to ENDS. 

Jiaying Liu Funding Mechanism: National Institutes of Health – Grant
ID number: 1K01DA049292-01A1
Institution: University of Georgia
 
08/01/2020

Novel Methods for Evaluating the Association of Electronic Cigarette Use with Cardiovascular Health

The goal of this study is to provide population-based evidence on the cardiovascular (CV) effects of e-cigarette use, including particular e-cigarette aerosol components that may be responsible for CV harm. Study aims are: (1) to examine the effects of e-cigarette use and cigarette/e-cigarette transitions on CV events; (2) to estimate associations of e-cigarette use with risk factors and preclinical biomarkers of CV injury, and to analyze biomarkers of exposure as potential mediators; and (3) to identify unique biomarker signatures of e-cigarette exposure and to associate clusters with preclinical biomarkers of CV injury. To achieve Aim 1, the researcher will use data from the Population Assessment of Tobacco and Health (PATH) Study Waves 1-4 (2013-2017) to investigate to what extent e-cigarette use is associated with CV events including myocardial infarction, stroke, and heart failure. To achieve Aim 2, the researcher will assess the effects of e-cigarette use on CV risk factors (blood pressure, triglycerides, and cholesterol) using data from the National Health and Nutrition Examination Survey (NHANES, 2013-2016) and on preclinical biomarkers of CV injury (inflammation, thrombosis, and oxidative stress) using data from PATH Wave 1 (2013-2014). To identify specific e-cigarette aerosol components that mediate CV risk, the researcher will analyze urinary exposure biomarkers for product constituents (nicotine, tobacco-specific nitrosamines [TSNAs], volatile organic compounds [VOCs], polycyclic aromatic hydrocarbons [PAHs], and metals). To achieve Aim 3, the researcher will use data from PATH Wave 1 to define clusters of e-cigarette use based on shared urinary exposure biomarker profiles related to use behaviors (frequency, other tobacco products, and reasons for use) and product characteristics (type and flavors), and associate each with preclinical biomarkers of CV injury. Study findings may inform regulatory activities related to e-cigarettes.

Andrew Stokes Funding Mechanism: National Institutes of Health - Grant
ID number: 1K01HL154130-01
Institution: Boston University Medical Campus
07/30/2020

Development of Early Warning System for Toxins Related to EVALI and Vaping

In this CTP supplement to a parent grant (Co-Abuse of Cannabis and Tobacco), researchers will lay the foundation for developing an early warning system that identifies and evaluates emerging chemical threats posed by e-liquids that may lead to acute illnesses such as e-cigarette/vaping-associated acute lung injury (EVALI). The goal is to detect emerging trends in the composition of vaping liquids and would allow identification and evaluation of possible hazards before their use becomes widespread. Study aims are: (1) to mine social media data to identify emerging vaping products and potential hazardous constituents used in vape liquids; and (2) to analyze the aerosol properties and chemical composition of aerosolized vitamin E acetate (i.e., a chemical already suspected to be hazardous) and other potential hazardous constituents identified from social media monitoring in Aim 1 to determine their effects in lung tissue. Findings may inform future regulatory activities related to e-cigarettes. 

Jenny Wiley Funding Mechanism: National Institutes of Health - Grant
ID number: 3R33DA044377-04S1
Institution: Research Triangle Institute (RTI) International
07/27/2020

Hispanic and Latino Youth and Tobacco Use: Foundational Research

The goal of this research effort is to guide CTP audience segmentation and communications strategies to inform evidence-based decisions about communications activities designed to prevent initiation of tobacco use among Hispanic/Latino youth and young adults. The research includes three tasks: (1) a comprehensive literature review and environmental scan, (2) secondary data analysis and audience segmentation, and (3) primary data collection among high-risk audiences. The scope and approach of the primary data collection will be informed by the first two phases and will include at least one round of qualitative data collection (e.g., focus group discussions) and may also include quantitative data collection/survey research; the number of subjects and age ranges have yet to be determined. This research will inform future CTP communications activities that are targeted toward Hispanic/Latino youth.

Everly Marcario and Emily Sanders Funding Mechanism: Contract
ID number: 75F40120A00002
Institution: IQ Solutions
07/27/2020

Respiratory Health and Cigar and Pipe Use in the NHLBI Pooled Cohorts Study

Cigarette smoking is the major risk factor for chronic lower respiratory disease (CLRD), which includes chronic obstructive pulmonary disease (COPD) and asthma. The goal of this study is to test whether cigar and pipe use is associated with accelerated lung function decline and CLRD-related hospitalizations and mortality. Researchers will analyze data from the National Heart, Lung, and Blood Institute (NHLBI) Pooled Cohorts Study, which collected lung function data (including spirometry exam data) from nine US general population-based cohorts that included 65,251 American Indian, Asian, Black, Hispanic and White adult men and women. Study aims are: (1) to harmonize self-reported interview questions on cigar and pipe use across the study cohorts in order to characterize cigar/pipe use; (2) to assess associations between cigar/pipe use and lung function changes over time, including rates of forced expiratory volume in one second (FEV1) decline, forced vital capacity (FVC) decline, FEV1/FVC, and airflow obstruction; and (3) to assess the association between cigar/pipe use and CLRD-related hospitalizations and mortality. Study findings may inform future regulatory activities related to cigar and pipe tobacco products.

Elizabeth Oelsner Funding Mechanism: National Institutes of Health - Grant
ID number: 1R21HL153700-01
Institution: Columbia University Health Sciences
 
07/25/2020

Respiratory Effects of Exposure to Metals from Electronic Cigarettes (RE-EMIT)

Several metals, including lead and nickel, are known lung toxicants and have been found in e-cigarette aerosols. In this CTP supplement to a parent grant (The Exposure to Metals from E-Cigarettes (EMIT) Study), researchers will study how patterns of “pod” e-cigarette device use impact exposure to metals among young adults (ages 18-24) and how these metal exposures may be associated with pulmonary health effects. Study aims are: (1) to evaluate the contribution of pod devices to metal exposure; (2) to measure pod users’ pulmonary health outcomes and evaluate their association with pod use; and (3) to assess the role of metals in pod-related pulmonary health outcomes. To achieve Aim 1, researchers will assess metal concentrations in pod aerosol (collected from each participant’s device) and assess their association with use patterns (from a questionnaire) as well as established biomarkers of metal exposure in blood (lead, cadmium, manganese and zinc) and urine (nickel, arsenic, chromium, antimony, and tungsten); they will also measure chromium and arsenic in the aerosol. To achieve Aim 2, researchers will characterize differences in pulmonary outcomes between pod users and non-users at 0 and 6 months; among users, researchers will evaluate differences by age, sex, and pod type. To achieve Aim 3, researchers will assess the association of metals in pods and in biomarkers of exposure (e.g., urine nickel) with measures of lung effects by evaluating which patients fall below the lower limit of normal for pulmonary function tests. Researchers will add pulmonary outcome measures to 25 pod users and 25 control participants from the parent study, and will recruit an additional 25 pod users and 25 non-users (ages 18-24) to characterize pulmonary outcomes (reductions in the forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing capacity of carbon monoxide (DLCO)), measures of metals in device aerosols, and measures of exposure to metals in urine and blood at 0 and 6 months. Study findings may inform future regulatory activities related to e-cigarettes. 

Ana Maria Rule Funding Mechanism: National Institutes of Health - Grant
ID number: 3R01ES030025-03S1
Institution: Johns Hopkins University
07/22/2020

Modeling Tyrosine Kinase Inhibitor-Induced Vascular Dysfunction Using Human iPSCs

Additional information about the pulmonary health effects of e-cigarettes would be useful, particularly given the growing number of e-cigarette or vaping use-associated lung injury (EVALI) cases. In this CTP Supplement to a parent grant (Modeling Tyrosine Kinase Inhibitor-Induced Vascular Dysfunction Using Human iPSCs), researchers will use a human induced pluripotent stem cell (iPSC)-based in vitro pulmonary toxicity screen to investigate the cellular, molecular, and genomic effects of six common e-cigarette components on lung tissue. Study aims are: (1) to generate iPSC-derived lung cells (i.e., alveolar epithelial cells, fibroblasts, smooth muscle cells, endothelial cells) from 12 existing healthy iPSC lines (6 male/6 female); and (2) to investigate the effects of e-cigarette components implicated in EVALI, including vitamin E acetate, tetrahydrocannabinol (THC), nicotine, propylene glycol, vegetable glycerin, and cannabidiol (CBD). Study findings may lead to new biomarkers and may inform future regulatory activities related to e-cigarettes.    

Joseph Wu and Thomas Quertermous Funding Mechanism: National Institutes of Health - Grant
ID number: 3R01HL141851-02S1
Institution: Stanford University
07/20/2020

Cigarette Smoking as a Risk Factor for Greater Psychiatric Symptom Severity Across Serious Mental Illnesses: A Secondary Analysis of Three Nationally-Representative NIH Datasets

People with serious mental illnesses (SMIs) such as bipolar disorder (BD), schizophrenia (SCZ), and major depressive disorder (MDD) comprise a population that is especially vulnerable to tobacco use; people with SMIs are twice as likely to smoke as people without SMIs. However, a federal tobacco education campaign targeted to the SMI subpopulation has not yet been developed. The goal of this study is to provide scientific evidence that could be used to develop such a campaign. Specific aims are: (1) to determine whether smoking is a risk factor for increased time in illness episodes (mood episodes in BD smokers; psychotic episodes in SCZ smokers; and depressive episodes in MDD smokers) in people with SMIs; (2) to determine whether smoking is a risk factor for increased time in depression across SMIs; and (3) to determine predictors of within-person changes in smoking behavior (initiating, quitting, relapsing). To achieve these aims, researchers will analyze data from three large National Institutes of Health datasets (BD: STEP-BD study, N=4361; SCZ: CATIE study, N=1460; and MDD: STAR*D study, N=2248). Study findings will provide scientific evidence that may be used to inform the development of a tobacco education campaign targeted to people with SMIs. 

David Bond Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051538-01
Institution: University of Minnesota 
07/20/2020

Predicting Longitudinal Patterns of Change in Adolescent Polytobacco Use: A Socio-Ecological Framework

More information about how patterns of single and polytobacco use change from early adolescence into emerging adulthood would be useful. The goal of this project is to examine patterns of change and associated predictive factors over an extended time period. Study aims are: (1) to examine trajectories and related predictors of single tobacco product use from early adolescence (age 12) to emerging adulthood (age 23); (2) to examine transitions into and out of polytobacco use classes, as well as predictors of these classes, from early adolescence (age 12) to emerging adulthood (age 23), and (3) to examine interactions among individual (e.g., motives for use, sensation seeking), interpersonal (e.g., parent modeling, rules), and contextual (e.g., geographic location) factors in predicting trajectories of single tobacco product use and transitions in polytobacco use. Researchers will analyze Population Assessment of Tobacco and Health (PATH) Study data (total of 52,731 respondents) from study waves 1 (2013-2014), 2 (2014-2015), 3 (2015-2016) and 4 (2016-2018) to examine the changes over time in use of tobacco products (cigarettes, cigars, waterpipes, smokeless tobacco, electronic cigarettes) individually and in combination. Study findings may inform regulatory activities related to youth and young adult use of tobacco products.  

Melissa Blank Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051628-01
Institution: West Virginia University
07/20/2020

Measuring Anatalline and Nicotelline to Differentiate Non-combusted Tobacco Use Using the PATH Study

Biomarkers that can distinguish between types of tobacco product use can be used to help track associated health effects. The goal of this study is to measure nicotelline, a minor tobacco alkaloid associated with tobacco smoke particulate matter, in urine biospecimens gathered during Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study. Previous research has shown that, when expressed as a ratio with its parent compound (anatalline), nicotelline may distinguish smokeless tobacco use from combusted tobacco use. Study Aim 1 will validate the anatalline/nicotelline ratio cut-points (as well as nicotelline in combination with other tobacco exposure biomarkers) that distinguish exclusive cigarette use, exclusive smokeless tobacco use, and dual smokeless plus cigarette use (140 adults each). In Study Aim 2, researchers will use the same participant groups defined in Study Aim 1 to explore whether nicotelline and ratios of nicotelline-to-traditional tobacco biomarkers (i.e., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL]) can differentiate e-cigarette use from exclusive cigarette use using data from exclusive e-cigarette users and dual e-cigarette plus cigarette users. Study findings may confirm nicotelline’s usefulness as a biomarker to discriminate among tobacco products and to identify patterns of polytobacco use.

Kathryn Edwards and Gideon St. Helen Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051491-01
Institution: Westat
07/20/2020

Tobacco Use Trajectories and Disparities Among Sexual Minorities in U.S Adolescents and Adults

Sexual minority individuals comprise a population that is particularly vulnerable to tobacco use. The goal of this project is to analyze tobacco use across time in sexual minorities and resulting tobacco-related health disparities using Population Assessment of Tobacco and Health (PATH) Study data. Of PATH respondents with valid self-reported sexual identity (gay/lesbian, bisexual, something else, or straight) at all four study waves (N=26,696, ages 12+years), 2,520 reported sexual minority identity at one wave or more; 1,474 reported sexual minority identify at wave 1; and 905 reported sexual minority identity at all four waves. Study aims are: (1) to examine tobacco product initiation and use trajectories by sexual orientation and their associations with regular tobacco use and tobacco use disorder symptoms; (2) to identify tobacco use trajectories by sexual orientation and different associations with self-reported and biological health outcomes; and (3) to examine the role of biological and psychological stress on tobacco use trajectories, tobacco cessation, and tobacco-related health outcomes among adults and how these measures differ by sexual orientation. Researchers will assess tobacco use trajectories, including tobacco use initiation; progression in the number of products used, with a focus on e-cigarette use/non-use; and increase and decrease in use frequency. Aims 2 and 3 will involve analysis of survey self-report measures of stress (psychological distress) and health outcomes (respiratory illness, cancer, cardiovascular disease) alongside biological markers of stress (e.g. C-reactive protein, interleukin-6) and tobacco-specific markers linked to cancer risk (NNAL, NNN, TNE2). Researchers will also examine important moderators including age, sex, race and ethnicity throughout in all analyses. This project will provide new data that may inform regulatory activities to address the health burden of tobacco use among sexual minorities.

Rebecca Evans-Polce Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051388-01
Institution: University of Michigan
07/20/2020

Do E-Cigarette Users Airways Have an Altered Lipid Content?

In this study, researchers will use previously-collected serum, saliva, sputum, and bronchoalveolar lavage fluid (BALF) from healthy never-smokers, tobacco smokers or vapers to determine whether the airways of e-cigarette users have an altered lipid (fat) content that may cause acute lung injury. Study aims are: (1) to determine the concentrations of lipid-associated surfactant proteins in samples of BALF, sputum and saliva from non-smokers, smokers and vapers; (2) to measure lung cell lipid content and stain alveolar macrophages (a type of white blood cell in the lung) with Oil Red O to look for altered lipid content in vapers’ alveolar macrophages and airway secretions; and (3) to study metabolites on samples of BALF, sputum and saliva from non-smokers, smokers and vapers. To achieve Aim 1, researchers will use western blotting techniques to determine the amounts of lipid-associated surfactant proteins in vapers’ airway secretions. To achieve Aim 2, researchers will use mass spectrometry as well as standard histological techniques to better understand the impact of lipid accumulation on vapers’ lungs. To achieve Aim 3, researchers will use mass spectrometry to determine levels of nicotine, cotinine, tetrahydrocannabinol (THC), and metabolites that are associated with lung injury in vapers’, non-smokers’, and smokers’ lungs. Findings may inform future regulatory activities related to e-cigarettes. 

Robert Tarran Funding Mechanism: National Institutes of Health - Grant
ID number: 1R21HL153698-01
Institution: University of North Carolina, Chapel Hill
07/20/2020

Do E-cigarette Design Features Impact Cigarette Initiation, Cessation & Relapse?

More information about how e-cigarette characteristics impact transitions to and from cigarette smoking would be useful. This project will evaluate the independent effects of four e-cigarette design features (flavors, device type, nicotine content, and nicotine formulation) on later cigarette smoking initiation, cessation, and relapse among youth (ages 12-17), young adults (ages 18-24) and adults (ages 25 and older) in the U.S. Researchers will analyze data from the Population Assessment of Tobacco and Health (PATH) Study, the U.S. arm of the International Tobacco Control (ITC) Youth Tobacco and E-cigarette Survey, and the U.S. arm of the ITC Four Country Smoking and Vaping Survey. Study aims are: (1) to examine e-cigarette use and cigarette initiation among non-smoking youth and young adults, particularly whether and how e-cigarette design features predict future cigarette smoking initiation, including progression to regular cigarette smoking; (2) to examine e-cigarette use and cigarette cessation among youth and adult cigarette smokers, specifically whether and how e-cigarette design features impact later cigarette smoking cessation, considering both the potential reach and effectiveness of design features; and (3) to examine e-cigarette use and cigarette relapse among adult former cigarette smokers, specifically whether and how e-cigarette design features impact later cigarette smoking relapse. These findings may inform FDA regulatory activities related to e-cigarettes.

Karin Kasza Funding Mechanism: National Institutes of Health – Grant
ID number: 1R21DA051446-01
Institution: Roswell Park Cancer Institute Corporation
07/17/2020

Derivation of Lung Epithelia from iPS cells for Advanced Disease Modeling

The goal of this CTP supplement to a parent grant (which funds the study of alveolar epithelial type 2 cells [AEC2s], a type of lung cell) is to determine the effects of e-cigarette vapor exposure on the human alveolar epithelium (the internal surface area of the lung). Researchers will use newly-developed protocols to generate human AEC2s from induced pluripotent stem cells (iPSCs). They will culture the AEC2s using an air-liquid interface method and then expose them to (1) e-cigarette vapor containing nicotine, (2) e-cigarette vapor containing vitamin E-acetate (implicated in e-cigarette/vaping acute lung injury, or EVALI), (3) cigarette smoke, or (4) air (a control condition). Researchers will then measure the effects of these exposures on the RNA molecules, proteins, and metabolites in the AEC2s and generate a dataset. Study findings will describe e-cigarette vapor injury to this key lung cell type.

Darrell Kotton Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01HL095993-11S1
Institution: Boston University Medical Campus
07/17/2020

CTP Supplement to Parent Grant: The Role of Histone Deacetylase 9 in Vascular Calcification

In this CTP Supplement to a parent grant studying the role of histone deacetylase 9 (HDAC9, an essential regulator of vascular function), researchers will investigate whether toxic metals from vaping products prompt HDAC9-dependent dysregulation of vascular cell function and increased inflammation. Study aims are: (1) to analyze the heavy metal profiles of aerosol vapor generated by different open-system vaping devices, and (2) to determine the effects of toxic heavy metals in vaping aerosols and e-fluids on vascular cell function in vitro and cardiovascular and pulmonary function in vivo. To achieve Aim 1, researchers will use mass spectrometry to profile metals (by element and concentration) in aerosol vapor from six different open-system vaping devices (three refillable cartridges and three tank devices) and identify the origin (e-fluid, reservoir, heating coil) of each metal. To achieve Aim 2, researchers will use cell culture-based assays to determine how vaping aerosols, e-fluids, and metal constituents identified in Aim 1 affect gene and protein expression patterns and cellular function. They will also use wild-type and HDAC9-deficient mice to study the effects of chronic (1 month) vaping aerosol exposure on cardiovascular function (echocardiography), blood pressure, endothelial function, vascular reactivity, pulmonary function, and inflammation profile. Study findings may inform regulatory activities related to e-cigarettes. 

Rajeev Malhotra Funding Mechanism: National Institutes of Health – Grant
ID number: 3R01HL142809-03S1
Institution: Massachusetts General Hospital
07/17/2020

A Mouse Model of Vaping Vitamin E Acetate: Effects on Lung Function and Pathology

In this CTP supplement to a parent grant (Effects of E-cigarette Exposure during Pregnancy on Offspring Lung Function and Disease: Characterization of Pulmonary, Intergenerational, and Epigenetic Effects), researchers will study the effects of inhaling vitamin E acetate (VEA) compared to aerosolized nicotine in propylene glycol/vegetable glycerol (PG/VG), which is linked to e-cigarette/vaping-associated lung injury (EVALI), on lung function and pathology in a mouse model. Study aims are: (1) to characterize the acute effects of vaping with increasing e-liquid percentage of VEA; and (2) to characterize the chronic effects of vaping VEA on lung function and pathology. To achieve Aim 1, researchers will expose mice that have not previously been exposed to vaping (naïve mice) and mice that have been exposed to house dust mite antigen (sensitized mice) or to aerosolized nicotine in PG/VG to increasing percentages (0, 10, 20, 40, or 80%) of VEA in PG/VG (1:1) e-liquid; researchers will determine VEA effects on pulse oximetry, bronchial lavage composition, and lung pathology compared to nicotine. At the optimal condition found to induce EVALI-like changes, researchers will determine the effects of modifying voltage. To achieve Aim 2, researchers will determine the chronic pulmonary effects of vaping (measured at 2 and 4 weeks) using a complete battery of pulmonary function tests, pulse oximetry, heart rate, bronchial lavage and lung pathology on naïve and sensitized mice. Study findings may inform the understanding of the link of pre-disposing factors, such as prior ENDS use, and pre-existing respiratory conditions, such as asthma, on the incidence of EVALI. 

Eliot Spindel Funding Mechanism: National Institutes of Health - Grant
ID number: 3R01HL144384-02S1
Institution: Oregon Health & Science University
07/09/2020

Impact of E-cigarette Prevention Messages on Adolescents

Additional research to inform effective communications related to e-cigarette prevention among adolescents would be useful. The goal of this project is to identify e-cigarette prevention messages that will reduce adolescents’ (ages 13-17) willingness to use e-cigarettes. Study aims are: (1) to identify promising ways to communicate with adolescents to prevent e-cigarette use; (2) to develop a set of e-cigarette prevention messages that discourage adolescents from wanting to use e-cigarettes; and (3) to evaluate whether prevention messages reduce at-risk adolescents’ willingness to use e-cigarettes and e-cigarette use behavior in a randomized controlled trial (RCT). To achieve Aim 1, researchers will: identify promising prevention message themes (e.g., health effects, social norms, addiction) targeted to adolescents based on the empirical literature; vet these themes with the study team, expert consultants, and a teen advisory panel; work with an advertising agency to develop creative concepts for the most prominent themes; and conduct six focus groups with about 60 adolescents to examine their responses to the creative concepts. To achieve Aim 2, researchers will: develop 10 e-cigarette prevention messages based on the chosen concepts from Aim 1; conduct 30 cognitive interviews with 10 tobacco-using, 10 tobacco-susceptible, and 10 non-susceptible non-user adolescents to refine the messages; and conduct an online study of 1,600 adolescents to examine the perceived effectiveness of the messages in discouraging e-cigarette use. To achieve Aim 3, researchers will select a set of the most promising messages from Aim 2 to test in an RCT with 506 adolescents who will receive daily text messages for 20 days; one group will receive one of the five e-cigarette prevention messages in a randomized order, while the other group will receive a control message such as “This study will help others in the future. Thanks for taking part!”. Researchers will examine the impact of messages on willingness to use e-cigarettes (primary outcome) and e-cigarette use, cognitive elaboration, negative affect, e-cigarette beliefs, and social interactions (secondary outcomes) with a brief daily assessment, 3 weekly surveys, and a survey at 3 months. Study findings may inform e-cigarette prevention messages and campaigns for adolescents. 

Seth M. Noar Funding Mechanism: National Institutes of Health – Grant
ID number: 1R01DA049155-01A1
Institution: University of North Carolina at Chapel Hill
06/12/2020

Translational Studies on Electronic Cigarette-Derived Oxidants and Their Long-term Pulmonary Effects

Oxidative stress and damage resulting from exposure to oxidants such as free radicals and aldehydes play critical roles in the development and progression of most tobacco-caused diseases, including chronic obstructive pulmonary disease (COPD). The goal of this project is to evaluate toxicities caused by exposure to e-cigarette-derived free radicals and aldehydes and their role in the development of COPD. Study aims are: (1) to investigate the long-term pulmonary effects of e-cigarette exposure from products delivering high vs. low oxidant levels in a COPD mouse model; (2) to determine the impact of switching from cigarettes to e-cigarettes; and (3) to conduct a pilot single arm trial to determine the impact of switching from cigarettes to e-cigarettes on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting COPD. To address Aim 1, researchers will conduct 3-month exposure studies to compare high vs. low oxidant e-cigarette products (Mod vs. Juul, respectively). To address Aim 2, researchers will pre-expose mice for 1.5 months to cigarette smoke prior to switching them to filtered air, e-cigarette aerosol, or 50/50 e-cigarette aerosol/cigarette smoke for the remaining 1.5 months to mimic the harm from “real world” e-cigarette use patterns in smokers (smoking cessation, switching to e-cigarettes, and dual use). The primary outcomes of Aims 1 and 2 will be development of a COPD phenotype (including changes in lung function and histology) and assessment of systemic and lung-specific biomarkers of oxidative stress/damage and inflammation. To address Aim 3, researchers will provide e-cigarettes to 30 smokers (ages 18-65) with mild/moderate COPD and ask them to use these products exclusively for a year; e-cigarette and cigarette usage will be monitored along with assessments of COPD-related clinical symptoms, spirometric lung function, and biomarkers of oxidative stress and inflammation. These studies will provide new information about the toxicological impact of oxidant exposure from specific e-cigarette devices. 

John P. Richie Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01HL152436-01
Institution: Pennsylvania State University
05/22/2020

Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

The public health impact of FDA’s proposed nicotine reduction policy hinges on the extent to which tobacco users and non-users understand the harms of nicotine in specific products (e.g., e-cigarettes, nicotine replacement therapy (NRT), reduced nicotine content (RNC) cigarettes) and how this understanding influences decisions made by non-users to try a product and by users regarding cessation, product switching, or continued use. Research has highlighted widespread public misperceptions of the health risks of nicotine. A brief nicotine corrective messaging intervention may correct misperceptions of nicotine, NRT, e-cigarettes, and RNC cigarettes. The goal of this study is to examine the effect of multiple exposures to a nicotine corrective messaging (NCM) intervention (compared to a delayed intervention control) on nicotine beliefs and intention/use of tobacco and nicotine products in U.S. adults (age 18 and older). Study aims are: (1) to test the impact of NCM on nicotine beliefs and the subsequent impact on intention and use of tobacco and nicotine products in a national sample of 715 adult smokers and non-smokers followed for 12 weeks; and (2) to test the impact of NCM (messaging vs. control) and nicotine content of study cigarettes (normal vs. reduced) on nicotine beliefs and subsequent use of tobacco and nicotine products using a 2 x 2 factorial design in a sample of 160 adult current smokers followed for 4 weeks (participants will be explicitly told which product they have been given). In both studies, participants will complete online surveys at scheduled intervals throughout the study period in which they will be exposed to up to six corrective messages and subsequently complete survey questions. Study findings will provide information about the potential of NCM communication efforts on tobacco use behavior in the general population and in adult smokers affected by a reduced nicotine content standard in combustible cigarettes. 

Andrea Villanti and Andrew Strasser Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01DA051001-01
Institution: University of Vermont and State Agricultural College
05/22/2020

Modified Use of E-Cigarettes and Marketing on YouTube

The goal of this study is to understand ways in which youth modify e-cigarettes, their motivations for doing so, and marketing sources. Study aims are: (1) to identify and characterize modified uses of e-cigarettes and associated marketing sources on youth-accessible YouTube videos, and (2) to examine modified uses and marketing exposure among an online sample of 500 adolescent (ages 13-17) and 500 young adult (ages 18-25) e-cigarette users. To address Aim 1, researchers will identify modified uses of e-cigarettes and marketing using fictitious youth YouTube viewer profiles to search for e-cigarettes using a browser plug-in and custom scripted web-crawling; then they will use machine-learning to automatically code the videos to identify e-cigarette modifications, motivations for modification, marketing sources, and appeal (number of views, number of likes). Subject matter experts in tobacco regulatory science, social media, youth tobacco use, toxicology, communications, and tobacco marketing will assess the potential impact of identified modified uses on e-cigarette appeal, addiction, and health effects. To address Aim 2, researchers will conduct an online survey with 1000 adolescent and young adult e-cigarette users to examine the prevalence, appeal, motivations, risk perceptions, and marketing exposure related to these modified uses and their predictors (i.e., demographic variables, past-month e-cigarette use frequency, e-cigarette dependence, other tobacco/substance use, interpersonal and intrapersonal risk factors). Findings may inform regulatory activities related to e-cigarettes. 

Grace Kong Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01DA049878-01A1
Institution: Yale University
05/22/2020

Greenwashing Cigarettes: Perceptual and Behavioral Evidence of Inaccurate Modified Risk Advertising

“Greenwashing” is an increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. Greenwashing tactics may inaccurately convey modified product risk to consumers. The goal of this project is to describe how cigarette companies use greenwashing to market their products and test the effect of these tactics on young adult (ages 18-29) risk perceptions in an online sample and actual smoking behavior in a controlled laboratory study. Study aims are: (1) to identify specific greenwashing tactics used in cigarette ads, determine their prevalence across brands and sub-brands, and determine changes in these tactics over time; (2) to test the extent to which the greenwashing tactics identified in Aim 1 contribute to inaccurate modified risk perception in 1,500 young adults using an online survey; and (3) to test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study of 35 young adults. Findings will provide new information about the connection of greenwashing strategies to product risk perceptions and actual smoking behavior and may inform future regulatory activities.

Meghan B. Moran and Matthew Johnson Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01DA049814-01A1
Institution: Johns Hopkins University
05/21/2020

Shrinking the Size of the Tobacco Powerwall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use

The most prominent source of retail point-of-sale (POS) tobacco advertising comes from the tobacco power wall, the large, expansive display of hundreds of different tobacco products typically located behind the cashier in full view of consumers. Adolescents are frequent visitors to retail stores and thus are at significant risk for having repeated exposures to the tobacco power wall. The goal of this project is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents. Study aims are: (1) to evaluate the extent to which reducing the size of the power wall and number of units of each tobacco product displayed on the power wall influences tobacco use risk; (2) to model the mediational pathways through which these reductions initiatives have their effects; and (3) to examine whether gender and/or tobacco use experience moderate adolescents’ reactions to the power wall regulatory options under investigation. This study will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store developed to evaluate how altering aspects of POS promotion influences tobacco use risk during simulated shopping experiences. A total of 750 adolescents (ages 11-20) will be randomly assigned to shop in the RSL under one of three conditions (250 per condition): (1) large power wall/ multiple product units displayed; (2) small power wall/multiple product units displayed; and (3) small power wall/single product units displayed. Researchers will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco. Tobacco use risk will be indexed by: attention to the tobacco power wall, perceived tobacco use norms, perceived availability of tobacco products, and tobacco use intentions. Findings may inform future regulatory activities related to POS tobacco advertising. 

William G. Shadel Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01DA050972-01
Institution: RAND Corporation
05/19/2020

Assessing Toxicant Properties and Health Effects of Cigarillo and Hookah Tobacco Aerosols in Rats

The goal of this project is to evaluate whether cigarillo and hookah tobacco aerosols exhibit differences in toxicants associated with five health outcomes (cancer, transcriptional reprogramming, lung function and inflammation, cardiovascular effects and serum circulatory inflammation) compared to cigarette smoke using a rat model. Study aims are: (1) to evaluate 14-day nose-only dose response exposures to aerosols generated from cigarettes, cigarillos, and hookah products; and (2) to evaluate the effect of these exposures on biomarkers of cardiopulmonary health effects. To address Aim 1, researchers will expose a total of 360 rats (10/sex/group) for one hour per day for 14 days to one of three exposure groups (250, 500, or 750 mg total particulate matter (TPM)/m3) and one of six tobacco products (two major consumer brands each of cigarettes, cigarillos, or hookah tobacco, selected based on their in vitro toxicant properties); an air exposure group of 20 rats will be included as a control group. The exposure atmosphere will be characterized for hazardous chemical substances including (but not limited to) carbon monoxide, tobacco-specific nitrosamines, nicotine, volatile carbonyls, and tar. To address Aim 2, researchers will use biospecimens collected following the exposures to assess and compare effects across the five health outcomes listed above. Researchers will obtain quantitative readouts of cardiopulmonary biomarkers to enable comparisons across products and to evaluate dose effects; biomarkers will include specific DNA adducts, lipid peroxidation, cytokine panels, global assessment of lung transcriptional reprogramming, gene expression changes in the heart and aorta, and gene expression changes predictive of circulatory inflammation. Findings may inform regulatory activities related to cigarillos and hookah tobacco. 

Steven A. Belinsky and Carmen Tellez Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01ES031787-01
Institution: Lovelace Biomedical and Environmental Research Institute (LBERI)
05/15/2020

Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

Sugars are present naturally in some tobacco types and are also added to cigarette tobacco filler. Data suggest that sugars in tobacco filler may contribute to the harmful properties of cigarettes by enhancing smoke palatability and appeal and, as precursors to aldehydes and furans in smoke, by increasing smoke toxicity and carcinogenicity and potentially addictiveness. The goal of this study is to provide additional quantitative data on the relationship between tobacco sugar content and relevant toxicant yields in U.S. commercial cigarettes, and associated user exposures, behaviors, and cigarette appeal. Study aims are: (1) to characterize the impact of sugars in the filler of U.S. cigarettes on the chemical profile of cigarette smoke; (2) to investigate the impact of sugar content in cigarette tobacco on toxicant and carcinogen intake in U.S. smokers; and (3) to investigate the impact of sugar content in cigarette tobacco on cigarette abuse liability and appeal. To address Aim 1, researchers will add stable isotope-labeled sugars to a commercial cigarette that is low in sugars and will analyze the dose-dependent formation of corresponding pyrolysis products in the smoke of this cigarette; they will also analyze the impact of sugar content on the levels of nicotine and tobacco-specific nitrosamines (TSNAs) in the smoke. To address Aim 2, researchers will analyze sugars in U.S. commercial cigarettes and use Population Assessment of Tobacco and Heath (PATH) Study biomarker data to investigate the impact of sugar content in cigarette tobacco on toxicant and carcinogen intake in U.S. smokers. To address Aim 3, researchers will investigate the impact of sugar content on cigarette abuse liability and appeal by conducting a laboratory study in which 30 smokers (aged 18 and older) will assess study cigarettes with different sugar levels. Findings may inform future regulatory measures related to sugar levels in tobacco products. 

Irina Stepanov and Dorothy Hatsukami Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01DA051005-01
Institution: University of Minnesota
04/28/2020

Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-Menthol Cigarettes

The goal of this study is to examine response to smoking menthol and non-menthol very low nicotine cigarettes (VLNCs) in 100 young adult (ages 18-24) menthol smokers. Study aims are: (1) to determine the influence of menthol flavoring on smoking reinforcement in the context of a reduced nicotine standard in the laboratory; (2) to determine the influence of menthol flavoring on smoking reinforcement in the context of a reduced nicotine standard in the natural environment; and (3) to examine the impact reinforcement on tobacco product purchasing. To achieve Aim 1, abstinent smokers (>12 hours) will attend three laboratory visits where they will smoke a cigarette. During Visit 1, smokers will smoke their usual brand cigarette ad libitum; researchers will measure subjective response (satisfaction, craving reduction, psychological reward, sensory effects like throat hit), smoking exposure (carbon monoxide [CO] boost), and behavior (number of puffs, puff volume). Next, after 7 days of usual brand smoking, participants will undergo two experimental conditions at home: (1) 7 days smoking menthol VLNCs; and (2) 7 days smoking non-menthol VLNCs. For each condition, participants will be instructed to switch their usual cigarette for the assigned research cigarette but may use other tobacco products. (Each experimental condition will be separated by a 7-day wash-out period.) On the last day of each condition, participants will smoke the assigned research cigarette in the laboratory, and researchers will collect data on subjective response, smoking exposure, and behavior to compare craving reduction, positive subjective response, and CO boost among menthol VLNCs, non-menthol VLNCs, and usual brand.  To address Aim 2, during each 7-day period, participants will complete twice-daily assessments of cigarette and other tobacco use, withdrawal, and subjective response; data will allow researchers to compare cigarettes per day, craving reduction, and positive subjective response for menthol VLNCs, non-menthol VLNCs, and usual brand.  To address Aim 3, in a fourth visit participants will complete two tasks in the laboratory to indicate the impact of menthol and nicotine content on cigarette purchasing behavior in the context of all tobacco products currently on the market. Findings will provide new information about the abuse liability of menthol VLNCs.

Amy M. Cohn Funding Mechanism: National Institutes of Health - Grant
ID number: 1R01DA050990-01
Institution: University of Oklahoma Health Sciences Center
03/31/2020

A Measurement Burst Study of Vaping in a National Sample of Young Adults

In this supplement to the Monitoring the Future (MTF) parent grant (Monitoring the Future: Drug Use and Lifestyles of American Youth), researchers will conduct a new longitudinal study of approximately 1100 individuals who participated in MTF as 12th graders in 2019 and will be modal age 19 in 2020, with an oversample of those who reported vaping and other substance use in high school. Approximately 570 respondents who report current vaping at age 19 will be invited to complete a one-time web-based survey (30 minutes) followed by 14 consecutive daily web-based surveys (5-7 minutes) to capture real-time fluctuation in vaping use patterns, consequences, and co-use with other substances. Study aims are to examine: (1) vaping frequency, products, devices, patterns, and contexts with daily data over two weeks, (2) signs of vaping addiction, craving, quit attempts, and physical consequences in real time, (3) co-use of vaping and other substances including alcohol, cigarettes, marijuana, and non-prescription drugs, and (4) recent exposure to nicotine through collection of biometric samples. Findings will provide new information about vaping behaviors and consequences among young adults that may inform future regulatory activities. 

Richard Miech and Megan Patrick Funding Mechanism: National Institutes of Health - Grant
ID number: 5R01DA001411-46S1
Institution: University of Michigan
03/26/2020

Identification of Free Radical Induced Biomarkers of Exposure to Electronic Cigarette Aerosol

E-cigarette aerosol contains highly reactive free radicals that can cause oxidative damage, which can contribute to the progression of cancers and other diseases. The goal of this study is to identify these free radicals and use their unique structures to develop an e-cigarette-specific biomarker of exposure. Study aims are: (1) to determine the structures of the free radicals produced by propylene glycol and glycerin in e-cigarettes; and (2) to determine the primary targets of radical adduct formation in the tissue of e-cigarette-exposed mice and identify metabolites formed from radical adducts in the serum. To address Aim 1, researchers will use free radical spin trapping, electron paramagnetic resonance spectroscopy techniques, and mass spectroscopy to identify and analyze the unique structural features of free radicals in e-cigarette aerosol produced from a popular temperature-controlled e-cigarette device. To address Aim 2, 120 mice will be exposed to e-cigarette aerosols and either pre- or post-exposed to 5,5-dimethyl-1-pyrroline noxide (DMPO) spin traps via nose-only exposures. Using an anti-DMPO antibody, the areas of free radical exposure will be observed in the pre-DMPO exposures and targets of radical damage will be observed in the post-DMPO exposures. Radical adducts formed in the post-DMPO exposures will be identified via mass spectroscopy and metabolites of these adducts will be identified in the serum to find viable e-cigarette-specific biomarkers of exposure. Findings may inform future regulatory activities related to e-cigarettes. 

Zachary T. Bitzer Funding Mechanism: National Institutes of Health - Grant
ID number: 1K99HL147346-01A1
Institution: Pennsylvania State University
03/12/2020

Cardiopulmonary Effects Induced by Electronic Cigarette and JUUL Aerosols in Both In Vivo and In Vitro Models

Although clinical evidence demonstrates declines in lung function and increases in heart attack risk in healthy dual-users of e-cigarettes and cigarettes, more evidence regarding the cardiopulmonary effects of chronic inhalation of electronic nicotine delivery system (ENDS) aerosols would be useful. The goal of this study is to evaluate how two ENDS products -- open system e-cigarette devices and closed system JUUL-type devices -- impact individual or combinations of aerosol constituents and their toxicity using innovative cell culture systems and mouse models. Study aims are: (1) to examine the roles that e-liquid constituents (i.e., propylene glycol/vegetable glycerin, flavors, nicotine) play in the chemical profiles and lung toxicity of ENDS aerosols using in vitro models; (2) to define a panel of biomarkers for cardiopulmonary effects following exposures to e-cigarette aerosols, JUUL aerosols, and dual use of cigarettes and e-cigarettes in juvenile mice; and (3) to compare pulmonary toxicity induced by e-cigarette or JUUL aerosols in mice. Findings may clarify the cardiopulmonary effects caused by prolonged use of ENDS and inform regulatory activities. 

Alexandra Noël Funding Mechanism: NIH Grant
ID number: 1K01HL149053-01
Institution: Louisiana State University A&M College Baton Rouge
03/6/2020

Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents (YCSTP) (TCORS 2.0)

Systematic data collection can provide more information about e-cigarette or vaping product use-associated lung injury (EVALI), particularly regarding number of cases and specific products involved. In this supplement to the Yale University TCORS 2.0 parent grant, researchers will develop a robust surveillance system that will prospectively identify hospitalized patients with acute lung injury who vape or smoke. Study aims are: (1) to develop a robust surveillance system to prospectively identify admitted patients with acute lung injury who vape or smoke; (2) to perform toxicology analyses of e-liquids and device contents that are associated with EVALI; and (3) to build a biorepository of patient blood and urine samples among patients with acute lung injury who vape or smoke to investigate disease mechanisms. This project will enable research into disease mechanisms and elucidate risk factors associated with EVALI.

Suchitra Krishnan-Sarin and Stephanie O’Malley Funding Mechanism: National Institutes of Health - Grant
ID number: 3U54DA036151-07S1
Institution: Yale University
03/02/2020

Center for the Study of Tobacco Products - Electronic Cigarette Use and Alveolar Macrophages: A Preliminary Study

Data from animal studies suggest that e-cigarette users may be at risk for a potentially debilitating condition called lipoid pneumonia. In this supplement to the Virginia Commonwealth University TCORS 2.0 parent grant, this supplement will collect pilot data relevant to the generalizability of lipoid pneumonia-related animal study data to humans. Study aims are: (1) to investigate lipid-laden macrophages in e-cigarette users, and (2) to characterize other disease biomarkers in e-cigarette users’ bronchoalveolar lavage (BAL) fluid. To address Aim 1, researchers will recruit 10 high-wattage (i.e., >20 W) e-cigarette users (ages 21-55) with over one year of experience exclusively using nicotine-containing e-cigarettes as well as an additional 10 never-e-cigarette-using, never-smoking controls. Using well-established methods, all 20 participants will undergo bronchoscopy and BAL to enable the collection of alveolar macrophages. Researchers will then compare the incidence of lipid-laden macrophages between groups. To satisfy Aim 2, researchers will determine the alveolar fluid composition differences in miRNA expression, extra-vesicle-miRNA, and microbiome profiles between the e-cigarette users and the control group. Findings may inform regulatory activities related to e-cigarette liquid constituents that have the potential to cause lung disease. 

Thomas Eissenberg and Alison Breland Funding Mechanism: National Institutes of Health - Grant
ID number: 3U54DA036105-07S1
Institution: Virginia Commonwealth University
01/31/2020

FDA CTP This is Our Watch Retailer Feedback Study

FDA’s Center for Tobacco Products (CTP) Office of Health Communication and Education has created and maintains retailer education materials, referred to as This Is Our Watch (TIOW), designed to give retailers the tools they need to comply with tobacco regulations. As a result of the Tobacco 21 legislation raising the federal minimum age for the sale of tobacco products from 18 to 21, FDA CTP is required to update TIOW retailer education materials. The goal of this study is to obtain feedback from retailers about their awareness, preferences and experiences related to the TIOW materials. Researchers will conduct 32 in-depth interviews (22 English, 10 Spanish) that will each last up to 60 minutes. Participants will include clerks, managers, and owners of tobacco retail establishments identified through government contacts, such as the State Synar Program managed by the Substance Abuse and Mental Health Services Administration (SAMHSA). Study aims are: (1) to identify T21 knowledge gaps and educational opportunities among tobacco retailers, and (2) to understand retailers’ sentiments, needs and challenges related to minimum legal purchase age compliance. Findings will allow FDA to understand what additional messages, information, and material format would complement the current TIOW education materials.

Alessandra Raimondi (CTP Contacts: Megan Wall, Matthew Walker, Emily Sanders) Funding Mechanism: Research Contract
ID Number: 75F40120A00002-75F40120F19001
Institution: Fors Marsh Group
09/30/2019

The Human Dose-Response Effects of Methyl Salicylate in Smokeless Tobacco

The goals of this project are to determine how changes in the methyl salicylate content of smokeless tobacco may affect HPHC exposure and nicotine pharmacokinetics (the body’s effects on nicotine), as well as to determine how changes in methyl salicylate content affect nicotine pharmacodynamics (nicotine’s effects on the body) and abuse liability. First, researchers will amend commercially available smokeless tobacco to create four investigational smokeless tobacco products (no methyl salicylate and low, medium, and high methyl salicylate content ranging from 0.3-30 mg/g). Next, researchers will administer each of the four products to 56 adult smokeless tobacco users (aged 21-65) under specific use conditions. Researchers will measure heart rate, blood pressure, pharmacokinetics, exposure to harmful and potentially harmfully constituents (HPHCs), and abuse liability (measures of liking, craving, and withdrawal) before and after product use. Findings may inform future regulatory activities related to smokeless tobacco products.  

Bortosz Koszowski and Mollie Miller Funding Mechanism: Research Contract
ID number: HHSF223201710040I
Institution: Battelle
09/27/2019

Study of E-Cigarette Aerosol Toxicity in In Vivo Nonclinical Models

Few peer-reviewed studies have compared the toxicity associated with inhaling aerosol from different types of e-cigarettes; therefore, a thorough comparison of the chemical constituent levels, pharmacokinetics (PK), and toxicity from different e-cigarettes would be informative for future toxicological assessments. Researchers will perform a 28-day study with PK assessment, a 90-day nose-only inhalation study with 45-day recovery groups, and a 6-month nose-only inhalation study; all studies will be conducted in male and female Sprague Dawley rats. The 28-day study will evaluate the toxicity of two e-cigarettes and will provide PK data (results will be used to inform dose selection in the 90-day and 6-month studies). The objective of the 90-day and 6-month studies is to perform longer-term comprehensive studies of four top-market-share e-cigarette products in the U.S. Researchers will gather data including e-liquid and aerosol concentration measurements; measurements in animals such as body weight and food/water consumption; clinical observations; and biomarkers of exposure. Findings will provide new information about the potential toxicological effects of e-cigarette use. 

Jake McDonald, Gladys V. Erives, and Cissy Li Funding Mechanism: Research Contract
ID number: 75F40119C10161
Institution: Lovelace Biomedical and Environmental Research Institute (LBERI)
09/19/2019

Smokers’ Decision-Making about Tobacco Use: The Interplay of Affective and Cognitive Factors with Product Characteristics

Misperceptions about the health risks and benefits of electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP), as well as consumer dissatisfaction with product characteristics, may limit initiation and complete substitution for cigarettes. This project will investigate how price, indoor-air policies, and ENDS and HTP product characteristics (type/design, flavors, ability to reduce cravings to smoke) interact with risk/benefit perceptions to affect smokers’ decisions to reject ENDS, to substitute them for only a few cigarettes, to switch exclusively to ENDS, or to use ENDS to completely quit using tobacco products. Study aims are: (1) to examine how cognitive, affective, and contextual factors (e.g., whether products can be used where smoking is prohibited) moderate the influence of ENDS/HTP product characteristics on product choice and tobacco use patterns and trajectories; and (2) to examine how the effects of specific ENDS/HTP product characteristics on product use patterns are moderated by risk/benefit perceptions. Aim 1 will involve qualitative focus group interviews with 120 current and former adult smokers (aged 18+) and an intensive one-year (12 weekly, then 3 quarterly) assessment with 300 current smokers who recently initiated ENDS use to examine how ENDS/HTP product characteristics influence smokers’ decisions to initiate, dual use with, or substitute for combustible product use. Aim 2 involves two experiments and a randomized clinical trial. A discrete-choice experiment (DCE) will be embedded in a survey of 300 current adult smokers to examine the relative importance of ENDS/HTP product characteristics on risk/benefit perceptions, product preferences, and use intentions, and evaluate the predictive validity of these preferences on future tobacco use. A second DCE will examine the interaction of product characteristics, risk/benefit perceptions, and contextual factors on product preferences among 2,400 adult current smokers who currently, formerly, or never used ENDS/HTP products. These results will inform the design of a randomized clinical trial with 1,800 adult smokers involving a hypothetical purchase task that will manipulate risk/benefit perceptions of ENDS/HTP products to estimate the effect on smokers’ consumption of cigarettes, ENDS, and HTP, including the substitutability or complementarity of ENDS and HTP for each other and for cigarettes. Findings may inform regulatory activities related to cigarettes, ENDS and HTP products.

Terry Frank Pechacek and Scott R. Weaver Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA235719-01A1
Institution: Georgia State University
09/18/2019

Assessing IQOS Marketing Influences and Consumer Behavior in Israel: Implications for the US

Developing an understanding of how heated tobacco products (HTPs) are marketed would be useful. IQOS, the global HTP leader, has a presence in several markets, including Israel. Israel is unique in that it represents three distinct regulatory contexts for IQOS: (1) during IQOS’s initial emergence in Israel, it was not categorized as a tobacco product (Dec 2016-Apr 2017); (2) IQOS was classified as a tobacco product in a relatively weak regulatory context (Apr 2017- December 2019); and (3) IQOS will be regulated as a tobacco product within new progressive legislation (study period starting January 2020). The goal of this study is to examine IQOS marketing strategies used in Israel during these three regulatory periods and assess their impact on segments of the Israeli and U.S. populations. Study aims are: (1) to examine IQOS marketing strategies in Israel from its emergence in the Israeli market and begin surveillance as IQOS is launched in the US; and (2) to examine market segments of Israeli and U.S. adults (users and nonusers aged 18-45) in relation to IQOS use and/or likelihood of future use. The researchers will study marketing content and consumer reactions in both Israel and the U.S. via examination of marketing channels (including point-of-sale audits), content analysis of advertising messaging strategies, interviews with IQOS retailers, online surveys of 1,000 Israeli and 1,000 U.S. adults, and interviews with 40 Israeli and 40 U.S. adults. Among the panel of Israeli and U.S. adults, the researchers will conduct market segmentation research on consumer characteristics; four specific market segments defined by the IQOS website will be examined: business and current events; art, culture and fashion; nature and hiking; and innovation and technology. By examining IQOS marketing strategies used in the three different regulatory periods in Israel and understanding the impact of these strategies on different consumer segments and the extent to which they generalize to U.S. consumers, findings will provide information to better estimate the potential impact of IQOS and its marketing in the U.S.

Carla J. Berg and Hagai Levine Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA239178-01A1
Institution: Emory University
09/18/2019

Assessing the Effects of Smokeless Tobacco Influencer Marketing in the Rapidly Changing Media Environment

Social media marketing remains an understudied area in tobacco control, particularly related to smokeless tobacco. The goal of this project is to examine the effects of exposure to smokeless tobacco-related social media content. Study aims are: (1) to conduct a content analysis to identify and characterize social media messages related to smokeless tobacco by source and major themes (e.g., new user targeting, health risks, flavors); (2) to assess the impact of social media content exposure on smokeless tobacco use, attitudes, harm perceptions, perceived prevalence of use, initiation, and use intentions) using data from the Truth Longitudinal Cohort Survey on Tobacco-Related Attitudes, Beliefs and Behavior (13,892 youth and young adults aged 15-21 at baseline [April 2014]); and (3) to study whether/to what extent tobacco control policies moderate the relationship between exposure to smokeless tobacco-related social media content and smokeless tobacco use. Investigators will apply various research and analytic methods to a unique combination of data sets, including social media data from Twitter, Instagram and Facebook and survey data on tobacco-related outcomes. Findings will provide policy-relevant scientific evidence on the impact of social media marketing of smokeless tobacco products. 

Ganna Kostygina Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA234082-01A1
Institution: National Opinion Research Center
09/18/2019

The E-Cigarette Population Paradox: Testing Effects of Youth-Targeted Population Warnings for E-Cigarettes among Two Key Populations

Warnings on e-cigarette advertisements and packaging should communicate the risks of e-cigarettes to youth and non-smokers while also protecting perceptions of the potential benefits of switching completely to e-cigarettes among combustible cigarette smokers. The goal of this study is to identify effective e-cigarette ad warnings given this complex population paradox. Study aims are: (1) to develop and test a set of proposed warning messages to maximize desirable outcomes among both nonsmoking youth and adult smokers; (2) to evaluate e-cigarette ad warnings that maximize favorable effects on youth as the critical at-risk population; and (3) to test for unintended effects of e-cigarette ad warnings among adult cigarette smokers who may be discouraged from switching to e-cigarettes when exposed to some types of warnings. To address Aim 1, researchers will conduct a series of 16 focus groups (30 youth aged 14-18 and 30 adults aged 19+) to identify warnings that are likely to discourage non-smoking youth from using the product but do not discourage cigarette smokers from wanting to switch completely. To address Aim 2, researchers will use a mobile lab outfitted with computing and eye-tracking technology to test the effects of promising warnings from Aim 1 in a randomized experiment with 400 youth aged 14-18 to identify warnings that increase visual attention to the warnings, decrease attention to ad appeals, increase risk beliefs, and reduce use intentions. To address Aim 3, using the same mobile lab, researchers will randomize 400 adults aged 19+ to test whether the most effective warnings among youth that emerge in Aim 2 have any unintended consequences among adult smokers; specifically, they will test whether youth-effective warnings influence visual attention, comparative risks between combustible and e-cigarettes, and intentions to use both products (switching completely to e-cigarettes, dual use, or continued smoking of combustible cigarettes) among adults. Findings may inform regulatory activities related to e-cigarette ad warnings. 

Sahara Byrne and Jeff Niederdeppe Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA246605-01
Institution: Cornell University
09/17/2019

Advancing Perceived Message Effectiveness: A New Measure for Youth Prevention Media Campaigns

Among other tools, the FDA uses the perceived message effectiveness (PME) scale to select ads for The Real Cost campaign. However, this scale has some limitations, including: (1) it was developed with adult smokers; (2) it was developed before the advent of e-cigarettes and vaping; and (3) it assesses message PME (beliefs about the message; i.e., “This ad is informative”), while a growing body of literature suggests that effects PME (beliefs about the message’s impact; i.e., “This ad gives me good reasons not to smoke”) better predicts the impact of ads on intention and behavior change. The goals of this project are to develop and validate an effects PME scale for adolescent (aged 13-17) tobacco prevention and to compare the performance of this new scale to the FDA’s current message PME scale. Study aims are: (1) to develop a youth effects PME scale for vetting cigarette and e-cigarette prevention ads; (2) to establish whether effects and message PME prospectively predict the impact of smoking prevention ads on intentions to smoke cigarettes; and (3) to examine whether effects and message PME predict the impact of vaping prevention ads on intentions to vape. To achieve Aim 1, researchers will develop a youth effects PME scale for vetting cigarette and e-cigarette prevention ads. They will develop and refine an item pool, cognitively test items with 48 adolescents, and conduct a scale development study with a national sample of 800 adolescents. To achieve Aim 2, researchers will randomize 1,280 adolescents at risk of cigarette smoking to one of three The Real Cost cigarette prevention ad conditions or to a control ad condition; participants will view a set of ads each week and complete a final assessment at week 3, and the researchers will examine whether PME predicts the impact of ads on intentions to smoke, risk beliefs about smoking, and smoking behavior. To achieve Aim 3, researchers will randomize 1,024 adolescents to view three The Real Cost e-cigarette ads or to a control ad condition and examine whether PME predicts the impact of e-cigarette ads on intentions to vape and risk beliefs. Findings may help campaign designers select more effective ads, thereby increasing the impact of tobacco education campaigns targeted to youth.

Seth Michael Noar Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA246600-01
Institution: University of North Carolina at Chapel Hill
09/16/2019

Communicating about Nicotine and Differential Risks of Tobacco Products

The goal of this project is to study a communication strategy that combines messages about reduced nicotine in combusted cigarettes with messages about relative risks of other tobacco products (i.e., potential “modified risk claims”). Study aims are: (1) to develop preliminary messages about reduced nicotine in combusted tobacco products; (2) to quantify the relative importance of different types of information in communications about reduced nicotine; and (3) to test the impact of messages about reduced nicotine in combusted tobacco products in the context of potential modified risk statements for novel tobacco products in a randomized clinical trial. To achieve Aim 1, researchers will conduct focus groups with 36 adult (aged 18+) current exclusive smokers, 36 adult dual users of cigarettes and ENDS, 36 adult former smokers, and 36 young adult non-smokers (aged 18-29). To achieve Aim 2, researchers will assess the relative effects of various message attributes (e.g., specific numbers for reduction, mention of addiction and health effects, source) on affect, perceived risk, and intentions to quit (for smokers) or to try reduced nicotine cigarettes (for non-smokers) in a discrete choice experiment; participants will be adult current exclusive smokers, adult dual users, adult former smokers, and young adult non-smokers (450 from each group). To achieve Aim 3, researchers will conduct a randomized clinical trial with 900 adult current exclusive smokers, 450 adult dual users, and 450 young adult non-smokers to compare effects of reduced nicotine and potential modified risk messages (executed as full-color ads) alone and in combination; outcomes will include risk perceptions, affect, behavioral intentions and recall and behavioral outcomes. Findings may inform regulatory activities related to communication strategies involving low nicotine tobacco products. 

Lyudmila Popova and James Thrasher Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA239308-01A1
Institution: Georgia State University
09/16/2019

Impact of Adding Tobacco Constituents Nornicotine and Anatabine on Self-Administered Nicotine

Because most electronic cigarettes contain nicotine, users may be at greater risk of transitioning to other tobacco products given the addictive nature of nicotine. More information about the interactions between nicotine and other tobacco constituent compounds in the context of this addictive risk would be useful. The objective of this research is to assess the impact of the addition of other tobacco constituent compounds to nicotine in an intravenous self-administration model in male and female adult and adolescent rats. Study aims are: (1) to assess the impact of adding nornicotine and anatabine to self-administered nicotine on the motivational value of nicotine in rats that began their nicotine consumption as adults; and (2) to assess the impact of adding those constituents to self-administered nicotine on the motivational value of nicotine in rats that began their nicotine consumption as adolescents. Findings on the impact of adding tobacco constituent compounds to ongoing nicotine self-administration may inform future regulatory activities. 

Jennifer E. Murray Funding Mechanism: NIH Grant
ID number: 1R03DA045740-01A1
Institution: University of Guelph
09/16/2019

The Role of Humectants and Flavor on Microbial Growth in Waterpipe Tobacco

More information regarding how additives like humectants and flavors alter microorganisms in waterpipe tobacco would be useful. The goal of this study is to assess the impact of humectants (humidifying ingredients) and flavor additives on microbial growth in waterpipe tobacco. Study aims are: (1) to evaluate the effect of flavor and humectant content on microbial growth in waterpipe tobacco; and (2) to assess the relationship between tobacco-specific nitrosamine (TSNA) production and microbial activity in waterpipe tobacco. To address Aim 1, researchers will use an unflavored, low-humectant commercially available waterpipe tobacco as a control and prepare it several different ways to determine the individual and cumulative effects of additives (glycerin, propylene glycol, and vanillin) on microbial growth; flavor and humectants will be added at quantities comparable to those in commercially available waterpipe tobacco. Researchers will quantify microbial composition using whole genome sequencing analysis, and will use shotgun proteomic analysis to characterize proteins expressed by organisms colonizing tobacco. To achieve Aim 2, two TSNAs (Nʹ-nitrosonornicotine [NNN] and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK]) will be quantified in each tobacco preparation after 1 and 6 months of incubation and compared to levels found in the control. Study findings will provide new information about how humectants and flavors influence toxic exposures associated with waterpipe tobacco. 

Anna Marie Adetona Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21CA244305-01
Institution: Battelle Centers/Public Health Research & Evaluation
09/16/2019

E-Cigarettes and Youth: Tests of Strategies to Prevent Recreational Use

Use of e-cigarettes by non-smoking youth has increased dramatically in recent years. The goal of this study is to test how variations in modified risk statements, novelty flavors, and flavor representation (pictorial images vs. plain-text flavor names) influence middle school youth (aged 11-14) e-cigarette perceptions and use susceptibility. Study aims are: (1) to determine how modified risk statements and the specificity of the health risks addressed by them influence middle school students’ perceptions of e-cigarettes and the FDA’s warning label; (2) to determine how flavor category influences middle school students’ perceptions of e-cigarettes and the FDA’s warning label; and (3) to determine how flavor representation influences middle school students’ perceptions of e-cigarettes and the FDA’s warning label. Two randomized experiments will be conducted on a sample of middle school students. The first, with 150 participants, will vary whether participants view a modified risk statement alongside the FDA warning on e-cigarette packages, as well as the type of modified risk statement (abstract health consequence vs. specific health consequence). The second experiment, with 550 participants, will vary whether participants view e-liquid vials with tobacco flavor or a novelty flavor (menthol, fruit, candy, goth). Outcome measures include risk perceptions, message comprehension, harm minimizing beliefs, susceptibility, and behavioral intentions toward e-cigarette uptake. Findings may inform communication strategies that minimize uptake of e-cigarettes by middle school youth.

Sherri Jean Katz Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21CA246602-01
Institution: University of Minnesota
09/16/2019

Evaluating the Impact of Waterpipe Tobacco Marketing Claims on Young Adults

Specific evidence related to waterpipe tobacco packaging and marketing to identify claims and determine their influence on consumer harm misperceptions would be useful. The goal of this study is to document claims on waterpipe tobacco packaging and in digital marketing (websites and social media) and evaluate how such claims influence consumer perceptions and willingness to try waterpipe tobacco. Study aims are: (1) to identify waterpipe tobacco product packaging and digital marketing; (2) to analyze waterpipe tobacco product packaging and digital marketing to determine whether they contain health claims; and (3) to evaluate the impact of health claims on young adults’ willingness to try the product, product appeal, and perceptions of harm. To achieve Aim 1, researchers will we will select a random sample of 30 waterpipe tobacco manufacturers and purchase five flavors from each manufacturer to document claims made on product packaging (150 packages). Researchers will also randomly select 30 U.S. retailers (i.e., waterpipe cafés, bars, lounges). For each of the 30 manufacturers and 30 retailers identified, researchers will capture content from their websites, as well as capture the 20 most recent Instagram (n=1,200) and Facebook (n=1,200) posts. To achieve Aim 2, researchers will content analyze all the packaging and digital marketing content captured in Aim 1. They will then use an expert panel to determine whether claims found on packaging and in digital marketing are health claims. To achieve Aim 3, researchers will conduct a randomized online experiment with 1,500 young adults (aged 18-29), including waterpipe users or those susceptible to future use, to evaluate the impact of the health claims on willingness to try the product, perceptions of harm, and product appeal. Findings will provide new information about which claims consumers perceive as health claims and may inform related regulatory activities.

Erin L. Sutfin Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA239192-01A1
Institution: Wake Forest University Health Sciences
09/16/2019

Analysis of ENDS Products

The goal of this project is to identify which of the 93 harmful and potentially harmful constituents (HPHCs) identified by the FDA are present in electronic nicotine delivery system (ENDS) products. Using validated testing methods, researchers will analyze ENDS e-liquids (33 e-liquids and four disposable devices containing e-liquid cartridges) and ENDS aerosols (aerosols of the 33 e-liquids produced from 21 different ENDS devices). In addition, researchers will provide relevant information (when available) about the products’ physical attributes and design characteristics, including e-liquid volume or weight, labelled nicotine concentration, power output, resistance, heating coil temperature, and battery capacity.

Karen Carter and Tianrong Cheng Funding Mechanism: Research Contract
ID number: 75F40119D10003
Institution: Enthalpy Analytical
09/13/2019

CTP Supplement to Parent Grant: Center for the Assessment of the Public Health Impact of Tobacco Regulations – Diversity Supplement for Project 3 (TCORS 2.0)

This is a supplement to an existing study titled “Modeling the Impact of Tobacco Control Policies on Polytobacco Use and Associated Health Disparities.” The aims of the supplemental research study are: (1) to evaluate the relationship between perceived discrimination and individual tobacco product use by race/ethnicity and gender; and (2) to evaluate the relationship between perceived discrimination and polytobacco use by race/ethnicity and gender. Using nationally representative data of adults aged 18 years and older, the study will examine the role of perceived discrimination on the use of cigarettes, cigars, pipe, smokeless tobacco, and e-cigarettes, individually and in combination. Importantly, differences by race/ethnicity (i.e., non-Hispanic White, non-Hispanic Black, Hispanic, and other races) and gender will be examined. Findings may lead to a better understanding of the complex interplay between social determinants and tobacco-related health disparities of polytobacco use among racial/ethnic minorities. 

Rafael Meza and David Levy Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3U54CA229974-02S1
Institution: University of Michigan at Ann Arbor
09/13/2019

Modeling the Public Health Impact of a National Menthol Cigarette Ban

The goal of this project is to use microsimulation modeling to estimate the impact of a national menthol cigarette ban on tobacco use and tobacco-related disease, specifically cardiovascular disease (CVD) and tobacco-related cancers. Study aims are: (1) to identify trajectories of cigarette use over time among youth and adults using longitudinal, nationally representative survey data; (2) to conduct a review of studies examining the effects of a menthol cigarette ban on product use; and (3) to build a model of smoking and tobacco-related disease to estimate the impact of a national menthol cigarette ban on smoking, CVD, and tobacco-related cancers. To achieve Aim 1, the researcher will compute transition probabilities of tobacco use behavior (frequency, intensity, flavor preference) over time using Population Assessment on Tobacco and Health (PATH) Study data. To achieve Aim 2, the researcher will synthesize the literature on the impact of a menthol cigarette ban and conduct a meta-analysis to pool data from individual studies, generating critical information for simulation modeling. To achieve Aim 3, the researcher will build a microsimulation model of tobacco use and tobacco-related diseases, incorporate the effect of a national menthol cigarette ban on cigarette use, and estimate changes in smoking, CVD, and tobacco-related cancers that would occur in the total population and in specific socioeconomic and racial/ethnic groups if a ban were implemented. Findings may inform potential regulatory activities on menthol cigarettes.

Sarah D. Mills Funding Mechanism: NIH Grant
ID number: 1K01CA242530-01
Institution: University of North Carolina, Chapel Hill
09/13/2019

Prospective Health Outcomes and Inflammatory Biomarkers Associated with e-Cigarette Use

The goal of this project is to identify validated biomarkers for use in the assessment of electronic nicotine delivery systems (ENDS). By analyzing data from two studies (the COPDGene and UCSD ENDS studies), researchers propose to identify ENDS-related inflammatory biomarkers in ENDS-only and dual (ENDS + cigarette) users and relate these biomarkers to five-year lung health outcomes. COPDGene is an ongoing longitudinal study of >6,000 current and former cigarette smokers; the study is identifying factors that increase chronic obstructive pulmonary disease (COPD) risk and includes detailed longitudinal lung phenotyping data (including chest computed tomography [CT]), genome-wide blood RNA-sequencing, and proteomic data. The UCSD ENDS Study is a study of young ENDS-only users and controls involving detailed assessment of inflammatory biomarkers in the oropharynx, airways and blood. Study aims are: (1) to identify and validate inflammatory transcriptomic and proteomic biomarkers of ENDS exposure in ENDS-only and dual users from the COPDGene five-year study visit; biomarkers will be validated in two independent sets of subjects from the COPDGene ten-year visit and the UCSD ENDS Study; (2) to identify antibody-specific adaptive immune response biomarkers of ENDS exposure in ENDS-only and dual users using adaptive immune receptor repertoire sequencing; and (3) to relate ENDS use and biomarker panels to five-year lung health outcomes using spirometry, chest CT, and questionnaire data from COPDGene. Findings may inform future regulatory activities related to ENDS. 

Peter Castaldi Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01HL147326-01A1
Institution: Brigham and Women’s Hospital
09/13/2019

Using PET to Measure Pulmonary Oxidative Stress in E-cigarette Users

Inducible nitric oxide synthase (iNOS) is an enzyme that is expressed in lung epithelium and causes inflammation, a common pathway for many types of lung disease. Researchers will measure lung inflammation using positron emission tomography (PET) imaging with [18F]-6-(1/2)(2-fluoro-propyl)-4-methylpyridin-2-amine ([18F]NOS), a new PET radiotracer that targets iNOS. The goal of the study is to use this technique to compare lung inflammation in adult (aged 18+) electronic nicotine delivery system (ENDS) users, cigarette smokers, and nonsmokers. Study aims are: (1) to quantify and localize the effects of ENDS use, cigarette smoking, and nonsmoking on lung inflammation, and (2) to examine the effect of ENDS use, cigarette smoking, and nonsmoking on biomarkers of airway and lung inflammation and lung function. To accomplish these aims, 60 subjects (three groups of 20: ENDS users, traditional cigarette smokers who report having smoked ≥10 cigarettes per day for the past year with no history of ENDS use or cannabis smoking, and nonsmoking controls) will complete self-report measures, undergo a one-hour [18F]NOS PET/CT (computed tomography) scan of the chest, provide a breath and blood sample for measurement of biomarkers of airway and lung inflammation, and complete lung function tests using spirometry. Researchers will compare biomarkers of airway (fractional exhaled nitric oxide (FeNO)) and lung inflammation (proinflammatory cytokines TNF-α, IL-1β, and IL-8) and lung function (forced expiratory volume (FEV), forced vital capacity (FVC)). Findings may inform regulatory activities related to ENDS. 

Reagan R. Wetherill Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21HL144673-01A1
Institution: University of Pennsylvania
09/13/2019

The Impact of E-cigarette Marketing Features on Youths’ E-cigarette Perceptions and Use Intentions

The goal of this study is to determine the impact of branded e-cigarette marketing features – such as color, use of people in images, and language specifically targeting smokers – on e-cigarette perceptions and use intentions among youth. Study aims are: (1) to examine the e-cigarette marketing context surrounding youth over time; (2) to assess the impact of e-cigarette marketing features on youth’s e-cigarette perceptions and use intentions; and (3) to explore the impact of branded e-cigarette marketing features on youths’ attention using eye tracking. Studies will be conducted with non-current users of e-cigarettes who are aged 13-17. To achieve Aim 1, the researcher will conduct a longitudinal content analysis over five years, as well as yearly, of print, online, and point-of-sale marketing materials for five brands of e-cigarettes to monitor the potential for youth exposure and to identify e-cigarette marketing trends. To achieve Aim 2, the researcher will first conduct four online focus groups (each with 8-12 youth) to understand their perceptions about e-cigarettes and e-cigarette marketing; the researcher will then conduct an online survey experiment with 600 youth to test the effects of use of color, use of people in images, and language specifically targeting smokers on e-cigarette perceptions and use intentions. To achieve Aim 3, the researcher will use eye tracking technology to objectively measure attention (e.g., dwell time, gaze patterns) among 60 youth exposed to e-cigarette marketing materials. Findings may inform future regulatory activities related to e-cigarette marketing, packaging, and labeling.

Michelle Jeong Funding Mechanism: NIH Grant
ID number: 1K01CA242591-01
Institution: Rutgers University, RBHS-School of Public Health
09/12/2019

CTP Supplement to Parent Grant: Graphic and Text-Based Waterpipe Warning Labels to Combat Harm Misperceptions

This study is a supplement to a parent study that investigated the impact of the placement of text-only or graphic-and-text health warning labels on waterpipes on smoking behavior and toxicant exposure. The supplemental study will investigate warning label placement and whether changes in participants’ waterpipe smoking behavior due to warning labels result in measurable changes in biomarkers of potential harm and puffing behavior. The parent study aims are: (1) to determine the optimal message and placement of the health warning label on a waterpipe to attract user attention; (2) determine the effect of the presence of the optimal text vs. text/graphic vs. no health warning label on a carbon monoxide biomarker, waterpipe puffing behavior, and other behaviors, including perceptions of risk as measured by the social interaction among participants during the waterpipe smoking session; and (3) to explore the impact of the presence of a health warning label (text vs. text/graphic) on smoking behavior at 3 and 6 months post-experiment. For Aim 1, researchers will determine the optimal placement of heath warning labels on different waterpipes using focus group methods (n = up to 36) and eye tracking research (n=72) in samples of young adults ages 18-29 years. For Aim 2, researchers will randomize 246 young adults (ages 21-29 years) to view text-only labels, text/graphic labels, or no health warning label on waterpipes that they smoke ad libitum in a controlled laboratory setting; outcomes will include waterpipe puffing topography measures; subjective ratings of nicotine dependence, craving, and liking/disliking; exhaled carbon monoxide; and conversation topics related to fear, health risks, and the health warning label. For Aim 3, researchers will measure changes in smoking behavior at 3 and 6 months after the experiment. The supplement will add spirometry and genotoxicity measures to the laboratory experiment and the 3-month assessment in order to study lung function and biomarkers of harm, respectively. This study will provide new information about waterpipe health warning labels that may inform regulatory activities. 

Amy K. Ferketich and Marielle C. Brinkman Funding Mechanism: NIH Grant
ID number: 3R01CA229306-02S2(Suppl)
Institution: Ohio State University
09/12/2019

A State-of-Art NMR Technique to Investigate Biologicals Effects of Electronic Nicotine Delivery Systems

More information regarding the molecular structures of electronic nicotine delivery system (ENDS) aerosols and their biological consequences would be useful. The goal of this study is to determine whether ENDS use at different temperatures alters aerosol constituents and/or molecular structure and toxicity by identifying and using metabolic signatures. Specific aims are: (1) to investigate the formation of ENDS aerosols at different temperatures using a magic angle spinning (MAS) technique, and (2) to apply a non-destructive slow-MAS nuclear magnetic resonance (NMR) metabolomics platform to define the dynamic response of lung organotypic cultures to ENDS aerosols. To address Aim 1, researchers will use their recently developed in situ MAS technique, which generates high resolution NMR spectra on samples containing a mixture of gases, liquids, and solids at significantly elevated temperature and pressure. To address Aim 2, researchers will use their lung organotypic culture platform, which enables the investigation of single cell populations (e.g., normal vs. cancer cells) as well as mixed cell populations (e.g., normal/cancer cell co-cultures) to define the baseline metabolome of normal human lung epithelial cells, lung cancer cells, and their mixture as cultures, as well as changes induced by ENDS aerosols generated at different temperatures. Findings may inform regulatory activities related to ENDS.

Jian Zhi Hu Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R21ES029778-01A1
Institution: Battelle Pacific Northwest Laboratories
09/11/2019

Early Phase Pharmacokinetic Analysis of Nicotine in Sprague-Dawley Rats

Nicotine is a naturally occurring alkaloid that is found in many nightshade plants, with most human exposure occurring through exposure to tobacco. The CTP-NCTR InhaleCore Group has recently completed studies evaluating nicotine pharmacokinetics (PK) profiles in rats following a single dose administration by inhalation, oral gavage, and intravenous injection (E07607.01). In these studies, the dose formulations for inhalation exposure consisted of nicotine in propylene glycol and water. PK samples were collected at 10 different timepoints ranging from 3 minutes to 48 hours post-dose exposure. Early PK timepoints (< 15 minutes post-dose) were collected using venous blood via the tail vein (i.e., peripheral source), whereas later PK timepoints were collected using arterial blood via terminal cardiac puncture (i.e., systemic source). For the venous blood to reflect the PK sample of the arterial blood, a minimum of 15 minutes is needed post-dose exposure. In this study, early PK timepoints will be collected using arterial blood via cardiac puncture to obtain a more accurate assessment of nicotine levels post-dose exposure. Two timepoints (5 and 10 minutes) to replace the timepoints from the previous study data collection via the tail vein and one additional 30-minute timepoint will be included, to provide an overlapping datapoint with the previous study data collection via cardiac puncture. Results will provide useful information to characterize nicotine kinetics across different routes of exposure, which is critical for the development of the physiologically-based PK model for nicotine and its metabolites (cotinine and 3-hydroxycotinine) in rodents across different routes of exposure. This scientific data may be used to identify and assess potential public health concerns related to nicotine inhalation exposure and may inform potential nicotine product standards.

Yunan Tang (CTP Contact: Prabha Kc) Funding Mechanism: FDA Internal
ID Number: E07716.01
Institution: National Center for Toxicological Research (NCTR)
09/02/2019

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease

Few studies have examined the effectiveness of currently mandated little cigar and cigarillo (LCC) warnings. The goal of this study is to clarify which LCC warning characteristics (i.e., content, format, size) are most influential in reducing LCC use and how an additional LCC policy, the removal of flavor descriptors on packaging, could influence LCC warning impact. Study aims are: (1) to develop a comprehensive set of effective LCC warning statements and images; (2) to determine whether effective LCC warnings increase LCC quit intentions; and (3) to determine how removal of LCC flavor descriptors on packaging further impacts attention and affective responses to LCC warnings. To address Aim 1, researchers will use existing research and expert review to develop new LCC warnings (text plus images) and test them using online experiments with 500 adult (aged 18-65) LCC users to identify warnings that subjects perceive to be the most effective. To address Aim 2, researchers will conduct a national, web-based randomized controlled trial with 900 adult LCC users to examine whether the most effective warnings identified in Aim 1 encourage quitting compared to the currently mandated warnings and a control condition. To address Aim 3, researchers will conduct an in-person laboratory study with 100 adult LCC users using objective measures of attention (eye tracking), affect (facial electromyography), and arousal (electrodermal activity) to determine how flavor descriptors influence the effectiveness of new warnings compared to currently mandated warnings. Findings may inform regulatory activities related to LCC warnings.

Adam O. Goldstein Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01CA240732-01
Institution: University of North Carolina at Chapel Hill
09/01/2019

Using Social Media for Tobacco Regulatory Intelligence

This research involves two projects that will use artificial intelligence (Al) methods to analyze social media posts and comments. Researchers will apply Al models to messages collected from Twitter and Reddit; these models will enable the timely identification, organization, and analysis of millions of social media posts and comments. Separate models will be developed for Twitter and Reddit, which will allow researchers to compare and contrast findings from the two social media platforms. Project 1 will detect and identify tobacco brands and products from a list of previously established brands and products. Project 2 will identify the mentions of tobacco product-related adverse events (e.g., burns from e-cigarettes, vaping lung illnesses) and the perceived health benefits and harms of tobacco products. Project findings will provide new information that may inform FDA regulatory activities and communications. 

Mark Dredze (CTP contact: Mario Navarro) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005942-04S1
Institution: Johns Hopkins University
09/01/2019

Understanding How Flavors and Nicotine are Used in Electronic Nicotine Delivery Systems Advertising (Phase 2)

This work represents an extension of earlier CERSI-funded analysis of the content of electronic nicotine delivery systems (ENDS) advertising. The goal of Phase 2 of this research is to understand how ENDS design features including flavors are presented in advertising content, as well as how nicotine and its concentration/volume/mass and type (nicotine or nicotine salts, for example) are depicted/communicated in ads. Researchers will purchase ENDS advertisements and their associated spend data (i.e., cost per ad) for 2018-2020 from a media tracking service. The sample will include ENDS ads from magazines (consumer and business-to-business), newspapers, radio, television, out-of-home (e.g., billboards, point-of-sale), and electronic media (e.g., direct-to-consumer emails, online displays, banner ads). Researchers will then content-code the ads for features, focusing on how flavors and nicotine are presented, including written and visual content; ads will also be coded for the prevalence and content of health warnings. Results across all ad years of the Phase 1 and Phase 2 study periods (2015-2020) will be combined. Researchers will analyze the depiction of flavor and nicotine content by advertisement medium over time, the depiction of flavor and nicotine content by medium audience, and marketing investments by manufacturer, brand, advertising medium, and products (including flavor and nicotine features). Researchers will also assess the presence and content of health warnings now required in ENDS advertisements. Findings of this study may be used to inform future regulatory activities related to ENDS marketing. 

Ryan Kennedy (CTP contact: Dannielle Kelley) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005942-03S1
Institution: Johns Hopkins University 
08/30/2019

CTP Supplement to Parent Grant: Assessing the Intended and Unintended Consequences of E-cigarette TV Advertising

This proposed administrative supplement will build upon the parent project, titled “Assessing the Intended and Unintended Consequences of E-cigarette TV Advertising”, to leverage resources and infrastructure to investigate how a newly authorized heated tobacco product, IQOS, will be marketed in Atlanta, GA, the first test market for IQOS in the U.S. Study aims are: (1) to monitor and conduct surveillance of IQOS marketing in retail stores and public events in Atlanta, and IQOS marketing on social media, print media, and via direct mail/email; and (2) to analyze the content of IQOS marketing to determine whether it may target or appeal to tobacco disparity populations defined by gender, age, race/ethnicity, sexual orientation and socioeconomic status. Findings may inform regulatory activities related to heated tobacco products, particularly those related to youth and other priority populations.

Jidong Huang Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3R01CA194681-05S1
Institution: Georgia State University
08/29/2019

CTP Supplement to Parent Grant: The Impact of Design Characteristics on the Modification Potential of Electronic Nicotine Delivery Systems

The goal of this project is to study early adopters of the IQOS heated tobacco product in Atlanta, Georgia by assessing their knowledge, risk perceptions, exposure to marketing, tobacco use history, and reasons for using IQOS; studying their IQOS use experience and behaviors, including dual or poly use with other tobacco products; and investigating their sociodemographics to understand the characteristics of early IQOS adopters. Study aims are: (1) to examine reasons for purchase, use intentions, risk/harm and benefit perceptions, knowledge about tobacco products, marketing exposure, tobacco use history, and sociodemographics among early adopters of IQOS in the greater Atlanta area, and (2) to conduct an in-depth examination of the IQOS retail experience, marketing exposure, and product use behaviors among IQOS early adopters, including experience with using IQOS, patterns of use, and dual or poly use with other tobacco products. To achieve Aim 1, researchers will conduct 400 intercept surveys within the first six months of product release among a convenience sample of adult (aged 18+) consumers who purchase IQOS at the IQOS store at Lenox Square and other Atlanta area retail stores that sell lQOS products. To achieve Aim 2, researchers will conduct six focus groups among IQOS early adopters (three among 20 young adults aged 18-29 and three among 20 adults aged 30+). Findings will provide information about early IQOS adopters. 

Lyudmila Popova Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3R01DA047397-02S1
Institution: Georgia State University
08/23/2019

CTP Supplement to Parent Grant: Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-cigarettes Among Daily and Non-Daily Smokers on Abuse Liability

In this supplement to an existing study titled "Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E­cigarettes Among Daily and Non-Daily Smokers on Abuse Liability," researchers will add a third arm to the study: one that exposes 80 adult daily cigarette smokers (aged 21 and older) to high and low nicotine dose JUUL e-cigarettes, along with very low nicotine content cigarettes (VLNCCs). Parent study aims are: (1) to characterize the effects of dual use of VLNCC and e-cigarettes on abuse liability, nicotine compensation, and product use, liking, and relative reinforcing efficacy among 80 adult daily smokers; (2) to characterize the effects of dual use of VLNCC and e-cigarettes on abuse liability, nicotine compensation, and product use, liking, and relative reinforcing efficacy among 80 adult intermittent smokers; and (3) to characterize the effects of dual product use on abuse liability as measured by retrospective measures, smartphone daily diary, and real-time measures captured via smartphone ecological momentary assessment. The study is obtaining information about the effects of dual use of VLNCCs and e-cigarettes with differing levels of nicotine on nicotine abuse liability, as measured by nicotine compensation, product use and liking, relative reinforcing efficacy, and assessments of withdrawal, craving, affect and satisfaction.  In the parent study, smokers are provided with eGo-T e-cigarettes, which are second-generation devices; given the growth in market share of JUUL, researchers will add a third study arm that will use the same design and measures as existing study arms but will expose smokers to JUUL e-cigarettes rather than the eGo-T product. Findings may inform regulatory activities related to JUUL products.

Paul Cinciripini and Jason Robinson Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3R01DA042526-03S1
Institution: University of Texas, M.D. Anderson Cancer Center
08/19/2019

Tobacco Longitudinal Mortality Study

The Tobacco Longitudinal Mortality Study (TLMS) will examine tobacco use and associated mortality in a large national sample of American households. Researchers will create a TUMS database using data from the Current Population Survey (CPS) Tobacco Use Supplements (TUS) (which includes 3 million individuals), the National Death Index (NDI), the Centers for Medicare and Medicaid Services (CMS), and other health agencies and researchers. Researchers will then link and analyze this data to estimate all-cause and cause-specific mortality outcomes including cardiovascular disease, stroke, heart attack, and respiratory disease (including chronic obstructive pulmonary disease (COPD)) associated with the use of cigarettes, cigars, pipes, hookah, and smokeless tobacco products. Finally, researchers will incorporate data from the National Cancer Institute to assess risks of lung, colorectal and breast cancer. Researchers will assess the mortality and cancer risk of common dual and poly-use patterns and may also examine the influence of tobacco cessation on total mortality, cause-specific mortality and cancer incidence. Findings will provide new information about the link between tobacco use and mortality. 

Norman Johnson and Carol Christensen Funding Mechanism: Research Contract
ID number: 75F40119S90002
Institution: US Census Bureau
08/15/2019

Impact of Flavor on Youth & Young Adults use Intention, Abuse Liability and Perceptions of Cigarillos

The goal of this study is to examine the impact of characterizing flavors in cigarillos on product appeal, attention to marketing, product perceptions, abuse liability, and subsequent use behavior among youth (ages 14-20) and young adults (ages 21-28). Study aims are: (1) to evaluate perceptions of flavors on appeal, purchasing and risk perceptions of cigarillo products among young adult and adolescent cigarillo users; (2) to examine differences in visual attention and risk perceptions of flavored and unflavored cigarillo advertisements among young adult cigarillo users and nonusers; and (3) to evaluate, in an experimental tobacco marketplace, the abuse liability/addictive potential of flavored versus unflavored cigarillos while simultaneously evaluating the substitutability of flavored versus unflavored JUUL e-cigarettes. To achieve Aim 1, researchers will ask 392 youth and young adult cigarillo smokers to quantitatively rate the role of flavor and report perceptions of product appeal, health risk, advertising exposure and use intentions; participants will also complete purchase and substitution tasks. To achieve Aim 2, researchers will use eye tracking equipment to compare visual attention across a set of flavored only, unflavored only, or mixed advertisements for cigarillo products and JUUL in a randomized experiment involving 150 young adult and adolescent users and non-users; participants will provide absolute and relative risk perception ratings immediately and one week after advertisement exposure. To achieve Aim 3, researchers will randomly assign 162 young adult cigarillo users to one of four conditions in an experimental online store with different products available: (1) flavored cigarillos and fruit-flavored JUUL devices, (2) unflavored cigarillos and fruit-flavored JUUL devices, (3) flavored cigarillos and tobacco-flavored JUUL devices, or (4) unflavored cigarillos and tobacco-flavored JUUL devices; researchers will then evaluate purchasing behavior, price sensitivity, product substitutability, and motivation to quit. Findings may inform regulatory activities related to cigarillos.

Erika Trapl Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01DA048529-01A1
Institution: Case Western Reserve University
08/15/2019

Blood and Brain Based Biomarkers of Injury to Assess the Cerebrovascular Impact of Emerging Alternatives to Classic Cigarette Products

While traditional measures exist for assessing cardiovascular and respiratory health in response to the short- and long-term effects of tobacco smoking and, to a lesser extent, e-cigarette use, more data concerning the cerebrovascular toxicity of these products would be useful. The goals of this study are to investigate the impact of cigarette smoking vs. e-cigarette use on the brain microvascular environment; validate selected biomarkers associated with pro-thrombotic alteration of blood hemostasis (increased risk of stroke) and severity of post-ischemic brain injury in response to chronic exposure to tobacco smoking and/or e-cigarette use; and evaluate the relevance of selected biomarkers in assessing e-cigarette vs. tobacco smoking harm with respect to blood-brain barrier viability, neurovascular inflammation, onset of stroke, and stroke outcome. Study aims are: (1) to assess the cerebrovascular impact of e-cigarette vaping and JUULing vs. tobacco smoking in mice and develop potential biomarkers to determine harm/toxicity; and (2) to evaluate and validate the impact of chronic exposure to e-cigarettes and JUUL vs. tobacco smoking on the risk of stroke, secondary brain damage, and post-ischemic neurological impairments in mice. To address Aim 1, researchers will compare the harm/toxicity of vaping/JUULing vs. tobacco smoking on the blood-brain barrier and will evaluate potential biomarkers of harm. To address Aim 2, researchers will compare the impact of tobacco smoking and vaping/JUULing on brain vascular damage, focusing specifically on the impact on stroke risk and outcomes using brain and blood-based biomarkers specific to inflammation, hemostasis and antioxidative response that were evaluated in Aim 1. Findings may inform regulatory activities related to cigarettes, e-cigarettes, and JUUL.

Luca Cucullo and Thomas Abbruscato Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R01DA049737-01
Institution: Texas Tech University Health Science Center
08/14/2019

Physical and Chemical Characterization of Aerosols Produced by Nicotine Salt Based E-Liquids

E-liquids containing nicotine salts of volatile organic acids can deliver nicotine more rapidly and efficiently than traditional free-base nicotine formulations. Manufacturers have incorporated this formulation into electronic nicotine delivery systems (ENDS) production, and nicotine salt-based products (led by JUUL) now have a major share of the U.S. ENDS market. More information regarding the chemical and physical characteristics of nicotine salt-based ENDS would be useful, specifically related to how nicotine salt aerosols differ from those produced by other nicotine formulations, which characteristics may influence nicotine delivery, and whether nicotine salt aerosols have a different profile of harmful and potentially harmful constituents (HPHCs). The goal of this project is to provide comparative data on the aerosol characteristics and HPHC profiles of nicotine salt and free-base nicotine ENDS. Researchers will develop and validate a set of analytical methods that will physically and chemically characterize nicotine salt e-liquids and the aerosols produced by both nicotine salt and free-base nicotine e-liquids. Findings will provide information about how nicotine formulation affects nicotine delivery and HPHC emissions.

Karen Carter and Margaret Schmierer Funding Mechanism: Research Contract
ID number: 75F40119D10003
Institution: Enthalpy Analytical 
08/13/2019

Respiratory Effects of E-Cigarette Use Among Youth: A Prospective, Longitudinal Investigation

More information about the acute and chronic pulmonary and respiratory effects of e-cigarettes would be useful. The goal of this study is to investigate pulmonary functioning and respiratory effects among 150 youth aged 15-17 years, 100 of whom are exclusive-e-cigarette users and 50 of whom are never-users. Study aims are: (1) to compare changes over one year in pulmonary functioning and respiratory health between exclusive e-cigarette users and never-users in repeated laboratory sessions; and (2) to identify a dose-response relationship between quantity/frequency of e-cigarette use (via daily self-monitoring on a mobile phone app) and acute changes in pulmonary functioning (via same-day, home-based spirometry measurements). To achieve Aim 1, subjects will complete one baseline and four subsequent laboratory assessments over one year to provide a comprehensive assessment of respiratory health (e.g., airway reactivity, airway inflammation, pulmonary functioning). To achieve Aim 2, subjects will track their e-cigarette use by using a mobile phone app and take home-based spirometry measurements daily for four two-week periods (one prior to each laboratory assessment) so that the immediate acute effects of e-cigarette use on respiratory markers can be tracked. Findings may inform regulatory activities related to e-cigarettes. 

Alayna Pauline Tackett Funding Mechanism: NIH Grant
ID number: 1K01HL148907-01
Institution: University of Oklahoma, Health Sciences Center
08/09/2019

Modeling the Impact of Flavor Bans Among Young Adult Tobacco Users Using Discrete Choice Experiments and Agent-Based Modeling

The goal of this study is to examine the impact of two flavor ban alternatives on young adults (aged 18-34) who are recent (past 30-day) users of tobacco products including electronic nicotine delivery systems (ENDS). Products studied will include menthol cigarettes; flavored cigars, cigarillos, and little cigars; and menthol and non-menthol flavored ENDS. Study aims are: (1) to assess product switching after implementation of a flavor ban and examine related determinants; (2) to estimate consumer response to hypothetical flavor bans using discrete choice experiments; and (3) to examine the impact of flavor ban policies using agent-based models. To address Aim 1, researchers will conduct an online survey among 600 young adult tobacco/ENDS users to assess product switching behavior after implementation of a flavor ban in San Francisco; researchers will evaluate flavor ban compliance enforcement, examine switching patterns, and analyze the determinants of changes in product use. To address Aim 2, researchers will conduct online discrete choice experiments with 600 young adults to estimate the impact of hypothetical flavor bans on product demand. They will examine multiple flavor ban policies related to menthol cigarette and flavored ENDS and will estimate the effects of product, flavor, price, nicotine content, and perceived harmfulness on smoker/user behavior. To address Aim 3, researchers will develop simulation models that capture the key determinants of switching behaviors and use the models to examine the impact of various flavor ban policies on switching behaviors as well as conversations between tobacco retailers and consumers. Researchers will also examine additional intervention strategies (price/tax policy, mass media campaign, smoking cessation program) that may work in concert with flavor ban policies. Findings will provide new information about the effects of tobacco product flavor bans on young adult use behavior.

Yong Yang Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 1R03DA048460-01A1
Institution: University of Memphis
07/30/2019

Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers with a Mental Health Condition

Individuals with mental health conditions are particularly vulnerable to tobacco use. The goal of this project is to determine the likely health effects of use of very low nicotine content (VLNC) cigarettes, in conjunction with availability of nicotine-containing e-cigarettes, in adult smokers (aged 18-65) with mental health conditions. Study aims are: (1) to determine whether smokers with mental health conditions have lower levels of markers of harm (e.g. urine NNAL, carbon monoxide [CO]), measures of mental health, and cigarette addiction when switched to VLNC cigarettes for 16 weeks, as compared with normal nicotine content cigarettes (NNCs); (2) to determine whether smokers with mental health conditions have lower levels of markers of harm and cigarette addiction when provided with nicotine-containing (15mg/ml) versus zero nicotine e-cigarettes in order to switch to e-cigarettes or lower their cigarette consumption; and (3) to determine whether use of VLNCs increases the proportion of smokers who completely switch away from combustible tobacco use, as assessed four weeks after the end of the randomized phase of the trial. Researchers will randomize 240 smokers with mental health conditions to one of four groups: (1) NNCs (11mg nicotine/cigarette) and 15 mg/mL nicotine e-cigarettes; (2) NNCs and zero mg/mL nicotine e-cigarettes; (3) VLNCs (0.2 mg nicotine/cigarette) and 15mg/mL nicotine e-cigarettes; and (4) VLNCs and zero mg/mL nicotine e-cigarettes. Subjects will be followed for 16 weeks on study products and then another four weeks thereafter. At the end of the 16-week phase, participants will attend their last visit, receive encouragement to quit all tobacco products, and notified of community resources where they can receive smoking cessation counseling. Participants will be asked to provide information about their intentions for ongoing tobacco product use or cessation and will be followed for four weeks to assess these outcomes; those claiming to be no longer using combustible tobacco products will be visited to verify with a measure of exhaled CO. Study findings may inform regulatory activities related to VLNCs.

Jonathan Foulds Funding Mechanism: NIH Grant
ID number: 1R01DA048428-01
Institution: Pennsylvania State University
06/28/2019

SmartVape: Real-Time Assessment of ECIG Device Characteristics using a Smartphone App

Most e-cigarettes use an electrically-powered heater to aerosolize a liquid that usually contains nicotine, a solvent (i.e., propylene glycol and/or vegetable glycerin), and flavorants. The power of the e-cigarette device, which is based on the device’s operating voltage and heater resistance, varies across devices and is a major determinant of how much nicotine and other toxicants are aerosolized. The goal of this study is to develop a tool to assess e-cigarette power objectively in real-world settings. Study aims are: (1) to standardize methods for e-cigarette and e-liquid image capture; (2) to develop the SmartVape app and supporting software; and (3) to test the app’s usability and data quality in real-world conditions. Researchers will develop a smartphone app (SmartVape) designed for e-cigarette users to capture images of their devices and e-liquid. On a back-end server, an operator will be able to compare these images to an image-based product registry with known data on device characteristics and e-liquid nicotine content. The result will be the ability to assess accurately the device used and the amount of liquids consumed over a discrete time period. With this information, researchers will be able to estimate nicotine intake from e-cigarettes more accurately in real-world settings. To address Aim 1, researchers will recruit 200 adult (aged 18+) e-cigarette users who will bring all of their e-cigarette devices and e-liquids to a laboratory, where the devices will be measured and photographed. To address Aim 2, researchers will develop the app and the image-based product registry. To address Aim 3, 50 adult e-cigarette users will use the app to record the devices and liquids they use over a 14-day period. The tool will provide a feasible and objective method for assessing e-cigarette device and e-liquid characteristics in surveillance research.

Bernard Fuemmeler and Thomas Eissenberg Funding Mechanism: NIH Grant
ID number: 1R21CA239188-01
Institution: Virginia Commonwealth University
06/26/2019

Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

In July 2017, FDA announced a comprehensive approach to tobacco and nicotine regulation that includes moving toward a very low nicotine content (VLNC) standard for cigarettes. The goal of this study is to reduce unintended consequences of a VLNC policy by developing campaign messages that address the common public misperception that VLNC cigarettes are safer to smoke than normal nicotine content cigarettes (a misperception that could potentially lead to lower quit rates). Study aims are: (1) to develop communication campaign messages that address the misperception that VLNC cigarettes are less likely to cause cancer than current cigarettes; and (2) to determine whether selected campaign messages reduce this misperception. Researchers will first develop 24 potential campaign messages and will obtain feedback from a panel of communication experts to refine the messages. Next, they will conduct an online experiment in 1,000 adult (ages 18 and older) smokers to identify the six most effective messages; conduct six focus groups, each with 8-10 adult smokers, to obtain feedback about the six messages; and work with the expert panel to select three messages for evaluation. They will then conduct an online experiment with a nationally representative sample of 1,096 adult smokers to understand the extent to which the three campaign messages reduce VLNC misperceptions and increase motivation to quit if a VLNC standard is enacted. Study findings may inform communication campaigns about VLNC cigarettes.

M. Justin Byron Funding Mechanism: NIH Grant
ID number: 1R21CA234968-01A1
Institution: University of North Carolina at Chapel Hill
06/21/2019

Investigation into Waterpipe Physical Design Parameters' Effects on HPHC yields in Smoke and Charcoal Emissions (Phase II)

The goal of this project is to investigate the relationship between waterpipe physical parameters and harmful and potentially harmful constituent (HPHC) yields. Researchers will methodically isolate and alter individual waterpipe physical parameters (e.g., hose length; stem length, stem depth in water) and determine how these parameters affect yields of HPHCs such as quantities of aldehydes, metals, nicotine, tobacco-specific nitrosamines (TSNAs), and volatile organic compound (VOC) levels in waterpipe tobacco smoke. Phase II of this project seeks to determine how waterpipe dimensions affect waterpipe tobacco smoke chemistry and explores the need for a standardized testing waterpipe. Findings may provide new information about a standard waterpipe design for waterpipe tobacco product testing.

Timothy Fennell and Megan Mekoli Funding Mechanism: Contract
ID number: 75F40119P10251
Institution: RTI
06/15/2019

Impact of Flavors on Nicotine Perception and Self-Administration via E-cigarettes

Mechanisms by which flavors impact the initiation and maintenance of tobacco use are not well understood. Existing evidence suggests that flavors may enhance the appeal of and facilitate the development of addiction to tobacco products by influencing nicotine's reinforcing or aversive actions. The goal of this study is to examine whether menthol and fruit flavors impact e-cigarette use through specific behavioral mechanisms and exert different effects across nicotine concentrations. Study aims are to assess the impacts of nicotine and flavor (and their interactions) on participants' subjective ratings of different e-liquids and the cumulative amounts of self-administered e-liquids.  Fifty young adults (ages 18-30 years) will be asked to attend four test sessions each. Each test session will consist of two components. During the first component, subjects will use five different e-cigarettes and will be directed to take two 4-second puffs at 15-second intervals for each e-cigarette, with a 5-minute break between each e-cigarette. Subjects will be asked to self-administer a total of 12 puffs of the e-cigarette across approximately half an hour. They will be asked to report subjective effects for each e-cigarette during the 5-minute breaks using the Drug Effects Questionnaire (DEQ). In the second component, subjects will be given access to the same five e-cigarettes and be allowed to use them as they choose for 45 minutes in total; researchers will track number of puffs. The sessions will be identical except that the e-liquids in the e-cigarettes will differ between sessions. The subjects will use 20 e-liquid types across the entire study (4 test sessions x 5 e-liquid conditions per session) and the e-liquids will vary by flavor (unflavored, menthol, menthol mint, green apple, watermelon) and nicotine level (0, 6, 12, 24 mg/ml nicotine). The order of flavors and nicotine levels will be randomly assigned to each subject and neither the subject nor the researcher will be told the order. This study will provide new information about the impact of flavors on e-cigarette use.

Elise DeVito Funding Mechanism: NIH Grant
ID number: 1R01DA046360-01A1
Institution: Yale University
06/12/2019

Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users

The rapid increase in dual use of flavored little cigars/cigarillos (LCCs) with cigarettes among U.S. young adults has significant implications for their health, addiction, and cessation. The goal of this study is to determine the addiction potential of flavored and unflavored LCCs compared with cigarettes, and if addiction potential varies by flavor and sex, among young adult (ages 18-34) dual users. Study aims are: (1) to characterize the addiction potential of LCCs compared with cigarettes; (2) to determine the extent to which the addiction potential of LCCs varies by flavor and sex of user; and (3) to determine the extent to which flavoring affects LCC use in the natural environment. The study will be conducted over three weeks with 145 young adult dual users of cigarettes and LCCs. Participants will be asked to substitute preferred flavor LCCs for one week and unflavored LCCs for one week in place of their normal LCCs. The study will include survey-based measures and ecological momentary assessments (EMAs) of addiction potential, dependence, and tobacco use, and biomarkers of exposure (exhaled carbon monoxide and urinary cotinine). Addiction potential of cigarettes and LCCs will be characterized by behavioral economic indices of demand (such as hypothetical consumption at escalating prices) and other standardized measures to address Aims 1 and 2. Participants will record their tobacco use, craving, mood, and setting using EMA on their mobile phones to address Aim 3. This study will provide new information about LCCs that may inform regulatory activities. 

Erin Mead Funding Mechanism: NIH Grant
ID number: 1K01DA048494-01
Institution: University of Connecticut School of Medicine
05/24/2019

Understanding the Association Between Electronic Cigarette Aerosol Emissions, Tobacco Product Characteristics and User Topography and Consumption Behavior

There is a lack of consensus regarding appropriate metrics for reporting e-cigarette emissions.  The total particulate mass concentration, CTPM, of whole aerosol emissions is dependent upon both user topography behavior and e-cigarette/e-liquid product characteristics; the mass ratio of harmful and potentially harmful constituents (HPHC) (fHPHC) and nicotine (fNic) present in aerosol emissions are different functions of topography behavior and product characteristics. The researchers propose a theoretical framework that defines the product of the two terms as HPHC mass concentration: CHPHC [mg/mL] = fHPHC [mg/mg] x CTPM [mg/mL]; similarly, for nicotine, CNic [mg/mL] = fNic [mg/mg] x CTPM [mg/mL];. The goals of this study are to use this framework to develop a standardized test protocol for e-cigarettes and e-liquids, propose standardized emissions outcome measures, and inform the development of criteria to distinguish low- and high-dose ENDS. Study aims are: (1) to conduct screening studies of 24 e-cigarette products and 8 e-liquid compositions to inform the creation of a formal, standardized e-cigarette emissions test protocol; (2) to evaluate total particulate mass concentration as a function of product characteristics and user topography behavior; and (3) to evaluate HPHC and nicotine mass ratio of emissions present in whole aerosol as a function of product characteristics and user behavior characteristics. Findings may inform standardized testing processes for e-cigarette emissions. 

Edward Hensel Funding Mechanism: NIH Grant
ID number: 1R21ES029984-01A1
Institution: Rochester Institute of Technology
05/21/2019

Differences in Inflammation, Cardiovascular Risk Factors and Respiratory Health with Use of Menthol Cigarettes: Informing the Regulation of Tobacco Flavorings to Protect Public Health

There is limited information regarding potential differences in cardiovascular risk factors or respiratory health with menthol cigarette use. The goal of this project is to evaluate differences in systemic inflammation, cardiovascular risk factors, and respiratory health with use of menthol cigarettes among US smokers. Researchers will use interview, physical examination, and biological specimen data from 9,880 adult current smokers who participated in the National Health and Nutrition Examination Survey (NHANES), a series of nationally-representative surveys of the US population, from 1999 through 2016. Study aims are to evaluate the associations between menthol compared to nonmenthol cigarette use by analyzing: (1) markers of systemic inflammation (C-reactive protein, fibrinogen, white blood cell count, and homocysteine); (2) cardiovascular risk factors (hypertension, diabetes, and reduced kidney function); and (3) respiratory health outcomes (fractional exhaled nitric oxide levels, spirometry-defined pulmonary impairment, past year wheeze, and frequent cough and frequent phlegm). Findings may inform regulatory activities related to menthol cigarettes.

Miranda Jones Funding Mechanism: NIH Grant
ID number: 1R03HL147318-01
Institution: Johns Hopkins University
05/21/2019

Mitochondrial Genetic Alterations: A Clinical Trial of a Standardized Research E-cigarette

E-cigarettes may have the potential to reduce harm for current smokers, but additional research on target organ toxicity (e.g., the respiratory tract) would be useful. This study will focus on the effects of e-cigarette use on mitochondrial DNA (mtDNA) in the lung and nasal tract. Researchers will use bronchoscopy to evaluate the lungs of smokers who are switched to e-cigarettes, namely the National Institute on Drug Abuse (NIDA) Standardized Research E-cigarette (SREC). In this study, 96 smokers aged 21-45, following baseline bronchial and nasal brushings, will be randomized to continue smoking their usual brand (control group), completely switch to the SREC, or receive nicotine replacement therapy (NRT). A follow-up bronchial and nasal brushing will be done after two months of use. Study aims are: (1) to assess changes in mtDNA genetic features (mutations and copy numbers) in the bronchial and nasal epithelium of smokers randomized to continued smoking, exclusive e-cigarette, or NRT use; (2) to investigate whether changes in mtDNA alterations are associated with lung inflammation and gene expression; and (3) to compare mtDNA alterations between bronchial and nasal samples. This study will determine the extent to which mtDNA alterations as a biomarker of harm are reduced following the use of e-cigarettes and provide evidence for the use of nasal epithelium for noninvasive biomarkers of harm. 

Min-Ae Song Funding Mechanism: NIH Grant
ID number: 1R21HL147401-01
Institution: The Ohio State University
05/21/2019

Electronic Cigarette Cardiotoxicity Varies by Flavorings: What Can We Learn from Mice?

More information about the potential pulmonary toxicity of e-cigarette flavorings would be useful.  The goal of this study is to evaluate whether long-term (three-month) inhalation exposure of adolescent mice to flavored e-cigarette aerosols leads to changes in pulmonary blood vessels (vasculature) -- such as inflammation, pulmonary remodeling, artery thickening, and increase in right ventricular systolic pressure -- that predispose adult male and female mice to pulmonary hypertension. Researchers selected flavors (vanilla, cinnamon, menthol, double apple hookah, and peach schnapps) based on human usage and published diacetyl levels. The study aim (with multiple sub-aims) is: (1A) to determine whether three-month inhalation exposure of adolescent mice to e-cigarette aerosols (with or without flavorings) produces changes in pulmonary vasculature; (1B) to investigate the time course of effects by examining changes associated with the development of pulmonary hypertension and/or emphysema on days 30, 60, and 90; and (1C) to determine persistent effects 90 days after cessation of the three-month exposure. Study findings may inform regulatory activities related to flavored e-cigarettes.

Judith Zelikoff Funding Mechanism: NIH Grant
ID number: 1R21HL142507-01A1
Institution: New York University School of Medicine
05/21/2019

Oxidant Exposure and Related Harm from Tobacco Smoke

Oxidants are a major class of toxicant in tobacco smoke and likely play a critical role in the development of tobacco-related diseases including chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD), and cancer by causing oxidative stress/damage and inflammation. However, the specific oxidants most responsible remain unclear. The goals of this project are to identify specific oxidants responsible for tobacco-related harm and determine the impact of oxidant reduction on tobacco-related toxicity endpoints. Study aims are: (1): to determine the levels and identity of free radicals and other oxidants delivered by different combustible tobacco products/brands using advanced electron paramagnetic resonance (EPR) spectroscopy and liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodologies; (2) to determine the impact of tobacco smoke oxidants on lung damage and inflammation, comparing effects of high vs. low oxidant brands and tobacco varieties, in mice; and (3) to determine the impact of charcoal filtration of cigarette smoke on oxidant-induced lung damage in mice. Findings will reveal new information on the toxicological importance of oxidant exposure.

John Richie Funding Mechanism: NIH Grant
ID number: 1R01HL147344-01
Institution: Pennsylvania State University
05/20/2019

Impact of New Standards for Tobacco Products among Dual E-cigarette/Combusted Cigarette Users

Dual users of e-cigarettes and combusted cigarettes comprise 40% of multiple tobacco product users. The goal of this research is to evaluate the potential effects of limiting e-cigarette/e-liquid flavors to tobacco-only on preference for combusted cigarettes. In this study, 280 adult dual users (aged 18 and older) will undergo preference sessions during which they will make choices between an e-cigarette and a combusted cigarette. Study aims are to evaluate users’ self-reported anticipated choices if e-liquid flavors would be limited to tobacco only on: (1) choices for usual brand cigarettes; (2) choices for menthol and non-menthol cigarettes (among menthol-preferring participants); and (3) choices for cigarettes with normal nicotine content versus very low nicotine content. Findings may inform regulatory activities related to product standards. 

Francis McClernon Funding Mechanism: NIH Grant
ID number: 1R01DA048454-01
Institution: Duke University
05/20/2019

The Role of E-cigarette Characteristics and Constituents in Cardiac Dysfunction

The acute and chronic health effects of e-cigarettes are mostly unknown. The goal of this project is to identify specific e-cigarette device characteristics and constituents associated with cardiac toxicity. Researchers will conduct electrocardiogram (ECG) and programmed stimulus electrophysiology (EP) studies in mice to test the hypothesis that e-cigarettes induce electrical disturbances in the heart that are related to e-cigarette characteristics and constituents. Study aims are: (1) to determine how device characteristics influence the acute electrophysiologic effects of e-cigarettes in mice, and (2) to assess the impacts of chronic e-cigarette exposure on cardiac electrophysiology and hemodynamics. Real-time cardiac physiology will be monitored during and after acute exposures to aerosols of e-cigarettes with various characteristics (device type, user settings, nicotine levels) to determine how they affect both harmful and potentially harmful constituent (HPHC) production and ECG measures of cardiac dysfunction. The device characteristics with the greatest and smallest acute cardiac effects will be selected for chronic exposure studies that will comprehensively assess cardiac EP and hemodynamics. E-cigarette exposure groups will be simultaneously compared to cigarette smoke and filtered-air exposure groups. This study will present new data regarding the relative cardiac toxicity of different e-cigarette devices, constituents, and settings, particularly with regard to their potential to cause cardiac arrhythmia.

Alex Carll Funding Mechanism: NIH Grant
ID number: 1R01HL147343-01
Institution: University of Louisville
05/17/2019

Impact of Novel Heat-not-Burn Cigarettes on Pulmonary Inflammation and Immunity

More information about the impact of heat-not-burn (HnB) aerosols generated from a product called IQOS on pulmonary inflammation and immunity to pathogens that cause respiratory diseases would be useful. The goal of this project is to determine whether HnB aerosol inhalation results in pulmonary damage and suppresses the immune response to respiratory infection and vaccination. Researchers will compare the potential effects of HnB aerosol inhalation exposure to effects caused by cigarette smoke and e-cigarette aerosols in both male and female mice. Study aims are: (1) to evaluate whether chronic inhalation exposure to HnB aerosol has the potential to cause lung inflammation and prompt changes in inflammatory cell numbers and cytokine levels in the lung, thereby altering the innate immune response; (2) to evaluate whether chronic inhalation of HnB aerosol creates an environment in the lungs that has the potential to impair adaptive immune responses to a vaccine and reduce the ability to overcome infection in the lung; and (3) to evaluate whether transition to HnB use following tobacco smoke exposure hinders the reduction in pulmonary inflammation and immune suppression that could be achieved by true cessation. Findings will provide new insights on the health risks of HnB products.

Yasmin Thanavala Funding Mechanism: NIH Grant
ID number: 1R01HL142511-01A1
Institution: Roswell Park Cancer Institute Corp
05/17/2019

The Impact of E-Cigarette Advertising and Warning Labels on E-Cigarette Use Behavior in Adolescents

Images of sweet/fruit flavors on e-cigarette advertisements may distract youth from health warnings. To better understand how these factors impact youth e-cigarette use, researchers will use functional magnetic resonance imaging (fMRI) and eye tracking to link neural responses to e-cigarette advertising and health warnings to future e-cigarette use in 80 adolescents aged 14-17 years. Participants will view e-cigarette advertisements and health warnings and complete quarterly follow-up surveys for one year. Medial prefrontal cortex (MPFC) and nucleus accumbens (NAc) activity will be measured and tested for relationships with future e-cigarette attitudes, intentions and use. Researchers will also test the specific impact of different categories of health warnings and different flavors and the interactions between these factors, including impact on memory of health warnings. Study aims are: (1) to test the hypothesis that greater MPFC activity as adolescents view e-cigarette health warnings will be related to more negative e-cigarette attitudes and intentions and lower use of e-cigarettes in the next year; (2) to test the hypothesis that greater NAc activity as adolescents view e-cigarette advertisements will be related to more positive e-cigarette attitudes and intentions and greater use of e-cigarettes in the next year; and (3) to compare the relative value of multiple measures –fMRI, eye tracking and surveys -- to predict future e-cigarette use in the next year. This project will generate evidence on the impact of e-cigarette advertising and health warnings on youth e-cigarette use and may inform regulatory activities related to flavors, labeling and marketing. 

Kathleen Garrison Funding Mechanism: NIH Grant
ID number: 1R01DA046334-01A1
Institution: Yale University
05/09/2019

Age of Initiation of Tobacco Products Among USA Youth and Young Adults

Estimating the age of onset of tobacco product initiation, transition or trajectories of patterns of use, and correlates of use among U.S. youth and young adults could be informative. This study involves a prospective secondary analysis of the first three waves of the Population Assessment of Tobacco and Health (PATH) Study among U.S. youth (aged 12-17 years) and young adults (aged 18-24 years) who reported never use at Wave 1. Use of the following tobacco products will be analyzed: cigarettes, e-cigarettes, cigars (traditional cigars, cigarillo, filtered cigars), hookah, and smokeless tobacco. Seven outcomes will be evaluated for each product: age to first report ever or past 30-day use, age to become susceptible to use, age to be an established user (i.e. ever use fairly regularly), age to first report dual/poly use, age to report first use of a flavored product, and age of ever combustible use. Study aims are: (1) among youth who were never users at Wave 1, to estimate their age of initiation of tobacco products and to identify the risk factors associated with age of initiation of each product; (2) among young adults who were never users at Wave 1, to estimate their age of initiation of tobacco products and to identify the risk factors associated with age of initiation of each product; and (3) among all participants, to identify trajectories and transitions in the onset of tobacco product use across time and to identify associated risk factors. Researchers will explore socio-demographic, interpersonal, intrapersonal, social, and environmental factors potentially associated with the age of initiation of the different products. This study will provide new data regarding tobacco product use trajectories among youth and young adults.

Adriana Perez Funding Mechanism: NIH Grant 
ID number: 1R01CA234205-01A1
Institution: The University of Texas
05/08/2019

Understanding the Real-World Impact of the Use of Three Alternate Nicotine-Delivery Products on Combustible Cigarette Use

In this study, researchers will examine how well e-cigarettes and very low nicotine content cigarettes (VLNCs) substitute for combustible cigarettes in real-world settings and whether this is influenced by nicotine patch use. Study aims are: (1) to examine the ability of VLNCs, e-cigarettes, and no alternative product to substitute for smokers’ usual cigarettes in real-world settings and whether these effects are influenced by nicotine replacement; and (2) to examine the effects of VLNC, e-cigarette, and no alternative product use on the use of study products and the underlying mechanisms that drive such use and whether these effects are influenced by nicotine replacement. Researchers will randomly assign 180 daily smokers aged 18 and older who are not planning to quit smoking to one of three study conditions: VLNCs, Juul e-cigarettes, or no alternative product. Participants will have access to these products for four weeks. During two different weeks, participants will be asked to switch from their usual cigarettes and use only their assigned study product. They will also be asked to use either a nicotine or placebo patch. Participants will record each time they use their own cigarettes or the alternative product in real time via a smartphone, and, for some use events, answer questions about the use context (e.g., affect, smoking permitted) and possible mechanisms driving use behavior (e.g., withdrawal alleviation, taste, satisfaction). Researchers will also examine the impact of factors such as sex, dependence, psychiatric comorbidity, and risk perceptions on use behavior. Findings may inform regulatory activities regarding e-cigarettes and VLNCs.

Megan Piper Funding Mechanism: NIH Grant
ID number: 1R01CA239309-01
Institution: University of Wisconsin-Madison
02/26/2019

Investigation into Waterpipe Regimen Effects on HPHC Yields in Smoke and Project Title Charcoal Emissions (Phase l)

The goal of this project is to investigate the relationship between waterpipe smoking regimen parameters and harmful and potentially harmful constituent (HPHC) yields. Researchers will methodically isolate and alter waterpipe smoking regimen parameters (e.g., puff duration, puff volume, interpuff interval) and determine how these parameters affect yields of HPHCs such as quantities of aldehydes, metals, nicotine, tobacco-specific nitrosamines (TSNAs), and volatile organic compound (VOC) levels in waterpipe tobacco smoke. Phase I of this project focuses on the way waterpipes and waterpipe tobaccos are smoked and seeks to determine how these parameters affect waterpipe tobacco smoke chemistry. Findings may provide new information about intense and non-intense smoking regimens for waterpipe tobacco product testing.

Timothy Fennell and Megan Mekoli Funding Mechanism: Contract
ID number: HHSF223201910059P
Institution: RTI
02/14/2019

Analysis of Tobacco Filler/Matrix-Specific HPHCs

The goal of this study is to identify which of the 93 harmful and potentially harmful constituents (HPHCs) identified by the FDA are present in tobacco products currently marketed in the U.S. Researchers will use validated analytical testing methods to conduct qualitative and quantitative analyses on 27 brands of cigarette tobacco fillers, 24 brands of roll-your-own tobacco fillers, 27 brands of smokeless tobacco fillers, and 21 brands of waterpipe tobacco fillers. Findings may inform regulatory activities regarding HPHCs. 

Karen Carter and Tianrong Cheng Funding Mechanism: Research Contract
ID number: HHSF2232013100381
Institution: Enthalpy Analytical
11/01/2018

Identification and Validation of a Biomarker of Electronic Cigarette Exposure

The goal of this study is to identify and confirm a biomarker specific to e-cigarette use and secondhand exposure. Study aims are: (1) to confirm that the exact oligomer compounds formed by the thermal degradation of propylene glycol (PG) and vegetable glycerin (VG) are unique to e-cigarettes and not common in other tobacco products; and (2) to determine whether these chemicals or their metabolites are found in urine and/or blood specimens of e-cigarette users and bystanders who experience secondhand exposure. Researchers will confirm the chemical structure of the VG and PG oligomers formed during e-cigarette use. This information will guide a review of the literature to identify metabolites and metabolic pathways in urine and adducts in blood specimens and to inform the selection of the most appropriate biospecimen analytical approach. Researchers will then collect and analyze blood (serum and plasma) and urine from 63 e-cigarette users, conventional cigarette smokers, and non-users (ages 18 and older) to determine whether the biomarker is unique to e-cigarette users and present at measurable concentrations in the aerosol produced from 20 e-liquids. Upon agreement from FDA that a biomarker unique to e-cigarette aerosol has been identified, researchers will proceed with additional experiments to develop an empirical model that predicts the mass of the biomarker produced per puff. This model will correlate e-cigarette use with biomarker intensity in the biospecimens collected as part of a later study of e-cigarette user exposure and secondhand exposure. Study findings may provide the identification of a unique biomarker of e-cigarette use to be used in epidemiological and clinical studies that evaluate the acute and chronic health effects from e-cigarette use and secondhand exposure.

Jonathan Thornburg (CTP Contact: Marcella Ferlito) Funding Mechanism: Research Contract
ID Number: HHSF223201810194C
Institution: Research Triangle Institute (RTI), International
10/01/2018

Developing Brand and Creative Concepts Designed to Prevent AI/AN Youth Tobacco Use

FDA Center for Tobacco Products (CTP) will conduct formative research to inform the development of messaging and creative concepts for a tobacco prevention campaign targeting American Indian/Alaska Native (AI/AN) youth. Researchers will conduct 12 focus groups with up to 16 AI/AN youth ages 13-17 per group who are either experimental cigarette users or at-risk non-triers. Participants will be recruited through community-intercept recruitment. Focus group activities will include individual surveys and discussions to gain insight into youth perceptions related to local teen culture, tobacco use trends, tobacco-related facts, and campaign brands and creative concepts to inform campaign development. Findings will inform the development of an AI/AN tobacco public education campaign. 

Dana Wagner and Mario Navarro Funding Mechanism: Research Contract
ID number: HHSF223201710001G
Institution: Rescue Agency
10/01/2018

Development of a Multi-pathway Physiologically Based Pharmacokinetic (PBPK) Model for Nicotine in Humans

In this study, researchers will build a computational tool to characterize nicotine pharmacokinetics in humans. This tool will include databases, referenced literature, and a multi-pathway physiologically-based pharmacokinetic (PBPK) model. In addition, the Population Assessment of Tobacco and Health (PATH) Study human nicotine and metabolite biomarker data, and potentially behavioral and physiological response profiles established in animal models, will be included. Overall, this model will be used to evaluate the nicotine exposure-response relationship across tobacco product types and user populations. The model will also be incorporated with other existing software to predict lung deposition of nicotine via inhalation exposure from tobacco product use. This computational tool may be used to inform regulatory science efforts. 

Ying Bryant Funding Mechanism: Research Contract
ID number: E07682.01
Institution: National Center for Toxicological Research
09/30/2018

Experimental Study to Test Acute Nicotine Toxicity Warnings for E-Liquids on Consumer Knowledge and Perceptions

The goal of this study is to assess the effectiveness of draft acute nicotine toxicity warnings for e-liquids in promoting consumer awareness and understanding of nicotine toxicity due to exposure to electronic nicotine delivery systems (ENDS). Specific aims of this study are to evaluate the effect of acute nicotine toxicity warnings for e-liquids on: (a) consumer knowledge of the health effects of acute toxicity from e-liquid exposure; (b) consumer knowledge of precautionary storage and handling practices for products that contain e-liquids; and (c) consumer knowledge of what to do in case of accidental contact with e-liquids. The final study sample will include approximately 5,000 current ENDS users. This study will include both young adult (aged 18-24) and adult (aged 25-65) participants from an Internet panel. Findings may inform regulatory activities related to ENDS warnings.  

Anh “Bao” Zarndt Funding Mechanism: Research Contract
ID number: HHSF223201510003B
Institution: Fors Marsh Group
09/21/2018

E-Cigarettes - Relationship between Wicking Rate and Other ENDS Design Parameters

As e-cigarettes have evolved, new models have increased user control of device settings, including a variety of choices in atomizers, atomizer coils, wicks, and airflow settings. If the wicking rate is insufficient, all of these parameters combined can cause a “dry puff,” essentially burning the wick and leading to an increase in carcinogenic carbonyls and other harmful and potentially harmful constituents (HPHCs). Currently, no published studies directly measure wicking rate and isolate the effects of other ENDS design parameters (e.g., puff topography, wattage, coil configuration, preheat time, wicking material and amount) on wicking rate. The goal of this study is to understand the impact of each of these design parameters on wicking rate and eventual production of HPHCs. Findings may inform future regulatory activities related to e-cigarettes.

Karen Coyne Funding Mechanism: Research Contract
ID number: HHSF223201810047I
Institution: Research Triangle Institute International
09/19/2018

Toxicity and Carcinogenicity Profiling of Tobacco Products via Organ Microengineering and Systems Biology

The goal of this study is to advance our recently developed “Breathing-Smoking Human Lung-on-a-Chip” technology to determine the toxic effects of hookah tobacco smoke and e-cigarette emissions. In Phase 1 (18 months) of this project, we will develop a three-dimensional (3D) functional organomimetic human lung airway by combining organ-on-a-chip and 3D bioprinting technologies. The synthetic living human lung will then be validated for recreating physiological responses in vitro. In Phase 2 (6 months), we will enhance a smoking robot prototype by creating add-on modules that will generate fresh whole smoke/vapors from a diverse range of hookah tobacco and e-cigarette products; we will also use tubing with minimal adsorption properties to transfer gases and aerosols and upgrade the control software to execute e-smoking and waterpipe tobacco smoking topographies. In Phase 3 (18 months), we will integrate the lung airway with the smoking robot for system- and organ-level evaluation of tobacco products.  We will expose the synthetic living human lung to freshly produced emissions of two different e-cigarette products and hookah tobacco from two commercial sources and examine pathological responses, including oxidative stress, inflammation, matrix remodeling, pH changes, nicotine absorption, and pre-neoplastic transformation at molecular, cellular, tissue and organ levels. Findings may inform future regulatory activities related to hookah and e-cigarette products. 
    

Erica Clark Funding Mechanism: Research Contract
ID number: HHSF223201810127C
Institution: University of Colorado Denver
09/19/2018

Tracking Metals from E-cigarettes: From the Coil into Lung Tissue

E-cigarette devices may release nickel, chromium, lead, and other metals into the heated aerosol that may accumulate in lung tissue and blood. The goals of this study are to analyze the metal content of e-cigarette aerosol and to measure metal concentrations in lung tissue and blood using a mouse model of exposure. Study aims are: (1) to use Neutron Activation Analysis (NAA) to radiolabel various disassembled e-cigarette hardware components, followed by reassembly and measurement of the radiation energy spectrum of collected aerosol to identify specific sources of metal contamination; and (2) to conduct mouse exposure experiments to measure and analyze time- and dose-response relationships for nickel, chromium, and lead concentrations in lungs and blood following four-week exposure to e-cigarette aerosol. Findings will provide information about toxic metal exposures arising from e-cigarette use.

Markus Hilpert Funding Mechanism: NIH Grant
ID number: 1R21ES029777-01
Institution: Columbia University Health Sciences
09/19/2018

Emerging Chemicals of Concern in Evolving Electronic Nicotine Delivery Systems

Because electronic nicotine delivery systems (ENDS) contain plastic, glass and metal parts as well as e-liquids, they may contain a number of emerging chemicals of concern (ECCs), including phthalates, phenolic compounds, and flame retardants, that have been associated with adverse health outcomes such as asthma, endocrine disruption, reproductive and developmental abnormalities, and carcinogenic activity. The goal of this study is to characterize the types and levels of these chemicals in ENDS products, using various rigorous and reproducible analytical methods. Study aims are: (1) to characterize the contamination of e-liquids with ECCs by identifying the types and levels of ECCs in e-liquids; (2) to identify and measure the types and levels of ECCs in certain parts of ENDS, including refillable cartridge/tanks, as well as mouthpieces, which are potential ECC exposure sources; (3) to characterize thes types and levels of ECCs in ENDS aerosols; and (4) to examine and characterize the similarities and differences in types and levels of ECCs in e-liquids, extracted samples, and ENDS aerosols. Findings may inform future regulatory activities related to ENDS products.

Binnian Wei Funding Mechanism: NIH Grant
ID number: 1R21ES030028-01
Institution: Roswell Park Cancer Institute Corp
09/19/2018

The Exposure to Metals from E-Cigarettes (EMIT) Study

E-cigarettes expose users to metals, since a metal coil is used to generate aerosol and most coils are composed of nickel and chromium, which are known inhalation carcinogens. A new e-cigarette type called POD is growing in popularity with unknown potential for exposure. The goal of this study is to evaluate how e-cigarette use patterns impact exposure to toxic metals. Study aims are: (1) to understand the role of metal heating components on the transfer of metals into the aerosol, by analyzing metal concentrations in e-liquid before it is in contact with the heating coil, and in the aerosol generated; (2) to characterize patterns of e-cigarette use and other potential sources of metal exposures; and (3) to measure metals in blood, urine, saliva, and exhaled breath condensate of e-cigarette users, non-users, smokers and dual users, to evaluate how different patterns of e-cigarette and smoking use impact metal exposure. Researchers will assign 250 adults ages 18 and older to one of five groups: (1) 50 MOD e-cigarette users, (2) 50 POD users, (3) 50 cigarette smokers, (4) 50 dual users of e-cigarettes and combustible tobacco products, and (5) 50 non-users/non-smokers. All participants will answer a questionnaire on smoking history, e-cigarette use patterns, and work/hobbies that may involve metal use. Researchers will collect samples of blood, urine, saliva, and exhaled breath to measure and compare metal levels; samples of e-liquid and vapor will also be collected from e-cigarette users. Researchers will then use linear regression models to estimate the association of metals in biomarkers with e-cigarette use patterns, cotinine biomarkers, and metal concentrations in e-liquid and aerosol. Findings will provide new information about e-cigarette user exposure to metals and may inform regulatory activities related to e-cigarettes.

Ana Maria Rule Funding Mechanism: Intra-Departmental Delegation of Authority (IDDA)  
ID number: 1R01ES030025-01
Institution: Johns Hopkins University
09/19/2018

Assessing Toxicant Properties of Cigarillo and Hookah Aerosols in Lung Epithelial and Cardiac Cells Through Aerosol Exposure

The goal of this study is to evaluate the toxicant properties and predicted health effects of cigarillo and hookah tobacco products compared to cigarettes. Study aims are: (1) to characterize the hazardous chemicals linked to cancer and cardiopulmonary diseases in aerosols from eight common hookah tobacco products using standardized cytotoxicity, mutagenicity, and genotoxicity assays; (2) to evaluate complete and fractionated (particles and gas only) aerosols generated from cigarettes, cigarillos, and hookah products in lung epithelial cells, cardiac cells, and endothelial cells using short-term assays and biomarkers (cytokines, DNA adducts); and (3) to evaluate the adaptive responses of lung epithelial cells in response to treatment of cells for four weeks with aerosols from one of each type of tobacco product. Findings will indicate new information about the potential respiratory and cardiac health effects associated with cigarillo and hookah use. 

Stephen A. Belinsky Funding Mechanism: NIH Grant
ID number: 1R01ES029448-01A1
Institution: Lovelace Biomedical & Environmental Research Institute
09/18/2018

Characterization of Potential Harm Caused by Electronic Cigarette Flavor Chemicals and their Reaction Products

The flavor chemicals and their degradation reaction products (generated by heating) in e-cigarette aerosols may cause cell toxicity. The goals of this project are to analyze commercial e-liquids to identify and quantify flavor chemicals and their degradation reaction products and to evaluate cellular responses. The researchers will test 550 popular refill and cartomizer fluids and 100 fluids that have been anecdotally reported to cause sickness in users using gas chromatography/mass spectrometry, liquid chromatography/mass spectrometry, and other analytical methods. Study aims are: (1) to understand the identities and concentrations of dominant flavor chemicals in e-cigarette refill fluids and heat-generated reaction products in aerosols; (2) to analyze 3D lung epithelial cells at the air liquid interface to identify and characterize their response to heat-generated aerosols containing high potency flavor chemicals; and (3) to evaluate the potency and biological effects of individual flavor chemicals and reaction products in aerosols generated without heating. Study findings may inform future regulatory activities related to e-cigarettes.

Prudence Talbot Funding Mechanism: NIH Grant
ID number: 1R01ES029741-01
Institution: University of California Riverside
09/17/2018

Studies Using the Tobacco Consumer Studies Panel - Topical Study B

This study is part of a larger contract to conduct a series of studies using the Tobacco Consumer Studies (TCS) Panel to research consumer reactions to tobacco-related information/communications and perceptions of tobacco products and their association with product use, intention, and behaviors; and consumer reactions (such as purchasing behaviors) to anticipated or actual changes in tobacco product availability and in tobacco product constituents. This study focuses specifically on free samples of tobacco products and tobacco product coupons participants may have received, how they received them, and where they redeemed them for tobacco products. The full TCS panel of approximately 4,000 tobacco users will be invited to take part in this study via web or mail. Researchers will conduct analyses to assess the prevalence of coupon and free sample receipt and use as well as details surrounding the receipt and use context (e.g., demographics, product type/brands, locations). Further analyses may explore the relationships between receipt of free samples/coupons and use behaviors, quit intentions, and harm perceptions. 

Caryn Nagler Funding Mechanism: Research Contract
ID number: HHSF223201510002B
Institution: Research Triangle Institute International
09/14/2018

Linking E-Cigarette Aerosol Characteristics to Mechanisms of Pulmonary Toxicity

The goal of this study is to understand how atomizer parameters and key ingredients in e-liquids contribute to undesirable aerosol characteristics and pulmonary toxicity. Study aims are: (1) to systematically vary e-cigarette device parameters (e.g., coil composition, coil resistance, applied voltage) and e-liquid components (propylene glycol, vegetable glycerin, nicotine, flavoring) to determine their impacts on aerosol physiochemical characteristics and in vitro toxicity; (2) to expose human airway epithelial cells to e-cigarette aerosols and determine toxicity signatures resulting from specific physiochemical features; and (3) to determine acute and sub-chronic lung toxicity profiles resulting from exposures to e-cigarette aerosols in mice. Findings may inform future regulatory activities related to e-cigarettes.

Yifang Zhu Funding Mechanism: NIH Grant
ID number: 1R01HL139379-01A1
Institution: University of California Los Angeles
09/14/2018

Implied Modified Risk Statements as Predictors of Flavored Little Cigar and Cigarillo Use

Several brands of flavored little cigar and cigarillos (LCCs) come in packages that use potential modified risk descriptors (e.g., “additive-free”). The goal of this study is to examine how young adults’ receptivity to flavored LCC product packaging features (e.g., text, colors, images, pack size) and price influences their smoking behavior. Study aims are: (1) to assess the impact of flavored LCC packaging descriptors in risk perceptions and future LCC smoking behaviors among young adult LCC current users and non-users; and (2) to assess the influence of flavored LCC package features on young adults’ preferences for LCCs. Researchers will conduct a 12- and 24- month online survey (1,120 young adults ages 18-34 in each wave) to examine transitions in risk perceptions and subsequent LCC smoking behavior that occur due to receptivity to flavored LCC packaging descriptions. Also, six focus groups (with 6-8 participants per group), stratified by race/ethnicity and smoking status, will be conducted after each survey wave to understand what factors influenced transitions in receptivity, risk perceptions, and LCC smoking profiles. Next, researchers will conduct a discrete choice experiment to assess the impact of packaging features such as text, color, images, and pack size, as well as price, on the product preferences on 250 ever and 250 never LCC users ages 18-34. Findings may inform future regulatory activities related to LCC packaging.

Kymberle L. Sterling Funding Mechanism: NIH Grant
ID number: 1R01CA228906-01A1
Institution: University of Texas Health Sciences Center School of Public Health
09/14/2018

Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking

Electronic hookah (e-hookah) bowls, which contain flavored e-liquid that is heated electrically but inhaled through traditional waterpipes, are increasing in popularity in the United States. The goals of this study are to compare the effects of traditional hookah smoking with e-hookah inhalation on human vascular and endothelial function, and to examine the role of inflammation and oxidative stress in hookah-related cardiovascular disease development. Study aims are: (1) to determine the acute effects of e-hookah bowl inhalation on endothelial function; (2) to determine the acute effects of e-hookah bowl inhalation on arterial stiffness; and (3) to determine the acute effects of e-hookah bowl inhalation on biomarkers of oxidative stress and inflammation. Researchers will conduct cross-over studies in 18 young adult hookah smokers (ages 21-39). Findings will provide new information about the effects of e-hookah use on human health and may inform regulatory activities related to e-hookah.

Mary Rezk-Hanna Funding Mechanism: NIH Grant
ID number: 1R21HL145002-01
Institution: University of California-Los Angeles
09/14/2018

Effects of E-Cigarette Exposure During Pregnancy on Offspring Lung Function and Disease: Characterization of Pulmonary, Intergenerational, and Epigenetic Effects

Nearly all the effects of maternal smoking during pregnancy on fetal lung development are caused by nicotine crossing the placenta to interact with nicotinic receptors in the developing lung. The goal of this study is to use a mouse model to describe the effects of perinatal e-cigarette exposure on offspring pulmonary function and disease. Study aims are: (1) to characterize the direct effect of maternal in-utero e-cigarette exposure on first-generation offspring pulmonary function, respiratory disease and epigenetic changes; (2) to characterize the intergenerational effect of grand-maternal in-utero e-cigarette exposure on second-generation offspring pulmonary function, respiratory disease and epigenetic changes; and (3) to characterize the additive, multigenerational effect of both grand-maternal and maternal in-utero e-cigarette exposure on offspring pulmonary function, respiratory disease and epigenetic changes. Researchers will expose pregnant mice to filtered air, e-cigarettes without nicotine, and e-cigarettes with nicotine from gestation day 1 to postnatal day 7 and will analyze effects on lungs at age 8 weeks; in addition, they will analyze the effects of in-utero exposures on asthma susceptibility based on sensitivity to house dust mite antigen. Researchers will conduct similar analyses on the second-generation mice to determine intergenerational effects. Findings will provide new information about the effects of e-cigarette use by pregnant women.

Eliot R. Spindel and Kent Pinkerton Funding Mechanism: NIH Grant
ID number: 1R01HL144384-01
Institution(s): Oregon Health & Science University and University of California, Davis
09/14/2018

Airway Protein Modifications caused by New and Emerging Tobacco Products as Markers of Exposure and Potential Health Risks

The use of new and emerging tobacco products (NETPs) such as hookah and e-cigarettes is increasing, particularly by the younger population in the US. The goal of this study is to examine airway protein modifications that result from NETP use. Study aims are: (1) to identify NETP-induced protein modifications in vitro of smoke/vapor-exposed human bronchial epithelial cell (HBEC) surfaces (airway epithelial cells for analysis are routinely received and subsequently maintained by the institution); and (2) to establish protein modifications as markers of NETP use and effects in vivo by conducting mass spectrometry analysis of tobacco product user sputum samples (previously collected from healthy cigarette, e-cigarette and hookah users ages 18-50). Findings will provide new information about the airway toxicity effects of tobacco product use.

Boris Reidel Funding Mechanism: NIH Grant
ID number: 1R03HL140402-01A1
Institution: University of North Carolina - Chapel Hill
09/14/2018

CRoFT TCORS: WNY Center for Research on Flavored Tobacco Products (CRoFT)

Many tobacco flavoring ingredients are labeled Generally Recognized as Safe (GRAS) as they are intended for ingestion; however, they have not been evaluated for inhalation toxicity. More data can provide understanding regarding how consumers perceive and use flavored tobacco products and whether these have implications for health. The goal of the Western New York (WNY) Center for Research on Flavored Tobacco Products (CRoFT) is to develop a novel framework and approaches for assessing the impact of tobacco product flavors and flavorings on consumer behavior, exposures, and health. Four projects will provide useful information about the toxicological, health, and behavioral implications of flavors and flavoring chemicals. Project 1 will apply state-of-the art methods to assess the chronic toxicity of specific flavorings used in tobacco products using chemical reactivity, in vitro models, and in vivo research studies. Project 2 will apply consumer sensory and behavioral laboratory approaches to examine the behavioral impacts of flavors, including sensory thresholds for single and combined flavorings, and the impact of flavoring concentration on use patterns (puffing topography, inhalation). Project 3 will apply longitudinal cohort and product-switching designs to examine the chronic respiratory health effects of flavorings in tobacco products among current users. Project 4 will apply qualitative, quantitative, and experimental approaches to examine the effects of information on flavor choice and flavored product use.

Richard J. O'Connor and Maciej Goniewicz Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA228110-01
Institution: Roswell Park Cancer Institute and University of Rochester
09/14/2018

CRoFT TCORS Project 1: In Vitro and In Vivo Assessment of Flavorant Toxicity

Commonly-marketed flavors in emerging tobacco products such as e-cigarettes, cigarillos, and waterpipe tobacco include tobacco, mint/menthol, fruits/candy, coffee/tea, chocolate, berries, crème/butter, clove/cinnamon, and alcoholic beverages. Underlying these flavors are chemical flavorings, some of which have known respiratory toxicity (e.g., diacetyl, cinnamaldehyde). Comparative toxicity data would be useful to clarify the health effects of these tobacco products. The goal of this Center for Research on Flavored Tobacco Products (CRoFT) project is to determine and compare the effects of various flavorings in e-cigarettes, cigarillos, and waterpipe tobacco on toxicological and immune-inflammatory responses. Study aims are: (1) to determine comparative in vitro toxicity of selected tobacco product flavorings using (a) the aerosol exposure system for cell-free reactive oxygen species reactivity, and (b) exposure to human lung epithelial cells via air-liquid interface and 3D culture; (2) to determine comparative oxidative, DNA damage and immune-inflammatory responses to tobacco product flavorings in a mouse model to determine the link between flavoring toxicity and adverse respiratory health outcomes; and (3) to identify comparative biomarkers in response to tobacco product flavorings. Assessment of toxicity within the same class of flavorings across different types of tobacco products will allow a toxicity/hazard ranking and information related to flavoring-specific adverse health outcomes.

Irfan Rahman Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA228110-01
Institution: University of Rochester
09/14/2018

CRoFT TCORS Project 2: Human Thresholds for Characterizing Flavors and Impact on Behavior

Flavors are common in electronic nicotine delivery systems (ENDS) and are often named as a primary reason for their use. The goal of this Center for Research on Flavored Tobacco Products (CRoFT) study is to evaluate whether flavors might have “indirect” toxicity: that is, regardless of whether flavorings show biological evidence of toxicity, they may increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use. Study aims are: (1) to develop expert (trained per industry best practices) and consumer (untrained) sensory panels to identify and assess characterizing flavors in e-liquids; and (2) to examine the effects of flavorings on use topography, subjective effects of vaping, and sensory experience among current ENDS users. For Aim 1, researchers will compare the ability of trained and untrained individuals to identify and characterize flavors, determine threshold detection levels for individual and mixed flavors, and identify the dominant flavor of mixtures; four panels (expert user, expert nonuser, consumer user, consumer nonuser) of 35 individuals each (ages 18-55) will be convened. For Aim 2, researchers will examine whether flavor concentration affects use topography (puff volume, puff duration, inhalation volume, breathhold duration), subjective effects, and detection of “dry puff” under high power conditions in 120 daily e-cigarette users (ages 18-49). Findings may inform future regulatory activities related to flavors.

Richard J. O'Connor Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA228110-01
Institution: Roswell Park Cancer Institute
09/14/2018

CRoFT TCORS Project 3: Respiratory Health Effects of Flavors

More information about the respiratory health hazards of the flavorings used in tobacco products would be useful. The goal of this Center for Research on Flavored Tobacco Products (CRoFT) project is to characterize the respiratory health effects -- including inflammation, biomarkers of exposure, and clinical markers with relevance to disease endpoints -- attributable to the use of flavored tobacco products. Two studies will evaluate daily ENDS users as they switch among various flavors. Study aims are: (1) to assess changes in respiratory symptoms and biomarker levels in ENDS users during spontaneous switching between flavors (Study 1); (2) to evaluate respiratory symptoms in ENDS users switching from flavors of potentially high toxicity to flavors of potentially low toxicity (Study 2); and (3) to characterize ENDS users’ preferences, selection, patterns of use and switching between various flavors (Studies 1&2). In Study 1, researchers will establish a cohort of 176 ENDS users (ages 18-54) to assess changes in respiratory symptoms during spontaneous switching among flavors over one year. In Study 2, researchers will conduct a randomized, parallel-group open-label trial to evaluate respiratory symptoms in 216 ENDS users (ages 18-54) switching from higher-toxicity to lower-toxicity flavors (as identified by Project 1). Endpoints will include clinically relevant biomarkers of inflammation and oxidative stress, changes in respiratory function, subjective respiratory symptoms and side-effects, and expression of immune and inflammatory response genes in nasal epithelial cells. Results may inform future regulatory activities related to flavors.

Maciej Lukasz Goniewicz Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA228110-01
Institution: Roswell Park Cancer Institute
09/14/2018

CRoFT TCORS Project 4: Evaluating Effects of Packaging and Market Availability of Flavored Tobacco Products on Consumer Perception and Behavior

Flavored tobacco products influence appeal, use, and perceptions of reduced harm. This project will investigate how descriptor terms such as “natural”, “cherry gummy bear”, “Neapolitan ice cream”, and “chocolate milk shake” and pictures illustrating those terms influence perceptions of appeal, harm, and intention to use, among both current and susceptible non-users of electronic nicotine delivery systems (ENDS). The goal of this Center for Research on Flavored Tobacco Products (CRoFT) project is to evaluate perceptions of flavored tobacco products and relevant messages as conveyed by package design characteristics (i.e., colors, design, descriptor terms), as well as the potential impact on demand and behavior, for cigarettes, cigarillos/little cigars, and ENDS. Study aims are: (1) to evaluate how to communicate messages about flavors and potential harms associated with specific flavors to consumers of combustible tobacco products and ENDS; and (2) to evaluate the potential effects on tobacco use behavior of flavored tobacco products with varied risk messaging and changes in market availability (e.g., restricted range of flavors, changes in descriptors). Researchers will conduct three studies in adults (ages 18 and older) to achieve these aims. In Study 1, researchers will conduct eight focus groups with 100 participants and 20 in-depth one-on-one interviews to examine beliefs and behaviors related to flavored e-cigarette use. In Study 2, researchers will conduct a mall-intercept survey experiment with 192 e-cigarette users and susceptible non-users to obtain reactions to e-cigarettes/e-liquids with fictitious packaging/brand names. In Study 3, researchers will conduct an experimental auction in which 384 participants bid on five unflavored and flavored products (four types of e-cigarettes and one pack of cigarettes or little cigars) to examine the influence of changes in market availability of flavored tobacco products on willingness to pay. Findings may inform future regulatory activities related to flavors.

Maansi Bansal-Travers Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA228110-01
Institution: Roswell Park Cancer Institute
09/14/2018

USC TCORS: Tobacco Regulatory Science Investigating the Intersections of Products with Diverse Populations

The University of Southern California Tobacco Center of Regulatory Science (USC-TCORS) will conduct research on the use and health effects of specific e-cigarette products across populations. Researchers will study e-cigarette product characteristics and marketing approaches hypothesized to increase tobacco product attraction, use, and addiction in youth and young adult non-smokers and have little impact on tobacco product use in older smokers. These characteristics and marketing approaches include: (a) non-tobacco flavorings; (b) constituents and devices that produce large vapor clouds and the user experience; (c) modifiable devices; (d) device designs not resembling cigarettes; (e) cartoons in packaging and advertising; and (f) candy flavors or other youth-oriented marketing themes. The TCORS will include four projects. Project 1 will characterize publicly available social media postings of e-cigarette product characteristics and marketing themes and will study links with tobacco product use behavior in youth and young adults. Project 2 will involve vape shop customer interviews to assess the impact different e-cigarette regulation scenarios on tobacco product use. Project 3 will study associations of e-cigarette product characteristics and marketing exposures with tobacco product use and dependence across 10 years (ages 14-25). Project 4 will involve laboratory tests of the impact of e-cigarette product characteristics and marketing exposure manipulations on product appeal, abuse liability, and other outcomes.

Mary Ann Pentz and Adam Matthew Leventhal Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 CA180905-06
Institution: University of Southern California
09/14/2018

USC TCORS Project 1: Effects of Social Media Marketing and Messages on Tobacco Transitions

More information about e-cigarette product diversity portrayed on social media and how social media exposure impacts tobacco product use would be useful. The goal of this project is to examine how social media portrays e-cigarette product diversity and how this portrayal may affect tobacco product transitions. Study aims are: (1) to analyze continuously collected social media posts that include e-cigarette and other tobacco product-related keywords to determine trends in product marketing and conversations about e-cigarette products and their diverse product characteristics; and (2) to determine whether participation (e.g., posting, liking, sharing) in e-cigarette-related social media, especially posts that contain youth-oriented themes, is associated with tobacco product susceptibility and use among youth and young adults. To address Aim 1, researchers will collect, code, and analyze messages posted on popular social media sites using existing tobacco-related keywords and identifying new keywords; they will identify types of tobacco messages (e.g., youth-oriented messages, health-oriented messages aimed at current smokers) and the characteristics of messages about e-cigarettes that generate the most user engagement and dissemination. To address Aim 2, researchers will analyze publicly-available and accessible e-cigarette-related social media postings generated by participants in a cohort of adolescents and young adults (ages 14-25) in Southern California to determine links between posting and transitions across six stages of tobacco use (non-susceptible never-user, susceptible never-user, single product experimenter, poly-tobacco experimenter, single-product regular user, poly-tobacco regular user). Findings will provide new information about the links between exposure to products and marketing via social media and tobacco product use and transitions.

Jennifer Beth Unger and Tess Boley Cruz Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 CA180905-06
Institution: University of Southern California
09/14/2018

USC TCORS Project 2: Influence of Tobacco Product Characteristics and Marketing on Diverse Populations of Vape Shop Customers

Vape shops, which specialize in selling a variety of e-cigarette products, are a key channel of exposure to these products. The goal of this project is to examine how different segments of the vape shop customer population would likely react to hypothetical e-cigarette regulations. The project will contrast three groups of vape shop customers — e-cigarette-only users (who never smoked cigarettes extensively); switchers (who quit smoking and now only use e-cigarettes); and dual users (who currently use both e-cigarettes and cigarettes) —regarding perceived appeal and anticipated purchase/use of e-cigarettes and combustible products currently and after hypothetical regulatory changes. Study aims are: (1) to test the hypothesis that hypothetical regulations related to sweet flavors, e-liquid propylene glycol/vegetable glycerin ratios, and ability to calibrate a device will be associated with lower e-cigarette appeal and lower anticipated future purchase/use in e-cigarette-only users (vs. switchers and dual users); (2) to test hypothetical marketing practices that may be associated with lower e-cigarette appeal and lower anticipated future purchase/use in e-cigarette-only users (vs. switchers and dual users); (3) to test the hypothesis that these hypothetical product regulations and marketing practices will be associated with lower e-cigarette appeal and lower anticipated purchase/use among young adults (age 21-29) vs. middle/older adults (30+); and (4) to examine the above associations as a function of (a) current product(s) used, (b) race/ethnicity, (c) gender, (d) socioeconomic status, and (e) shop location. Researchers will conduct interviews with customers (ages 21 and older) exiting vape shops in a racially/ethnically diverse set of neighborhoods. Findings may inform future regulatory activities related to e-cigarettes.

Steven Yale Sussman and Lourdes Baezconde-Garbanati Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 CA180905-06
Institution: University of Southern California
09/14/2018

USC TCORS Project 3: Product Characteristics, Marketing, and E-cigarette and Cigarette Use Across Adolescence and Young Adults

E-cigarette product diversity (i.e., product characteristics and associated marketing strategies) can affect product appeal and use, especially among adolescents and young adults. The goal of this project is to test hypothesized e-cigarette product characteristics and marketing strategies that may attract never-smokers and put them at risk for tobacco product use but do not affect the likelihood that young smokers will adopt and switch to e-cigarettes. Examples of product features that may disproportionately attract never smokers (vs. smokers) include sweet flavors (vs. tobacco or other flavors), devices and e-liquid compositions used to generate large aerosol clouds for “vape tricks” (vs. devices that look and feel like cigarettes), and youth-oriented marketing strategies for e-liquid naming (such as “Kustard Killer”) and packaging with cartoon images. Study aims are: (1) to evaluate the associations of: (a) product characteristics and marketing exposure with e-cigarette interest, (b) e-cigarette interest with subsequent initiation, and (c) marketing exposure with subsequent initiation; (2) to evaluate the association of (a) e-cigarette initiation with cigarette initiation and progression, or discontinuation of tobacco product use, and (b) e-cigarette product characteristics and marketing exposure with dual use, nicotine dependence, or discontinuation of tobacco product use; and (3) to evaluate whether associations of product characteristics and marketing with outcomes observed in Aims 1 and 2 differ between baseline never-smokers and smokers. Researchers will survey participants in a cohort of adolescents and young adults (ages 14-25) in Southern California.  Findings may inform future regulatory activities related to e-cigarettes.

Rob Scot McConnell and Jessica Barrington-Trimis Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 CA180905-06
Institution: University of Southern California
09/14/2018

USC TCORS Project 4: Human Laboratory Research to Inform Precision Regulation of E-cigarettes Across Populations

E-cigarettes may adversely impact the health of some populations (e.g., young never-smokers), but also may reduce health risk in others (e.g., middle-aged/older smokers who completely switch to e-cigarettes). The goal of this project is to identify dimensions of e-cigarette product diversity that put young adult never-smokers at risk of using e-cigarettes, yet do not deter middle/older adult smokers from adopting and potentially switching to e-cigarettes. Study aims are: (1) to determine which dimensions of e-cigarette product diversity differentially affect product appeal in never-smoking young adult e-cigarette users and middle-aged/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) to determine which dimensions of e-cigarette product diversity differentially affect abuse liability in never-smoking young adult e-cigarette users and ability to resist smoking in middle-aged/older adult smokers with an interest in, but no significant experience with, e-cigarettes; and (3) to examine sex differences in the effects of product diversity on appeal, abuse liability, and ability to resist smoking by testing sex and product dimension interactions. In two studies, subjects will self-administer e-cigarette products varied according to three dimensions: flavor (e.g., sweet vs. menthol vs. tobacco); propylene glycol/vegetable glycerin ratio (e.g., 20:80 vs. 40:60 vs. 60:40 vs. 80:20); and packaging design (e-liquid characterizing flavor label [e.g., “peach”] vs. youth-oriented non-characterizing flavor [e.g., “gummy heaven”] vs. non-characterizing flavor + cartoon). The Aim 1 study will test product exposure effects on subjective ratings of appeal (e.g., liking, desire to use again). The Aim 2 study will test product exposure effects on choice to use (vs. earn money) the previously-exposed e-cigarette product (an abuse liability test; never-smoking young adults only), or own brand cigarettes (test of ability to resist smoking; middle-age/older adult smokers only). Findings may inform future regulatory activities related to e-cigarettes.

Adam Matthew Leventhal Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 CA180905-06
Institution: University of Southern California
09/14/2018

UPenn/Rutgers TCORS: Examining the Effects of Advertising, Packaging and Labeling on Perceptions, Use and Exposure of Combustible Tobacco Products

Tobacco advertisements are an important marketing vehicle that allows companies to prominently and creatively feature brand imagery and benefit claims, including those that might suggest modified risk. In addition, tobacco packaging uniquely provides repeated opportunities to express brand image and implicitly convey brand attractiveness, quality and health appeals to consumers every time the product is used. The goal of the University of Pennsylvania – Rutgers University TCORS is to accumulate a comprehensive and rigorous body of knowledge on the effects of tobacco communication, including advertising, marketing, packaging and labeling, on regulatory-relevant outcomes of risk perceptions, use, behavior and exposure for combustible tobacco products, given their disproportional burden on public health. The UPenn & Rutgers TCORS includes four projects. Project 1 will study the effects of cigarette package color on smoking behavior, exposure and risk perception when using low nicotine content cigarettes. Project 2 will examine the effects of advertising and correctives for reduced harm tobacco products. Project 3 will study the influence of cigarillo packaging and labeling on young adults. Project 4 will examine products that have descriptors that may imply modified risk.

Andrew A. Strasser and Cristine Delnevo Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229973-01
Institution: University of Pennsylvania and Rutgers University
09/14/2018

UPenn/Rutgers TCORS Project 1: The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception when using Low Nicotine Content Cigarettes

Cigarettes with reduced nicotine content decrease dependence and toxicant exposure, suggesting potential public health benefits of mandating a low nicotine product standard. These findings, however, come primarily from studies using investigational low nicotine content (LNC) cigarettes in basic packaging with no accompanying marketing campaign. Thus, there is no data currently available to clarify the impact of product marketing. The goal of this project seeks to evaluate the effects of LNC cigarette packaging on two primary outcomes: smoking behavior and biological toxicant exposure. Study aims are: (1) to examine the effect of cigarette packaging on smoking behavior during LNC use; and (2) to examine the effect of cigarette packaging on biological exposure during LNC use. Researchers will recruit 500 currently daily cigarette smokers (ages 21-65) to a 35-day randomized controlled trial; after a five-day period of smoking their own cigarettes, participants will be randomized to continue smoking their own brand (control group) or to smoke investigational LNC cigarettes in one of four types of packaging (red/blue/gray/plain) for 30 days. Outcomes will include smoking behavior (daily cigarette consumption, total puff volume), biological exposure (total nicotine equivalents, NNAL, carbon monoxide), subjective ratings (taste, smoking satisfaction, perceived nicotine strength, harshness), and risk and harm perceptions. Findings will provide important information about low nicotine content cigarettes in the context of cigarette packaging.

Andrew A. Strasser Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229973-01
Institution: University of Pennsylvania
09/14/2018

UPenn/Rutgers TCORS Project 2: The Effects of Advertising and Correctives for Reduced Harm Tobacco Products

Misperceptions of the risks of potential modified risk tobacco products (MRTPs) can be exacerbated by product marketing. The goal of this project is to develop scientifically rigorous protocols to establish the magnitude and strength of inaccurate beliefs created by advertising and marketing practices for potential MRTPs in target audiences. The studies proposed in this project focus on advertising claims about combustible MRTPs and identifying the associated beliefs – both harms and benefits – in the minds of both likely users (smokers) and former smokers. Study aims are: (1) to understand the effects of advertising about potential MRTPs on product beliefs; (2) to assess the impact of potential MRTP ad content on beliefs about and attitudes and intentions toward MRTPs and examine whether false beliefs mediate the link between ad claims and attitudes/intentions; and (3) to design simple correctives to modify inaccurate inferences about potential MRTPs and assess their ability to change inaccurate (but not accurate) beliefs, redirect attention to corrective information, and affect MRTP use behavior.  Eight studies will address these three aims. To address Aim 1, researchers will monitor past and current requests to FDA for MRTP approval of combustible tobacco products (Study 1), track beliefs about MRTPs derived from online comments by members of the public (Study 2), conduct a descriptive pilot study with 1000 current and 1000 former smokers (ages 18 and older) to derive a set of targeted beliefs (Studies 3 and 4), and conduct a study to determine whether ad content can encourage beliefs in one direction or another (Study 5). To address Aim 2, researchers will evaluate beliefs of 1500 participants (ages 18 and older) using standardized assessment tools to determine whether beliefs mediate between advertising claims and attitudes and use intentions (Study 6). To address Aim 3, researchers will conduct two studies in current daily smokers (ages 21-60); an eye tracking study (Study 7) as well as behavioral tests of MRTP use in the presence and absence of corrective statements (Study 8). Findings may inform future regulatory activities related to potential MRTP advertising.  

Joseph Nicholas Cappella Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229973-01
Institution: University of Pennsylvania
09/14/2018

UPenn/Rutgers TCORS Project 3: Influence of Cigarillo Packaging and Labeling on Young Adults

The use of cigarillos is growing among young adults. Therefore, more information about the influence of cigarillo packaging and labeling on young adults would be useful. The goal of this project is to understand how cigar and cigarillo packaging and labeling may both facilitate and dissuade cigar among young adults (ages 18-24). Using a series of complementary mixed methods studies (i.e., online exposure experiments, observational secondary data analyses, smoking lab study), researchers will study the effects of exposure to cigar/cigarillo packaging with varying warning labels (text and pictorial) and descriptors (flavors and potentially modified-risk claims) on perceptions, use intentions, and use. Study aims are: (1) to test the effect of different cigarillo packaging features (descriptors, colors, presence of current warning labels) on perceptions and use intentions among 2400 young adult past-year cigarillo smokers using a between-subjects online experiment; (2) to compare the effect of different text and pictorial warnings on cigarillo perceptions and use intentions among 1,800 young adults using an online experiment; and (3) to evaluate exposure to cigar warnings (and associations with cigar harm perceptions and use) over time through an analysis of Population Assessment of Tobacco and Health (PATH) survey data. In addition, in an exploratory smoking experiment, 100 young adult past 30-day cigarillo smokers will smoke non-flavored cigarillos placed in packaging with flavor descriptors, allowing researchers independently examine the potential impact of packaging and descriptors on cigar ratings. Study findings may inform future regulatory activities related to cigar and cigarillo flavoring, packaging descriptors, packaging, and pictorial warnings.

Cristine D. Delnevo & Olivia Wackowski Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229973-01
Institution: Rutgers University
09/14/2018

UPenn/Rutgers TCORS Project 4: Examining Product Descriptors in Natural American Spirit Cigarette Marketing

Extensive research has confirmed that cigarettes marketed as “light,” “low tar,” and “mild” were misperceived as having lower risks. In recognition of this, the 2009 Tobacco Control Act (TCA) banned the use of these descriptors in one of its earliest regulatory actions but did not address other misleading terms that studies have shown also suggest reduced harm for products utilizing them. One of these products is Natural American Spirit, a heavily-advertised and top-selling premium cigarette brand popular among young adults that promoted itself using the terms “additive free,” “natural,” and “organic.” The goal of this project is to provide additional scientific evidence on product descriptors that may imply a health claim, such as the terms “natural,” “additive-free,” and “organic.” Study aims are: (1) to understand consumer perceptions of brand name, descriptors (e.g., “organic”, “Tobacco Ingredients: Tobacco and Water”), and imagery  advertising by conducting 12 focus groups each with 6-8 young adult (ages 18-24) smokers and nonsmokers; (2) to assess the effect of potentially misleading descriptors in print advertising on cigarette risk perceptions and use intentions among 2400 young adult (ages 18-24) smokers and non-smokers using a between-subjects online experiment; and (3) to examine population differences in tobacco perceptions, use intentions, and use between products that may imply a modified risk or health claim and other brand smokers, comparing them over time through analysis of Population Assessment of Tobacco and Health (PATH) study data. A secondary aim will be to monitor claims and images used in cigarette advertising with a longitudinal content analysis of print and direct mail advertising. Findings will advance the evidence base on the impact of misleading terms implying reduced risk.

Jane Lewis Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229973-01
Institution: Rutgers University
09/14/2018

U of M TCORS: Center for the Assessment of the Public Health Impact of Tobacco Regulations

The University of Michigan Center for the Assessment of the Public Health Impact of Tobacco Regulations aims to provide evidence-based and expert-informed modeling of the behavioral and public health impacts of tobacco regulations. The Center will have three projects based on detailed analysis of historical tobacco use patterns in the U.S. and will use four established tobacco simulation models. Project 1 will involve comparative modeling analyses of the impact of tobacco regulations and policies on smoking and e-cigarette use and related long-term health outcomes, including heart, pulmonary disease and maternal and child health. Project 2 will extend two well-established models to examine the possible consequences of regulating nicotine in combusted tobacco products. Project 3 will model tobacco-related health disparities associated with single- and multi-product tobacco use and will investigate how potential policy options may impact tobacco use and tobacco-related health disparities.

Rafael Meza and David T. Levy Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229974-01
Institution: University of Michigan and Georgetown University
09/14/2018

U of M TCORS Project 1: Comparative Modeling of the Impact of E-cigarettes use on Smoking and Long-Term Health Outcomes

The goal of this project is to use four established tobacco control simulation models to examine the impact of different possible FDA regulatory actions on future trends in cigarette and e-cigarette use and associated health outcomes. Study aims are: (1) to characterize differences in cigarette and e-cigarette use patterns and to monitor changes in use patterns over time; (2) to extend well-established simulation models so that they consider mortality from specific health outcomes, including lung cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease, and maternal and child health outcomes; (3) to project mortality from lung cancer, COPD, cardiovascular disease, and low birth weight births under current cigarette and e-cigarette use patterns (status quo); (4) to estimate the impact of past and potential new tobacco control policies on patterns of cigarette and e-cigarette use; and (5) to model the impact of past and potential new policies on all-cause mortality and health outcomes associated with cigarettes and e-cigarettes. Researchers will use a generalized decision analysis framework and statistical approaches to develop initial prevalence rates for the models, a range of plausible future status quo transitions by age and gender for initiation and cessation of cigarettes and e-cigarettes, and a range of plausible switching rates between cigarettes and e-cigarettes. Using literature reviews and expert elicitation panels, researchers will develop relative risk estimates for specific health outcomes, and then will project tobacco-related mortality due to cardiovascular disease, COPD, and adverse maternal and child health outcomes. Researchers will extend the models to project how specific potential regulatory activities (e.g., health warnings on cigarette packages; public education campaign) individually and in combination will likely impact cigarette and e-cigarette use rates and associated health outcomes over a 50-year future period. The models may be extended to consider other nicotine delivery products, including cigars, smokeless tobacco and heat-not-burn products. Results will provide evidence-based, expert-informed estimates of tobacco use prevalence, health outcomes, and policy impacts.

David T. Levy, Theodore R. Holford, David Mendez and Rafael Meza Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229974-01
Institution: Georgetown University, Yale University, and University of Michigan
09/14/2018

U of M TCORS Project 2: Modeling the Impact of Nicotine Regulation on Smoking and Smoking-Related Mortality

The Food and Drug Administration (FDA) has the authority to regulate nicotine levels on all tobacco products. The focus has been primarily on lowering nicotine to minimally or non-addictive levels in cigarettes. While lowering nicotine levels in cigarettes might lead to declining smoking rates, such policies could generate unintended consequences that would undermine their effectiveness. The goal of this project is to examine how nicotine regulation may impact public health, including possible unintended consequences from compensation behaviors and the emergence of a black market. Study aims are: (1) to modify two existing U.S. population-based dynamic smoking prevalence and mortality models to account for the effects of policies that reduce nicotine to non-addictive levels in all combusted tobacco products; (2) to model the number of new smokers, smoking prevalence trajectory, and smoking-related mortality in the U.S. population from 2018-2100 in the absence of nicotine regulation; and (3) to conduct policy simulation exercises on the impact of nicotine regulations on smoking prevalence and associated mortality. Researchers will focus on the impact of potential nicotine policy-related changes on smoking prevalence and overall mortality; however, other health outcomes may be incorporated as they become available from Project 1 of this TCORS. While the focus of this project will be on nicotine reduction, the models will be flexible enough to examine the effect of other FDA regulations to alter cigarette content, such as limits on specific toxic ingredients, as well as the influence of other tobacco control policies. Results may inform potential regulatory activities related to nicotine.

David Mendez and Rafael Meza Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229974-01
Institution: University of Michigan
09/14/2018

U of M TCORS Project 3: Modeling the Impact of Tobacco Control Policies on Polytobacco Use and Associated Health Disparities

More information about how the evolving tobacco marketplace will shape the patterns of tobacco use, their subsequent long-term health effects, and potential disparities by socioeconomic status (SES) and race/ethnicity would be useful. Simulation modeling can predict future health outcomes and provide insights into how different policies and regulations may affect disparities in tobacco use and downstream health outcomes. The goal of this project is to estimate tobacco-related health disparities associated with tobacco use and to investigate the impact of specific tobacco control policy options on these disparities. Study aims are: (1) to estimate current disparities in single- and multi-product tobacco use by SES and race/ethnicity and monitor changes in consumption patterns over time; (2) to estimate the impact of past tobacco control policies on patterns of tobacco and nicotine product use by SES and race/ethnicity; (3) to estimate tobacco-related health disparities in all-cause mortality, cardiovascular mortality, and other health outcomes associated with single- and multi-product tobacco use and the role of past policies in influencing these outcomes; and (4) to model the impact of potential new policies on tobacco use and on tobacco-related health disparities associated with single- and multi-product tobacco use. To address Aim 1, researchers will use five datasets to characterize single- and multi-product tobacco use, including initiation, cessation, relapse, and switching, across demographic groups. To address Aim 2, researchers will use literature reviews, data analyses, and expert panels to determine a range of plausible values for the effect of different potential policies on initiation, cessation, relapse, and single- and multi-product use for key sociodemographic subgroups. Using results from Aims 1 and 2, Aims 3 and 4 will expand simulation models to project the consequences of tobacco use on tobacco-related health disparities. Results will indicate which potential tobacco control policies may be most effective in reducing tobacco-related health disparities due to tobacco use over time.

Nancy Fleischer and David T. Levy Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 1 U54 CA229974-01
Institution: University of Michigan and Georgetown University
09/13/2018

The Effects of E-liquid Nicotine Concentration on the Abuse Liability of ENDS in Current Users

Studies reveal that large differences (>100%) in nicotine content affect the abuse liability of e-liquids, but more information demonstrating how smaller differences in nicotine affect abuse liability of electronic nicotine delivery systems (ENDS) would be useful. The goal of this study is to determine how modest differences (e.g., ±20%) in e-liquid nicotine concentration affect the abuse liability of ENDS. Following an initial laboratory phase where study e-liquids/aerosol and participants’ own brands of e-liquids will be chemically characterized, 30 adult current ENDS users will participate in five ad libitum vaping sessions where they will use five e-liquids, each containing a different nicotine concentration. Measures of abuse liability will include pharmacokinetic and pharmacodynamic data, biomarkers of nicotine exposure, puff topography, and subjective measures of craving, withdrawal, liking, and reinforcement. Findings may inform regulatory standards for tobacco products. 

Babita Das and Olga Rass Funding Mechanism: Research Contract
ID number: HHSF223201710040I
Institution: Battelle 
09/13/2018

E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease Risk

The goal of this study is to relate the acute and long-term use of e-cigarettes and conventional cigarettes to cardiovascular and pulmonary disease biomarkers. Researchers will enroll four different “use-groups” of adults ages 18 and older (n=440): exclusive e-cigarette users (n=110), exclusive cigarette smokers (n=110), dual product users (who both smoke and vape; n=110), and never smokers (n=110). These groups reflect the primary decisions that individuals can make regarding their future tobacco use: to continue to smoke cigarettes, to switch to e-cigarettes, to use both cigarettes and e-cigarettes, or not to use these products. Product use will be related to biomarkers that accurately and reproducibly reflect mechanisms, injury, and future risks related to cardiovascular or pulmonary disease. Primary cardiovascular biomarkers measured will include brachial artery flow-mediated dilation (a measure of endothelial function) and carotid intima-media thickness, a measure of subclinical arterial injury and atherosclerosis. Primary pulmonary disease biomarkers will be measures of lung volumes and flow rates (predicted FEV1, FVC, FEV1/FVC) obtained by spirometry. Researchers will also conduct treadmill exercise stress testing (to assess aerobic fitness), perform electrocardiography (to measure heart rate and its variability), and measure blood pressure, lipids, HgbA1c, inflammation/oxidation markers (leukocyte count, C-reactive protein, urinary F2 isoprostanes) and exhaled nitric oxide. Study findings will yield new data regarding product use, subclinical arterial injury, atherosclerosis burden, arterial and pulmonary function, cardiac and aerobic fitness, cardiac autonomic dysregulation, systemic and pulmonary inflammation, and oxidative stress, as well as other key outcomes.

Timothy Baker and James Stein Funding Mechanism:  NIH Grant
ID number: 1R01HL139331-01A1
Institution: University of Wisconsin-Madison
09/13/2018

Integrated Risk Assessment and Molecular Characterization of Pulmonary Response to E-cigarette Exposure

E-cigarette aerosol is a complex mixture of e-liquid components (propylene glycol, vegetable glycerol, nicotine, water, and flavoring additives) and other constituents (such as aldehydes, metals, nanoparticles, and some unknown compounds) produced during e-cigarette heating. The goals of this study are to evaluate the oxidative stress and inflammation resulting from e-cigarette aerosol, identify aerosol constituents’ distinct “signatures” of early oxidative/nitrative damage in cells and tissue, and use these findings to evaluate the relative hazards of constituents. Researchers will use the Research Grade E-cigarette (REC) device developed at Battelle to generate and characterize aerosol from individual e-liquid components with and without the use of a heated coil. Study aims are: (1) to characterize e-cigarette aerosol generated at moderate and high heating temperatures; (2) to characterize pulmonary response to e-cigarette aerosol constituents in mice; and (3) to predict airway deposition and site-specific tissue dose and translation to humans using computational fluid dynamic-physiologically-based pharmacokinetic (CFD/PBPK) models. Study findings will provide new information about the oxidative and inflammatory effects of e-cigarette use.

Charles K. Ansong Funding Mechanism: NIH Grant
ID number: 1R01HL139335-01A1
Institution: Battelle Pacific Northwest Laboratories
09/13/2018

Exploring Cardiovascular and Other Health Associations of Electronic Cigarette Use in US Persons of Hispanic Heritage: The Hispanic Community Health Study / Study of Latinos (HCHS/SOL)

Information on the effects of electronic nicotine delivery system (ENDS) use on cardiovascular disease (CVD) and other health risks in minority populations would be useful. The goal of this study is to examine associations between ENDS use and CVD and other health risks in the Hispanic/Latino population. Researchers will analyze existing data from a large community-based sample of more than 12,000 individuals of Hispanic/Latino origin (ages 18-74 at baseline) who participated in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) at both baseline (2008-2011) and follow-up (2015-2017). Study aims are: (1) to determine the prevalence of ENDS use and assess demographic, socio-economic, and cultural factors associated with use; (2) to study associations of ENDS use with levels of CVD risk factors, other health measures, assessments of subclinical atherosclerosis, and markers of inflammation, including heart rate, blood pressure, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, fasting glucose, body mass index, and white blood count, taking into account history and current use of tobacco products; (3) to study changes between baseline and follow-up in associations of ENDS use with CVD risk factors, other health measures, and markers of inflammation, taking into account history and current use of tobacco products; and (4) to obtain new data to examine ENDS use as it relates to motivations, dose, flavors, and duration by mailing a questionnaire to users who participated in the HCHS/SOL follow-up. Findings will provide new information about the cardiovascular impact of ENDS use in the Hispanic/Latino population.

Thanh Huyen and Thiv Vu
 
Funding Mechanism: NIH Grant
ID number: 1R03HL144902-01
Institution: Northwestern University at Chicago
09/11/2018

Evaluation Support: Rapid Assessments of State and Local Tobacco Control Policies

This project involves maintaining and evaluating an ongoing systematic approach for identifying relevant state and local tobacco control policies for potential evaluation. This approach includes conducting environmental scans, performing evaluability assessments, conducting pilot evaluations, conducting data analyses for evaluation purposes, and reporting key findings to FDA-CTP on an ongoing basis. 

Tarsha McCrae Funding Mechanism: Research Contract
ID number: HHSF223201310007B
Institution: Research Triangle Institute International
09/11/2018

The Role of ENDS Use in Changing Rates of Escalation and Quitting of Cigarette Smoking in Those Under Age 35 Years in US Population

Electronic nicotine delivery systems (ENDS) have the potential to reduce the proportion of young adults who are addicted to cigarette smoking, either by reducing escalation to daily cigarette smoking or increasing cessation before age 35. The goal of this study is to determine whether ENDS use changes the pattern of escalation and early cessation among those younger than age 35 using data from the first four waves of the Population Assessment of Tobacco and Health (PATH) Study. Study aims are: (1) to examine the contribution of early use of ENDS and other tobacco products in differentiating early cigarette smoking escalators from those who do not escalate before age 20; (2) to examine the contribution of ENDS use to late escalation of tobacco use; and (3) to identify whether ENDS use is associated with long-term discontinuation of cigarette smoking in people under age 35. Researchers will conduct separate analyses for early escalators, late escalators, and quitters before age 35, and will use various analytical methods including propensity score matching, marginal structural models, and targeted maximum likelihood estimation techniques. Findings may provide new information related to the potential long-term impact of ENDS use. 

John P. Pierce and Tarik Benmarhnia Funding Mechanism: NIH Grant
ID number: 1R01CA234539-01
Institution: University of California, San Diego
09/07/2018

The Impact of Design Characteristics on the Modification Potential of Electronic Nicotine Delivery Systems

Different designs of electronic nicotine delivery systems (ENDS) make them more or less likely to be modified by users, which may impact the public health effect of their use. The goal of this study is to evaluate who is most likely to modify ENDS, how and why consumers modify ENDS, how much modification is occurring, and what design characteristics lead to modification. Study aims are: (1) to identify ways that consumers modify ENDS; (2) to determine the extent to which ENDS modification occurs in the U.S. population; and (3) to evaluate the ENDS product characteristics that lead to modification and what motivates modification. To address Aim 1, researchers will conduct interviews with 12 ENDS enthusiasts, analyze social media websites, conduct three focus groups with 20 young adult ENDS users (ages 18-29) and three focus groups with 20 adult ends users (ages 30+); and individual interviews with 20 adolescent ENDS users (ages 12-17). To address Aim 2, researchers will conduct a population-level quantitative survey of current ENDS users (750 adults, 750 young adults, and 750 adolescents) to estimate the prevalence of modification activities and differences by user profile (e.g., dual ENDS/cigarette users vs. exclusive ENDS users). To address Aim 3, researchers will use the data from the quantitative survey to evaluate the association of ENDS characteristics with different types of product modifications. Findings will provide new information about ENDS modification activities and may inform regulatory activities related to ENDS design.

Lyudmila (Lucy) Popova and David L. Ashley Funding Mechanism: NIH Grant
ID number: 1R01DA047397-01
Institution: Georgia State University
09/07/2018

Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm from Tobacco

Youth who use multiple tobacco products differ from youth who solely smoke cigarettes in ways that may affect their responses to a nicotine reduction regulatory policy, which would mandate a reduction of nicotine in all commercially available cigarettes. The goal of this study is to examine the effects of very low nicotine content (VLNC) cigarettes on multiple tobacco product use and toxicant exposure in youth. Following a one-week baseline period, researchers will randomize adolescent cigarette smokers (ages 15-19, n=120) who report past-month alternative tobacco product use to a four-week trial during which they will switch from their usual brand cigarettes to either VLNC or normal-nicotine content (15.8 mg/g nicotine) study cigarettes. This study will use laboratory-based assessments to investigate the effects of cigarette nicotine reduction on: cigarette and multiple tobacco product use; the harms associated with tobacco use, including nicotine and toxicant exposure; and effects on respiratory symptoms, perceived health risk, and nicotine dependence. Using real-time smartphone-based assessments in the natural environment, researchers will also examine the role of nicotine withdrawal and craving in understanding how cigarette nicotine reduction may affect other tobacco use. Findings will provide new information about the effects of VLNC cigarettes on real-world tobacco use and indices of tobacco-related harm in adolescents.

Rachel N. Cassidy and Suzanne Colby Funding Mechanism: NIH Grant
ID number: 1R01DA047356-01
Institution: Brown University
09/01/2018

How Consumers Use Flavors to Make Inferences about Electronic Nicotine Delivery System (ENDS) Product Qualities and Intentions to Use (Phase 2)

This project (Phase 2) will test how different features used to advertise electronic nicotine delivery system (ENDS) flavors are associated with product appeal and intentions to use the product. Specifically, researchers will examine three features identified previously (Phase 1): the use of flavor-related imagery (e.g., picture of a cherry), the use of flavor name modifiers (e.g., Cherry Crush), and the use of flavor descriptors (e.g., “cool”, “fresh”). In Phase 2, researchers will collect data and conduct six analyses, each with four outcomes: (a) product appeal, (b) curiosity about the product, (c) interest in using the product, and (d) increased positive product perceptions (e.g., likeliness to switch from cigarettes, good taste, health effects). Analyses 1 and 2 will investigate whether absence of a flavor-representing image is associated with decreased outcomes compared to an identical ad with a flavor-representing image, and whether presence of the image is associated with increased outcomes compared to an identical ad without any flavor feature. Analyses 3 and 4 will investigate whether absence of a flavor name modifier is associated with decreased outcomes compared to an identical ad with the modifier, and whether presence of the modifier is associated with increased outcomes compared to an identical ad without any flavor features. Finally, analyses 5 and 6 will investigate whether absence of a flavor descriptor is associated with decreased outcomes compared to an identical ad with the descriptor, and whether presence of a descriptor is associated with increased outcomes compared to an identical ad without any flavor features. Secondary analyses will explore sub-group differences among flavors and brands, as well as effects on broader product perceptions, including relative risk and harm. Findings may inform future regulatory activities related to ENDS flavors and marketing. 

Meghan Moran (CTP contact: Lexie Perreras) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005942-03S1
Institution: Johns Hopkins University
09/01/2018

Evaluation of Canada's Menthol Ban

Menthol cigarettes comprise a substantial portion of the American cigarette market, with prevalence estimates reaching about 25%. A US ban on menthol cigarettes would likely elicit changes in the behavior of menthol cigarette smokers and the tobacco industry. On January 1, 2017, the Province of Ontario implemented one of the first bans on menthol products worldwide; a full Canadian ban followed on October 1, 2017. The goal of this study is to conduct a long-term assessment of the menthol ban in Ontario to provide information about its potential impact. Study aims are: (1) to understand tobacco use behavior changes by pre-ban menthol smokers; (2) to characterize industry and sales changes subsequent to the ban; and (3) to explore how menthol cigarette smokers transition from menthol cigarettes to either smoking cessation/reduction or replacement tobacco products. To address these aims, researchers will follow up with of a cohort of 1,738 smokers aged 16 and older surveyed pre-ban to examine smoking behaviors and attitudes two years post-ban. Researchers will also conduct an analysis of administrative tobacco product sales data reported to Health Canada to examine changes in sales and changes in characteristics of products sold post-pan in Ontario and nationally. Finally, researchers will conduct a concept mapping study to supplement the self-reported data and administrative data with an in-depth understanding of user behavior. Findings will reveal menthol smoker and tobacco industry responses to a real-world menthol-flavored tobacco ban, which may inform future regulation and associated public education messaging.

Michael Chaiton Funding Mechanism: NIH Grant
ID number: 1R21DA047358-01
Institution: University of Toronto
09/01/2018

Assessing Physiological, Neural, and Self-Reported Response to Tobacco Education Messages

This project uses neuroimaging, physiological, and self-report measures to assess responses to FDA tobacco education messages from “The Fresh Empire”, “The Real Cost” and “This Free Life” campaigns. To align with FDA campaign target audiences, the project will recruit 100 adolescents (ages 12-17, stratified by race/ethnicity), 50 young adults (ages 18-24, stratified by LGBT status), and 50 adult smokers (ages 25-54, stratified by past-year quit attempt). Physiological measures will assess indicators of arousal (such as heart rate variability) and affective response (such as facial muscle activity). Functional near-infrared spectroscopy (fNIRS), a brain monitoring technique, will measure activation of different brain areas to assess message processing and acceptance. Eye tracking methods will be used to assess attention to messages and message features. Self-report measures will assess message efficacy (e.g., perceived effectiveness, recall, comprehension, agreement with the message main point) and indicators of persuasive processes (e.g., identification with characters, transportation into the message, emotional response, counterarguing). Outcome measures will include changes from baseline in knowledge, attitudes and behavioral intent. Findings will enhance the understanding of effective tobacco education messaging tactics and may inform future tobacco education campaigns.

Meghan Moran (CTP contacts: Matthew Walker and Mario Navarro) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005942-03S1
Institution: Johns Hopkins University 
09/01/2018

Measurement of Metal Ions and HPHCs in Electronic Nicotine Delivery Systems (ENDS) and Their Physio-pathological Impact on Cells of the Oral Cavity and Upper Respiratory Tract

This project will use the electronic nicotine delivery systems (ENDS) aerosolization machine previously developed by the research team to expose normal human cells to complex ENDS aerosol mixtures and determine the physiological and pathological effects from exposure. Study aims are: (1) to determine the effects of ENDS aerosol on cells of the oral cavity and upper respiratory tract, and (2) to identify the constituents of e-liquids, hardware and aerosol to which ENDS users are exposed. In this study, five pre-filled ENDS and two cartomizers and their associated e-liquid formulations will be aerosolized and effects on cells will be assessed (via proteomics and in vitro cell biology assays of specific biological pathways by immunoblotting, cytokine quantitation and metallomics) against appropriate controls. Researchers will also analyze ENDS hardware, e-liquids (including color and ingredients), and the constituents of the complex aerosol for each ENDS category evaluated. All data collected will be compiled into a database that may help to inform the regulatory decision-making process. Project findings may inform future regulatory activities related to ENDS. 

Sarah Michel (CTP contact: Vyomesh Patel) Funding Mechanism: Centers of Excellence in Regulatory Science and Innovation Grant (CERSI)
ID number: 3U01FD005946-03W1
Institution: University of Maryland School of Pharmacy
08/31/2018

Addiction and Behavior Related to Menthol Cigarette Substitutes

Several products in the tobacco marketplace – including mentholated pipe tobacco (for roll-your-own cigarettes, mRYO), menthol filtered little cigars (mFLC), and non-menthol cigarettes (nmC) -- could serve as substitutes for menthol cigarettes. The goal of this study is to examine the abuse liability and substitutability of these potential menthol cigarette alternatives. Specific aims are: (1) to assess the abuse liability of menthol cigarette alternatives; (2) to assess the substitutability of menthol cigarette alternatives; and (3) to evaluate which product characteristics and perceived effects influence greater substitution. Eighty current menthol cigarette smokers (40 smokers ages 18-24 and 40 smokers ages 25+) will complete a three-phase study. In Phase 1, participants will complete four smoking sessions, smoking a different product in each session to examine each product’s abuse liability, demand, and topography. Products will include participants’ usual brand menthol cigarette (UBMC) and three commercially-available alternatives, including mFLC, an mRYO product, and nmC. In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and completely substitute the product for their UBMC for one week. Participants will complete ecological momentary assessments (EMA) during this period to more accurately assess substitution and perceived effects in real time. In Phase 3, participants will complete a final laboratory visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated menthol cigarette ban conditions using a progressive ratio task. In all phases, multiple domains of abuse liability will be assessed, including product administration, product liking/craving, and withdrawal suppression. Findings will provide new information regarding the substitutability of potential menthol cigarette substitutes in adult smokers and may inform future regulatory activities related to menthol cigarettes.

Theodore Lee Wagener and Andrea Villanti Funding Mechanism: NIH Grant
ID number: 1R21DA046333-01A1
Institution: University of Oklahoma Health Sciences Center
08/31/2018

UVM TCORS: University of Vermont Tobacco Center of Regulatory Science

Building upon research in the previous TCORS, the University of Vermont TCORS will conduct research projects on the impact of low nicotine content cigarette use in four vulnerable populations: socioeconomically disadvantaged women of reproductive age (Project 1), individuals with comorbid opioid use disorders (Project 2), individuals with comorbid affective disorders (Project 3), and pregnant women (Project 4). Each of these populations is at increased risk for tobacco use, dependence, and/or tobacco-related adverse health outcomes. Despite their increased risk, these populations are often excluded from tobacco regulatory studies, leaving a significant knowledge gap. The overall goal of the UVM TCORS is to provide sound scientific evidence on the impacts of tobacco products in vulnerable populations. The projects will examine the extent to which the availability and appeal of alternative non-combusted sources of nicotine (i.e., e-cigarettes) may moderate the impact of reduced nicotine standards on reducing cigarette smoking. That topic will be investigated in each of the primary vulnerable populations of interest, using common study protocols to the extent possible, as well as protocols that facilitate comparisons with studies in healthier populations as noted above.

Stephen T. Higgins Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036114-06
Institution: University of Vermont and State Agricultural College
08/31/2018

UVM TCORS Project 1: Low Nicotine Content Cigarettes in Vulnerable Populations: Economically Disadvantaged Women (Non-Pregnant)

Despite marked reductions in cigarette smoking in the general population, smoking rates among economically disadvantaged women have increased. Smoking among women of reproductive age is a concern because in addition to the usual health risks, they face additional risks should they become pregnant. Research indicates that economically disadvantaged women respond to low nicotine content cigarettes (VLNCCs) with reductions in smoking rates, cigarette demand, dependence severity, and other measures of addiction.  The goal of this project is to evaluate whether increased availability and appeal of an alternative non-combusted nicotine source (e-cigarettes) will enhance the effectiveness of a reduced-nicotine standard for cigarettes in socioeconomically disadvantaged female smokers of reproductive age. Study aims are: (1) to compare the effects of normal nicotine content cigarettes (NNCCs) alone, VLNCCs alone, VLNCCs + tobacco-flavored e-cigarettes, and VLNCCs + preferred-flavor e-cigarettes on total number of cigarettes per day; (2) to compare the effects of the four study conditions on cigarette demand, smoke exposure (breath carbon monoxide), and tobacco carcinogen biomarkers (NNAL, PAH metabolites); (3) to explore the effects of the four study conditions on cerebral blood flow, other measures of brain function and structure, and airway inflammation; and (4) to explore the effects of the four study conditions on abstinence-induced cigarette demand, craving, and withdrawal. In this study, 212 disadvantaged female smokers (ages 18-44) will be randomized to 16 weeks of: (1) NNCCs alone (the control condition); (2) VLNCCs alone; (3) VLNCCs + nicotinized tobacco-flavored e-cigarettes; or (4) VLNCCs + nicotinized preferred-flavor e-cigarettes. Participants will complete two in-person assessments (involving baseline health and smoking assessments, a variety of questionnaires, biomarker assessments, cognitive functioning tests, and functional MRI) and use an interactive voice response system to report daily product use and nicotine withdrawal symptoms. After 16 weeks of use, participants will undergo an abstinence assessment in which researchers will examine the effects of the study conditions on participants’ ability to abstain from cigarettes and their responses to abstinence. Findings may inform regulatory activities related to reduced-nicotine cigarettes.

Stephen T. Higgins Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036114-06
Institution: University of Vermont and State Agricultural College
08/31/2018

UVM TCORS Project 3: Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

Affective disorders (ADs; mood and anxiety disorders) are the most common mental health conditions in the US. Over 40% of people with ADs are current smokers, and they experience disproportionately high rates of tobacco-related disease and death. Research indicates that smokers with ADs respond to very low nicotine content cigarettes (VLNCCs) with reductions in cigarette demand and other measures of addiction. The goal of this project is to evaluate whether increased availability and appeal of an alternative non-combusted nicotine source (e-cigarettes) will enhance the effectiveness of a reduced-nicotine standard for cigarettes in smokers with ADs. Study aims are: (1) to compare the effects of normal nicotine content cigarettes (NNCCs) alone, VLNCCs alone, VLNCCs + tobacco-flavored e-cigarettes, and VLNCCs + preferred-flavor e-cigarettes on total number of cigarettes per day; (2) to compare the effects of the four study conditions on cigarette demand, psychiatric symptoms, smoke exposure (breath carbon monoxide), and tobacco carcinogen biomarkers (NNAL, PAH metabolites); (3) to explore the effects of the four study conditions on cerebral blood flow, other measures of brain function and structure, and airway inflammation; and (4) to explore the effects of the four study conditions on abstinence-induced cigarette demand, craving, and withdrawal. In this study, 236 adults with ADs (ages 18-70) will be randomized to 16 weeks of exposure to (1) normal nicotine content cigarettes alone, which will serve as the control condition, (2) VLNC cigarettes alone, (3) VLNCs + tobacco-flavored nicotinized e-cigarettes, or (4) VLNCs + nicotinized e-cigarette with preferred flavoring. Participants will complete two in-person assessments (involving baseline health and smoking assessments, a variety of questionnaires, biomarker assessments, cognitive functioning tests, and functional MRI) and use an interactive voice response system to report daily product use and nicotine withdrawal symptoms. After 16 weeks of use, participants will undergo an abstinence assessment in which researchers will examine the effects of the study conditions on participants’ ability to abstain from cigarettes and their responses to abstinence. Findings may inform regulatory activities related to reduced-nicotine cigarettes.

Jennifer W. Tidey Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036114-06
Institution: Brown University
08/31/2018

UVM TCORS Project 4: Low Nicotine Content Cigarettes in Vulnerable Populations: Pregnant Women

Approximately 11% of U.S. women (~17 million women) are smokers when they become pregnant, with prevalence as high as 40% among socioeconomically disadvantaged women. Smoking during pregnancy can cause catastrophic pregnancy complications and adverse effects on fetal development that a growing body of evidence suggests can compromise health throughout the lifespan. Researchers are currently conducting a multi-site study examining the acute effects of very low nicotine content cigarettes (VLNCCs) on the addiction potential of smoking in pregnant women; the goal of this project is to further this line of research by examining extended exposure. Study aims are: (1) to compare extended exposure to either usual brand cigarettes or VLNCCs on number of cigarettes smoked per day; (2) to quantify the effects of extended exposure to VLNCCs on measures of biomarkers of exposure (total cotinine, NNAL, PAH) and sonographic assessments of fetal growth and body composition; and (3) to compare the effects of VLNCCs on abstinence-induced cigarette demand, craving, and withdrawal. It should be noted that a recommendation to all women screened for this study will be that they should quit, consistent with ethical guidelines about smoking during pregnancy. All potential participants will be asked at screening about their intentions to quit smoking during pregnancy. Those with intentions to quit in the next 12 weeks will be referred to our ongoing studies on smoking cessation in pregnant women. Those who do not will be randomized to smoke either usual brand cigarettes or VLNCCs for 12 weeks. Ninety participants (ages 18-44) will complete two in-person baseline assessments (involving baseline health and smoking assessments, a variety of questionnaires, biomarker assessments, and fetal measurements) and will be seen weekly throughout the study. Findings may inform regulatory activities related to reduced-nicotine cigarettes.

Sarah H. Heil Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036114-06
Institution: University of Vermont and State Agricultural College
08/31/2018

A-TRAC TCORS: American Heart Association Tobacco Center for Regulatory Science (A-TRAC) 2.0

The overall goal of the American Heart Association (AHA) Tobacco Regulation Center (A-TRAC) is to provide scientific data relevant to the cardiovascular effects of tobacco products by evaluating the cardiovascular effects of tobacco products and their constituents. A-TRAC will support three projects. Project 1 will assess the toxicity of tobacco products and their constituents in in vitro assays and animal models. Project 2 will evaluate short- and long-term cardiovascular health effects of tobacco products. Project 3 will assess the cardiovascular disease risk associated with the use of non-cigarette tobacco products in multiple large NIH-supported cardiovascular cohorts. Research supported by the A-TRAC will develop new understanding of the cardiovascular effects of current, new and emerging tobacco products; and build and deploy capacity and expertise to respond to new developments. 

Rose Marie Robertson and Aruni Bhatnagar Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 HL120163-06
Institution: American Heart Association and University of Louisville
08/31/2018

A-TRAC TCORS Project 1: Cardiovascular Toxicity of Tobacco Products

Cardiovascular disease (CVD), including coronary heart disease and stroke, is the leading causes of death and disability associated with tobacco use. However, more information would be useful regarding specific tobacco product constituents that affect cardiovascular toxicity. The goal of this American Heart Association Tobacco Center for Regulatory Science (A-TRAC) project is to test the hypothesis that cardiovascular injury due to tobacco product use could be attributed mostly to volatile organic compounds (VOCs; e.g., formaldehyde, acetaldehyde, acrolein, benzene, xylene) generated in a variety of tobacco products. Study aims are: (1) to quantify the cardiovascular toxicity of tobacco product-derived VOCs in human cells in vitro; (2) to assess short-term and chronic toxicity of tobacco products (i.e., combustible cigarettes, smokeless tobacco, electronic nicotine delivery systems, electronic and conventional hookah) using a mouse model; and, (3) to identify individual VOCs that mediate the cardiovascular toxicity of tobacco products. To test this hypothesis, researchers will define the contribution of VOCs to the cardiovascular toxicity of tobacco products using sensitive and informative in vitro assays and well-controlled animal exposures. Findings will provide new information related to the cardiovascular toxicity of tobacco products and their constituents to inform future regulatory activities.

Daniel Joseph Conklin Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 HL120163-06
Institution: University of Louisville
08/31/2018

A-TRAC TCORS Project 2: Cardiovascular Injury Due to Tobacco Use

The goal of this American Heart Association Tobacco Center for Regulatory Science (A-TRAC) project is to assess and evaluate the cardiovascular effects of non-cigarette tobacco products and to determine whether cardiovascular injury due to tobacco product use is mediated, in part, by exposure to volatile organic chemicals (VOCs) present in or generated by tobacco products. To describe the contribution of VOCs to cardiovascular injury and dysfunction induced by tobacco products, researchers will evaluate the short- and long-term cardiovascular health and disease risk in 555 adult (ages 18-45) users of cigarettes, e-cigarettes, and cigarillos. Study aims are: (1) to identify cardiovascular harm associated with the use of e-cigarettes and cigarillos; (2) to examine the acute cardiovascular effects of e-cigarettes and cigarillos; and (3) to identify cardiovascular disease risk associated with chronic use of e-cigarettes and cigarillos. To accomplish these aims, researchers will examine baseline differences in biomarkers of endothelial injury, inflammation and thrombosis and indices of vascular function and cardiac excitability in e-cigarette and cigarillo users and compare results with cigarette smokers and individuals who do not use tobacco products. To examine long-term effects of tobacco products, researchers will identify progressive changes in cardiovascular disease risk due to continued use of tobacco products over two to six years. Findings will provide new information related to the cardiovascular toxicity of tobacco products and may inform future regulatory activities.

Aruni Bhatnagar Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 HL120163-06
Institution: University of Louisville
08/31/2018

A-TRAC TCORS Project 3: Cardiovascular Effects of Tobacco Products in Community-based Cohorts

Although overwhelming evidence supports the association between cigarette smoking and cardiovascular disease, the cardiovascular effects of other tobacco products such as cigars, pipes, smokeless tobacco, and e-cigarettes remain unclear. The goal of this American Heart Association Tobacco Center for Regulatory Science (A-TRAC) project is to assess the cardiovascular health impact of these less frequently used tobacco products. Study aims are: (1) to use the Cross Cohort Collaboration (CCC) dataset to harmonize tobacco data across 18 cohort studies and to create the largest cardiovascular study of cigar, pipe, and smokeless tobacco users yet undertaken (among 200,000 total cohort participants, there are 65,000 former smokers, 24,000 current smokers, 2,900 cigar users, 3,300 pipe users, and 1,900 smokeless tobacco users); (2) to use the CCC dataset to examine whether the use of cigars, pipes, and smokeless tobacco is associated with volatile organic compound (VOC) exposure, biomarkers of subclinical inflammation, vascular injury, and cardiovascular events; and (3) to develop e-cigarette use data from existing cardiovascular cohort studies to undertake first-of-its-kind study of the cardiovascular health effects of e-cigarettes in a large geographically dispersed, community-based sample (~1500-2000 ever e-cigarette users, ~600 current e-cigarette users). Aggregate data from these aims will be used to test the hypothesis that non-cigarette tobacco product use is associated with significant cardiovascular injury, which is attributable, in part, to VOCs generated by or present in these products. Findings will provide new information related to the cardiovascular impact of tobacco product use and may inform future regulatory activities.

Michael J. Blaha Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 HL120163-06
Institution: Johns Hopkins University
08/29/2018

UCSF TCORS: Integrated Health, Behavioral and Economic Research on Current and Emerging Tobacco Products

The goal of this TCORS is to examine health effects, behavior, and impact related to current and emerging tobacco products, including e-cigarettes, smokeless tobacco, and new “heated tobacco products (HTPs). Specific aims are: (1) to evaluate the short-term health effects, including respiratory and cardiovascular effects, of e-cigarettes, HTPs, and other tobacco products and how specific tobacco product characteristics influence health effects and behavior; (2) to further add to the science base to inform product standards and marketing regulations for these tobacco products, integrating the health and behavioral dimensions of tobacco use with economic models, with particular emphasis on specific product characteristics and short-term effects; and (3) to build the tobacco regulatory science research community through mentoring, developmental grants, and other support. The TCORS will accomplish these aims through five projects; topics are as follows: (1) the impact of different e-cigarette characteristics on acute lung injury; (2) the short-term cardiovascular effects of e-cigarettes, including the influence of device power and e-liquid pH, and how e-cigarettes compare with HTPs; (3) the cardiovascular health effects of emerging HTPs; (4) the influences of product characteristics on perceptions, behaviors, and biologic exposures in rural adolescents; and (5) the impact of changing tobacco product use on healthcare costs for general and vulnerable populations. Project findings may provide information that may inform future regulatory activities.

Pamela Ling Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 9-U54HL147127-06
Institution: University of California, San Francisco
08/29/2018

UCSF TCORS Project 1: Impact of Different E-Cigarette Characteristics on Acute Lung Injury

Variation in e-cigarette characteristics may have a significant impact on pulmonary health. Changes in e-cigarette device and liquid characteristics may influence acute pulmonary effects, both under healthy conditions and in the setting of acute respiratory infection and/or inflammation. This project proposes a comprehensive assessment of the impact of e-cigarette characteristics on acute lung injury, combining data from cell culture, mouse models, and human subjects. Study aims are: (1) to test how different device characteristics (applied power and metal coil components) impact the acute pulmonary effects of e-cigarettes; and (2) to test how different e-liquid characteristics (nicotine concentration and flavorings) impact the acute pulmonary effects of e-cigarettes. Both aims begin with an evaluation of the impact of varying e-cigarette characteristics on susceptibility to viral or bacterial lung injury in cell culture and mouse models. This evaluation will be conducted with and without infectious and inflammatory stimuli, including viral (influenza) and bacterial (pneumococcal) infection. The e-cigarette characteristics that appear to be most important in these models will then be tested in a human model of lung inflammation, in which 60 healthy adult (age >21) e-cigarette users and dual cigarette/e-cigarette users inhale endotoxin, followed by bronchoscopy with bronchoalveolar lavage. Findings will yield new information regarding how specific e-cigarette device and e-liquid characteristics impact their potential to cause acute lung injury and may inform future regulatory activities.

Carolyn Calfee Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 9-U54HL147127-06
Institution: University of California, San Francisco
08/29/2018

UCSF TCORS Project 2: Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power and E-Liquid pH and How E-Cigarettes Compare with Heat-Not-Burn Products

This project will provide more information about how specific aspects of e-cigarettes influence their overall health effects, including short-term cardiovascular effects. The goal of this project is to evaluate the impact of e-cigarette power on cardiovascular effects; the influence of e-liquid pH on rate of systemic nicotine absorption, nicotine-induced sympathetic nervous system stimulation, and heart rate increase (a risk factor for cardiovascular disease); and the health effects of heated tobacco products (HTPs), which heat tobacco without combustion. Study aims are: (1) to determine the impact of e-cigarette power on nicotine pharmacology, systemic exposure to toxic volatile organic compounds (VOCs), and short-term cardiovascular effects; (2) to determine the impact of changes in e-liquid pH on nicotine pharmacokinetics, cardiovascular, and subjective effects of e-cigarettes; and (3) to compare differences in nicotine pharmacology, systemic exposure to toxic VOCs, and short-term cardiovascular effects of e-cigarettes and an HTP (iQOS). These aims will be achieved through three studies, one study for each aim. Each study will be conducted on an inpatient research ward and will include 21 healthy users (age >21) of e-cigarettes and/or an HTP. Studies 1 and 2 will test different electrical power and e-liquid pH levels, respectively. Study 3 will be a within-subject comparison of toxicant exposure and the cardiovascular effects of e-cigarettes compared to iQOS. Study endpoints will include markers of cardiovascular disease risk, such as heart rate and blood pressure changes, hormonal release, biomarkers of endothelial function, platelet activation, inflammation, and oxidative stress. Findings will contribute to knowledge of the influence of e-cigarette characteristics on short-term cardiovascular effects and may inform future regulatory activities.

Gideon St. Helen Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 9-U54HL147127-06
Institution: University of California, San Francisco
08/29/2018

UCSF TCORS Project 3: Cardiovascular Health Effects of Emerging Heat-Not-Burn Tobacco Products

Heated tobacco products (HTPs), which heat a mixture of tobacco and other compounds to temperatures below those at which combustion occurs, deliver an inhalable aerosol containing nicotine and other chemicals. Despite harm reduction claims, the health effects of HTPs are poorly understood. The goal of this project is to evaluate the cardiovascular effects of an HTP (iQOS), including effects on cardiac and peripheral vascular function and cardiac tissue preservation after acute myocardial infarction, relative to tobacco smoke and e-cigarette aerosol. Study aims are: (1) to understand the chemical properties of HTP aerosol and chemical changes during its generation; (2) to evaluate and understand cardiovascular health effects of both acute and repeated exposure to HTP aerosol in rats; and (3) to determine whether acute and chronic exposure to HTP aerosol prior to acute myocardial infarction increases the extent of the resulting cardiac tissue death. To satisfy aim 1, researchers will perform chemical analyses of HTP aerosol and compare results to the chemical composition of unused HTP tobacco and to residual HTP tobacco after use. To satisfy aim 2, researchers will collect functional measurements in rats following HTP aerosol exposure and will evaluate the effects of single acute exposures and repeated exposures over 14 days. To satisfy aim 3, researchers will induce myocardial infarction in rats after a single brief exposure or multiple exposures to HTP aerosol or cigarette smoke and measure the extent of cardiac tissue damage. Results may inform future regulatory activities related to HTPs.

Matthew Lawrence Springer Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 9-U54HL147127-06
Institution: University of California, San Francisco
08/29/2018

UCSF TCORS Project 4: Current and Emerging Tobacco Products in a Rural Context: Influences of Product Characteristics on Perceptions, Behaviors, and Biologic Exposures

In recent decades, smokeless tobacco (ST) use has shifted from an older to a younger demographic, along with increasing industry marketing and expanding diversity in ST product characteristics. New ST products include different types, brands, flavors, and levels of nicotine and cancer-causing nitrosamines. More information about how different characteristics of ST products and other tobacco products contribute to youth perceptions, initiation, established use, poly-use, and exposure to nicotine and carcinogens would be useful. Study aims are: (1) to identify the impact of ST and other tobacco product characteristics, including packaging, characterizing flavors, and product design, on rural adolescents’ perceived harm, acceptability, and appeal of current and emerging smokeless, combustible, and alternative tobacco products; (2) to characterize tobacco use behaviors over time (e.g., initiation, cessation, changes in intensity, product switching, and poly-use) and how family and social factors and specific product characteristics predict transitions in behavior; and (3) to evaluate the impact of tobacco product use on rural adolescents' exposure to nicotine and tobacco-specific nitrosamines. This study will include 1500 adolescents (aged 14-16) attending seven rural high schools in California, followed for five survey waves over 24 months. Qualitative studies (focus groups and one-on-one interviews) with adolescents and their parents/guardians will be conducted to provide information about how product characteristics and socio-contextual factors influence perceptions and behavioral decisions regarding tobacco products. Collected biomarkers (saliva specimens to measure cotinine levels; urine specimens to measure levels of the nitrosamines NNN and NNAL) will reveal how exposure to nicotine and nitrosamines varies with differences in product use and use patterns. Study findings will improve understanding of how different characteristics of ST and emerging tobacco products impact behavior and health effects in rural adolescents.

Benjamin Wilk Chaffee Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 9-U54HL147127-06
Institution: University of California, San Francisco
08/29/2018

UCSF TCORS Project 5: Impact of Changing Tobacco Product Use on Healthcare Costs for General and Vulnerable Populations

Many factors contribute to tobacco-attributable healthcare costs, including changing tobacco product use patterns, sociodemographic characteristics, health status, and socioeconomic status (SES). The goal of this project is to develop economic models that analyze the impact of new patterns of tobacco product use on healthcare costs for different populations, including vulnerable populations. Study aims are: (1) to develop microeconomic models to estimate the healthcare costs attributable to e-cigarette use; (2) to estimate healthcare costs attributable to cigarette smoking and e-cigarette use for vulnerable populations (people with low SES, rural populations, people with medical co-morbidities, and youth); (3) to develop microeconomic models to estimate the healthcare costs attributable to the most common combinations of tobacco product use (i.e., dual use of cigarettes and e-cigarettes; dual use of cigarettes and cigars; and poly-use of cigarettes, e-cigarettes, and other tobacco products); and (4) to analyze potential scenarios to determine the likely impact of regulatory changes on healthcare costs. Tobacco-attributable healthcare costs will be estimated using econometric models and an approach in which costs among product users are compared with costs among people assumed to be never tobacco users or sole cigarette smokers (depending on the relevant comparison group). The healthcare cost estimates from this project will be useful metrics for measuring the impact of tobacco use on public health, allowing a comparison of the relative magnitude of health effects of different tobacco products on specific populations.

Wendy B. Max Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 9-U54HL147127-06
Institution: University of California, San Francisco
08/28/2018

VCU TCORS: Center for the Study of Tobacco Products

Methods exist for assessing a regulation’s effects once it is in place, but few models predict impact beforehand. The VCU Center for the Study of Tobacco Projects (CSTP) will explore a model that may allow the prediction of regulatory impact. The model assesses how a potential regulation might change product toxicity, user behavior, and addiction/abuse liability. To verify the model, the CSTP will also examine the extent to which its predictions about potential regulatory effects describe actual population-level outcomes. This TCORS includes four projects. Projects 1, 2 and 3 will test hypotheses and generate predictions regarding the impact of three potential e-cigarette regulations (i.e., limit e-cigarette liquid nicotine concentration, constrain rate of e-cigarette nicotine emission or “flux”, reduce e-cigarette liquid flavor availability); specifically, researchers will assess how each potential regulation might influence product toxicity (Project 1), user behavior (Project 2), and addiction/abuse liability (Project 3). Project 4 will evaluate the predictions generated by Projects 1,2, and 3 at the population level by surveying current exclusive e-cigarette users and e-cigarette/cigarette dual users (ages 18 and older) every three months for four years. VCU CSTP’s goal is to provide tools to guide regulation development so that, by the time a regulation goes into effect, validated methods have tested it, refined it, and generated data showing that its health-promoting effects are maximized and unintended consequences are minimized. The model and associated tools may be used to shape, refine, and predict the effects of many potential regulatory actions in the future.

Thomas Eissenberg and Alison Breland Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036105-06
Institution: Virginia Commonwealth University
08/28/2018

VCU TCORS Project 1: Using Toxicity Testing Data to Test Hypotheses about Advanced-Generation ECIGs and Generate Population-level Predictions Regarding Potential Regulatory Action

The goal of this project is to examine how e-cigarette toxicant emissions are influenced by several potential regulatory actions. This project’s three study aims will use established aerosol research and analytical chemistry methods to evaluate how three potential regulatory actions -- (1) limits on e-cigarette nicotine concentration, (2) constraints on e-cigarette nicotine flux, and (3) reduction in e-cigarette flavor availability – might influence e-cigarette emissions. For Aim 1, researchers will use our previously published mathematical model that predicts e-cigarette nicotine flux to explore conditions under which e-cigarette liquids containing <20 mg/ml nicotine might exceed tobacco cigarette nicotine yield, and then measure actual nicotine and non-nicotine toxicant yields for these conditions. For Aim 2, researchers will manipulate nicotine flux and then examine how flux manipulation influences the toxicity of the resulting e-cigarette aerosols. For Aim 3, researchers will explore the non-nicotine toxicant emissions produced by do-it-yourself e-cigarette liquids. This project will provide new data regarding the role of nicotine concentration, flux, and liquid flavor availability on e-cigarette toxicity, while informing predictions regarding the consequences of potential regulatory action. 

Alan Shihadeh Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036105-06
Institution: American University of Beirut
08/28/2018

VCU TCORS Project 2: Using User Behavior Data Collected in the Clinical Lab to Test Hypotheses about Advanced-generation ECIGs and Generate Population-level Predictions Regarding Potential Regulatory Action

E-cigarette nicotine delivery, user subjective response, and user behavior measures (such as puff topography) can be assessed using rigorously-controlled, well-established clinical laboratory methods. The goal of this project is to use these established clinical laboratory methods to examine the extent to which e-cigarette nicotine delivery, e-cigarette liquid consumption, subjective response, and puff topography are influenced by manipulations of e-cigarette liquid nicotine concentration and device power, nicotine flux, and flavor availability. Study aims are: (1) to manipulate e-cigarette liquid nicotine concentration and device power to evaluate how nicotine delivery, abstinence suppression, and e-cigarette liquid consumption change as nicotine concentration is lowered, and whether these changes are offset by higher power; (2) to manipulate nicotine flux to determine whether nicotine delivery and abstinence suppression are related directly to flux; and (3) to manipulate e-cigarette liquid flavors to determine whether nicotine delivery, abstinence suppression, and e-cigarette liquid consumption vary by flavor for e-cigarette users and for smokers. The three aims correspond to three independent studies, each involving exclusive e-cigarette users and non-e-cigarette-using cigarette smokers (ages 18-55).  This project will assess the nicotine delivery and subjective response profile of e-cigarettes, will generate new data regarding the effects of advanced-generation e-cigarettes on user behavior, and will contribute to population-level predictions.

Alison Breland Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036105-06
Institution: Virginia Commonwealth University
08/28/2018

VCU TCORS Project 3: Using Abuse Liability Data to Test Hypotheses about Advanced-Generation ECIGs and Generate Population-level Predictions Regarding Potential Regulatory Action

Behavioral economic tasks reveal how much people are willing to pay for nicotine delivery, how hard they will work to earn nicotine delivery, and how price sensitive their product choices are. This project will use standard abuse liability assessments to examine the extent to which response to behavioral economic tasks is influenced by three potential regulatory actions: limits on e-cigarette liquid nicotine concentration, constraints on nicotine flux, and reduction in flavor availability. Study aims are: (1) to manipulate e-cigarette liquid nicotine concentration and device power to evaluate whether abuse liability is altered as nicotine concentration is lowered, and whether this effect is offset by higher power; (2) to manipulate nicotine flux to determine the extent to which willingness to pay/work and price sensitivity are directly related to nicotine flux; and (3) to manipulate e-cigarette liquid flavors to determine whether predictors of abuse liability vary with flavor differently for e-cigarette exclusive users than for dual users. The three aims correspond to three independent studies, each involving exclusive e-cigarette users and dual e-cigarette and tobacco cigarette users (ages 18-55).  Findings will provide new data regarding e-cigarette abuse liability in two populations that will likely be impacted by regulatory actions, and will generate predictions regarding the consequences of three potential regulatory actions.

Caroline O. Cobb Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036105-06
Institution: Virginia Commonwealth University
08/28/2018

VCU TCORS Project 4: Using a Prospective Cohort Survey to Test Population-level Predictions Generated by Projects 1-3

Examining how potential regulatory actions influence product toxicity, user behavior, and product abuse liability in controlled settings can help generate predictions regarding regulatory consequences at the population level. However, the extent to which these predictions reflect real-world behavior should be tested. The goal of this project is to survey current exclusive e-cigarette users and e-cigarette/cigarette dual users (ages 18 and older) to test population-level predictions that arise from the studies conducted in Projects 1-3 of the VCU TCORS. Specifically, the study will assess the population-level effects of three potential regulatory actions: limits on e-cigarette liquid nicotine concentration, constraints on e-cigarette nicotine flux, and reduction in e-cigarette flavor availability. Study aims are: (1) to assess relationships among nicotine concentration, amount of e-cigarette liquid consumed, and device power; (2) to assess relationships among nicotine flux and e-cigarette use, dependence and transitions; and (3) to examine associations between availability of e-cigarette liquid flavors and e-cigarette use behavior. After an initial survey, follow-up survey waves will occur regularly for four years. Survey questions will be designed to monitor e-cigarette use behaviors and e-cigarette liquid and device characteristics. Measures will include frequency of use; current device type, wattage, voltage, and resistance; presence of nicotine; nicotine concentration, propylene glycol/vegetable glycerin ratio; flavor preference; frequency of do-it-yourself e-cigarette liquid mixing; method, location and price of purchase; length of e-cigarette/tobacco cigarette cessation (if any); abstinence effects; tobacco cravings; dependence; and respiratory symptoms.  A subgroup of participants will undergo puff topography measurement so that nicotine flux can be calculated. 

Joanna E. Cohen Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036105-06
Institution: Johns Hopkins University
08/27/2018

Animal Models to Inform FDA Tobacco Regulation: Assessing the Relative Abuse Liability of Different Classes of Tobacco Products

Although nicotine is the main addictive chemical in tobacco, other chemicals may also contribute to tobacco addiction. The goal is to understand whether non-nicotine constituents unique to cigarette smoke contribute to differences in abuse liability between conventional combusted cigarettes and non-combusted products like e-cigarettes, smokeless tobacco, and nicotine replacement therapy (NRT), using rat models of abuse liability including self-administration. Researchers will measure levels of non-nicotine constituents (e.g., monoamine oxidase [MAO] inhibitors, volatile organic compounds [VOCs]) and identify the specific constituents that may be responsible for observed differences in abuse liability.  Study aims are: (1) to compare demand for cigarette smoke extract to nicotine dose-equivalent concentrations of smokeless tobacco extract, e-cigarette extract, and nicotine alone when each is available in isolation or under choice procedures to determine relative reinforcing efficacy and substitutability of the extracts and nicotine alone; (2) to compare reinforcement-enhancing and aversive effects between extracts and nicotine alone; and (3) to evaluate the reinforcement-enhancing and aversive effects of isolated MAO inhibitors and VOCs when administered alone or in combination with nicotine. Findings will provide information about how chemicals other than nicotine contribute to tobacco addiction and may inform regulatory activities. 

Andrew Charles Harris and Mark G. LeSage Funding Mechanism: NIH Grant
ID number: 1R01DA046318-01A1
Institution: Minneapolis Medical Research Foundation, Inc.
08/17/2018

Dissolution of Smokeless Tobacco Products

The purpose of this study is to characterize the nicotine release profiles of smokeless tobacco products available in the US to investigate the effects of tobacco blend changes, formulation changes, pH changes, and differences in physical parameters on nicotine release and to create a baseline for product comparison. Study aims are: (1) to develop and validate a method for nicotine quantification using high performance liquid chromatography/ultra-performance liquid chromatography-mass spectrometry (HPLC/UPLC-MS) to measure nicotine in the selected dissolution medium; and (2) to develop and validate dissolution methods (USP 4 and Chewing gum tester) for different categories of smokeless tobacco products and to analyze their nicotine release profiles. Findings will provide new information about the effects that different tobacco blends, pouch materials, pH buffers and buffering capacity, and other additives have on nicotine release from smokeless products. 

Mimy Young Funding Mechanism: Research Contract
ID number: HHSF223201810173P
Institution: Texas A&M
08/15/2018

Yale TCORS Project 1: Effects of Sweet and Coolant Flavors on Nicotine Choice, Consumption and Seeking

The proportion of users of sweet-flavored and mentholated tobacco products has increased dramatically, especially among adolescents, raising concerns that flavors may facilitate tobacco product initiation and promote nicotine addiction. An additional concern is the recent introduction of synthetic cooling agents that may have effects similar to menthol. Children and adolescents are conditioned, through prior experience, to associate sweet and cooling flavors (fruit, candy, mints, etc.) with high sweetener content (sugar or artificial sweeteners). However, the role of flavors in the initiation of tobacco product use is difficult to study in humans, especially in adolescents and never-users. The goal of this project is to use adolescent and adult rodent models of inhaled and smokeless tobacco product use, and of oral flavor-paired nicotine self-administration, to examine whether sweet and cooling flavors in tobacco products enhance nicotine use behavior and addiction. Researchers will determine whether early flavor exposure and early flavorant associations with sweeteners influence subsequent nicotine choice and initiation, maintenance, and relapse. Study aims are: (1) to examine sweet and cooling flavor exposure and conditioning effects on nicotine choice and use using the two-bottle choice test in mice and nicotine self-administration in rats; and (2) to examine the effects of synthetic cooling agents on respiratory irritation caused by e-cigarette vapors. Study findings will provide new information about sweet and cooling flavor effects on the initiation and persistence of tobacco use.

Nii A. Addy Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036151-06
Institution: Yale University
08/15/2018

Yale TCORS Project 2: Sweet and Cooling Flavors and Nicotine: Examinations in New and Established Tobacco Product Users

Evidence suggests that younger tobacco users have a greater preference for flavors compared with older tobacco users. Furthermore, youth who are initiating tobacco use often report the availability of appealing flavors as one of the primary reasons for trying and using certain tobacco/nicotine products, like e-cigarettes, cigars and hookahs. Flavors could alter the appeal and abuse potential of nicotine/tobacco either through offering appealing aroma or taste or by ameliorating aversive characteristics of tobacco/nicotine. The goal of this project is to conduct two studies to determine the influence of the “aroma and taste” and “ameliorating” attributes of popular sweet and menthol flavors on the appeal and use of e-cigarettes. Study 1 will examine the influence of brief exposures to sweet, cool and tobacco flavors (and combinations) on the appeal and abuse potential of e-cigarettes containing nicotine concentrations varying in harshness (3 and 12 mg/ml), among 60 youth (aged 16-20), who have tried e-cigarettes, do not use regularly, but plan to continue use in the future. This study will provide useful information about the influence of sensory responses to flavors on the appeal of e-cigarettes among new users. This study will also explore whether sensory responses to flavors predict emergence of e-cigarette and other tobacco use behaviors at six-month and one-year follow-ups. Study 2 will examine whether different classes of flavors (i.e., sweet, cool, tobacco), when combined with nicotine concentrations differing in harshness (6 and 18 mg/ml) alter appeal and nicotine reward among 60 young adult (aged 18-24) and 60 older adult (aged 35-50) cigarette/cigar smokers; this study will also explore the differential influence of sweet, cool, and tobacco flavors on switching from combustible tobacco product use to e-cigarettes. Findings may inform future regulatory activities related to flavors in tobacco/nicotine products.

Suchitra Krishnan-Sarin Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036151-06
Institution: Yale University
08/15/2018

Yale TCORS Project 3: Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

Rapid delivery to the brain enhances the abuse potential of drugs of abuse, including nicotine. As proposed by Shihadeh and Eissenberg, nicotine flux, or the rate at which an e-cigarette delivers nicotine, is the most critical factor for evaluating its abuse potential. In this model, when an e-cigarette delivers nicotine at rates above a certain (undetermined) threshold, it can have high abuse potential and may initiate or maintain tobacco addiction. In contrast, when the nicotine flux is optimal, the e-cigarette may have low addiction potential while providing sufficient nicotine delivery to help smokers quit smoking by alleviating urges to smoke. This proposed “optimal nicotine flux” concept has yet to be assessed in human studies. In addition, flavors and other e-cigarette ingredients may affect nicotine flux; notably, menthol may have such an effect through inhibition of nicotinic receptors and slowing of nicotine metabolism. The goal of this project is to examine the impact of nicotine delivery rate on nicotine’s abuse potential and its potentially beneficial effects of alleviating smoking urges and withdrawal. Researchers will also determine whether switching from menthol to non-menthol cigarettes changes the impact of nicotine delivery rate on the study outcomes. To achieve these goals, researchers will conduct two studies in adult (aged 18-30) smokers. Study 1 will recruit equal numbers of menthol (n=35) and non-menthol (n=35) smokers for five experimental sessions, which will be at least 24 hours apart. Each session will include one randomly-assigned infusion that will be either saline or a single dose of nicotine (1 mg per 70 kg body weight) delivered at four different infusion rates (0.24, 0.096, 0.048 or 0.024 μg per kg body weight per second). In Study 2, menthol-preferring smokers (n=38) will be randomized to a menthol or non-menthol cigarette smoking condition for two weeks and will then be crossed over to the alternative smoking condition for two weeks. For both studies, the main outcome measures will be measures of abuse potential (subjective drug effects and reinforcement) smoking urges, tobacco withdrawal, plasma nicotine concentrations, nicotine metabolite ratio, heart rate, and blood pressure. Study findings may inform standards for nicotine delivery rates that minimize the addictive risks of e-cigarettes and other electronic nicotine delivery systems.

Mehmet Sofuoglu Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036151-06
Institution: Yale University
08/15/2018

Yale TCORS: Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents (YCSTP)

The Family Smoking Prevention and Tobacco Control Act prohibits adding characterizing artificial or natural flavors to tobacco cigarettes other than tobacco flavor and menthol. Menthol and a wide variety of flavors, however, are in other tobacco products.  Research addressing the influence of flavors on the appeal of tobacco/nicotine and the initiation, progression and maintenance of tobacco use can inform further regulation of flavors. Toward this end, the Yale Center for the Study of Tobacco Product Use and Addiction (YCSTP) will examine the role of different classes of sweet and cool flavors, including sweeteners. on initiation, continued use and addiction to nicotine/tobacco, and their relevance to harm reduction. Researchers will integrate biological and behavioral testing in animal models and in humans to generate a firm scientific foundation for potential future regulation of flavors in tobacco products. Project 1 will examine whether preconditioning to flavors and sweeteners influences nicotine use behaviors and addiction and will evaluate the influence of novel cooling agents, which may ultimately replace menthol in tobacco products. Project 2 will examine the influence of sweet and cool flavors on initiation behaviors in youth who are susceptible to future use; it will also evaluate whether sweet and cool flavors have different impacts on nicotine reward and switching behaviors in both younger and older combustible tobacco users. Project 3 will determine the optimal delivery rate needed by tobacco users to relieve nicotine withdrawal while producing minimal positive effects, and whether the influence of this delivery rate is altered if combustible tobacco users switch from using mentholated to non-mentholated products. This TCORS may inform future regulatory activities related to flavors in tobacco products.

Suchitra Krishnan-Sarin and Stephanie O'Malley Funding Mechanism: National Institutes of Health – TCORS Grant
ID number: 2 U54 DA036151-06
Institution: Yale University
08/14/2018

Leachables and Extractables in E-liquid Bottles and Closed ENDS Products

Electronic nicotine delivery system (ENDS) products can be defined as having a closed-ENDS or open-ENDS design. In closed-ENDS products, e-liquid is contained in a non-refillable reservoir; in open-ENDS products, e-liquid is contained in a refillable reservoir, and may include e-liquid drip tip devices designed to allow individual drops of liquids, waxes, or tobacco to be placed on the atomizing element.  E-liquids are commonly packaged in plastic containers manufactured from a variety of polymers, co-polymers, plasticizers, colors, and other additives that may migrate or leach into the e-liquid.  The goal of this study is to develop and validate a controlled extraction method to measure extractable compounds from low density polyethylene (LDPE) and polyethylene terephthalate (PET) plastic bottles with a plastic dropper and/or rubber stopper, closed ENDS devices, and e-liquid drip tips.  If any of the extractables exceed the determined safety threshold, researchers will conduct a study to identify leachable compounds using the e-liquid constituents solvents propylene glycol and vegetable glycerin at various ratios, and a long-term (shelf-life) study of final packaging.  Findings will provide new information about the harmful compounds that may leach into e-liquid. 

Jenna DuMond and Margaret Schmerier Funding Mechanism: Research Contract
ID number: HHSF223201820229A
Institution: EAG
08/06/2018

CTP Supplement to Parent Grant: Monitoring the Future: Drug Use and Lifestyles of American Youth

Anecdotal reports indicate rampant youth use of JUUL; however, quantitative information about use among youth and information on use patterns, beliefs and perceptions would be useful. Researchers will add questions about JUUL and other pod-mods to the Monitoring the Future (MTF) survey, an annual nationally-representative in-school survey of 45,000 8th, 10th, and 12th grade US students. Study aims are: (1) to estimate past-month, past-year, and lifetime use prevalence of JUUL and other pod-mods among US 8th, 10th, and 12th grade students in 2019, 2020, and 2021; (2) to develop state-of-the-science survey questions on vaping frequency and topography; (3) to collect information related to JUUL and other pod-mod nicotine beliefs, methods of access, use and appeal perceptions about flavors, advertising, and abuse liability and addiction symptoms; (4) to document perception and use of JUULs in vulnerable populations by analyzing demographic and age differences in pod-mod use, attitudes, and terminology, as well as co-use of pod-mods with the 50+ other drugs and drug classes that MTF surveys; and (5) to assess trends over the next three years in pod-mod use, attitudes, and terminology with analysis of survey results from 2019 to 2021. Results will provide new information about JUUL use and related issues.

Richard A. Miech Funding Mechanism: NIH Grant
ID number: 3R01DA001411-44S1
Institution: University of Michigan at Ann Arbor
08/06/2018

CTP Supplement to Parent Grant: Reactions to Reduced Nicotine Cigarettes in Young Adult Low- Frequency Smokers-Supplement

The goal of the parent study was to evaluate reactions to and choices of cigarettes with varying nicotine content among low-frequency, non-dependent smokers aged 18-25 years; this supplement extends the age range of the sample by recruiting and collecting data from adolescents aged 15-17 years. (Note: The research plan was developed in consultation with an expert in adolescent smoking research; all participants will be given information about smoking cessation resources.) As in the parent study, participants will undergo three sessions in which they will receive fixed doses of smoke from investigational cigarettes with three different nicotine content levels (15.8 mg/g, 2.5 mg/g, and 0.4 mg/g of tobacco). Following the third fixed-dose session, participants will return to the lab to choose one of the cigarettes to self-administer. Study aims are: (1) to combine the 15-17-year old sample with the parent grant sample and evaluates initial reactions to, and choices of, cigarettes with varying nicotine content; and (2) to identify correlates of reactions to, and choices of, cigarettes with varying nicotine content in the entire sample of low-frequency smokers. Findings will present an evaluation of the amount of nicotine in cigarette smoke that produces reactions associated with progression from initial smoking to nicotine dependence in a sample representative of individuals experimenting with cigarette use.

Francis Joseph McClernon Funding Mechanism: NIH Grant
ID number: 3R01DA042532-03S1
Institution: Duke University
07/24/2018

Support Services for Evaluating Minnesota Tobacco Policies Restricting the Sale of Flavored Tobacco Products

From 2015 to 2017, three cities in Minnesota (i.e., Minneapolis, St. Paul and Duluth) passed ordinances that restricted the sale of flavored and/or menthol tobacco products. These city ordinances provide a unique opportunity to evaluate the potential impacts of flavor restrictions. This study will employ various methods to evaluate these ordinances. Researchers will develop questions to evaluate process, outcomes, and potential unintended consequences and will use these questions to design a data collection and analysis plan. Key study components will be as follows: conducting stakeholder interviews (n=9 per interview protocol); compiling and analyzing retail scanner data; obtaining data about the implementation activities of area tobacco and liquor stores; reviewing archival data regarding enforcement and licensure; analyzing existing population survey data regarding behavior; and purchasing and visually assessing actual tobacco products in retail settings. This evaluation study will allow CTP to learn from policy development and implementation experiences; explore barriers and facilitators to policy implementation and enforcement; document policy effects on outcomes such as product availability and sales and consumer behavior; and uncover potentially unintended consequences of the policies.

Ashley Ross Funding Mechanism: Research Contract
ID number: HHSF223201310007B
Institution: Research Triangle Institute International
06/14/2018

User Exposure to Toxicants from Vaporized Nicotine Products

This study supplements the research objectives of a parent grant entitled, “Evaluating How Tobacco Control Policies are Shaping the Nicotine Delivery Market (P01CA200512).” In this supplemental study, researchers will evaluate the relative exposure profile of nicotine metabolites and tobacco-related carcinogens in ex-smokers using heated tobacco products (HTPs) products compared with ex-smokers using e-cigarettes, cigarette-only smokers, and never nicotine users. Using a web panel recruitment and mail-based urine sample collection strategy, researchers will examine attitudes, behaviors, and exposures in users and nonusers of HTPs and other tobacco products, including dual users of cigarettes and HTPs and/or e-cigarettes in Japan and Canada. Findings may inform future regulatory activities related to HTPs and other tobacco products. 

K. Michael Cummings, Geoffrey T. Fong Funding Mechanism: Intra-Departmental Delegation of Authority
ID number: 3P01CA200512-03S1
Institution: Medical University of South Carolina
05/25/2018

CTP Supplement to Parent Grant: Informing Tobacco Regulatory Policy Through Laboratory Assessment of Appeal and Demand for Flavored Tobacco Products Among Young Adults

This supplement to the parent grant will address the impact of flavored tobacco product (FTP) packaging on young adult (ages 18-24) perceptions of harm, addictiveness, curiosity, and intentions to use. Specific aims are: (1) to augment the parent grant sample size from 30 to 60 to enhance the power of the parent grant’s experimental paradigm, and (2) to investigate the link between tobacco marketing techniques (i.e., packaging) with susceptibility and use of flavored e-cigarettes and little cigars/cigarillos (LCCs); this will be accomplished via two separate randomized controlled trials in which 5,600 young adults will be randomized to view one of seven pack images of an e-cigarette (n =2,800) or LCC (n = 2,800) that vary by color and flavor descriptor.  Findings will provide a comprehensive assessment of factors related to FTP use and appeal.

Amy Cohn Funding Mechanism: National Institutes of Health - Grant
ID Number: 3R03DA042010-02S1
Institution: Battelle Centers Public Health Research and Evaluation
05/01/2018

Smokeless Tobacco Variability Lab Analysis Testing

The goal of this project is to determine the minimal number of testing replicates that provides acceptable variability in the measurement of harmful and potentially harmful constituents (HPHCs) and physical product characteristics data for smokeless tobacco products in the US.  The project has two phases. Phase 1 will measure HPHCs and physical characteristics for a variety of smokeless tobacco products by systematically varying the number of test measurements and will determine the changes in analytical variability to give an optimal number of replicates. Phase 2 will use the optimum number of replicates, determined from Phase 1, and will evaluate inter-batch variability of smokeless tobacco products.  Various products will be tested from common smokeless tobacco subcategories.  Researchers will use published testing methods for benzo[a]pyrene, nicotine, NNN and NNK, pH, and water.  A laboratory-validated method will be used to test acetaldehyde, crotonaldehyde, and formaldehyde levels.  Findings will provide data regarding the number of replicates needed for reliable smokeless tobacco HPHC testing and may inform future regulatory activities. 

Kenneth Taylor Funding Mechanism: Research Contract
ID number: HHSF223201310038I
Institution: Enthalpy Analytical
12/04/2017

Role of Menthol vs. Non-menthol Cigarette Smoking in Progression to Regular Tobacco Use Among Youth: Analysis of the ExPECTT Longitudinal Survey Data

The goal of this study is to investigate the role of menthol in progression to regular smoking among youth. Researchers will analyze FDA's Public Education Campaign on Teen Tobacco (ExPECTT) longitudinal survey data to evaluate differences between menthol and non-menthol cigarette smokers in the likelihood of progression and rates of progression from never or experimental use to established smoking. Youth aged 11-16 years were enrolled in the ExPECTT study (n=6,743), and 4,210 completed all five surveys. Findings will provide new information about the use of menthol cigarettes by youth and young adults and may inform regulatory activities related to menthol.

Olga Rass Funding Mechanism: Research Contract
ID number: HHSF223201510002B
Institution: Research Triangle Institute International
09/21/2017

Consumer Perceptions of Health Claims in Vape Shops

More information about consumer perceptions of health claims related to advertising for electronic nicotine delivery systems (ENDS) would be useful, particularly advertising claims made in vape shops, which are the fastest growing segment of ENDS retailers. This study will build upon a pilot study that developed the methodology to photographically document ENDS claims in vape shops using wearable imaging technology. In this study, researchers will use this methodology to collect data related to advertising claims in vape shops. The claims from both the pilot and the new wave of data collection will be combined to create a comprehensive list of unsubstantiated claims for use in a survey that will investigate consumer perceptions of these claims. This study will provide new information about how consumers interpret real-world ENDS health claims made by retailers.

Kimberly G. Wagoner Funding Mechanism: National Institutes of Health - Grant
ID number: 1R03CA223600-01
Institution: Wake Forest University Health Sciences
09/21/2017

A Regulatory Impact Analysis of the FDA Warning Statement on Youth Preferences for Electronic Nicotine Delivery Systems

Since the U.S. Food & Drug Administration announced its final Deeming Rule, electronic nicotine delivery systems (ENDS) have been deemed a tobacco product and are now subject to several regulations, including a new warning statement requirement for ENDS products and advertisements that will take effect in August 2018. The goal of this project is to inform a regulatory impact analysis by evaluating the effects of the required warning statement on the likelihood that youth and young adults will purchase ENDS, and whether this effect depends on ENDS flavor. Researchers will conduct an experiment with 900 youth and young adults aged 16-25 years to address three aims: (1) to examine the effects of the ENDS warning statement on willingness to purchase and intentions to use ENDS; (2) to determine whether the effect of the warning statement on willingness to purchase is mediated by risk perceptions of ENDS; and (3) to determine whether product flavors and individual factors (e.g., demographics, tobacco use) modify the warning statement’s effect on risk perceptions, intentions to use, and willingness to purchase. In this online experiment, researchers will randomize participants into conditions varying according to the warning statement and ENDS flavor, and will be asked to complete a hypothetical purchase task. Study findings will provide new information regarding the impact of the ENDS warning statement and flavors on ENDS use, purchase intentions, and risk perceptions.

Scott R. Weaver Funding Mechanism: National Institutes of Health - Grant
ID number: 1R03CA216834-01A1
Institution: Georgia State University Research Foundation
09/11/2017

Genotoxicity Assessments of Flavoring Ingredients in ENDS Product

More information about the potential of flavoring ingredients to cause genotoxicity (gene toxicity) would be useful. The primary objective of this study is to conduct a high throughput mammalian cell genotoxicity study using commercially-available validated genotoxicity screening assays. The results from the screening assays will indicate whether a flavor ingredient is potentially genotoxic and, for those that are positive, describe the mechanism of action of the genotoxic effects. The secondary objective is to conduct statistical quantitative structure-activity relationship (QSAR) and structure-activity relationship (SAR) analyses for predicting the genotoxicity of the flavoring agents tested in the screening assay. Comparing the results of the QSAR and SAR analyses with the findings of the in vitro screening assays will help in the creation of a predictive model for genotoxicity assessment of the flavoring ingredients in tobacco products.

Carol Swartz and Mamata De Funding Mechanism: Research Contract
ID number: HHSF223201510009I
Institution: Integrated Laboratory System
08/31/2017

Qualitative Study on Nicotine Exposure Risk: Knowledge, Beliefs, Perceptions, and Behaviors

Researchers will conduct a qualitative study to gain insight on consumer knowledge and perceptions surrounding risk of acute toxicity due to nicotine exposure. In addition, consumers will be asked to view a variety of draft electronic nicotine delivery systems (ENDS) warnings for e-liquid nicotine toxicity. A total of twelve focus groups will be conducted with 104 participants. Of these, eight focus groups will be conducted with young adult (aged 18-24) and adult (aged 25-65) ENDS users. In addition, four focus groups will be conducted with youth (aged 13-17) who have used or currently use ENDS. Focus groups will discuss what adults and youth know about acute toxicity due to exposure to e-liquids, the best ways to present information about e-liquid nicotine toxicity to consumers, and reactions to draft ENDS warnings for acute nicotine toxicity. 

Anh “Bao” Zarndt Funding Mechanism: Research Contract
ID number: HHSF223201510002B
Institution: Research Triangle Institute International
08/27/2017

Cognitive Interviews with Adult E-cigarette Users Designed to Inform CTP Infographic and Website Content

Some of the adverse experiences associated with electronic nicotine delivery systems (ENDS) that have been reported to FDA include burns and injuries resulting from battery explosions. CTP has developed a set of materials (an infographic, shareable images, and website content) to educate consumers about the risks of battery explosions when using e-cigarettes. Researchers will conduct a qualitative study to gather information about the utility of these materials in helping consumers avoid an e-cigarette battery explosion. Qualitative and in-depth interviews will be conducted with nine participants, including four young adults (aged 18-25) and five adults (aged 26-65) who are current established and experimental e-cigarette users. The interviews will be conducted at professional focus group and interviewing facilities in Arlington, VA. Potential participants will be recruited and screened by the interviewing facilities. One-on-one interviews will be facilitated by a professional moderator using a structured moderator guide. Study findings will be used to refine the existing content and inform the development of future materials.

Atanaska Dineva Funding Mechanism: Research Contract
ID number: HHSF223201510003B
Institution: Fors Marsh Group
08/24/2017

Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Clinical trials evaluating reduced nicotine content cigarettes generally have not found evidence of compensatory smoking behaviors among participants; however, most participants in low nicotine groups use non-study cigarettes, despite explicit instructions to use only the study cigarettes provided to them. The aim of this study is to test the impact of nicotine reduction on smoking behavior and toxicant exposure when participants do not have access to normal nicotine content cigarettes. Twenty adult smokers (aged 18 years and older) will be confined to a hotel setting for two four-night stays during which they will only have access to research cigarettes. During one hotel stay they will have access to normal nicotine content cigarettes, and during the second hotel stay they will only have access to very low nicotine content cigarettes. Participants will purchase all of their cigarettes using a study bank, and will be able to purchase up to three packs of cigarettes per day. To assess whether smokers engage in compensatory smoking (e.g., smoking more cigarettes, taking longer puffs) as a result of nicotine reduction, biomarkers of smoke and toxicant exposure (e.g., expired carbon monoxide) and behavioral measures of smoking (e.g., cigarettes smoked per day, puff topography) will be compared between the two conditions. This study will provide new information about the effects of reduced nicotine content cigarettes. 

Tracy Smith Funding Mechanism: National Institutes of Health - Grant
ID number: 1R03DA045197-01
Institution: University of Pittsburgh at Pittsburgh
08/15/2017

CTP Supplement to Parent Grant: Metals in Electronic Cigarette Aerosol

This study is a supplement to a parent study that sought to identify and quantify the metal content of e-cigarette aerosols from various products and designs, to examine the cell and gene toxicity of aerosols with metal content, and to examine biomarkers of metal exposure and health effects in e-cigarette users. E-liquids often contain high concentrations of the flavor chemicals menthol (M-ol) and/or menthone (M-one) and cinnamaldehyde (CAD). This supplemental project will: (1) identify and quantify flavor chemical degradation products formed by vaping e-liquids containing M-ol, M-one, and CAD; and (2) determine which in vitro assays best assess the toxicity of e-cigarette aerosols and which reaction products cause toxicity. This study will provide new information about e-cigarette aerosol toxicity.

Prudence Talbot Funding Mechanism:  National Institutes of Health - Grant
ID number:  3R01DA036493-04S1
Institution: University of California, Riverside
07/24/2017

Perceptions of Nicotine and Relative Harm of Tobacco Products in U.S. Young Adults

Existing studies on tobacco harm perceptions have largely focused on the tobacco products themselves without addressing perceptions of nicotine separately. This study seeks to provide new information about the interplay between nicotine harm perceptions and tobacco product harm perceptions and how these perceptions affect tobacco use susceptibility and population-level tobacco use patterns. Researchers will conduct secondary analyses of longitudinal data from a large, national sample of U.S. young adults (4,100 young adults aged 18-34 years) using new measures of nicotine harm perceptions to examine the perceived harm of nicotine, the relative harm of tobacco products, and the impact of these perceptions on tobacco-related intentions and behavior. Study aims are: (1) to examine perceptions of nicotine and relative harm of tobacco products in a national sample of U.S. young adults and identify correlates of these perceptions (e.g., sociodemographics, tobacco use); (2) to characterize young adult subgroups based on their perceptions of nicotine and relative harm of tobacco products using latent class analysis; and (3) to describe the impact of nicotine and tobacco harm perception “class” on longitudinal patterns in susceptibility and curiosity to use tobacco and tobacco use behavior. Study findings will provide new information related to tobacco product and nicotine harm perceptions, and may inform regulatory activities related to tobacco product warning labels and other public education efforts.

Andrea Villanti Funding Mechanism: National Institutes of Health - Grant
ID number: 1R03CA212694-01A1
Institution: Truth Initiative Foundation
05/23/2017

Reduction in Carbonyl Yields from Sheet-Wrapped Cigars by Charcoal Filtration

Carbonyl compounds, including formaldehyde, acetaldehyde, and acrolein, are harmful and potentially harmful constituents (HPHCs) present in the gas and particulate phases of the mainstream smoke of combusted tobacco products. Carbon-based materials like charcoal, which have a large surface area and are porous, have been incorporated into cigarette filters to capture HPHCs, including carbonyls, from mainstream cigarette smoke with varying degrees of effectiveness. However, more information about charcoal filtration in sheet-wrapped cigars would be useful. The goal of this project is to evaluate the effect of charcoal filtration on carbonyl reduction in the mainstream smoke of sheet-wrapped cigars. Researchers will modify currently marketed sheet-wrapped cigars with an adapted filter design that incorporates charcoal into the filter at varying quantities, and will measure carbonyl levels in the resulting mainstream smoke. Study findings may inform the development of technologies that could reduce levels of carbonyl and other HPHCs in the smoke of sheet-wrapped cigars. 

Clifford Watson and Julie Morabito Funding Mechanism:  Interagency Agreement (Non-PATH)
ID number:  224-11-9022
Institution:  Centers for Disease Control and Prevention
05/23/2017

Menthol Use in Roll-Your Own Tobacco and Little Cigars and Migration

Menthol is a common flavor additive that masks harshness and makes smoking tobacco more appealing. To better understand menthol application and migration in combusted tobacco products, menthol will be quantitatively determined in select cigarette, little cigar, and roll-your-own tobacco (RYO) tobacco products. Additionally, researchers will apply defined quantities of menthol to either the filter, tobacco rod, or packaging of various commercial non-menthol cigarettes and little cigars and measure the menthol in these components at different storage times. Researchers will also measure the menthol in the mainstream smoke from these products. Information from this study will expand upon our previous research activities related to menthol in combusted tobacco products and how its application and physical properties may influence its transfer to mainstream smoke.

Clifford Watson and Kenneth Taylor Funding Mechanism: Interagency Agreement (Non-PATH)
ID number: 224-11-9022
Institution:  Centers for Disease Control and Prevention (CDC)
04/10/2017

The Real Cost General Market: Wave 4 Creative Concept Testing Designed to Prevent Youth ENDS Use

Researchers will conduct a qualitative research study to inform the development of appropriate messaging to prevent the use of electronic nicotine delivery systems (ENDS) among youth (aged 12-17). Specifically, this study will use focus groups to explore the target audience’s reactions to various creative advertisement concepts and messaging probes intended to prevent youth ENDS use. Approximately 24 focus groups with up to 8 participants each will be conducted in various locations across the U.S. for a total sample of up to 192 youth. Participants will be youth who: (1) are at-risk of initiating ENDS use; (2) are ENDS-only experimenters (do not use or experiment with combustibles); and (3) have experimented with cigarettes and ENDS (dual experimenters). Participants will be diverse in terms of race/ethnicity, gender, and geographical location.  Findings will inform public education campaign messaging about ENDS. 

Kristen Holtz and Maria Roditis Funding Mechanism: Research Contract
ID number: HHSF223201750007A
Institution: KDH Research & Communication?
04/10/2017

The Real Cost Smokeless: Wave 2 In-depth Interviews Designed to Prevent Rural Youth Tobacco Use

In support of FDA’s efforts to refresh youth tobacco prevention campaign messaging, researchers will conduct a qualitative research study to gain a richer understanding of the target audience, including their home life, values, and exposure to smokeless tobacco. In-depth interviews will be conducted in three geographically distinct rural regions with 22 male adolescents aged 12-17 years who are at risk for smokeless tobacco use, experimenting with smokeless tobacco, or established users of smokeless tobacco. Interviews will be conducted in schools and will include a mix of races and ethnicities. This study will inform the development of appropriate messaging for subsequent waves of FDA’s The Real Cost Smokeless campaign.

Brian Griepentrog and Maria Roditis Funding Mechanism: Research Contract
ID number: HHSF223201750007A
Institution: Fors Marsh Group
04/10/2017

TRC Smokeless Wave 2 Creative Concept Testing – Focus Groups With Rural Youth

Researchers will conduct a qualitative research study to inform the development of a new set of messages for Wave 2 of FDA’s The Real Cost Smokeless campaign. Focus groups will be conducted in four rural regions with male youth aged 12-17 years who are at risk for smokeless tobacco use or who are experimenting with smokeless tobacco.  Researchers will conduct 18-24 focus groups with four to eight students each (for a maximum of 144 participants). Focus groups will be segmented by school level (middle or high school), smokeless tobacco status (at risk or experimenter) and race/ethnicity (Non-Hispanic White or all other races and ethnicities besides Non-Hispanic White). Focus groups will explore reactions to various creative concepts intended to prevent youth smokeless tobacco use. Findings will contribute to the development of appropriate educational campaign messaging. 

Brian Griepentrog and Maria Roditis Funding Mechanism: Research Contract
ID number: HHSF223201750007A
Institution: Fors Marsh Group
04/10/2017

Developing Strategic Concepts Designed to Prevent AI/AN Youth Tobacco Use

This study will involve qualitative research to inform the development of a public education campaign to discourage use of cigarettes by American Indian/Alaska Native (AI/AN) youth. Researchers will conduct focus groups with up to 168 U.S. AI/AN youth aged 12-17 who are experimental tobacco users and susceptible non-triers. Participants will be recruited using a community-intercept approach, and groups will be conducted in both community and commercial focus group facilities. Focus group activities will include individual surveys, facilitator-led activities, and group discussions. The activities are designed to provide insight into youth perceptions related to local teen cultures and tobacco use attitudes, beliefs, and perceptions. Findings will provide information to inform campaign development. 

Chaunetta Jones Funding Mechanism: Research Contract
ID number: HHSF223201750007A
Institution: Rescue Agency
04/06/2017

Creative Concept Testing Designed to Prevent Youth and Young Adult Smoking

In 2014, FDA launched its first youth tobacco education campaign, called The Real Cost, targeting at-risk youth aged 12-17. In 2018, the FDA expanded its public education campaigns to focus on the prevention of youth electronic nicotine delivery systems (ENDS) use. To support these efforts, the FDA’s Center for Tobacco Products (CTP) will conduct a qualitative research study to inform the development of appropriate campaign messaging to prevent combustible cigarette smoking and other nicotine use among youth and young adults. Focus groups will explore participants’ reactions to various creative advertisement concepts. Approximately 30 focus groups with up to eight participants each will be conducted remotely across the U.S. with a total sample of up to 240 youth (ages 13-17) and young adults (ages 18-20) who are at risk of initiating cigarettes (susceptible) or have experimented with cigarettes (experimenter). Discussion groups will include a diversity of participants and will be segmented by cigarette usage (i.e., experimenter/susceptible) and by age. Findings will inform messaging included in future tobacco education campaigns.

Kristen Holtz (CTP Contact: Andrea Malterud) Funding Mechanism: Research Contract
ID Number: HHSF2232017500007A
Institution: Rescue Agency, KDH Research & Communication, FCB
10/01/2016

Creative Concept Testing to Prevent Youth ENDS Use in General & Hip Hop Audiences

FDA’s Center for Tobacco Products (CTP) will conduct a qualitative research study to inform the development of appropriate messaging to prevent electronic nicotine delivery system (ENDS) use among youth. Specifically, this study will use focus group discussions to explore the target audience’s reactions to various creative advertisement concepts and messaging probes intended to prevent youth ENDS use. Approximately 30 focus groups with up to nine participants each will be conducted in various locations across the U.S. with a total of up to 270 youth aged 12-17 who: (1) are at risk of initiating ENDS use; (2) have experimented with ENDS only (do not use or experiment with combustibles); or (3) have experimented with cigarettes and ENDS (dual experimenters). Additionally, up to six of the 30 focus groups will have an added recruitment criterion for participants to self-report as part of the multicultural Hip-Hop peer crowd. Participants will be diverse in terms of race/ethnicity, gender, and geographical location. Findings will inform the development of future public education campaigns targeting youth and ENDS use.  

Kristen Holtz and Maria Roditis Funding Mechanism: Research Contract
ID number: HHSF223201710001G
Institution: KDH Research & Communication
10/01/2016

Nicotine Education Project: Qualitative Study to Gain Insights from Adult Current and Former Smokers to Educate the General Public

In order to inform potential communications to the public, FDA’s Center for Tobacco Products (CTP) will conduct a qualitative research study consisting of up to 30 focus groups to gain insights around tobacco perceptions and nicotine addiction messaging. Specifically, researchers will explore the target audience’s thoughts about nicotine and tobacco products as well as potential regulatory actions. Approximately 30 focus groups with up to eight participants each will be conducted in various locations across the U.S. with a total sample of up to 240 adults ages 19-54 who are: (1) current cigarette smokers, 2)  former smokers who currently use a non-combustible tobacco product or nicotine replacement therapy, or (3) former smokers who do not currently use any nicotine products. Individuals will be diverse in terms of race/ethnicity, gender, and geographical location. Findings may inform future public education efforts related to nicotine.

Dana Wagner and Maria Roditis Funding Mechanism: Research Contract
ID number: HHSF223201710001G
Institution: Rescue Agency 
10/01/2016

Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging (TFR II)

The goal of this study is to evaluate scientific tobacco facts with regard to their applicability to special populations. Specifically, study results will inform the American Indian/American Native (AI/AN), Fresh Empire (multicultural youth) and The Real Cost: Smokeless (rural youth) campaigns. Youth reactions to the facts will be assessed on a range of reaction measures, including Perceived Argument Strength (PAS), trust, likelihood of sharing, understandability, likelihood of outcome, and desirability of outcome. Researchers will identify top-performing facts that can help inform the development of messages for FDA’s youth tobacco prevention campaigns.  This study extends previous research that assessed the utility of cigarette and e-cigarette facts for use in future messaging with The Real Cost general market target audience (youth aged 13-17) who experimented with cigarette smoking or were susceptible to smoking.

Shane Mannis and Atanaska Dineva Funding Mechanism: Research Contract
ID number: HHSF223201510003B
Institution: Fors Marsh Group
10/01/2016

2019 Electronic Nicotine Delivery Systems Formative Data Collection to Inform Experimenter and Established User Definitions

The goal of this study is to develop a working definition for youth ENDS experimentation as contrasted with established ENDS use. Researchers will conduct a study to explore youth use of electronic nicotine delivery systems (ENDS) to assess what measures of use or the user’s knowledge, attitudes and behaviors best differentiate experimenters from established users. Study subjects will include up to 1,600 youth aged 13-17 who have ever used an ENDS device such as an e-cigarette. Participants will be recruited online and will complete an online screening survey to determine eligibility. Qualified youth will participate in a survey that addresses the participant’s ENDS use and its social context; measures of tobacco product-related knowledge, attitudes, and behaviors; advertising and counter-marketing exposure; sensation-seeking; measures of other tobacco product use; and demographics. After analyzing the survey data, researchers will construct definitions of experimental and established ENDS use and test which definitions are effective at discriminating between experimental and established youth ENDS users using various measures, such as harm perceptions.

Annice Kim and Mario Navarro Funding Mechanism: Research Contract
ID number: HHSF223201510002B
Institution: Research Triangle Institute (RTI), International
09/29/2016

Evaluation of the FDAs Public Education Campaign on Teen Tobacco (ExPECTT II)

To assess the effectiveness of the FDA's efforts to reduce or prevent tobacco use by youth, researchers will conduct an evaluation of The Real Cost public education campaign targeting youth aged 12-17 years who are at risk for smoking cigarettes and e-cigarettes. The specific aims of the study are to gauge campaign awareness and examine the statistical relationships between exposure to the campaigns and changes in outcome variables of interest, which include changes in beliefs and attitudes regarding cigarette smoking and e-cigarette use. Data are being collected through in-person and online surveys of adults and youth in the United States. Approximately 6,000 at-risk youth and their parents will complete questionnaires at four time points (baseline and three follow-up surveys) at eight-month intervals. The results of the study will inform the development of this and future youth-oriented tobacco education campaigns.

Alexandria Smith Funding Mechanism: Research Contract
ID number: HHSF223201610032I
Institution: Research Triangle Institute International
09/29/2016

Point of Sale Evaluation Intervention Evaluation (POSITEv)

The Center for Tobacco Products (CTP) launched a public education campaign, “Every Try Counts,” aimed at encouraging adult cigarette smokers to quit through messages of support that underscore the health benefits of quitting. The “Every Try Counts” campaign targets smokers aged 25-54 who have attempted to quit smoking in the last year but were unsuccessful. The campaign features motivational, positive messages that are displayed in and around gas stations or convenience stores – retail locations that typically feature cigarette advertisements and where smokers face multiple triggers. The campaign is being evaluated through a multi-year outcome evaluation study to determine the campaign’s effectiveness in affecting targeted tobacco-related knowledge, attitudes and beliefs, and changes in motivation to quit smoking among the target audience. The longitudinal study will follow a group of approximately 2500 individuals across up to four rounds of data collection conducted at approximately seven-month intervals. Data will be collected in person and online in 15 campaign-targeted media markets and 15 control markets across the U.S. Results from this study will be used to improve the current campaign and inform the development of future adult cessation public education initiatives.

Chaunetta Jones Funding Mechanism: Research Contract
ID number: HHSF223201610032I
Institution: Research Triangle Institute International
09/08/2016

Analysis of Chemical Constituents in Cigarette Butt Leachate

A major environmental consequence of cigarette use is the disposal of discarded cigarette filters: each year, an estimated 4.5 trillion cigarette butts (1.69 billion pounds of cigarette butts) are thrown away worldwide. The National Environmental Policy Act requires an environmental impact analysis with human health impact scenarios for federal actions such as tobacco product marketing authorizations; thus, more information about the identities and amounts of constituents that leach from cigarette butts would be useful. Investigators will conduct a preliminary study to identify leachable constituents, including harmful and potentially harmful constituents (HPHCs), from cigarette butts. The objectives of this study are (1) to conduct laboratory analyses of three replicates from a single cigarette butt leachate; and (2) to characterize and quantify the different chemical constituents and HPHCs for the leachate. This study will provide new information about the leachable constituents in cigarette butts.

Diane Waldschmidt and Gregory Gagliano Funding Mechanism: Research Contract
ID number: HHSF223201610575P
Institution: Environmental Data Services
10/22/2015

Detection of NNK-Induced DNA Adduct Formation in Human Air-Liquid-Interface Airway Tissue Models

The tobacco specific nitrosamine 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanone (NNK) is one of the major carcinogens found in tobacco smoke; it causes gene mutations in vivo and in vitro and cancer in rodents.  The aims of this six-month pilot study are: (1) to develop a liquid chromatography-mass spectrometry method to detect NNK-induced DNA adducts, and (2) to establish procedures to measure DNA damage using the Comet assay in in vitro human respiratory tract tissue models.  An air-liquid-interface (ALI) model using well-differentiated primary human bronchial epithelial cells will be compared with single-layer human lung cancer cells and normal human bronchial epithelial cells. These data will be compared to in vivo adduct formation and DNA damage in rats and humans. This pilot study may guide future studies that compare NNK-induced toxicity outcomes in vitro with the findings from existing in vivo studies involving different NNK doses. Pilot study results may provide methodology to develop new in vitro respiratory tissue models in evaluations of the cancer-causing and gene mutation-related effects of inhaled carcinogens, which will be a new approach in the toxicological evaluation of tobacco products.

Xuefei Cao and Xin Fu Funding Mechanism:  Internal FDA
ID number: E07604.01
Institution: National Center for Toxicological Research (NCTR)
09/01/2015

Focus Groups on ENDS: Device Types, User Experiences, and Product Appeal

Electronic nicotine delivery systems (ENDS), including e-cigarettes, are growing in popularity. The goal of this study is to understand how ENDS device characteristics influence users’ experiences, and how these experiences shape ENDS use behavior, beliefs, and attitudes. Researchers will conduct 23 focus groups with a total of 156 participants who are users of "cigalikes" (non-customizable devices that look similar to cigarettes) or "tank systems" (advanced-generation, customizable devices). Focus groups will be conducted in four locations -- New York, NY; Chicago, IL; Memphis, TN; and Denver, CO – and will be segmented by type of device used. Groups will be conducted with young adults (ages 18-29 years) and adults (ages 30+ years); and will include a mix of ages, sex, races/ethnicities, education levels, and rural/urban geography. 

Jennifer Alexander, Blair Coleman, and Sarah Johnson Funding Mechanism: Research Contract
ID number: HHSF223201110005B
Institution: RTI International
08/27/2015

Assessment of Tobacco Products and Tobacco Product Constituents’ Genetic Toxicology in In Vitro Assays: Comparative In Vitro Toxicity of Conventional Cigarettes Versus Electronic Cigarettes – Mutagenicity, Cytotoxicity, and Genotoxicity

More information about the toxicity differences between cigarette smoke and e-cigarette aerosol would be useful. The goals of this study are to compare the in vitro mutagenicity, cytotoxicity, and genotoxicity of total particulate matter (TPM) generated from conventional cigarettes to that of e-cigarettes, and to characterize the qualitative and quantitative profiles of conventional cigarette smoke and e-cigarette aerosols. Researchers will select 15 cigarettes of different brands and six e-cigarettes representative of first, second and third generation devices based on market share. Researchers will generate TPM from conventional cigarettes using the Canadian Intense (CI) and the International Organization for Standardization (ISO) regimens, and generate TPM from e-cigarettes using a modified puffing protocol described by Behar et al. (PLoS One 2015;10(2):e0117222). They will then quantify nicotine in TPM from each of the samples collected and measure nicotine and cotinine levels using the gas chromatography-mass spectrometry (GC-MS) method. Cytotoxicity will be assessed using the Neutral Red Uptake assay; genotoxicity will be assessed using the micronucleus assay; and mutagenic potency will be assessed using the bacterial Ames test and the thymidine kinase gene mutation assay. Study findings will provide new information about the differences in toxicity profiles between cigarette smoke and e-cigarette aerosol.

Kelly Brant (CTP Contact: Gladys Erives) Funding Mechanism: Research Contract
ID Number: HHSF22320151001I
Institution: Lovelace Biomedical and Environmental Research Institute (LBERI)
04/24/2015

Composition and Biologic Effects of Flavored E-Liquids

E-cigarettes are sold in many flavors, yet little is known about the impact of inhaling their chemical constituents or biological and psychophysiological effects and psychosocial influences contributing to their addictive properties. Both the tongue and the lung express taste receptors that elicit biological responses when savory, sweet and bitter compounds are detected. The goal of this supplement to an ongoing study is to determine the reinforcing properties of different e-liquid flavorings, determine the biological effects of flavored/sweet e-cigarette on taste receptors, and further determine the chemical constituents of e-liquids. Study aims are: (1) to determine the composition of flavored e-liquids by using mass spectrometry; (2) to determine the biologic effects of e-liquids by measuring the in vitro response of bitter and sweet taste receptors following exposure to common brands of e-liquids; and (3) to perform a psychophysical and psychosocial evaluation of the reinforcing properties of e-cigarette flavors, including menthol, to determine which flavors are associated with varying reinforcing and analgesic properties and how psychosocial stress affects the reinforcing properties of e-cigarettes. As part of Study Aim 3, researchers will test 75 adults (ages 18-45). Study findings may inform regulatory activities related to e-cigarette flavorings.

Robert Tarran Funding Mechanism:  National Institutes of Health - Grant
ID number: 3 P50 HL120100-02S2
Institution: The University of North Carolina at Chapel Hill
02/10/2015

USC TCORS: Abuse Liability of Flavored E-Cigarettes with and without Nicotine

Data characterizing the variation in abuse liability across different types of e-cigarettes are scant. Flavoring in e-cigarettes is a critical dimension of product diversity that may modulate abuse liability. Young adults may be especially vulnerable to using sweet-flavored e-cigarettes. The goal of this supplement to an ongoing study is to evaluate the abuse liability of sweet-flavored e-cigarettes with and without nicotine in 30 young adult e-cigarette users (ages 18-35). Study aims are: (1) to identify the main effects of sweet flavored (vs. unflavored) e-cigarettes on abuse liability; (2) to identify the main effects of nicotine (vs. placebo) e-cigarettes on abuse liability; and (3) to identify the interactive effects of flavoring and nicotine on abuse liability. Participants will attend four laboratory sessions following 16-hour abstinence; all sessions will be identical except the study e-cigarette flavor/drug combination supplied in a particular visit will vary (flavored + nicotine [18 mg/mL]; unflavored + nicotine [18 mg/mL]; flavored + placebo [0 mg/mL]; unflavored + placebo [0 mg/mL]). At each visit, investigators will evaluate subjective and physiological abuse liability measures (e.g., mood enhancement, nicotine withdrawal suppression, food craving suppression, heart rate); participants will also complete an objective behavioral task to measure product reinforcement. Study findings may inform regulatory activities related to e-cigarette flavors.

Jonathan Samet Funding Mechanism:  National Institutes of Health - Grant
ID number: 3 P50 CA180905-02S1
Institution: University of Southern California
12/09/2014

Adolescent Rodent fMRI Model of Nicotine Dependence

A cingulate-striatal addiction circuit, a neurological connection in the brain that has been identified in humans who are addicted to tobacco (but not in tobacco users who are not addicted), has been developed for use as a rodent model of nicotine addiction. This project extends the pilot study that established this circuit in rodents by examining factors that could alter the development of addiction. The circuit will be evaluated using resting state functional connectivity MRI, an imaging technique that measures brain activity while the subject is not engaging in any particular task or activity.  Since adolescence is the time of susceptibility to developing nicotine addiction, this project will examine the developmental trajectory of the circuit as a biomarker of nicotine addiction in adult versus adolescent rats. The impact of nicotine dose, age, and time course of nicotine exposure on circuit development and strength will be examined and analyzed in relation to the withdrawal/extinction time course. Specific aims are: 1) to compare the dose response range of nicotine exposure that elicits enhanced nicotine dependence in adolescent versus adult rats; 2) to identify the circuit strength associated with increased behavioral measures of nicotine dependence following adolescent rat nicotine exposure; and 3) to identify adolescent rat brain structure changes associated with enhanced behavioral measures of nicotine dependence.  As a biomarker of addiction, this circuit may subsequently be used to investigate the abuse liability of various tobacco products and constituents, which could inform future regulatory activities.

Elliot Stein and Kia Jackson Funding Mechanism: Interagency Agreement
ID number: 224-15-9004
Institution: National Institutes of Health - Contract
09/12/2014

Cognitive Testing of Measurement Instruments for the Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products Study

This qualitative study will gather information about different ways of presenting harmful and potentially harmful constituent (HPHC) information by brand and by quantity in a format that is understandable and not misleading to a layperson. Qualitative and in-depth interviews will be with a total of nine participants. Adult participants (aged 18 and older) will be current or former tobacco (cigarette and smokeless) users; youth participants (aged 14-17) will also include those who are susceptible to tobacco use. Topics covered in the interviews will include what participants know and perceive about HPHCs in tobacco products, how and in what formats do they prefer to receive information regarding HPHCs, and how they understand and perceive the information about HPHCs provided in four sample formats. Findings may inform regulatory activities related to the presentation of HPHC information.  

Anh “Bao” Zarndt Funding Mechanism: Research Contract
ID number: HHSF223201110005B
Institution: Research Triangle Institute International
09/12/2014

Cognitive Testing of Cigarette and Snus Perception Items

Researchers will conduct cognitive interviews with eight tobacco users in May 2015 to test survey questions proposed for use in research on consumer perceptions, awareness, beliefs, and behaviors related to cigarettes and snus. The objectives of the cognitive interviews are: (1) to assess participants’ comprehension of survey questions; (2) to understand how new or revised questions affect the usability of existing surveys; and (3) to provide insights that may be used to improve the survey design as needed. Findings from these interviews will be used to inform the measurement of consumer perceptions, awareness, beliefs, and behaviors regarding tobacco use.  

Anh “Bao” Zarndt Funding Mechanism: Research Contract
ID number: HHSF223201110005B
Institution: Research Triangle Institute International
09/12/2014

Cognitive Interviews with Adult E-Cigarette Users to Inform Label Development

The goal of this study is to conduct cognitive interviews with adult male and female e-cigarette users to inform the development of e-cigarette warnings. Nine participants will be interviewed in Philadelphia, PA. The interviewer will use a semi-structured guide to obtain participants’ reactions to and input on various e-liquid warning text and images describing the acute toxic effects of e-liquids.

Anh “Bao” Zarndt Funding Mechanism: Research Contract
ID number: HHSF223201110005B
Institution: Research Triangle Institute International
07/02/2014

/Metals in Electronic Cigarette Aerosol

A number of metals and elements in electronic cigarette (e-cigarette) aerosol – such as lead, chromium, iron, strontium, and aluminum – are known carcinogens, respiratory toxicants/irritants, reproductive and developmental toxicants, or have other human health effects. The goal of this project is to identify and quantify the metal content of e-cigarette aerosols generated by a variety of products and designs, to examine the cytoxicity (i.e. toxicity to cells) and genotoxicity (i.e., toxicity to genetic information within cells) of aerosols with metal content, and to examine biomarkers of metal exposure and effects in users. Specific aims are: (1) to identify and quantify the metals in the fluid and aerosol of a broad range of e-cigarettes from different manufacturers and of different styles; (2) to use an embryonic model and a three-dimensional adult lung air-interface model to evaluate the cytotoxicity and genotoxicity of aerosols from products that contain metals; and (3) to measure biomarkers of metal exposure and effects in e-cigarette users by comparing 75 adults aged 21-40 who use e-cigarettes only, conventional cigarettes only, or no tobacco products, by analyzing metals in oral cavity cells and metal concentrations in saliva, blood, and urine. Research findings may inform regulatory policies related to e-cigarettes.

Prudence Talbot Funding Mechanism: National Institutes of Health- Grant
ID Number: 1R01DA036493-01A1
Institution: University of California-Riverside 
09/30/2013

GSU TCORS: Testing Tobacco Ad Restrictions and Counterads in a 3D Virtual Retail Store

Exposure to point-of-sale (POS) cigarette advertising and promotions is associated with youth smoking experimentation, progression to regular smoking, unplanned tobacco purchases, and urges to smoke. This project will use a previously-developed virtual convenience store to compare policy options to curb and counter the influence of POS cigarette advertising and pack displays as well as increased visibility of other products such as electronic cigarettes. Studies will be conducted with youth (aged 13-17) current smokers and nonsmokers susceptible to smoking and adult (aged 18 and older) current smokers and recent quitters. Specific aims are: (1) to develop and pilot test virtual store conditions with POS tobacco advertising/product display restrictions, graphic health warnings, and product mix changes using 3D gaming software and eye tracking technology; and (2) to conduct randomized controlled experiments to test the impact of policy options to regulate POS tobacco ads and displays, promotions, graphic health warning signs, and product mix on purchase attempts, urges to smoke, and quit intentions. This study will provide policy-relevant data on the potential impact of restricting and countering tobacco marketing efforts at the POS on youth and adult smoking outcomes.

Matthew Farrelly Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50DA036128-01
Institution: RTI International
09/30/2013

Pennsylvania State University Tobacco Center of Regulatory Science (TCORS)

This Center will evaluate the effects of switching smokers from their usual cigarettes to reduced nicotine content cigarettes on nicotine dependence and tobacco harm, with a special focus on vulnerable (e.g. low socioeconomic status [SES], mental disorders) populations. Project 1, a randomized controlled trial, will evaluate the effect of progressive nicotine reduction in cigarettes on smoking behaviors, smoking biomarkers, and stress in smokers with low SES. Project 2, a second randomized controlled trial, will evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Project 3 will evaluate free radical exposure and oxidative stress associated with use of conventional and reduced nicotine cigarettes, via analysis of machine smoking data and a product switch intervention study.

Joshua Muscat and Jonathan Foulds Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50DA036107-01
Institution: Pennsylvania State University
09/30/2013

Yale Tobacco Center of Regulatory Science

The Center will conduct research to evaluate how flavors (including menthol), sweeteners, and related factors affect the initiation of, preference for, and development of addiction to current tobacco and potential modified risk tobacco products. Populations studied will include adolescent and adult mice and rats, adolescent and young adult smokers and nonsmokers, and chronic smokers. Project 1 will study the effects of flavors on nicotine choice and dopaminergic/central reward mechanisms in mice and rat models. Project 2 will study menthol’s effects on nicotine reinforcement in smokers. Project 3 will evaluate whether commonly used flavor constituents, including menthol, alter reinforcement from e-cigarettes in adolescent smokers. Project 4 will examine factors (including product attributes and informal/formal sources of information about risks) that influence both the perceptions of risk and interest in using tobacco products in different populations (i.e. populations that vary by age, race, smoking status, and socioeconomic status).

Suchitra Krishnan-Sarin and Stephanie O'Malley Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50DA036151-01
Institution: Yale University
09/19/2013

A-TRAC TCORS: Cardiovascular Injury Due to Tobacco Use

Tobacco smoke and tobacco products contain many harmful and potentially harmful constituents (HPHCs) that affect different organ systems and physiological processes. Therefore, an organ-systems approach is the preferred model to understand the adverse health consequences of tobacco use and to reduce tobacco-associated disease. The goal of this project is to understand the cardiovascular effects of tobacco products, with emphasis on early preclinical changes and their subsequent impact on health outcomes. Investigators will determine which cardiovascular disease (CVD) biomarkers are associated with specific measures of tobacco exposure and what magnitude of change in these biomarkers translates into a clinically meaningful impact on CVD outcomes. Specific aims are: (1) to elucidate the relationship between biomarkers of cardiovascular dysfunction/injury and specific measures of exposure to tobacco smoke and smokeless tobacco, by evaluating biomarkers of endothelial damage and predilection for thrombosis in a cross-sectional study of 480 smokers, smokeless tobacco users, and non-smokers without overt CVD (aged 26-45); (2) to identify and compare the dose-dependent associations between tobacco use, measures of subclinical cardiovascular disease, and clinical cardiovascular events, using data from the Multi-Ethnic Study of Atherosclerosis (which includes 6814 participants aged 45-84); and (3) to validate candidate biomarkers associated with tobacco exposure in independent human cohorts, using data from the Jackson Heart Study (which includes 5,301 African American residents of Jackson, Mississippi, aged 35-84). This project will improve the understanding of the cardiovascular consequences of tobacco use, particularly among vulnerable minority populations.

Aruni Bhatnagar Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50HL120163-01
Institution: University of Louisville, American Heart Association
09/19/2013

Communicating the Risks of Harmful Cigarette Smoke Constituents

New information about tobacco smoke constituents will have an uncertain impact on smoker behavior. It may prompt smokers to quit, or it may prompt them to switch to brands they perceive as less harmful and possibly smoke more. This project will identify the impact of new constituent information on smokers' risk beliefs and cigarette smoking; all studies and focus groups will include representation from vulnerable populations, including adolescents, low income populations, African-Americans, Hispanics, gays, lesbians, and bisexuals. Specific aims are: (1) to identify cigarette smoke constituents that adolescents (aged 13-17) and adults (aged 18-65) find threatening and discourage them from wanting to smoke, by conducting 10 focus groups (with approximately 7-10 participants each) and a population-based telephone survey of 800 adolescents and 3800 adults; (2) to develop a library of cigarette smoke constituent risk messages that have been vetted in 14 focus groups (approximately 10 participants each) of adult and adolescent smokers and non-smokers and tested in 2654 Internet survey participants; and (3) to determine which pack labels most effectively increase adult smokers' cessation behaviors in a randomized controlled trial of 672 adult smokers. The results of this project may inform decisions regarding the type and placement of constituent-related health messages on cigarette packaging.

Noel Brewer Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50CA180907-01
Institution: The University of North Carolina at Chapel Hill
09/19/2013

American Heart Association Tobacco Regulation and Addiction Center (A-TRAC)

This virtual Center will study the cardiovascular toxicity of tobacco products and the relationship between tobacco product use and subclinical progression of cardiovascular disease (CVD) in order to identify biomarkers of cardiovascular injury related to tobacco product exposure. Studies will identify specific domains of cardiovascular injury that are sensitive to tobacco exposure, facilitate the identification of harmful and potentially harmful constituents (HPHCs), and measure the impact of these constituents on cardiovascular disease outcomes. In cohorts of varying ethnicities, investigators will study behavior, perceptions, and attitudes regarding tobacco products in order to identify which communications channels are used by vulnerable populations to obtain information about tobacco products, as well as strategies that are likely to be effective in discouraging initiation and continuation of tobacco use. Project 1 will identify biomarkers of tobacco product exposure and relate them to biomarkers of cardiovascular injury in a well-controlled animal model; to determine the relationship between these two sets of biomarkers, investigators will identify metabolites of tobacco constituents, establish their relationship with the extent and duration of exposure, and determine how they are related to the extent of cardiovascular injury. Project 2 will determine which CVD biomarkers are associated with specific measures of tobacco exposure and what magnitude of change in these biomarkers translates into a clinically meaningful impact on CVD outcomes. Project 3 will evaluate the tobacco use pattern, clinical and non-clinical correlates, outcomes, and knowledge/perceptions among vulnerable populations (i.e. African-Americans, Hispanics, and youth), generating data that can inform optimal tobacco risk communication campaigns that target vulnerable minority populations. 

Aruni Bhatnagar and Rose Robertson Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50HL120163-01
Institution: American Heart Association
09/19/2013

A-TRAC TCORS: Cardiovascular Toxicity of Tobacco Products

Tobacco use is associated with an increase in cardiovascular disease risk factors; however, tobacco constituents that mediate the cardiovascular toxicity of tobacco use remain largely unknown. Biomarkers of tobacco-induced cardiovascular injury associated with exposure to cigarette smoke, smokeless tobacco and their constituents may inform the FDAs regulation of tobacco products to protect public health.  This project will identify biomarkers of tobacco product exposure and relate them to biomarkers of cardiovascular injury in a well-controlled animal model. To determine the relationship between these two sets of biomarkers, investigators will identify metabolites of tobacco constituents, establish their relationship with the extent and duration of exposure, and determine how they are related to the extent of cardiovascular injury. Specific aims are: (1) to examine tobacco-induced endothelial injury in adult mice exposed to varying intensities of tobacco smoke and smokeless tobacco; and (2) to delineate the contribution of harmful and potentially harmful (HPHC) constituents, such as aldehydes, to endothelial injury induced by tobacco exposure, by examining changes in endothelial injury biomarkers in mice exposed to individual constituents (i.e., nicotine, acrolein and crotonaldehyde). This project will provide information regarding how tobacco products could be evaluated for cardiovascular toxicity and how product constituents might be regulated to reduce the risk of cardiovascular injury.

Sanjay Srivastava Funding Mechanism: National Institutes of Health-TCORS Grant
ID number: 1P50HL120163-01
Institution: University of Louisville
09/18/2013

UMD TCORS: Exploring Tobacco Microbial Constituents and the Oral Microbiome of Tobacco Users

Tobacco microbial constituents may play significant roles in the development of infectious and chronic diseases among tobacco users, yet data regarding the microbial constituents of tobacco and smoke and their associated adverse health effects is lacking. This project will evaluate tobacco microbial constituents and characterize the oral microbiome of tobacco users. Specific aims are: (1) to explore the bacterial microbiome of conventional, new and manipulated smoked and smokeless tobacco products and smoke, and examine the role of tobacco-specific N-nitrosamine formation, in laboratory-based time-course experiments; (2) to gather novel baseline data on the composition of the oral microbiome and its associated expressed activities in 24 smokers, 24 smokeless tobacco users and 24 non-users (aged 18-35) in a longitudinal study involving self-administered tobacco use questionnaires and buccal swabs and saliva samples (enabling an analysis of nicotine and cotinine); and (3) to characterize the transient changes (i.e., bacterial community composition, expressed metabolic activities) in the oral microbiome after single use of new and manipulated smoked and smokeless tobacco products, in crossover trials of 20 users (aged 18 and older). These data may improve scientific knowledge of the role that tobacco bacterial communities may play in the development of both acute infectious diseases and chronic diseases, and could inform potential new tobacco standards that would address the public health implications associated with the microbial constituents of tobacco.

Amy Sapkota and Emmanuel Mongodin Funding Mechanism: National Institutes of Health- TCORS Grant
ID number: 1P50CA180523-01
Institution: University of Maryland 
12/20/2012

Rural Smokeless Focus Groups - Strategic Concept Testing with Rural Adolescent and Young Adults

In support of FDA’s efforts to reduce tobacco use or prevent tobacco initiation among youth, CTP will conduct a qualitative research study to inform the development of appropriate messaging for a smokeless tobacco prevention campaign. The specific aim of the study is to understand the reactions to various campaign strategic concepts of rural males ages 12-17 who are at risk for smokeless tobacco initiation or who are experimenting with smokeless tobacco.  Sixteen focus groups with six to eight participants each will be conducted in four locations with a total of 106 at-risk rural white male youth.  This study is the second part of a phased approach to formative research for developing the smokeless tobacco prevention campaign. (Project completed in February 2014.)

Matthew Walker and Kara Marsh Funding Mechanism: Research contract
ID Number: HHSF223201210039I
Institution: Fors Marsh Group
11/20/2012

Multicultural Campaign: Wave 3 Focus Group Study of Reactions to Creative Advertising Concepts Designed to Prevent Multicultural Youth Tobacco Use

In support of FDA's efforts to inform the public on tobacco-related health issues, the Center for Tobacco Products (CTP) will conduct research to inform the development of messaging and creative concepts for the “Fresh Empire” youth tobacco public education campaign. The target audience for this campaign is at-risk multicultural youth (i.e., youth who are African American, Asian/Pacific Islander, or Hispanic) who are 12-17 years old and are influenced by Hip Hop culture. Focus groups will be conducted with 180 youth in the target audience who are at risk for, have experimented with, or are susceptible to smoking cigarettes, little cigars, cigarillos, or hookah. Participants will be recruited from middle and high schools in multiple metropolitan areas representing the campaign target population. Each 90-minute focus group will include 3-12 participants, and will involve a discussion of preliminary creative concepts being developed for the “Fresh Empire” campaign. The purpose is to gain insight into youth perceptions related to tobacco use and creative concepts to inform campaign development.

Dana Wagner and Matthew Walker Funding Mechanism: Research Contract
ID number: HHSF223201210006I
Institution: Rescue Social Change Group
10/01/2012

Epigenetic Biomarkers of Tobacco Smoke Exposure

In previous research, the investigators used genomic arrays to identify specific DNA methylation changes associated with maternal smoking; they have identified a set of epigenetic biomarkers as well as mechanistic pathways for transplacental and adult smoking-associated diseases. The goal of the study is to extend these findings by examining the dose, time course, and persistence of the epigenetic changes spurred by tobacco product use, identifying the target cells for epigenetic-mediated change, and characterizing toxic effects at the molecular and cellular level. Study aims are: (1) to test the previously-developed methylation biomarker profile in DNA samples from 230 adult subjects with well-characterized smoking histories including measurements of cotinine, chromosome aberrations, somatic gene mutations, and genetic polymorphisms; (2) to conduct a prospective cohort study (including approximately 500 subjects with smoking-induced bladder cancer and 500 controls) to test the relationship between tobacco exposure, methylation biomarkers, and risk of developing tobacco-induced bladder cancer in order to evaluate the biomarkers’ predictive value; (3) to test the methylation biomarker in blood and other tissues from newly-recruited tobacco product users in order to determine the best tissue for regulatory-related population monitoring, assess profiles of DNA methylation and identify biomarkers that are shared by or unique to a specific tobacco exposure, and examine samples from recent quitters to determine the persistence of biomarkers; subjects will include never smokers, light smokers (<1pack day),="" heavy="" smokers="" (="">1 pack day), ex-smokers (6-12 months), menthol smokers, smokeless tobacco users, and e-cigarette users; and (4) to determine target cell types in blood (i.e., lymphoid, granulocytes, erythroid, and CD34+ cells) and compare the relationship between exposure, methylation, and gene expression to improve accuracy and sensitivity of the tobacco exposure biomarker. This study will reveal important epigenetic biomarker effects related to tobacco use, particularly with regard to the specific cell types affected, and will make connections between epigenetic biomarkers of effect, intermediate molecular phenotypes and tobacco-induced disease outcomes that could support regulatory review of the biomarker.

Douglas Bell Funding Mechanism: National Institutes of Health-Intramural
ID number: 251945
Institution: National Institute of Environmental Health Sciences (NIEHS)
10/01/2012

Genetics of Cellular Sensitivity to Tobacco Compounds

Tobacco compounds damage vascular endothelial cells (VECs) and vascular smooth muscle cells (VSMCs), often with life-threatening consequences. Tobacco’s effects on vascular integrity vary across individuals, suggesting that genetic variations contribute to differences in patient outcomes; however, the genetic components of tobacco-induced vascular disease susceptibility are unknown. The investigators will use induced pluripotent stem cell (iPSC) technology to investigate the susceptibility of patient-specific VECs and VSMCs to tobacco compounds and determine the effects of these compounds on genetically-susceptible individuals. Study aims are: (1) to determine the impact of 20 known and suspected toxic tobacco smoke compounds on patient-specific vascular cells to define individual susceptibility; and (2) to develop iPSC lines engineered for high-throughput screening of tobacco component chemicals and chemical admixtures. The investigators will generate patient-specific iPSC lines from 20 subjects (10 long-term smokers with severe coronary artery disease and 10 long-term smokers without coronary artery disease). These 20 iPSC lines will be differentiated into VECs and VSMCs in order to survey the genetic bases of vascular susceptibility/resistance to tobacco smoke. Investigators will individually test 20 tobacco smoke components for adverse effects on the iPSC lines using an 8-dose range of each chemical and a 1-5 biomarker assay endpoint. A second verification screen will contain 10 patient-specific iPSC lines from smokers unrelated to the initial patient population. Information from this study may inform the development of new biomarkers that will distinguish the impact of different tobacco products on vascular disease.

Manfred Boehm Funding Mechanism: National Institutes of Health-Intramural
ID number: 252406
Institution: National Heart Lung and Blood Institute (NHLBI)
10/01/2012

Genetic Factors in Taste Perception and Tobacco Usage

The importance of taste in tobacco product use is underscored by the widespread addition of flavorings to tobacco products. Added flavorings – including various sweeteners, fruit flavors, and menthol – improve product taste while masking the unpleasant flavor of nicotine and other bitter substances present in tobacco. Understanding genetic differences in taste perceptions in the context of tobacco use could help inform the development of more effective tobacco control campaigns targeted toward specific racial/ethnic population groups. To investigate the role of inherited differences in taste perceptions in tobacco use, researchers will catalog and quantify genetic variations in taste perceptions and then measure the association between these variations and tobacco use. Using DNA samples provided by the Dallas Heart Study (DHS) – a comprehensive multi-year study of cardiovascular health involving 4,700 subjects (including approximately 2,300 African Americans, 1,600 Caucasians and 800 Latinos) – the investigators will analyze 36 genes that encode a variety of taste perceptions, including menthol, bitter, sweet and savory, sour, and burning tastes. Study aims are: (1) to ascertain and characterize naturally occurring genetic variations in taste perceptions; (2) to use detailed genetic analysis and modeling techniques and tools to describe variations in taste perception characteristics (i.e., mutation properties, functional predictions, genomic architecture, and population distribution); and (3) to test the association between variants in taste perception and other genes and tobacco use using data from the Dallas Heart Study population. By analyzing variation in a broad array of genes involved in taste perception, this study will separate genetic variation in taste perceptions – much of which is specific to particular human racial populations – from other factors that affect tobacco use.

Dennis Drayna Funding Mechanism: National Institutes of Health-Intramural
ID number: 252311
Institution: National Institute on Deafness and Other Communication Disorders (NIDCD)
10/01/2012

Multi-model Neuroimaging Genetic Biomarkers of Nicotine Addiction

Emerging evidence suggests a biological basis for nicotine addiction; however, no consensus biomarkers that can objectively measure nicotine addiction severity, follow the trajectory of developing addition, or predict outcome for tobacco users exist. The goal of this project is to develop a quantitative, genetically-informed, brain-based nicotine addiction biomarker that predicts smoking and smokeless tobacco adverse health outcomes, quantifies addiction severity and reflects the addiction potential of alternative tobacco products. Study aims are: (1) to determine whether support vector machine (SVM)/network pattern classifiers identify ex-smokers as “current smokers” or “never smokers,” and whether SVM/network classification can separate non-treatment seeking smokers from treatment seekers; (2) to determine whether switching cigarette smokers to e-cigarettes yields a unique biomarker pattern that distinguishes them from smokers, ex-smokers and nonsmokers; (3) to determine whether changes in biomarkers predict successful tobacco use cessation; and (4) to determine the time course of biomarker changes as a function of abstinence duration. Subjects will include treatment-seeking smokers and three comparison groups: ex-smokers, non-treatment-seeking smokers, and healthy controls aged 18-55. The biomarker will be created using neuroimaging, genotyping and epigenetic data with multivariate feature selection techniques. Researchers will first engage subjects in a 12-week monitored cessation phase (with e-cigarettes substituting for tobacco cigarettes), which will allow an assessment of addiction severity based on withdrawal symptoms; anatomical and functional measures will be taken before a quit attempt and post-quit at days 2 and 7 and again at 3, 6 and 12 months.  Analysis of neuroanatomical, functional activation and resting data, informed by genetic markers, will classify cigarette smokers by addiction severity, differentiate traditional smokers from alternative tobacco users, and describe brain circuits that follow dependence severity and predict outcome success or failure.

Elliot Stein Funding Mechanism: National Institutes of Health-Intramural
ID number: 252400
Institution: National Institute on Drug Abuse (NIDA)
10/01/2012

Identification of Active Component Patterns in Tobacco Smoke

The majority of the thousands of compounds present in tobacco smoke have not been structurally identified, nor have their pharmacological activities been determined. In previously published research, investigators described an improved technique – called missing peak chromatography – for determining the pharmacologically active components of tobacco smoke based on online liquid chromatography affinity screens; the investigators demonstrated that a column containing immobilized nicotinic acetylcholine receptors (nAChRs) can be used to screen tobacco smoke condensates, to identify known and unknown compounds that bind to individual nAChR subtypes, and to produce a chromatographic fingerprint that can be used to establish active component patterns (ACPs). The goals of this project are to use missing peak chromatography to optimize and validate the determination of ACPs, to establish the role of this technique in the regulation of tobacco products, and to determine the effect of additives on the products produced by tobacco leaf combustion. Study aims include: (1) to screen tobacco smoke condensates obtained from standard, light and flavored cigarette brands for compounds that bind to the nAChRs and to establish ACPs; (2) to determine the binding affinity and functional activity of individual compounds contained in the ACP at several nAChR subtypes, and to determine if the compounds are agonists, competitive or non-competitive antagonists, and positive or negative allosteric modifiers; (3) to repeat the study using extracts from the same cigarettes used to obtain the tobacco smoke condensates in order to compare the ACPs, to identify the source of active components in the tobacco smoke condensates, and to establish ACPs that can be used to control tobacco products; and (4) to determine whether menthol affects the pyrolysis of tobacco leaf constituents that interact with nAChRs and whether vaporized menthol affects the binding of tobacco smoke condensate constituents with nAChRs. The study methodology will use missing peak chromatography to analyze tobacco smoke extracts and condensates and to characterize the pharmacological activity of compounds at the nAChR; the analysis will be repeated using non-combusted cigarettes and again after adding menthol to the tobacco leaves before combustion.

Irving Wainer Funding Mechanism: National Institutes of Health-Intramural
ID number: 252346
Institution: National Institute on Aging (NIA)
 
10/01/2012

Epigenomic Effects of Hookah Tobacco Smoke in Human Respiratory Epithelia

The decreasing prevalence of cigarette smoking in the U.S. has coincided with the emergence of alternatives such as smoking flavored tobacco (shisha) via waterpipe (hookah).  Although hookah smoke contains a number of carcinogens present in cigarette smoke, epidemiologic associations between hookah tobacco and lung cancer risk have not been firmly established, and the effects of hookah smoke on human respiratory epithelial cells have not been thoroughly investigated. The goal of this study is to determine whether, like cigarette smoke, hookah tobacco smoke will induce lung cancer-associated alterations in normal human respiratory epithelia in a time- and dose-dependent manner, and whether hookah smoke will increase stem cell signaling and enhance the malignant phenotype of human lung cancer cells. Study aims are: (1) to compare the effects of hookah tobacco and conventional cigarette smoke on DNA methylation, the histone code and global gene expression in cultured normal human respiratory epithelia and lung cancer cells; (2) to compare the effects of hookah tobacco and conventional cigarette smoke on microRNA expression in normal respiratory epithelia and lung cancer cells; (3) to compare the effects of hookah smoke and conventional cigarette smoke on stem cell gene expression in normal respiratory epithelia and lung cancer cells; and (4) to examine if hookah smoke enhances the malignant phenotype of lung cancer cells.  Briefly, human small airway epithelial cells, human bronchial epithelial cells, and lung cancer cells derived from smokers and never-smokers will be cultured in the presence or absence of hookah or cigarette smoke condensates for up to 24 months. The investigators will perform various analyses and experiments to examine the effects of hookah smoke on DNA methylation, messenger RNA and microRNA profiles, and the histone code relative to the effects of conventional un-mentholated and mentholated cigarette smoke. They will also perform comparative genomic hybridization and DNA/RNA sequencing experiments to evaluate DNA mutations induced by hookah tobacco relative to conventional cigarette smoke. Additional experiments will determine if hookah smoke enhances the malignant phenotype of lung cancer cells. Results of these analyses will provide insights about hookah tobacco’s carcinogenic effects.

David Schrump Funding Mechanism: National Institutes of Health-Intramural
ID number: 252451
Institution: National Cancer Institute (NCI)
10/01/2012

Impact of Tobacco Oral Health and the Oral Microbiome

Tobacco use is the primary cause of periodontal disease and causes other health consequences in the oral cavity including leukoplakia and cancers of the head and neck. Periodontal disease and the resulting tooth loss have been linked to other adverse health consequences including diabetes, heart disease, stroke, and premature births; gum bleeding associated with periodontal disease leads to chronic exposure to oral microbes, causing persistent inflammation and exposure to toxic secondary bacterial metabolites. However, no previous study has characterized the oral microbiome (i.e., the complete oral bacterial population) and assessed the effect of tobacco on oral bacteria in a large representative sample of the U.S. population. The goal of this study is to conduct a comprehensive assessment of the association between tobacco use and oral health measures using data from two cycles (2009-2010 and 2011-2012) of the National Health and Nutrition Examination Survey (NHANES), an extensive exposure and health information survey of a nationally representative sample of the U.S. population with oversampling of persons aged 60 and older, African-Americans, Asian-Americans, and Hispanics. Study aims are: (1) to characterize the association between tobacco and oral health in 11,000 NHANES participants (men and women aged 14-69; approximately 55% never smokers, 20% former smokers, 23% current smokers, and 2% tobacco chewers); (2) to investigate the association between types of tobacco use (e.g. cigarettes, pipes, cigars, and chewing tobacco) and the oral microbiome; and (3) to investigate the association between the oral microbiome and tobacco-related diseases (e.g., periodontitis, cardiovascular and respiratory disease, diabetes, etc.) and evaluate the degree to which the oral microbiome mediates the adverse health effects of tobacco use. To achieve these aims, investigators will use data and oral wash samples already collected by NHANES. Investigators will characterize the oral microbiome by using DNA extracted from oral samples and describe the bacterial species in each sample. They will then examine the effects of tobacco on the full microbiomic community; determine whether associations vary by type of tobacco used (e.g. menthol, filter, smokeless), household tobacco exposure, and ethnicity; and evaluate associations with tobacco-related diseases. Characterizing the effect of tobacco use on the oral microbiome may suggest new biomarkers of exposure that can be used to assess the effects of new and emerging tobacco products.

Christian Abnet Funding Mechanism: National Institutes of Health-Intramural
ID number: 252304
Institution: National Cancer Institute (NCI)
09/17/2012

2-Amino-9H-pyrido[2,3-b]indole: A Potential Colorectal Carcinogen Formed in Tobacco

Although smoking is a known risk factor for cancers of the gastrointestinal (GI) tract, little is known about the tobacco constituents that are potentially responsible for GI cancer development. Investigators previously reported that the heterocyclic aromatic amine 2-amino-9H-pyrido[2,3-b]indole (AαC) -- the most abundant aromatic amine carcinogen formed in tobacco smoke and a rodent GI genotoxicant -- is present in the urine of tobacco smokers in a dose-dependent manner but is absent in the urine of nonsmokers. The parent grant characterized the metabolic pathways involved in AαC bioactivation and detoxication in order to elucidate the causal role of AαC exposure in smoking-related GI cancers in humans. The objective of this study is to examine the reaction products of the carcinogenic metabolites of AαC with serum albumin and hemoglobin in order to eventually develop biomarkers of AαC adducts of these blood proteins as potential human biomarkers. Specific aims are: (1) to examine the reaction products of the carcinogenic metabolites of AαC with serum albumin and hemoglobin, in order to establish AαC adducts of these blood proteins as biomarkers; and (2) to develop analytical mass spectrometry methods to measure AαC blood protein biomarkers. Investigators will develop biomarkers based on blood samples obtained from seven habitual smokers and three nonsmokers. This investigation will establish a set of AαC biomarkers that can be used in population-based cohort studies of smoking and GI cancer and in analyses that measure and compare tobacco products’ toxicity and carcinogenicity.

Robert Turesky Funding Mechanism: National Institutes of Health- Grant
ID number: 3 R01 CA134700-03S1
Institution: Wadsworth Center
09/17/2012

Stem Cells and Cardiovascular Repair

This supplement to an ongoing research project is aimed at determining the effect of smoke exposure on the differentiation of human embryonic stem cells into cardiomyocytes (hESC-CMs) and the effect that smoke exposure has on remodeling of the coronary circulation in mice. Investigators will compare the effect of exposure to smoke generated by traditional cigarettes to that generated by e-cigarettes. Specific aims are: (1) to determine the effect of traditional and e-cigarette smoke on the differentiation and function of hESC-CMs in vitro (e.g., differentiation, migration, proliferation, Ca2+ handling, excitation-contraction [EC] coupling); and (2) to determine the effect of traditional smoke exposure on the remodeling of the coronary circulation in a mouse model of myocardial infarction.

Charles Murry Funding Mechanism: National Institutes of Health- Grant
ID number: 3P01HL094374-03S1
Institution: University of Washington
09/15/2011

Evaluating New Reduced Nicotine Standards for Cigarettes

Reduction in nicotine content has been proposed as a potential regulatory measure to render cigarettes non-addictive and, consequently, to reduce smoke exposure and improve public health. The goal of this research effort is to determine how a marked reduction in the nicotine content of cigarettes impacts the use and effects of tobacco in current smokers. This five-year research effort involves four interrelated projects. Project 1, a multisite trial, includes two human studies evaluating the dose-response relationship for nicotine yield within the range thought to be at or below threshold for dependence and the potential use of concurrent nicotine replacement therapy (NRT) to facilitate the transition to very low nicotine content (VLNC) cigarettes; study subjects include 1,080 daily smokers aged 18 and older. Project 2, a multi-site trial involving 1,250 subjects, assesses the effects of prolonged VLNC use and compares an immediate switch to VLNC cigarettes with a gradual reduction in cigarette nicotine content over 20 weeks. Project 3 focuses on the impact of VLNC cigarettes on smokers with schizophrenia; this project begins to address an important concern about the impact of a new nicotine content standard in smoker sub-populations who might be particularly vulnerable to the effects of nicotine reduction. Project 4 addresses concerns that the manipulation of other tobacco constituents could offset the predicted gains of VLNC cigarettes by investigating the relationship between the threshold dose for maintaining rat nicotine self-administration and the presence of minor alkaloids, beta-carbolines, acetaldehyde, and monoamine oxidase inhibitors (MAOIs). These four projects will reveal important information about whether establishing new lower nicotine standards for cigarettes would reduce cigarette use and, consequently, reduce the morbidity and mortality associated with smoking.

Eric C. Donny Funding Mechanism: National Institutes of Health- Grant
ID number: 1U54 DA031659-01
Institution: University of Pittsburgh at Pittsburgh
08/23/2010

Supplement to “The Effects of Minnesota State and Local Programs on Young Adult Tobacco Use”

Young adults represent a target market for the tobacco industry. The goal of the Minnesota Adolescent Community Cohort (MACC) Study is to describe current and potential tobacco marketing strategies targeting youth and young adults. The MACC Study is a population-based cohort study that initially enrolled 4,825 youth (4,220 from Minnesota and 605 from comparison states) aged 12-16. Every six months since October 2000, participants have been surveyed by telephone about their tobacco use and related attitudes and beliefs. The aims of this study supplement are: (1) to prepare background materials (including a summary of a literature search and a summary of pertinent regulations) for the May 2010 expert panel discussion on tobacco marketing; (2) to conduct and analyze the results of the expert panel discussion; (3) to recruit and conduct focus groups with 47 young adults about tobacco marketing strategies; and (4) to analyze focus group transcripts to create survey items to add to the MACC Round 21 survey. These findings may inform policies and regulations regarding the potential tobacco marketing strategies targeted toward young adults. (Project completed in 2011.)

Jean Forster Funding Mechanism: Interagency Agreement (IAA)
ID Number: 3R01CA086191-10A1S1
Institution:  University of Minnesota 
10/12/2022

FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.

Press Release / Public Statement Biologics
10/04/2022

FDA Roundup: October 4, 2022

Today, the FDA posted a Constituent Update, highlighting that in September, the FDA and CDC signed a MOU to strengthen food safety in retail environments. The goal of the renewed partnership between the FDA and the CDC is to help reduce the occurrence of foodborne illness in retail and foodservice establishments. 

Press Release / Public Statement Medical Devices
Biologics
09/27/2022

FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.

Press Release / Public Statement Medical Devices
09/27/2022

FDA Roundup: September 27, 2022

Today, the FDA released its Activities to Enhance the Safety of Imported Produce, which provides an overview of the work underway to advance the safety of produce imported into the United States. This overview follows the 2019 release of the Strategy for the Safety of Imported Food (Import Strategy) that describes the agency’s comprehensive approach to enhancing the safety of food imported into the United States.

Press Release / Public Statement Food & Beverages
Medical Devices
Biologics
09/23/2022

FDA Roundup: September 23, 2022

Today, the FDA published the FDA Voices: “FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death,” by Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health, Center for Drug Evaluation and Research. The FDA is building on actions to help expand the availability and access to this life-saving medication, an effort that it is hoped will be embraced by harm reduction programs and manufacturers.

Press Release / Public Statement Food & Beverages
Medical Devices
Biologics
Drugs
09/20/2022

FDA Roundup: September 20, 2022

Today, the FDA alerted medical device users about a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System due to a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. A nearby person other than the user or care partner may be able to gain access to the pump while the pump is being paired with other system components and, if compromised, may cause the pump to deliver too much or too little insulin.

Press Release / Public Statement Medical Devices
Biologics
Drugs
08/26/2022

FDA Roundup: August 26, 2022

Today, FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time.

Press Release / Public Statement Food & Beverages
Biologics
Drugs
Tobacco
08/23/2022

FDA Roundup: August 23, 2022

Today, the FDA’s Office of Global Policy and Strategy posted an article about the FDA’s fruitful partnership with the Inter-American Institute for Cooperation in Agriculture. Additionally, on October 11, the FDA and the Duke-Margolis Center for Health Policy will hold a virtual public workshop titled, “Challenges and Opportunities for REMS Integration, Innovation, and Modernization.” 

Press Release / Public Statement Food & Beverages
Biologics
Drugs
08/19/2022

FDA Roundup: August 19, 2022

Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.

Press Release / Public Statement Medical Devices
Biologics
08/18/2022

Report: FDA's Work to Combat the COVID-19 Pandemic

Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.

Consumer Information Food & Beverages
Animal & Veterinary
Medical Devices
Biologics
Drugs
Inspections
Warning Letters
Guidance Documents
Research
08/16/2022

FDA Roundup: August 16, 2022

Today, the FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. The agency also warned the public about certain spray sunscreens that have been recalled because of benzene contamination and launched a new external webpage to highlight the Operation Lascar Initiative. 

Press Release / Public Statement Biologics
Drugs
Medical Devices
08/12/2022

FDA Roundup: August 12, 2022

Today, the FDA posted a safety communication to provide information to blood establishments regarding monkeypox virus and blood donations. 

Press Release / Public Statement Biologics
Drugs
08/09/2022

FDA Roundup: August 9, 2022

Today, the FDA’s Office of Global Policy and Strategy published “How a European Data Law is Impacting FDA,” which looks at how the European Union’s General Data Protection Regulation may be impacting the FDA’s public health activities.

Press Release / Public Statement

Biologics
Drugs
Food & Beverages

08/05/2022

FDA Roundup: August 5, 2022

On Wednesday, the FDA published the FDA Voices: “FDA Recognizes National Immunization Awareness Month,” by Robert M. Califf, M.D., FDA Commissioner. The FDA plays a key role in immunization by evaluating vaccines for safety and effectiveness before they are made available to the public. 

Press Release / Public Statement

Biologics
Drugs
Animal & Veterinary
Medical Devices
Tobacco

08/02/2022

FDA Roundup: August 2, 2022

The FDA announced the approval of the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses.

Press Release / Public Statement Food & Beverages
Animal & Veterinary
07/29/2022

FDA Roundup: July 29, 2022

On Tuesday, the FDA updated the FAQs on Testing for SARS-CoV-2 to note that no tests remain on the commercial manufacturer serology test notification list described in the FDA’s Policy for Coronavirus Disease-2019 Tests. All tests previously on the commercial manufacturer serology test notification list have either been issued an Emergency Use Authorization or should no longer be distributed, marketed, or offered.

Press Release / Public Statement Food & Beverages
Animal & Veterinary
Medical Devices
07/26/2022

FDA Roundup: July 26, 2022

The FDA released new updates detailing the agency’s Cyclospora prevention and research efforts. Cyclospora cayetanensis (C. cayetanensis) is a parasite that causes the foodborne intestinal illness cyclosporiasis. People can become infected with cyclosporiasis by ingesting food or water that’s contaminated with C. cayetanensis. The most common symptoms of cyclosporiasis are diarrhea, weight loss, nausea, and fatigue. 

Press Release / Public Statement Drugs
Medical Devices
Food & Beverages
07/22/2022

FDA Roundup: July 22, 2022

The FDA today published the “Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe” guidance which provides information and recommendations for industry on potential courses of action for an abbreviated new drug application applicant after the issuance of a complete response letter and the actions the FDA can take if the applicant fails to respond to a CRL.

Press Release / Public Statement

Drugs
Medical Devices
Food & Beverages

07/19/2022

FDA Roundup: July 19, 2022

The FDA today updated the device shortage list and the device discontinuance list on the web page for Medical Device Shortages During the COVID-19 Public Health Emergency. In addition, the FDA is providing information about devices that have been removed from the device shortage list at this time.

Press Release / Public Statement Biologics
Drugs
Food & Beverages
Medical Devices
07/15/2022

FDA Roundup: July 15, 2022

The FDA today announced the agency’s Total Diet Study Report: Fiscal Years 2018-2010 Elements Data. The agency also issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus; announced the availability of educational resources for parents and caregivers with questions about using imported infant formula; provided updates on the FDA’s continued implementation of a new law to regulate non-tobacco nicotine products; and authorized additional over-the-counter at-home COVID-19 antigen tests.

Press Release / Public Statement Biologics
Drugs
Food & Beverages
Medical Devices
Tobacco
07/13/2022

FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

Press Release / Public Statement Biologics
07/08/2022

FDA Roundup: July 8, 2022

The FDA announced approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age. The agency also finalized the Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. Additionally, the agency will continue hosting virtual town halls for test developers for SARS-CoV-2 on July 27 and August 24 from 12:05 p.m. – 1 p.m. ET.

Press Release / Public Statement Biologics
Animal & Veterinary
Medical Devices
07/06/2022

Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

The FDA revised the EUA for Paxlovid to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.

Press Release / Public Statement Drugs
07/05/2022

FDA Roundup: July 5, 2022

The FDA announced registration opened for the 2022 Public Meeting of National Antimicrobial Resistance Monitoring System. The agency also issued warning letters, jointly with the Federal Trade Commission to four companies for selling unapproved kratom products and to one company for selling essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms. Additionally the agency announced its July Grand Rounds lecture series topic, “One Health at FDA: From Concept to Application.”

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
07/01/2022

FDA Roundup: July 1, 2022

Today, the FDA announced a request for nominations for consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future. 

Press Release / Public Statement Animal & Veterinary
Biologics
Drugs
Medical Devices
06/30/2022

Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.

Press Release / Public Statement

Biologics

06/28/2022

FDA Roundup: June 28, 2022

The FDA announces the authorization of an extension to the shelf-life of the refrigerated AstraZeneca monoclonal antibody, Evusheld, which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Consumers concerned about COVID-19 should consult with their health care provider.

Press Release / Public Statement

Biologics
Drugs
Medical Devices
Food & Beverages

06/24/2022

FDA Roundup: June 24, 2022

Today, the FDA announced its recognition of JANAAC as an Accreditation Body Under FSMA- Accredited Third Party Certification Program for a period of five years.

Press Release / Public Statement Biologics
Medical Devices
Food & Beverages
05/20/2022

FDA Roundup May 20, 2022

On May 17, the FDA published the refreshed Know Your Treatment Options for COVID-19 Consumer Update with the latest information on COVID therapies.

Press Release / Public Statement Biologics
Medical Devices
04/15/2022

FDA Roundup: April 15, 2022

On April 14, the FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19 Breathalyzer test is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The authorization for the InspectIR COVID-19 Breathalyzer test is an example of the FDA’s continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19.

Press Release / Public Statement Biologics
Drugs
Medical Devices
Tobacco
04/14/2022

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Today, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

Press Release / Public Statement Medical Devices
04/12/2022

FDA Roundup: April 12, 2022

As part of the FDA’s effort to protect consumers, on April 5, the agency issued a warning letter to CofixRx, LLC for selling an unapproved product with misleading COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.

Press Release / Public Statement Drugs
Medical Devices
04/08/2022

FDA Roundup: April 8, 2022

On April 7, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months.

Press Release / Public Statement Biologics
Drugs
Medical Devices
04/05/2022

FDA Roundup: April 5, 2022

Today, the FDA announced sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
04/01/2022

FDA Roundup: April 1, 2022

The FDA published two FDA voices - “Give Your Community a Boost: Combatting Misinformation Through Communication and Research” and “FDA’s Technology and Data Modernization in Action in 2022.” The FDA also published findings from a facility inspection of Abbott Nutrition in Sturgis, Michigan, revised the guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19, denied two the request in two citizen petitions, published the FDA voices announced the extension of a public comment period, approved a new animal drug, updated a list of which regions in which the drug Sotrovimab is not authorized, approved a medical device to treat defects or legions that can occur in cartilage covering bones in the knee joint, authorized marketing of a medical device for measuring the brain temperature of neonates (infants less than four weeks old) and updated a fact sheet and FAQ regarding dosing information of Evusheld.

Press Release / Public Statement Biologics
Drugs
Food & Beverages
Medical Devices
03/29/2022

FDA Roundup: March 29, 2022

Today, the FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only.

Press Release / Public Statement Biologics
Drugs
Medical Devices
03/29/2022

Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.

Press Release / Public Statement Biologics
03/25/2022

FDA Roundup: March 25, 2022

Today, the FDA announced the COVID-19 treatment sotrovimab is no longer authorized for use at this time in the U.S. Health and Human Services (HHS) regions 1 and 2 due to the high frequency of the Omicron BA.2 sub-variant and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
03/22/2022

FDA Roundup: March 22, 2022

On March 21, the FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
03/21/2022

Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.

Press Release / Public Statement Biologics
03/18/2022

FDA Roundup: March 18, 2022

The FDA issues warning letters against companies selling misbranded and unapproved drugs, and updates frequently asked questions to the COVID-19 Test FAQs.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
03/15/2022

FDA Roundup: March 15, 2022

On March 10, as part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Soda Pharm for selling unapproved products with fraudulent COVID-19 claims.

Press Release / Public Statement Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
03/11/2022

FDA Roundup: March 11, 2022

As part of the FDA’s effort to protect consumers, on March 7, the agency issued a warning letter jointly with the Federal Trade Commission to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.

Press Release / Public Statement Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
03/08/2022

FDA Roundup: March 8, 2022

Today, the FDA announced the signing of a domestic mutual reliance partnership agreement with the Minnesota Department of Agriculture, a consent decree of permanent injunction was signed by a judge requiring Salud Natural Entrepreneur, Inc. of Illinois not to engage in any distribution operations until it completes corrective actions to ensure the company is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), and announced a low-risk determination for the marketing of products from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns.

Press Release / Public Statement Animal & Veterinary
Drugs
Food & Beverages
Medical Devices
03/04/2022

FDA Roundup: March 4, 2022

FDA posted an FDA Voices piece on speeding therapies for rare diseases and announced, with NASA, NIH and HHS, the award of eight contracts to extend longevity of complex in vitro (human) models.

Press Release / Public Statement Drugs
Medical Devices
03/01/2022

FDA Roundup: March 1, 2022

Today, the FDA issued a safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging. The test has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.

Press Release / Public Statement Animal & Veterinary
Food & Beverages
Medical Devices
02/25/2022

FDA Roundup: February 25, 2022

On Feb. 24, the FDA issued an update on our continuing efforts to understand and reduce exposure to PFAS from foods. The FDA made available new PFAS test results from our most recent survey of the general food supply that showed three samples—tilapia, cod, and shrimp, had detectable levels of at least one type of PFAS. Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the samples tested indicate a need to avoid any particular food. The FDA also posted on the Authorized Uses of PFAS in Food Contact Applications webpage, the first annual updates provided to the FDA from the three manufacturers that committed to the voluntary market phase-out of certain short-chain PFAS used in food packaging.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
02/22/2022

FDA Roundup: February 22, 2022

Today, the FDA posted a new resource, At-Home COVID-19 Diagnostic Tests, that provides a list of all FDA-authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests. Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19. At-home OTC COVID-19 diagnostic tests play a key role in the fight against COVID-19.

Press Release / Public Statement Drugs
Medical Devices
02/18/2022

FDA Roundup: February 18, 2022

Today, the FDA that it has found an additional four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The agency also warned consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. Additionally, the FDA published a new batch of product-specific guidances to provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval.

Press Release / Public Statement Biologics
Food & Beverages
Drugs
Medical Devices
02/15/2022

FDA Roundup: February 15, 2022

Today, the FDA released a request for public comments about antimicrobial use in companion animals and the potential impact of this use on antimicrobial resistance in both animals and people. The agency also published the FDA Voices, “Innovation and Scientific Collaboration Moved the Generic Drug Program Forward In 2021.” Additionally, the FDA provided updates on interim results from two postmarket studies on Essure. Finally, the agency issued a warning letter to the operator of one website, www.pharmacy2home.com, for offering for sale in the U.S. unapproved drugs for multiple diseases, including COVID-19.

Press Release / Public Statement Animal & Veterinary
Drugs
Medical Devices
02/11/2022

FDA Roundup: February 11, 2022

On Feb. 7, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Also, as of today, 421 tests and sample collection devices for the virus that causes COVID-19 are authorized by the FDA under emergency use authorizations (EUAs).

Press Release / Public Statement Drugs
Medical Devices
02/11/2022

FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant

Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death.

Press Release / Public Statement Drugs
Biologics
02/11/2022

FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

The FDA has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.

Press Release / Public Statement Biologics
02/08/2022

FDA Roundup: February 8, 2022

The FDA issued a guidance for industry and investigators to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19. The agency also warned health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets.

Press Release / Public Statement Drugs
Medical Devices
02/04/2022

FDA Roundup: February 4, 2022

The FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country. The FDA also issued a draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure. Additionally, the FDA announced its 2022-2025 strategic priorities for the Center for Devices and Radiological Health, a proposed rule to improve the security of the drug supply chain as well as a new website showcasing the Center for Veterinary Medicine’s innovative research to protect human and animal health.

Press Release / Public Statement Drugs
Animal & Veterinary
Medical Devices
02/01/2022

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

Press Release / Public Statement Biologics
02/01/2022

FDA Roundup: February 1, 2022

The FDA issued a safety communication warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The FDA also published the 2021 Center for Devices and Radiological Health (CDRH) annual report, announced an upcoming workshop related to multi-component biomarkers and released a list of guidance topics that are a priority for the FDA Foods Program as well as a video that provides an overview of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
01/31/2022

FDA Takes Key Action By Approving Second COVID-19 Vaccine

The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.

Press Release / Public Statement Biologics
01/28/2022

FDA Roundup: January 28, 2022

The FDA added four bulk drug substances to list of substances that may be used in compounding by outsourcing facilities. FDA also posted an article discussing the agency’s commitment toward advancing two proposed tobacco product standards and published several guidances on generic drug application submissions, labeling and review.

Press Release / Public Statement Drugs
Food & Beverages
Medical Devices
Tobacco
01/25/2022

FDA Roundup: January 25, 2022

The FDA authorized another over-the-counter COVID-19 antigen test and also provided updates to its web pages on In Vitro Diagnostics EUAs for Molecular and Antigen Diagnostic Tests for SARS-CoV-2.

Press Release / Public Statement Animal & Veterinary
Drugs
Food & Beverages
Medical Devices
01/24/2022

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

The FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible of these treatments.

Press Release / Public Statement Drugs
01/21/2022

FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.

Press Release / Public Statement Drugs
01/21/2022

FDA Roundup: January 21, 2022

The FDA extended the previously announced temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.

Press Release / Public Statement Animal & Veterinary
Drugs
Medical Devices
01/18/2022

FDA Roundup: January 18, 2022

The FDA published the CDRH Health of Women Program Strategic Plan, which outlines the program’s priorities to protect and promote the health of women.

Press Release / Public Statement Food & Beverages
Medical Devices
01/14/2022

FDA Roundup: January 14, 2022

The FDA published an FDA Voices entitled, Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues, which highlights the wide variety of safe and effective new drug therapies approved in 2021 despite challenges brought on by the ongoing COVID-19 pandemic.

Press Release / Public Statement Animal & Veterinary
Cosmetics
Drugs
Food & Beverages
Medical Devices
01/13/2022

FDA 2021 Year in Review - Working for You

This year end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments. The report also highlights ways the FDA strengthened maternal and infant health, modernized food safety, and protected young people from the harmful effects of tobacco.

Consumer Information Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
Research
Tobacco
01/11/2022

FDA Roundup: January 11, 2022

The FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension).

Press Release / Public Statement Drugs
Medical Devices
01/11/2022

Addressing New Variants: A Federal Perspective on the COVID-19 Response

Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Acting Commissioner Janet Woodcock, M.D. testifies for the FDA. View written testimony.

Event Biologics
Drugs
Food & Beverages
Medical Devices
01/07/2022

FDA Roundup: January 7, 2022

The FDA published an interactive public data dashboard for viewing historical data from the Reportable Food Registry, issued an outbreak advisory regarding two salad blends, announced two virtual public meetings on a recently released proposed rule, and added organ preservation solutions to the device shortage list.

Press Release / Public Statement Biologics
Drugs
Food & Beverages
Medical Devices
01/07/2022

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

Today, the FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.

Press Release / Public Statement Biologics
01/03/2022

FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.

Press Release / Public Statement Biologics
12/10/2021

Coronavirus (COVID-19) Update

The FDA updates information about the Meridian Bioscience, Inc. Revogene SARS-CoV-2 test, including the impact of the SARS-CoV-2 omicron variant on test performance.

COVID-19 Update Medical Devices
12/09/2021

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

Today, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.

Press Release / Public Statement Biologics
12/08/2021

Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals

Today, the FDA issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

Press Release / Public Statement Drugs
12/07/2021

Coronavirus (COVID-19) Update

The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information, including FDA recommendations for clinical laboratory staff and health care providers. Additionally, the agency also added the Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test to another list of impacted tests.

COVID-19 Update Medical Devices
12/03/2021

FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns

FDA revised the EUA of bamlanivimab and etesevimab, administered together, to treat mild to moderate COVID-19 in all younger pediatric patients, including newborns. The drug combination is also now authorized for post-exposure prevention of COVID-19 in all pediatric patients, including newborns.

Press Release / Public Statement Drugs
11/30/2021

Coronavirus (COVID-19) Update

The FDA issues a statement regarding its work with federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant and announces a new project to expand the FDA-ARGOS database.

COVID-19 Update Medical Devices
11/30/2021

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.

Press Release / Public Statement Biologics
Medical Devices
11/30/2021

Antimicrobial Drugs Advisory Committee Meeting

The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. View webcast.

Event Drugs
11/23/2021

Coronavirus (COVID-19) Update

The FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests; and approved an abbreviated new drug application to treat serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.

COVID-19 Update Drugs
Medical Devices
11/19/2021

FDA Expands Eligibility for COVID-19 Vaccine Boosters

The FDA amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

Press Release / Public Statement Biologics
11/16/2021

Coronavirus (COVID-19) Update

The FDA takes several actions to increase access to accurate and reliable COVID-19 tests.

COVID-19 Update Medical Devices
11/15/2021

Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests

Today, the FDA is taking several important actions to support ongoing nationwide COVID-19 testing efforts.

Press Release / Public Statement Medical Devices
11/12/2021

Coronavirus (COVID-19) Update

The FDA posted an updated Molecular and Antigen Home Use Test Template intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. The template is intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA.

COVID-19 Update Medical Devices
11/05/2021

Coronavirus (COVID-19) Update

The FDA has issued an emergency use authorization (EUA) for the iHealth COVID-19 Antigen Rapid Test, an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes.

COVID-19 Update Biologics
Medical Devices
11/04/2021

Next Steps: The Road Ahead for the COVID-19 Response

Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Acting Commissioner Janet Woodcock, M.D. testifies for the FDA. View written testimony.

Event Biologics
Drugs
Food & Beverages
Medical Devices
11/02/2021

Coronavirus (COVID-19) Update

The FDA recently revised several extramural research contracts in the Medical Countermeasures Initiative (MCMi) Regulatory Science Program to expand efforts supporting COVID-19 medical countermeasure development.

COVID-19 Update Biologics
Medical Devices
10/29/2021

Coronavirus (COVID-19) Update

The FDA discussed the agency’s actions to expand the use of a single booster dose for COVID-19 vaccines in eligible populations. In addition, the FDA authorized the 11th over-the-counter (OTC) COVID-19 test and is investigating certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new.

COVID-19 Update Biologics
Medical Devices
10/29/2021

FDA Authorizes COVID-19 Vaccine in Children 5 through 11

The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

Press Release / Public Statement Biologics
10/26/2021

Coronavirus (COVID-19) Update

The FDA authorized the 10th over-the-counter (OTC) COVID-19 test, reissued the emergency use authorization (EUA) for another OTC COVID-19 test, and updated the EUA templates for test developers seeking an EUA for OTC tests.

COVID-19 Update Medical Devices
10/26/2021

Vaccines and Related Biological Products Advisory Committee Meeting

The committee will discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. View livestream.

Event Biologics
10/22/2021

Coronavirus (COVID-19) Update

Today, the FDA began posting materials for the next Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting, happening on Tuesday, Oct. 26. The committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

COVID-19 Update Drugs
Medical Devices
10/20/2021

FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

The FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or “mix and match”) booster doses in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. Listen to the media call.

Press Release / Public Statement Biologics
10/19/2021

Coronavirus (COVID-19) Update

On Oct. 12, the FDA approved an abbreviated new drug application for propofol injectable emulsion, single patient-use vials. This drug is an intravenous general anesthetic and sedation drug listed in the FDA Drug Shortage Database. Side effects of propofol emulsion injection include hypotension (low blood pressure), bradycardia (low heart rate), and apnea (temporary stopping of breathing).

COVID-19 Update Drugs
Medical Devices
10/14/2021

FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

The U.S. Food and Drug Administration is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) on November 30 to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.

Press Release / Public Statement Drugs
10/12/2021

Coronavirus (COVID-19) Update

Today, the FDA announced that it intends to withdraw, effective Dec. 31, 2021, guidance documents originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency.

COVID-19 Update Drugs
Medical Devices
10/08/2021

Coronavirus (COVID-19) Update

On Tuesday October 5, the FDA issued a safety communication to alert test users, caregivers, health care personnel and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test due to a recently identified manufacturing issue.

COVID-19 Update Medical Devices
10/05/2021

Coronavirus (COVID-19) Update

On Sept. 28, the FDA will issue a warning letter to Strategia Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims. The agency recommends that consumers who have concerns about COVID-19 should consult with their health care provider.

COVID-19 Update Medical Devices
10/04/2021

Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers

FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 test, which adds to the growing list of tests that can be used at home without a prescription.

Press Release / Public Statement Medical Devices
10/01/2021

Coronavirus (COVID-19) Update

The FDA authorizes an emergency use authorization for one additional batch of the Janssen COVID-19 vaccine and the FDA’s Acting Commissioner, Dr. Janet Woodcock, discusses the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

COVID-19 Update Biologics
Drugs
Medical Devices
10/01/2021

FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

The FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.

Press Release / Public Statement Biologics
09/24/2021

Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose

Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the Pfizer-BioNTech COVID-19 Vaccine booster dose.

Podcast / Video Biologics
09/22/2021

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.

Press Release / Public Statement Biologics
09/20/2021

Podcast: COVID-19 Vaccine Boosters and COVID-19 Vaccines for Kids

Acting FDA Commissioner Dr. Janet Woodcock discusses additional shots of the COVID-19 vaccine ("boosters") and COVID-19 vaccines for kids under 12

Podcast / Video Biologics
09/17/2021

Coronavirus (COVID-19) Update

The FDA took the following actions in the agency’s ongoing response to the COVID-19 pandemic: issued a Letter to Health Care Providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits; revised the Emegency Use Authorization (EUA) for bamlanivimab and etesevimab, administered together, to include an emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19; issued a revised guidance to help expand the availability of face masks, barrier face coverings and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency; and authorized the use, under the EUA for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility.

COVID-19 Update Biologics
Drugs
Medical Devices
09/17/2021

Vaccines and Related Biological Products Advisory Committee

The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. View livestream.

Event Biologics
09/16/2021

FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19

The FDA revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. Post-exposure prophylaxis with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19.

Press Release / Public Statement Biologics
Drugs
09/10/2021

Coronavirus (COVID-19) Update

The FDA approved an abbreviated new drug application indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, authorized the use--under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine--of one additional batch of vaccine drug substance manufactured at the Emergent facility, and issued a revised guidance which provides general recommendations to prospective generic drug applicants in the form of questions and answers that have been addressed during the COVID-19 public health emergency. The FDA also posted a statement titled “FDA Will Follow The Science On COVID-19 Vaccines For Young Children”.

COVID-19 Update Biologics
Drugs
Medical Devices
09/10/2021

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children.

Press Release / Public Statement Biologics
09/08/2021

Virtual Town Hall Series - COVID-19 Test Development and Validation

FDA will host a virtual Town Hall on 9/8/2021 from 12:15 to 1:15 ET to help answer technical questions about the development and validation of tests for SARS-CoV-2. Participants may ask questions during the call or submit questions by noon on 9/8/2021 to CDRHWebinars@fda.hhs.gov.

Event Medical Devices
09/07/2021

Coronavirus (COVID-19) Update

FDA issued a warning letter to a company for not complying with federal laws and regulations during the clinical investigation of an investigational drug to mitigate and treat COVID-19.

COVID-19 Update Medical Devices
09/01/2021

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster

Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.

Press Release / Public Statement Biologics
08/31/2021

Coronavirus (COVID-19) Update

The FDA makes changes to the authorized use of the monoclonal antibodies bamlanivimab and etesevimab, and issues a letter to veterinarians and retailers about the dangerous misuse of animal ivermectin to prevent or treat COVID-19 in people.

COVID-19 Update Medical Devices
08/30/2021

Help Stop Misuse of Animal Ivermectin to Prevent or Treat COVID-19 in Humans

Today the FDA issued a letter to veterinarians and retailers to help stop the misuse of animal ivermectin to prevent or treat COVID-19 in humans. Poison control centers across the United States are seeing a sharp spike in reports of people suffering adverse health effects after taking animal ivermectin.

Safety Information Animal & Veterinary
08/27/2021

Resumption in Use and Distribution of Bamlanivimab/Etesevimab in Certain States

Today the FDA reissued the Letter of Authorization to allow for the emergency use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Health care providers may refer to the fact sheet and frequently asked questions for more information.

Press Release / Public Statement Drugs, Biologics
08/27/2021

Coronavirus (COVID-19) Update

The FDA issued a letter to health care providers alerting health care facility risk managers, procurement staff and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co., Ltd. and the agency issued a warning letter to Invisi Smart Technologies for offering for sale adulterated and misbranded Invisi Smart Masks.

COVID-19 Update Medical Devices
08/24/2021

Coronavirus (COVID-19) Update

The FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months.

COVID-19 Update Biologics
Medical Devices
08/23/2021

FDA Approves First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

Press Release / Public Statement Biologics
08/20/2021

Coronavirus (COVID-19) Update

The FDA issued a warning letter regarding sale of unapproved products with unproven COVID-19 claims and held a stakeholder call in recognition of National Immunization Awareness Month to discuss vaccines for younger children and adolescents in preparation for the school year.

COVID-19 Update Medical Devices
08/18/2021

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administration’s plan for COVID-19 booster shots for the American people.

Press Release / Public Statement Biologics
08/13/2021

Coronavirus (COVID-19) Update

A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents and FDA’s vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination.

COVID-19 Update Biologics
08/12/2021

FDA Authorizes Additional Vaccine Dose for Immunocompromised People

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Press Release / Public Statement Biologics
07/16/2021

Coronavirus (COVID-19) Update

The FDA formally accepts Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.

COVID-19 Update Biologics
Medical Devices
07/13/2021

Coronavirus (COVID-19) Update

The FDA announces revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine.

COVID-19 Update Biologics
Medical Devices
07/13/2021

Webinar: Revocation of EUAs for Non-NIOSH-Approved Respirators and Decontamination Systems

From 12:00 to 1:00 p.m. ET on Tuesday, July 13, 2021, the FDA will host a webinar to share information and answer questions about revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.

Event Medical Devices
07/09/2021

Coronavirus (COVID-19) Update

The FDA issued a report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response, an EUA to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test as well as warning letters to 12 firms for offering for sale in the U.S. adulterated and misbranded tests, face masks, respirators and surgical masks, some of which are intended for use in the mitigation, prevention, treatment, diagnosis or cure of COVID-19 in people.

COVID-19 Update Biologics
Medical Devices
07/08/2021

Joint CDC and FDA Statement on Vaccine Boosters

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.

Press Release / Public Statement Biologics
07/06/2021

Coronavirus (COVID-19) Update

The FDA holds a stakeholder call with Vaccinate Your Family and pediatric and healthcare groups.

COVID-19 Update Biologics
Medical Devices
07/02/2021

Coronavirus (COVID-19) Update

The FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. Additionally, the FDA issued an updated Letter to Health Care Personnel and Facilities stating that the FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators.

COVID-19 Update

Biologics
Medical Devices

06/30/2021

FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide

FDA announced it is revoking EUAs of all non-NIOSH-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems.

Press Release / Public Statement

Medical Devices

06/29/2021

Coronavirus (COVID-19) Update

The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020, which includes a section on the agency’s drug shortage efforts in response to COVID-19. The FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, and Economic Security Act.

COVID-19 Update

Drugs

06/25/2021

Coronavirus (COVID-19) Update

The FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination; and reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic.

COVID-19 Update

Biologics
Drugs
Medical Devices
Warning Letters

06/24/2021

FDA Authorizes Drug for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Press Release / Public Statement Biologics
Drugs
06/22/2021

Coronavirus (COVID-19) Update

The FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger; and issued a warning letter to a company selling an unapproved product with fraudulent COVID-19 claims.

COVID-19 Update Drugs
Warning Letters
06/15/2021

Coronavirus (COVID-19) Update

The FDA posts updated translations for the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers and issues an updated FDA COVID-19 Response At-A-Glance Summary.

COVID-19 Update Biologics
Medical Devices
06/11/2021

Coronavirus (COVID-19) Update

FDA issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. FDA also added sodium citrate tubes used in blood specimen collection to the device shortage list.

COVID-19 Update Medical Devices
06/11/2021

FDA Takes Steps to Increase Availability of COVID-19 Vaccine

Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.

Press Release / Public Statement Biologics
06/10/2021

Vaccines and Related Biological Products Advisory Committee

The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss, in general, data needed to support authorization and/or licensure of COVID-19 vaccines for use in pediatric populations. View livestream

Event Biologics
06/08/2021

Coronavirus (COVID-19) Update

The White House, HHS and FDA release a series of policy recommendations to address vulnerabilities in U.S. pharmaceutical supply chains, and FDA issues warning letters for sale of unapproved products with unproven COVID-19 claims.

COVID-19 Update Medical Devices
06/04/2021

Coronavirus (COVID-19) Update

On June 1, the FDA approved an abbreviated new drug application for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation. Albuterol sulfate inhalation aerosol is used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease (such as asthma) and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

COVID-19 Update Drugs
Medical Devices
06/01/2021

Coronavirus (COVID-19) Update

The FDA issued a safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) because the FDA has serious concerns about the performance of the tests and believes there is likely a high risk of false results when using these tests.

COVID-19 Update Medical Devices
05/28/2021

Coronavirus (COVID-19) Update

FDA releases the Medical Countermeasures Initiative (MCMi) Program Update report which showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19.

COVID-19 Update Drugs
Medical Devices
05/26/2021

FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

Today, the FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Press Release / Public Statement Drugs
05/25/2021

Coronavirus (COVID-19) Update

The FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. Additionally, the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests.

COVID-19 Update Biologics
Medical Devices
05/21/2021

Coronavirus (COVID-19) Update

The FDA updated the definition of high risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease.

COVID-19 Update Drugs
Medical Devices
Warning Letters
05/19/2021

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

Press Release / Public Statement Biologics
05/19/2021

FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination

FDA issued a safety communication to advise against using SARS-CoV-2 antibody test results to evaluate immunity after COVID-19 vaccination.

Press Release / Public Statement Medical Devices
05/18/2021

Coronavirus (COVID-19) Update

The FDA provided summary information about the status of CytoDyn, Inc.’s development program for the monoclonal antibody investigational drug, leronlimab, for the treatment of COVID-19.

COVID-19 Update Medical Devices
05/14/2021

Coronavirus (COVID-19) Update

The FDA issued a warning letter to Crown Wellness, Inc. for, among other things, selling an unapproved product with COVID-19 claims.

COVID-19 Update Medical Devices
05/11/2021

Coronavirus (COVID-19) Update

The FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include 12 – 15 year olds and issued an updated FDA COVID-19 Response At-A-Glance Summary.

COVID-19 Update Biologics
Warning Letters
05/11/2021

An Update from Federal Officials on Efforts to Combat COVID-19

Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Director of the FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. testifies for the FDA. View written testimony.

Event Biologics
Drugs
Food & Beverages
Medical Devices
05/10/2021

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. View press briefing.

Press Release / Public Statement Biologics
05/10/2021

FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines

The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.

Press Release / Public Statement Biologics
05/07/2021

Coronavirus (COVID-19) Update

The agency issued a warning letter to Disinfect & Shield for selling an unapproved product with fraudulent COVID-19 claims.

COVID-19 Update Medical Devices
05/05/2021

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

FDA issued a new report outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations.

Press Release / Public Statement Biologics
Drugs
Food & Beverages
Medical Devices
05/04/2021

Coronavirus (COVID-19) Update

The FDA updated the CDER’s work to meet user fee goals webpage to include data from Fiscal Year 2021 Quarter 2.

COVID-19 Update Drugs
Medical Devices
04/30/2021

Coronavirus (COVID-19) Update

The FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System and updated the EUA Authorized Serology Test Performance page on the FDA’s website.

COVID-19 Update Drugs
Medical Devices
04/27/2021

Coronavirus (COVID-19) Update

The FDA lifted the recommended pause on the use of Janssen (Johnson & Johnson) COVID-19 Vaccine following a thorough safety review; and issued warning letters to companies selling unapproved products with fraudulent COVID-19 claims.

COVID-19 Update Biologics
Drugs
Medical Devices
04/23/2021

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted.

Press Release / Public Statement Biologics
04/23/2021

Coronavirus (COVID-19) Update

The FDA completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine and cited a number of observations concerning whether the facility’s processes met the agency’s requirements and standards. Additionally, the FDA’s Center for Food Safety and Applied Nutrition updated its COVID-19 Vaccination & Food and Agriculture Sector webpage to include the HHS COVID-19 Vaccination Toolkit for agriculture workers.

COVID-19 Update Medical Devices
04/16/2021

Coronavirus (COVID-19) Update

The FDA issues a statement regarding the Janssen COVID-19 vaccine, issues a warning letter and updates a frequently asked question about the Moderna COVID-19 vaccine.

COVID-19 Update Biologics
Drugs
Medical Devices
04/09/2021

Coronavirus (COVID-19) Update

The FDA recommends health care personnel and facilities transition from the use of decontaminated disposable respirators, and issues warning letters to two companies for selling unapproved products with fraudulent COVID-19 claims.

COVID-19 Update Medical Devices
Warning Letters
04/06/2021

Coronavirus (COVID-19) Update

The FDA issues COVID-19 related Emergency Use Authorization and implements a new guidance.

COVID-19 Update Drugs
Medical Devices
04/06/2021

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

The FDA today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.

Press Release / Public Statement Medical Devices
04/02/2021

FDA In Brief: FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative

This FDA In Brief provides an update on the PREPP initiative

Press Release / Public Statement Biologics
Drugs
Medical Devices
03/18/2021

FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic

The agency’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate.

FDA Voices: Leadership Perspectives Inspections
03/18/2021

Senate Health, Education, Labor, and Pensions Committee Hearing

FDA leadership will participate in the hearing titled “Examining Our COVID-19 Response: An Update from Federal Officials.”

View livestream and written testimony

Event Imports
Inspection
Recalls
Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
03/17/2021

Webinar: Therapeutics for Use in COVID-19

Acting FDA commissioner, Janet Woodcock, M.D. participated in a webinar for physicians to discuss the state of therapeutic clinical trials worldwide.

Podcast / Video Drugs
Research
03/17/2021

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.

Press Release / Public Statement Medical Devices
03/17/2021

House Subcommittee Hearing on COVID-19 Vaccinations

FDA leadership will participate in the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce hearing entitled, "Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations."

View livestream and written testimony

Event Biologics
03/16/2021

Coronavirus (COVID-19) Update

FDA launches the COVID-19 EUA FDA Adverse Events Reporting System Public Dashboard and issues a warning letter for sale of unapproved products with fraudulent COVID-19 claims.

COVID-19 Update Biologics
Drugs
Medical Devices
02/27/2021

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Press Release / Public Statement Biologics
02/22/2021

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Today, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.

Press Release / Public Statement Biologics
Drugs
Medical Devices
01/08/2021

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff

FDA is alerting labs and health care providers that it is monitoring the impact of viral mutations, including the B.1.1.7 variant, on SARS-CoV-2 molecular tests.

Press Release / Public Statement Medical Devices
01/05/2021

Coronavirus (COVID-19) Update

The FDA issues a warning letter and posts a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

COVID-19 Update Drugs
Medical Devices
12/08/2020

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic

The FDA continues this series of webinars on topics including respirators, surgical masks, protective barrier enclosures, gowns, and other apparel used by health care personnel during the COVID-19 pandemic.

Event Medical Devices
12/07/2020 Remarks by Dr. Hahn to the FDA-CMS Summit Event Biologics
Drugs
Medical Devices
12/04/2020

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples

The FDA authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).

Press Release / Public Statement Medical Devices
12/04/2020

Coronavirus (COVID-19) Update

The FDA issues new guidance and an EUA, updates another guidance, and launches an immunology app-a-thon.

COVID-19 Update Medical Devices
12/04/2020 Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine Event Biologics
12/03/2020

Coronavirus (COVID-19) Update

The FDA issues a health fraud warning letters and updates the reference panel comparative date online.

COVID-19 Update Drugs
Medical Devices
12/02/2020

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
12/01/2020

Coronavirus (COVID-19) Update

The FDA amends the convalescent plasma EUA, issues health fraud warning letters, revises guidance, and updates testing numbers.

COVID-19 Update Biologics
Drugs
Medical Devices
11/30/2020

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.

Press Release / Public Statement Biologics
11/25/2020

Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

Today, the FDA issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency.

Press Release / Public Statement Medical Devices
11/24/2020

Thank You, Food and Agriculture Workers! | Español

To the millions of food and agriculture workers across America at Thanksgiving, the FDA is Giving Thanks for you!

Podcast / Video Food & Beverages
11/24/2020

Coronavirus (COVID-19) Update

The FDA publishes new web resources, provides a testing update, approves an ANDA, and posts a “Thank You” video to our food and agriculture workers.

COVID-19 Update Drugs
Medical Devices
11/23/2020

Coronavirus (COVID-19) Update

The FDA issues an ANDA, an EUA, and posts a new infographic on the potential EUA pathway for vaccines.

COVID-19 Update Biologics
Drugs
Medical Devices
11/21/2020

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

Press Release / Public Statement Drugs
11/20/2020

Coronavirus (COVID-19) Update

The FDA issues an EUA, two warning letters, and more.

COVID-19 Update Biologics
Drugs
Medical Devices
11/20/2020

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

Press Release / Public Statement Biologics
11/20/2020

The FDA published new information about the vaccine development and review process:

Consumer Information Biologics
11/16/2020

A Closer Look at COVID-19 Diagnostic Testing

This overview may be of interest to health care providers, test purchasers, and public health staff who want to know more about different types of tests. A printable PDF is also available.

Consumer Information Medical Devices
11/13/2020

Coronavirus (COVID-19) Update

The FDA takes further action against company distributing a fraudulent product claiming to prevent or treat COVID-19.

COVID-19 Update Drugs
Medical Devices
11/12/2020

Coronavirus (COVID-19) Update

The FDA issues new Consumer Update offering tips on how to spot fraudulent flu products and updates treatment numbers on its CTAP dashboard.

COVID-19 Update Medical Devices
11/10/2020

Coronavirus (COVID-19) Update

The FDA to host a virtual “Grand Rounds” presentation on the agency’s research to evaluate the ability of facial coverings to reduce the spread of infection and more.

COVID-19 Update Medical Devices
11/10/2020

FDA Insight Podcast: Hand Hygiene During COVID-19

Dr. Shah welcomes Elizabeth Jungman, director of CDER’s Office of Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic.

Podcast / Video Drugs
Recalls
11/09/2020

Coronavirus (COVID-19) Update

The FDA issues an EUA for an investigational monoclonal antibody therapy for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients, a final guidance on designing and executing clinical trials that include people with diverse characteristics, a testing update, and more.

COVID-19 Update Biologics
Drugs
Medical Devices
11/09/2020

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

Press Release / Public Statement Drugs
11/09/2020

Remarks by FDA Commissioner Dr. Stephen Hahn to the GRx+Biosims 2020 Virtual Conference

Event Biologics
Drugs
11/09/2020

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

Statement by FDA Commissioner Dr. Stephen Hahn about a final guidance Issued today that provides the agency’s current thinking on steps to enhance diversity in clinical trials of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly.

Press Release / Public Statement Biologics
Drugs
11/06/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Today, the FDA authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.

Press Release / Public Statement Medical Devices
11/04/2020

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
11/03/2020

Coronavirus (COVID-19) Update

The FDA issues two health fraud warning letters, an alert that false positive results can occur with antigen tests for the rapid detection of SARS-CoV-2, and more.

COVID-19 Update Drugs
Medical Devices
11/01/2020

Lessons Learned From COVID

Remarks by Dr. Stephen Hahn for the Global Pharmaceutical Manufacturing Leadership Forum

Event Biologics
Drugs
Medical Devices
10/30/2020

Coronavirus (COVID-19) Update

The FDA issues a new Consumer Update.

COVID-19 Update Medical Devices
10/28/2020

Coronavirus (COVID-19) Update

The FDA updates an immediately in effect guidance, approves two generic muscle relaxation drugs, and issues warning letters.

COVID-19 Update Drugs
Medical Devices
10/28/2020

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
10/27/2020

I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe and effective.

USA Today Opinion: FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks

Press Release / Public Statement Biologics
10/27/2020

Get Your Flu Vaccine

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, discusses this year's flu season and the importance of getting vaccinated as we continue the fight against the COVID-19 pandemic.

Podcast / Video Biologics
10/27/2020

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic

During this webinar, the FDA will share information about surgical mask 510(k)s and representatives from the FDA and from the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) will be available to answer your questions.

Event Medical Devices
10/26/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA updates the Antigen Template for Test Developers.

Daily Roundup

Medical Devices

10/26/2020

FDA Presentation: American Public Health Association's 2020 Virtual Annual Meeting

Bruce Ross, director of the FDA's Office of Global Operations, on the topic "Department of Health and Human Services’ Global Health Workforce – On the Front Lines of Health Diplomacy During the Time of COVID-19."

Event Biologics
Drugs
Medical Devices
10/23/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA approves first drug to treat COVID-19 and issues an updated FDA COVID-19 Response At-A-Glance Summary.

Daily Roundup Biologics
Drugs
Medical Devices
10/22/2020

FDA Commissioner Talks to AARP About COVID-19 Vaccines

Dr. Stephen Hahn explains the FDA’s role in ensuring safety, effectiveness of COVID-19 vaccines.

Consumer Information Drugs
10/22/2020

FDA Approves First Treatment for COVID-19

Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.

Press Release / Public Statement Drugs
10/22/2020

Vaccines and Related Biological Products Advisory Committee

The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. View webcast

Event Biologics
10/21/2020

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
10/20/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA publishes new content on the "FDA Insight” podcast, in "FDA Voices", and issues a Consumer Update.

Daily Roundup Biologics
Drugs
Medical Devices
10/20/2020

The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines

This week, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.

FDA Voices: Leadership Perspectives Biologics
10/20/2020

Advisory Committee on COVID-19 Vaccines

Dr. Peter Marks provides an update on COVID-19 vaccines and discusses the upcoming Vaccines and Related Biological Products Advisory Committee meeting.

Podcast / Video Biologics
10/19/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA issues a joint warning letter with the Federal Trade Commission to prevent the sale of unapproved products with fraudulent COVID-19 claims.

Daily Roundup Drugs
Medical Devices
Warning Letters
10/15/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA re-issues Emergency Use Authorization for certain filtering facepiece respirators.

Daily Roundup Medical Devices
10/15/2020

FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China

The FDA reissued the EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).

Press Release / Public Statement Medical Devices
10/14/2020

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
10/13/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA issues and implements new guidance regarding molecular influenza and RSV tests.

Daily Roundup Guidance Documents
Medical Devices
10/13/2020

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic

FDA and representatives from the Occupational Safety and Health Administration (OSHA) answered questions about protective barrier enclosures.

Event Medical Devices
10/09/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA and the Federal Trade Commission issue warning letters for selling fraudulent COVID-19-related products.

Daily Roundup Drugs
Warning Letters
10/08/2020

The Review Process for Vaccines to Prevent COVID-19: A Discussion

FDA Commissioner Dr. Steven Hahn discussed the COVID-19 vaccine review process with the Center for Infectious Disease Research and Policy and others.

Podcast / Video Biologics
10/08/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA updates dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage.

Daily Roundup Drugs
10/08/2020

Interview: FDA Commissioner on COVID-19 Vaccines and Other Medical Countermeasures

FDA Commissioner Dr. Steven Hahn spoke about the COVID-19 vaccine development process and other medical countermeasures for COVID-19.

Podcast / Video Biologics
10/07/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA issues letter to healthcare providers regarding SARS-CoV-2 testing, and a warning letter for failure to comply with regulatory reporting requirements.

Daily Roundup Medical Devices
Warning Letters
10/07/2020

FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators

The FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting as specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System.

Press Release / Public Statement Medical Devices
Warning Letters
10/06/2020

Tell Me More About Vaccines

Learn more about how vaccines are developed from U.S. Department of Health and Human Services leaders.

Podcast / Video Biologics
10/06/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA launches new COVID-19 vaccine webpage and issues guidance with recommendations for vaccine sponsors.

Daily Roundup Biologics
Guidance Documents
10/06/2020

FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

Recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.

Press Release / Public Statement Biologics
Guidance Documents
10/05/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA awards Stanford University with a research contract to study SARS-CoV-2.

Daily Roundup Medical Devices
Research
10/02/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA posts transcript of Dr. Stephen M. Hahn, M.D.’s remarks to the National Consumers League, issues warning letter against unapproved and misbranded product related to COVID-19.

Daily Roundup Medical Devices
Drugs
10/01/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA revises an emergency use authorization, plus a warning letter to caution consumers against unapproved and misbranded products related to COVID-19.

Daily Roundup Medical Devices
Drugs
09/30/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues a new warning letter, a new FDA Voices and updates the SARS-CoV-2 reference panel comparative data in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
Drugs
09/30/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
09/29/2020

Dr. Hahn's remarks to the National Consumers League on the vaccine review process

Consumer Perspectives on the Covid-19 Pandemic: A Conversation with the FDA

Event Biologics
09/29/2020

A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response

CDRH’s response to the pandemic has been unprecedented in terms of volume, speed, and agility, including regulatory flexibility and EUAs.

FDA Voices: Leadership Perspectives Medical Devices
09/23/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

Today, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.

Press Release / Public Statement Medical Devices
09/23/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA’s actions on a new summary of evidence to support an EUA and FDA Commissioner Stephen M. Hahn’s testimony before a Senate committee in its ongoing response to the COVID-19 pandemic.

Daily Roundup Biologics
Medical Devices
09/15/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues two warning letters in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Warning Letters
09/15/2020

Webinar Series - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic

The FDA will present information on both the enforcement policy and the EUA for gowns and other apparel, and representatives from the FDA, CDC, and OSHA will be available to answer your questions.

Event Medical Devices
09/14/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA awards a new research contract in its ongoing response to the COVID-19 pandemic.

Daily Roundup Research
Medical Devices
09/14/2020

FDA and global partners to analyze coronavirus samples

Effort to help inform development of SARS-COV-2 diagnostics, vaccines, and therapeutics

Press Release / Public Statement Research
09/11/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues a temporary guidance and an FDA Voices in its ongoing response to the COVID-19 pandemic.

Daily Roundup Animal & Veterinary
Biologics
Drugs
Guidance Documents
09/11/2020

The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

FDA is committed to making decisions regarding the authorization or approval of COVID-19 vaccines that are guided by science and data.

FDA Voices: Leadership Perspectives Biologics
09/10/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA’s action on a warning letter in its ongoing response to the COVID-19 pandemic.

Daily Roundup Warning Letters
09/10/2020

Advancing the Science of Real-World Data to Address the COVID-19 Pandemic

FDA Principal Deputy Commissioner Amy P. Abernethy, M.D., Ph.D., discusses the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries and lab results to further inform our pandemic response.

Event Biologics
Drugs
Medical Devices
09/09/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues a consumer update on the Food and Cosmetics Information Center in its ongoing response to the COVID-19 pandemic.

Daily Roundup Food & Beverages
Medical Devices
09/09/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

he purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
Imports
09/08/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA deactivated the FDA registration for more than 300 foreign establishments in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
09/04/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues an updated COVID-19 Response At-A-Glance Summary in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
09/03/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA expands language availability for consumer updates in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
08/28/2020

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

FDA announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020.

Press Release / Public Statement Biologics
08/28/2020

COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19

The scope of the existing EUA was broadened to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

Press Release / Public Statement Drugs
08/28/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA approves an abbreviated new drug application for sedated and ventilated patients during the COVID-19 public health emergency.

Daily Roundup Drugs
08/27/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA issues a new warning as alcohol-based hand sanitizers are being packaged to appear as food or drink, putting consumers at risk.

Daily Roundup Drugs
Medical Devices
08/27/2020

COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers

FDA is warning consumers about hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.

Press Release / Public Statement Drugs
08/26/2020

COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card

The FDA issued an EUA for the first COVID-19 diagnostic that can be run without an analyzer.

Press Release / Public Statement Medical Devices
08/26/2020

Coronavirus (COVID-19) Update: Daily Roundup

The FDA posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., discussing drug shortages during the COVID-19 pandemic.

Daily Roundup Drugs
08/25/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues new Consumer Update and approves an Abbreviated New Drug Application during COVID-19 pandemic.

Daily Roundup Drugs
08/25/2020

FDA Insight: Drug Shortages and COVID-19

Valerie Jensen, the Associate Director of the Drug Shortages staff in FDA's Center for Drug Evaluation and Research, joins Deputy Commissioner Dr. Anand Shah for a discussion on drug shortages and how the COVID-19 pandemic can impact the drug supply chain.

Podcast / Video Drugs
08/24/2020

Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?

FDA testing uncovered toxic ingredients in some hand sanitizers – find out if your product on the list

Consumer Information
Safety Information
Drugs
08/24/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA provides new webpage with available COVID-19 testing resources.

Daily Roundup Medical Devices
08/23/2020

FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic

Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

Press Release / Public Statement Biologics
08/21/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues new emergency use authorization, plus letter to healthcare providers (HCP) as the COVID-19 public health emergency continues.

Daily Roundup Medical Devices
08/20/2020

FDA Leadership to Accelerate the Recovery from COVID-19

Remarks by Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. to the Alliance for Health Policy

Event Biologics
Drugs
Medical Devices
08/20/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA releases new checklist and guidance as COVID-19 continues to impact drug development programs and the food industry.

Daily Roundup Biologics
Drugs
Medical Devices
08/19/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA provides FAQs on UV lights and lamps for disinfection during the COVID-19 pandemic.

Daily Roundup Medical Devices
08/18/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA provides supporting information on respirators for healthcare providers and manufacturers amid COVID-19 pandemic.

Daily Roundup Medical Devices
08/18/2020

Health Fraud and COVID-19

Dr. Judy McMeekin, the Associate Commissioner for Regulatory Affairs, joins Dr. Shah on the show to discuss FDA's fight against health fraud during the COVID-19 pandemic.

Podcast / Video Biologics
Drugs
Medical Devices
Warning Letters
08/17/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues an emergency use authorization (EUA) for saliva sample COVID-19 diagnostic test.

Daily Roundup Medical Devices
08/15/2020

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing

The FDA issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples.

Press Release / Public Statement Medical Devices
08/14/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA provides device shortage list and issues an updated FDA COVID-19 Response-At-A-Glance-Summary as pandemic evolves.

Daily Roundup Medical Devices
08/13/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues warning about certain hand sanitizer products amid COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
08/12/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on consumer tips, warning letters, emergency use authorizations, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
08/11/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on issuing warning statements and warning letters; issuing Emergency Use Authorizations for tests; posting new FAQ webpages on the registration and listing, and importing of medical devices; and more, in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
07/22/2020

FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities

FDA and Syapse presented Real-World Data at the American Association of Clinical Research (AACR) COVID-19 and Cancer meeting. Findings from study reveal higher risk of hospitalization and death among cancer patients with COVID-19.

Press Release / Public Statement Drugs
07/22/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
07/20/2020

FDA Protects Patients and Consumers from Fraud During COVID-19

The FDA’s consumer protection work is a cornerstone of our mission and a critical component of our pandemic response efforts.

FDA Voices: Leadership Perspectives Drugs
Medical Devices
07/18/2020

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

FDA issued first emergency authorization for sample pooling in COVID-19 diagnostic testing to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test.

Press Release / Public Statement Medical Devices
07/17/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on issuing Emergency Use Authorizations for tests, warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
07/16/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on hand sanitizer recalls, testing-related emergency use authorizations, Industry Hotline closure, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
07/07/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, false positive test results, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
06/24/2020

Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19

U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19.

Press Release / Public Statement Food & Beverages
06/24/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
06/23/2020

FDA Insight Podcast: Fighting COVID-19 at the FDA

In this first episode of a new podcast series, FDA Commissioner Dr. Stephen Hahn, and FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah discuss FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment.

Podcast / Video

Drugs

06/23/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on food safety, the CURE Drug Repurposing Collaboratory, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Medical Devices
06/23/2020

FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic

FDA is currently on target to meet our user fee goals for drugs this year. We have reviewed and taken timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic.

FDA Voices: Leadership Perspectives Drugs
06/23/2020

House Committee on Energy & Commerce Hearing: Oversight of the Trump Administration’s Response to the COVID-19 Pandemic

FDA Commissioner Stephen M. Hahn, M.D., will be testifying for the FDA.
Written testimony

Event Medical Devices
Biologics
Drugs
Food & Beverages
06/23/2020

Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic

The FDA will host the second webinar in the webinar series on the topic of Importing Respirators for Health Care Personnel Use during COVID-19 Pandemic.

Event Imports
Medical Devices
06/22/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters as well as guidance on formal meetings, user-fee applications for medical devices, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
06/19/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions including its At-A-Glance Summary, a public-private partnership fostering innovation in devices and PPE, warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
06/18/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on a web resource listing EUAs, the CURE ID app, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Medical Devices
06/18/2020

FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

The FDA is announcing its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.

Press Release / Public Statement Medical Devices
06/17/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, statistical issues related to clinical trials, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
06/17/2020

Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk

The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.

Press Release / Public Statement Medical Devices
06/16/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on an online portal for adverse event reporting on EUA devices or COVID-19-related guidance and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
06/16/2020

Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling

Today, the FDA posted template updates on the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.

Press Release / Public Statement Medical Devices
06/16/2020

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test

Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.

Press Release / Public Statement Medical Devices
06/15/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on EUAs (hydroxychloroquine, chloroquine), remdesivir drug interaction alert, pet safety, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs

Medical Devices

Animal & Veterinary

06/15/2020

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use

Today, the FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease.

Press Release / Public Statement Drugs
06/15/2020

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Press Release / Public Statement Drugs
06/12/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, an EUA for a point-of-care diagnostic test, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Biologics
Medical Devices
06/11/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on continuing priorities regarding rare diseases, health-fraud warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
06/11/2020

Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19

FDA’s work to advance treatments for rare diseases and helping ensure continuity of care for people with rare diseases remain top priorities during COVID-19.

FDA Voices: Leadership Perspectives Biologics
Drugs
Medical Devices
06/10/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on updates to the CURE ID crowd-sourcing app, an EUA for the first COVID-19 diagnostic test utilizing next-generation gene sequencing, and more in FDA’s ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
06/10/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology.

Press Release / Public Statement Medical Devices
06/01/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA Voices (EUAs), consumer update on regulatory terminology and more on FDA’s ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
06/01/2020

Remarks by Commissioner Stephen Hahn, M.D.—The COVID-19 Pandemic—Finding Solutions, Applying Lessons Learned

Commissioner Hahn speaks to the Alliance for a Stronger FDA

Event Biologics
Drugs
Food & Beverages
Medical Devices
05/29/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on EUAs, warning letters, health fraud, informed consent, clinical trials and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
05/29/2020

Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic

FDA Commissioner Stephen M. Hahn, M.D., on the FDA's role in facilitating treatment options during the public health response to the COVID-19 pandemic.

FDA Voices: Leadership Perspectives Drugs
Biologics
05/29/2020

Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

Find information about the terms used to describe possible COVID-19 preventions or treatments and what they mean.

Consumer Information Drugs
Biologics
05/29/2020

Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

Today, the FDA took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.

Press Release / Public Statement Medical Devices
05/28/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on EUAs, N95 respirators, COVID-19 diagnosis, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
05/27/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on guidance for industry, warning letters, testing updates, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Biologics
Drugs
Food & Beverages
Guidance Documents
Medical Devices
Warning Letters
05/27/2020

Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

FDA provides SARS-CoV-2 reference panel to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.

Press Release / Public Statement Biologics
Medical Devices
05/27/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The FDA will host a virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.

Event Medical Devices
Guidance Documents
05/26/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on antibody testing updates, new abbreviated new drug applications, guidance on medical devices and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Medical Devices
05/22/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on PPE recommendations for the food and agriculture industry, testing updates, warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Biologics
Food & Beverages
Medical Devices
Warning Letters

05/21/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on antibody testing updates, new abbreviated new drug applications, guidance on medical devices and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Tobacco Products
05/21/2020

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

Press Release / Public Statement Medical Devices
05/20/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, MOU with USDA and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Dietary Supplements
Drugs
Food & Beverages
Medical Devices
Warning Letters
05/20/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The purpose of this Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
05/19/2020

USDA, FDA Strengthen U.S. Food Supply Chain Protections

As the COVID-19 pandemic response continues, the USDA and the FDA have been working around the clock on many fronts to support the U.S. food and agriculture sector so that Americans continue to have access to a safe and robust food supply.

Press Release / Public Statement Food & Beverages
05/19/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on diagnostics, succinylcholine chloride injection approval and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
05/19/2020

Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

The FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions.

Press Release / Public Statement Biologics
Drugs
Medical Devices
05/18/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, supply chain update, first standalone at-home sample collection kit EUA and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Medical Devices
Warning Letters
05/16/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests

The FDA has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing.

Press Release / Public Statement Medical Devices
05/15/2020

Consumer Update: Coronavirus Testing Basics

Learn more about the different types of coronavirus tests and what they mean. Print out a PDF version of this information.

Consumer Information Medical Devices
05/11/2020

Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

Today, the FDA took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area.

Press Release / Public Statement Biologics
Drugs
05/11/2020

Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19

During COVID-19, the FDA will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections.

Press Release / Public Statement Inspections
05/11/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the first antigen test, warning letters and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Warning Letters
05/09/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients

The FDA has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic.

Press Release / Public Statement Medical Devices
05/08/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the first at-home saliva test, warning letters and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Medical Devices
Warning Letters
05/08/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.

Press Release / Public Statement Medical Devices
05/07/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on new guidances, warning letters, updated EUAs for non-NIOSH approved respirators manufactured in China and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Animal & Veterinary
Medical Devices
Warning Letters
05/07/2020

Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products

Today, the FDA is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.

Press Release / Public Statement Drugs
Medical Devices
05/06/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on device manufacturing guidance, diagnostics and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
05/05/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, generic drug approvals and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Warning Letters
05/04/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on an updated serology policy, warning letters and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
05/04/2020

Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy

Today, the FDA announced important updates to our March 16, 2020 policy on commercial manufacturers’ serology—or antibody—tests for #COVID19. Under the new policy, FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of the updated policy publication date, or the date they notify FDA of their test validation, whichever is later.

FDA Voices: Leadership Perspectives Medical Devices
05/01/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the remdesivir EUA, convalescent plasma guidance, grocery shopping safety tips and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs
Biologics
Medical Devices
Food & Beverages

05/01/2020

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

FDA has issued emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

Press Release / Public Statement Drugs
04/30/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on new EUAs including an innovative ventilator developed in partnership with NASA, consumer update on pets, drug supply guidance and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Animal & Veterinary
04/30/2020

Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets

Questions and answers to help keep you, your family, and your pets safe during the pandemic.

Consumer Information Animal & Veterinary
04/30/2020

Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization

The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19.

Press Release / Public Statement Medical Devices
04/30/2020

Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency

FDA will discuss the challenges of, and guidance for, supporting clinical trials during the COVID-19 public health emergency. Note: This webinar is now full, but the recording of the webinar will be available shortly after the webinar concludes.

Event Drugs
04/30/2020

Remarks by FDA Commissioner Stephen M. Hahn, M.D., to the 2020 MDMA Annual Meeting

Event Medical Devices
04/29/2020

Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic

The newly updated Nutrition Facts Label can help you and your family eat healthy when daily routines change.

Consumer Information Food & Beverages
04/29/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on nutrition consumer updates, accelerated approval of new dosing for cancer regimens, EUAs on serology validation and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Food & Beverages
04/28/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, video resources on EUAs and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Tobacco Products
Warning Letters
04/27/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on hand sanitizer safety information, food production fact sheets and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Food & Beverages
04/27/2020

Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

Today, the FDA provided an update on its efforts to ensure the availability of alcohol-based sanitizer to help meet the demand for hand sanitizer during the COVID-19 pandemic.

Press Release / Public Statement Drugs
04/24/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on drug safety confirmation, warning letters and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
Drugs
Warning Letters
04/24/2020

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

FDA is reiterating the importance of close patient supervision for ‘off-label’ use of antimalarial drugs to mitigate known risks, including heart rhythm problems.

Press Release / Public Statement Drugs
04/23/2020

CTTI Webinar: Designing High-Quality COVID-19 Treatment Trials

FDA participated in a discussion of the current landscape of COVID-19 treatment trial designs and best practices for quickly launching trials that ensure both patient safety and reliable results.

Event Drugs
04/23/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on new guidances, Spanish resources for grocery shopping and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Medical Devices
Food & Beverages
Guidance Documents
04/23/2020

Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19

As a result of the COVID-19 pandemic, FDA requested and was granted by the court, a 120-day extension of the May 12 deadline for premarket applications for e-cigarettes, cigars and other new tobacco products. These premarket applications are now required to be filed by Sept. 9, 2020.

Press Release / Public Statement Tobacco Products
04/22/2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The purpose of this virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Event Medical Devices
Guidance Documents
04/22/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on remote monitoring EUAs, warning letters on fraudulent products and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Warning Letters
Guidance Documents
04/21/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the first diagnostic test with an at-home sample collection options, food supply and safety information and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Food & Beverages
Medical Devices
04/21/2020

FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19

The FDA is working closely with the food industry and USDA to provide flexibility regarding federal food labeling so consumers have access to the food they want.

FDA Voices: Leadership Perspectives Food & Beverages
04/21/2020

Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

The FDA authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

Press Release / Public Statement Medical Devices
04/20/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on recent agency guidance, the Coronavirus Treatment Acceleration Program, new EUAs for face masks and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Biologics
Medical Devices
Guidance Documents
04/20/2020

The Path Forward: Coronavirus Treatment Acceleration Program

The FDA has launched a new program called the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful.

FDA Voices: Leadership Perspectives

Drugs
Biologics

04/18/2020

Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts

Given the active dialogue about serological tests that are currently on the market, and their significance in the nation’s response efforts, we’d like to provide further details about our thinking on these tests and our approach to making accurate and reliable serology tests widely available, while also protecting Americans from tests marketed with false or unsubstantiated claims.

Press Release / Public Statement
Safety Information
Medical Devices
04/17/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on vaccine public-private partnerships, warning letters, EUAs and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Biologics
Medical Devices
Warning Letters
04/17/2020

Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

A federal court has entered a temporary injunction requiring Genesis to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases.

Press Release / Public Statement Drugs
04/17/2020

NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options

The FDA will participate in the ACTIV partnership aimed at developing a collaborative framework among all partners to rapidly respond to COVID-19 and future pandemics.

Press Release / Public Statement

Biologics
Drugs
Medical Devices

04/16/2020

Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

The FDA announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.

Press Release / Public Statement Medical Devices
04/16/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on guidances, warning letters, food safety resources, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Biologics
Medical Devices
Animal & Veterinary
Food & Beverages
Guidance Documents
Warning Letters
04/16/2020

Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19

The FDA’s User Fee programs help us fulfill our mission to protect public health while also helping to accelerate innovation in industry and bring new treatment options to the American public.

Press Release / Public Statement Drugs
Biologics
Medical Devices
Animal & Veterinary
04/16/2020

Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

The FDA is providing an update on one potential treatment called convalescent plasma and encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease.

Press Release / Public Statement Biologics
04/15/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on new serology EUAs, warning letters, consumer resources and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Guidance Documents
Warning Letters
04/15/2020 Remarks by FDA Commissioner Stephen M. Hahn, M.D., to the 2020 Rx Drug Abuse and Heroin Summit Event

Drugs
Biologics
Medical Devices

04/14/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on warning letters, updated consumer information on testing, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Warning Letters
04/13/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on product-specific guidances, news EUAs, hand sanitizer information and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Medical Devices
Guidance Documents
04/12/2020

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators

The FDA issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings.

Press Release / Public Statement Medical Devices
04/10/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on new EUAs for blood purification devices and PPE decontamination, warning letters and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs
Biologics
Medical Devices
Guidance Documents
Warning Letters

04/10/2020

A Perspective on the FDA’s COVID-19 Response

The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.

FDA Voices: Leadership Perspectives Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
04/10/2020

Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators

The FDA issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

Press Release / Public Statement Medical Devices
04/10/2020

Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19

The FDA issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

Press Release / Public Statement Medical Devices
Biologics
04/09/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on guidance for portable cryogenic containers during this public health emergency, warning letters, best practices for retail food stores, restaurants, and pickup and delivery services, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Biologics
Food & Beverages
Medical Devices
Guidance Documents
Warning Letters
04/08/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on recommendations on the administration and study of convalescent plasma, warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup Drugs
Biologics
Medical Devices
Warning Letters
04/08/2020

Coronavirus (COVID-19) Update: FDA Warns Company Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19

The FDA has issued a warning letter to a company that markets fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19).

Press Release / Public Statement Drugs
Warning Letters
04/07/2020

Coronavirus (COVID-19) Update: Serological Tests

Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19.

Press Release / Public Statement Medical Devices
04/07/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues new guidance documents for remote ophthalmic assessment and monitoring devices, ECMO and cardiopulmonary bypass devices, temporary policy regarding enforcement of the Egg Safety Rule, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Medical Devices
Food & Beverages
Drugs
Guidance Documents

04/06/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues new guidance on clinical electronic thermometers and infusion pumps and accessories and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Medical Devices
Guidance Documents

04/06/2020

Webinar: Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance

On April 6, 2020, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19.

Event Medical Devices
Guidance Documents
04/03/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on convalescent plasma, a new EUA for non-NIOSH-approved respirators made in China, flexibility regarding the packaging and labeling of shell eggs, and more in its ongoing response to the COVID-19 pandemic

Daily Roundup

Biologics
Medical Devices
Animal & Veterinary
Food & Beverages
Guidance Documents

04/03/2020

Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

The FDA is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus.

Press Release / Public Statement

Biologics

04/02/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on blood donor eligibility, authorizing the first serology test to date, informing the public on food safety and the food supply, and more in its ongoing response to the COVID-19 pandemic

Daily Roundup

Biologics
Food & Beverages
Drugs
Medical Devices
Guidance Documents
Warning Letters

04/02/2020

FDA Commissioned Corps Officers on the Front Line of COVID-19 Response

Almost 400 FDA Commissioned Corps officers have been deployed to aid in response to the coronavirus public health emergency.

FDA Voices: Leadership Perspectives  
04/02/2020

Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic

The FDA issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.

Press Release / Public Statement Biologics
Guidance Documents
04/01/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data, temporary flexibility to chain restaurants and similar retail food establishments, warning letters, and more in its ongoing response to the COVID-19 pandemic

Daily Roundup

Medical Devices
Food & Beverages
Drugs
Guidance Documents

03/31/2020

FDA: Food Access and COVID-19

Food availability and food safety are vitally important to our well-being, and the FDA is working hard to help ensure the foods you, your family, and your pets eat are safe and available during the COVID-19 pandemic.

Video Length: 1:20

Safety Information Food & Beverages
03/31/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the Coronavirus Treatment Acceleration Program, shortages of hydroxychloroquine and chloroquine, warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs
Medical Devices
Warning Letters

03/31/2020

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

The FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

Press Release / Public Statement Drugs
Biologics
03/30/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on hydroxychloroquine sulfate and chloroquine phosphate products, N95 respirators, surgical apparel for health care professionals, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs
Medical Devices
Guidance Documents
Warning Letters

03/30/2020

Virtual Town Hall Series – Topic: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

On April 1, 2020, the FDA will host the first of a series of virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.

Event Medical Devices
Guidance Documents
03/30/2020

Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19

The FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.

Press Release / Public Statement Medical Devices
03/30/2020

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation

The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.

Press Release / Public Statement Drugs
03/28/2020

Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products

The FDA is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response.

Press Release / Public Statement

Medical Devices
Drugs
Biologics
Animal & Veterinary
Food & Beverages
Imports

03/27/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic

Daily Roundup

Drugs
Biologics
Food & Beverages
Medical Devices
Guidance Documents

03/27/2020

Food Safety and Availability During the Coronavirus Pandemic

There is no evidence of food or food packaging being associated with transmission of the coronavirus. Currently there are no food shortages nationwide, although certain foods may be temporarily out of stock.

Safety Information Food & Beverages
03/27/2020

Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients

The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19.

Press Release / Public Statement Medical Devices
03/27/2020

Safely Using Hand Sanitizer

You can help stop the spread of COVID-19 by washing your hands with soap and water; if soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.

Consumer Information Drugs
03/26/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup

Food & Beverages
Drugs
Medical Devices
Guidance Documents

03/25/2020

FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 Response Public-Private Partnership

The FDA entered a Memorandum of Understanding (MOU) with the VA Innovation Ecosystem and the NIH 3D Print Exchange, to share data and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes to provide resources that will connect health care providers and 3D printing organizations.

Safety Information Medical Devices
03/25/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs
Medical Devices
Guidance Documents

03/24/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup

Biologics
Drugs
Medical Devices
Animal & Veterinary
Food & Beverages

03/24/2020

FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19

The U.S. food supply remains safe for both people and animals during the COVID-19 pandemic.

FDA Voices: Leadership Perspectives Animal & Veterinary, Food & Beverages
03/24/2020

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.

Press Release / Public Statement Medical Devices
Imports
03/24/2020

Investigational COVID-19 Convalescent Plasma - Emergency INDs

Information for healthcare providers about convalescent plasma—plasma collected from the blood of fully recovered COVID-19 patients and given as treatment to very ill COVID-19 patients.

Safety Information Biologics
03/24/2020

Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic

The FDA announced today that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.

Press Release / Public Statement Animal & Veterinary
03/23/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup

Drugs
Medical Devices

03/23/2020

FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development

FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines.

FDA Voices: Leadership Perspectives Biologics
03/22/2020

Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

The FDA issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

Press Release / Public Statement Drugs
03/22/2020

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

The FDA took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.

Press Release / Public Statement Medical Devices
03/21/2020

Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

The FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

Press Release / Public Statement Medical Devices
03/20/2020

Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The FDA is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

Press Release / Public Statement Medical Devices
Warning Letters
03/20/2020

Preguntas más frecuentes acerca de la Enfermedad del Coronavirus 2019 (COVID-19)

Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions are now available in Spanish.

Safety Information
Consumer Information
 
03/20/2020

Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

The FDA issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

Press Release / Public Statement Medical Devices
03/20/2020

Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health

As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Press Release / Public Statement Drugs
Guidance Documents
03/19/2020

DHS Issues Guidance on the Essential Critical Infrastructure Workforce

The Department of Homeland Security (DHS)/Cybersecurity & Infrastructure Agency (CISA) issued new guidance to support state, local, and industry partners in identifying the critical infrastructure sectors and the essential workers needed to maintain the services and functions Americans depend on daily and need to be able to operate resiliently during the COVID-19 pandemic response. This includes essential workers in the food, health care, and public health sectors, including FDA-regulated industries.

Safety Information Food & Beverages
Biologics
Drugs
Medical Devices
03/19/2020

FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19

At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.

Safety Information Drugs
03/19/2020

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

Press Release / Public Statement Biologics
Drugs
03/19/2020

Coronavirus (COVID-19) Update: Blood Donations

The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year. At this time the number of blood donations has been dramatically reduced due to the implementation of social distancing and the cancellation of blood drives. In order to ensure that blood is available to those who need it most, it is important for healthy individuals who are able to donate to take the time to do so.

Press Release / Public Statement Biologics
03/18/2020

Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

For the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.

Press Release / Public Statement Inspections
03/07/2020

Coronavirus (COVID-19) Update: White House Press Briefing by FDA Commissioner Stephen M. Hahn, M.D.

Event Medical Devices
03/02/2020

Webinar: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The FDA hosted a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance.

Event Medical Devices
Guidance Documents
03/02/2020

Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel

In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

Press Release / Public Statement Medical Devices
02/29/2020

Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

Press Release / Public Statement Medical Devices
Guidance Documents
02/27/2020

Coronavirus (COVID-19) Supply Chain Update

FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.

Press Release / Public Statement Animal & Veterinary
Biologics
Drugs
Food & Beverages
Medical Devices
02/24/2020

Coronavirus Update: FDA steps to ensure quality of foreign products

FDA continues to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity.

Press Release / Public Statement Imports
02/14/2020

FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

Press Release / Public Statement Medical Devices
Drugs
Biologics
Inspections
Imports
02/11/2020

The World Health Organization announced an official name for the disease that is causing the current outbreak of coronavirus disease, COVID-19. FDA's website has been updated to reflect the updated name.

Press Release / Public Statement  
02/05/2020

CDC Media Telebriefing: Update on 2019 Novel Coronavirus (COVID-19), including updates from FDA Chief Scientist RADM Denise Hinton.

Press Release / Public Statement  
02/04/2020

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic

FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

Press Release / Public Statement Medical Devices
01/30/2020

The HHS Assistant Secretary for Preparedness and Response (ASPR) hosted a stakeholder listening session (transcript PDF) to discuss medical countermeasure challenges associated with 2019-nCoV outbreak. FDA Acting Assistant Commissioner for Counterterrorism Policy Michael Mair provided FDA remarks.

Press Release / Public Statement Medical Devices
01/27/2020

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

“We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”

Press Release / Public Statement Medical Devices

Emergency Use Authorizations and Guidances

Emergency Use Authorizations (EUAs)

Expedited authorization of medical products to address public health emergencies.

Guidance Documents and Policies

Policies and guidances to support rapid response to COVID-19.

Frequently Asked Questions (FAQs)

English

Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

Español

Preguntas frecuentes sobre la Enfermedad del Coronavirus 2019 (COVID-19)

 

COVID-19 Information About FDA Regulated Products

Learn more about how FDA is facilitating the development and availability of medical countermeasures and protecting the public health.

Contact FDA

 

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