December 26, 2018
Spotlight on Science is a quarterly science and research digest from the FDA Center for Tobacco Products.
Note: The contents of publications discussed in this newsletter are the responsibility of their authors alone, and findings and conclusions are those of the authors and do not necessarily represent the views of FDA.
In this issue:
As FDA continues to pursue regulatory steps to protect the public from tobacco-related disease and death, continued rigorous research helps inform agency decision-making by adding to the science evidence base and improving the understanding of tobacco products, how they cause death and disease, and how to best reduce the harm from these products. The recently released 2018 National Youth Tobacco Survey (NYTS) data—which point to a troubling spike in youth use of e-cigarettes in the past year—helped spur some of the agency’s strongest steps yet to protect kids from tobacco’s harms and exemplifies how scientific data can help inform the agency’s priorities and actions.
Read about this pivotal report, as well as other science-based advances with the potential to inform FDA’s decision-making toward reducing disease and death from tobacco.
- NYTS Shows Spike in Youth E-Cig Use, FDA Plans Additional Forceful Prevention Steps
- FDA to Seek Public Input on Eliminating Youth E-Cigarette Use and the Role for Drug Therapies
- TPSAC Meeting on Smokeless Tobacco Product MRTP Applications: Feb. 6-7
- FDA Tobacco Regulatory Science Fellowship: Call for Applications
- Federally Funded TCORS Awards Announced
- CTP Research
- PATH Study Update
- Spotlight on a Study: 2017 National Health Interview Survey
- Study Snapshot: Research Examines Tobacco Product Toxicant Exposure
- Additional Recent Publications by CTP Researchers
- Funding Opportunities to Explore
Findings from the 2018 National Youth Tobacco Survey that were released in November by FDA and the Centers for Disease Control and Prevention (CDC) show that from 2017 to 2018 there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million—1.5 million more than in the previous year. The findings were reported in “Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students—United States, 2011–2018,” in the November 16, 2018, issue of the Morbidity and Mortality Weekly Report (MMWR).
This startling surge has caused FDA to announce an updated policy framework that includes plans for the strongest steps yet to confront youth e-cigarette use. The steps, as announced in a Nov. 15 statement by FDA Commissioner Scott Gottlieb, M.D., focus on the areas of appeal and access, which appear to be at the core of the increase in youth e-cigarette use.
Proposed changes to reduce youth appeal and access would affect tobacco product categories including flavored ENDS products (other than those with tobacco, mint, or menthol flavors) that are not sold in an age-restricted, in-person location. FDA is revisiting the compliance policy on premarket tobacco application (PMTA) authorization for such flavored products sold in physical locations where people under the age of 18 are permitted.
Proposed changes, as described further in the commissioner’s Nov. 15 statement, would also affect:
- Flavored ENDS products (other than those with tobacco, mint, or menthol flavors) that are sold online without heightened age verification processes;
- Flavored cigars;
- ENDS products that are marketed to kids; and
- Menthol-flavored combustible tobacco products, including cigarettes and cigars.
FDA intends to issue additional information soon about these steps. As the agency’s tobacco regulatory efforts in these and other areas continue, we invite you to stay up-to-date by visiting the agency’s webpage dedicated to the Comprehensive Plan for Tobacco and Nicotine Regulation, including the Youth Tobacco Prevention Plan page highlighting FDA’s intensive efforts under the plan to prevent youth use of, and access to, e-cigarettes and other tobacco products. And, for more on rates of youth e-cigarette use in the period 2011–2018, read the recent MMWR report.
FDA is announcing a public hearing to discuss the effort to eliminate youth e-cigarette use as well as other tobacco product use, with a focus on the potential role of drug therapies to support cessation and the issues impacting the development of such therapies. The meeting will be held at FDA’s White Oak Campus in Silver Spring, Maryland, on a new date of Jan. 18, 2019. The date for submitting comments to the public docket has been extended to Feb. 1, 2019.
A Tobacco Products Scientific Advisory Committee (TPSAC) meeting is planned to discuss scientific issues related to an amendment from Swedish Match North America, Inc. (SMNA) on its modified risk tobacco product (MRTP) applications for eight General Snus products. TPSAC members will also discuss the MRTP application submitted by U.S. Smokeless Tobacco Company (USSTC) for Copenhagen Snuff Fine Cut tobacco product, which is currently under scientific review by FDA.
FDA has issued a Federal Register notice about the meeting, which is scheduled for Feb. 6-7, 2019, at the agency’s White Oak campus.
During this meeting, TPSAC members will hear presentations from SMNA and FDA about the company’s recent amendment to its MRTP applications for eight General Snus smokeless tobacco products, which FDA previously acted on in December 2016. Also, representatives from Altria (parent company to USSTC) and CTP’s Office of Science will present information about the company’s MRTP application currently under FDA scientific review. In addition, TPSAC members may then discuss available scientific evidence related to issues and questions posed by FDA about the SMNA amendment and USSTC application. During this discussion, TPSAC voting members may vote on specific issues and questions or other topics arising during the committee’s discussion.
On FDA’s website, you can find additional meeting materials and other information as they become available.
Upcoming Call for Applications: Jan. 3–March 1, 2019
Are you interested in helping to shape the future of tobacco regulation, or do you know someone who is? Then consider the Tobacco Regulatory Science Fellowship, a collaborative program between CTP and the National Academy of Medicine (NAM). Since 2012, this 12-month multidisciplinary program has provided opportunities for professionals from different disciplines to gain experience in developing regulatory science relating to tobacco products and FDA’s authorities under the Family Smoking Prevention and Tobacco Control Act.
The next call for applications opens on Jan. 3, 2019 and closes at 3:00 p.m. ET on March 1, 2019. Candidate webinars are scheduled for Jan. 22 and Feb. 7.
Fellows are placed in various areas within CTP, including compliance and enforcement; health communication and education; administrative management; regulations; or science. Over the course of a year, fellows help lead defined projects, actively participate in the development of science-based public health strategies, and meet with policy leaders. The fellowship culminates with a formal presentation to CTP leadership about project outcomes and lessons learned. Each year, fellows are selected through a national competition based on professional achievements, expertise in an area of relevance to the center, and the quality of submitted essays and letters of recommendation. If selected as a finalist, each applicant must participate in an in-person interview in Washington, DC, on April 23, 2019.
On the FDA Tobacco Regulatory Science Fellowship website, you can join the mailing list, learn about important deadlines, and more. Inquiries should be directed to NAM at 202.334.1506 or firstname.lastname@example.org.
FDA and NIH, as part of an ongoing interagency partnership, awarded nine Tobacco Centers of Regulatory Science (TCORS) grants in September 2018. The TCORS program represents a significant investment in research designed to inform CTP’s mission to protect public health through tobacco product regulation.
The following organizations and investigators are recipients of TCORS awards for fiscal years 2018–2022:
- Thomas E. Eissenberg, Ph.D., and Alison Breland, Ph.D., Virginia Commonwealth University, Richmond
- Stanton A. Glantz, Ph.D., University of California-San Francisco
- Stephen T. Higgins, Ph.D., University of Vermont and State Agriculture College, Burlington
- Suchitra Krishnan-Sarin, Ph.D., and Stephanie S. O’Malley, Ph.D., Yale University, New Haven
- Rafael Meza, Ph.D., and David T. Levy, Ph.D., University of Michigan, Ann Arbor
- Richard J. O’Connor, Ph.D., and Maciej Goniewicz, Ph.D., PharmD., Roswell Park Cancer Institute Corporation, Buffalo
- Mary Ann Pentz, Ph.D., and Adam M. Leventhal, Ph.D., University of Southern California, Los Angeles
- Rose M. Robertson, M.D., and Aruni Bhatnagar, Ph.D., American Heart Association, Dallas
- Andrew A. Strasser, Ph.D., and Cristine Delnevo, Ph.D., University of Pennsylvania, Philadelphia
More information, including a list of the scientific domains that are the focus of TCORS 2.0, is available on CTP’s website.
PATH Study Update
Wave 3 public use files and additional information related to the Wave 1 Biomarkers of Potential Harm restricted use files are now available from the Population Assessment of Tobacco and Health (PATH) Study, a research collaboration between NIH’s National Institute on Drug Abuse and CTP to inform FDA’s tobacco regulatory activities.
Wave 3 Public Use Files
Public-use questionnaire data files (PUFs) from the PATH Study’s Wave 3 (collected from October 2015 to October 2016) may now be downloaded from the National Addiction & HIV Data Archive Program of the Inter-university Consortium for Political and Social Research (ICPSR).
Wave 1 Biomarker Restricted Use File: Additional Data
Data and documentation for five Wave 1 Biomarkers of Potential Harm assay panels have been added to the PATH Study Biomarker Restricted-Use Files (BRUF):
- F2PG2a: oxidative stress biomarker (8-isoprostane)
- hsCRP: high-sensitivity C-reactive protein
- IL6: interleukin 6
- sICAM: soluble Intercellular Adhesion Molecule 1
- Fibro: fibrinogen activity (Clauss)
Spotlight on a Study: 2017 National Health Interview Survey
Cigarette smoking among U.S. adults has dropped to the lowest level ever recorded, according to the 2017 National Health Interview Survey (NHIS) results published in the Nov. 9 issue of Morbidity and Mortality Weekly Report (MMWR). But, according to these data from the Centers for Disease Control and Prevention (CDC), FDA, and NIH’s National Cancer Institute, about 47 million U.S. adults—that’s one of every five—currently used tobacco products such as cigarettes, cigars, e-cigarettes, and smokeless tobacco in 2017.
This survey, which examines the range and extent of tobacco product use among U.S. adults, found that an estimated 14 percent of U.S. adults were current (every day or some days) cigarette smokers in 2017—down from 15.5 percent in 2016 and from 43 percent in 1965 when the survey of cigarette use began.
Full implementation of comprehensive national, state, and local tobacco control programs can contribute to reductions in tobacco-related death and disease in the United States, according to a CDC press release about the 2017 survey. The release cited FDA’s “Every Try Counts” campaign as among the promising efforts toward reducing harms from tobacco. “The continued drop in adult smoking rates to historic lows is encouraging,” stated FDA Commissioner Scott Gottlieb, M.D., “and the FDA is committed to accelerating declines in smoking and shifting the trajectory of tobacco-related disease and death through our comprehensive approach to tobacco and nicotine regulation.”
You can read more about the findings, including information about tobacco use disparities and which subgroups were found to have the highest rates of tobacco product use, in the MMWR article, “Tobacco Product Use Among Adults–United States, 2017.”
Study Snapshot: Research Examines Tobacco Product Toxicant Exposure
PATH Study Looks at Tobacco Users’ Nicotine, Toxicant Exposure
A scientific article published Dec. 14 in the journal JAMA Network Open compared concentrations of potentially harmful tobacco constituents in more than 5,000 adults who used cigarettes only, e-cigarettes only, both e-cigarettes and combustible cigarettes, or never used tobacco. The data for this article were collected in 2013-2014 from adults participating in the federally funded PATH Study.
Researchers found that those who used e-cigarettes alone had significantly greater concentrations of biomarkers of nicotine, tobacco-specific nitrosamines, volatile organic compounds, and metals compared to those who never used tobacco. Toxicant exposure in the study was greatest among dual users of e-cigarettes and combustible cigarettes, and exclusive combusted cigarette use was also associated with higher concentrations of potentially harmful tobacco constituents than use of e-cigarettes alone.
For more about the research findings, read the complete journal article.
Additional Recent Publications by CTP Researchers
- Frequency of use among middle and high school student tobacco product users — United States, 2015–2017. Morb Mortal Wkly Rep 2018 Dec 14;67(49): 1353-57
- U.S. adult perceptions of the harmfulness of tobacco products: descriptive findings from the 2013-14 baseline wave 1 of the path study. Addict Behav 2018 Nov 17 [Epub ahead of print]
- Associations of risk factors of e-cigarette and cigarette use and susceptibility to use among baseline PATH study youth participants (2013-2014). Addict Behav 2018 Nov 17 [Epub ahead of print]
- Correlates of transitions in tobacco product use by U.S. adult tobacco users between 2013-2014 and 2014-2015: findings from the PATH study wave 1 and wave 2. Int J Environ Res Public Health 2018 Nov 14;15(11):2556
- Negative affect, message reactance and perceived risk: how do pictorial cigarette pack warnings change quit intentions? Tob Control 2018 Oct;27(e2):e136-42
- Global evidence on the effect of point-of-sale display bans on smoking prevalence. Tob Control 2018 Jan 13 [Epub ahead of print]
- Transitions in tobacco product use by U.S. adults between 2013-2014 and 2014-2015: findings from the PATH study wave 1 and wave 2. Int J Environ Res Public Health 2018 Nov 9;15(11):2515
- Youth access to tobacco products in the United States: findings from Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health (PATH) study. Nicotine Tob Res 2018 Nov 8 [Epub ahead of print]
- Accuracy of commercial electronic nicotine delivery systems (ENDS) temperature control technology. PLoS One 2018 Nov 5;13(11):e0206937
- Smokeless tobacco use and circulatory disease risk: a systematic review and meta-analysis. Open Heart 2018 Oct 8;5(2):e000846
- Tobacco-related poison events involving young children in the US, 2001-2016. Tob Regul Sci 2017 Oct;3(4):525-35
- Compliance with a sales policy on flavored non-cigarette tobacco products. Tob Regul Sci 2017 Apr;3(2 Suppl 1):S84-93
- The association between perceived e-cigarette and nicotine addictiveness, information-seeking, and e-cigarette trial among U.S. adults. Prev Med 2019 Jan;118:66-72
- The future of nicotine regulation: key questions and challenges. Nicotine Tob Res 2018 Oct 12 [Epub ahead of print]
- Developing smokeless tobacco prevention messaging for at-risk youth: early lessons from "The Real Cost" smokeless campaign. Health Equity 2018 Aug 1;2(1):167-73
- Notes from the field: inspection of 59 "vape shops"--United States, October-November, 2016. MMWR Morb Mortal Wkly Rep 2018 Aug 31;67(34):964-5
- Item development and performance of tobacco product and regulation perception items for the Health Information National Trends Survey. Nicotine Tob Res 2018 Sep 15 [Epub ahead of print]
- Evaluating mode of action of acrolein toxicity in an in vitro human airway tissue model. Toxicol Sci 2018 Dec 1;166(2):451-64
- Mobile website characteristics of leading tobacco product brands: cigarettes, smokeless tobacco, e-cigarettes, hookah and cigars. Tob Control 2018 Aug 30 [Epub ahead of print]
Featured below are some current CTP funding opportunities. You can find more information by clicking on the appropriate funding opportunity announcement (FOA) number.
Scientific Conference Grant Program
The Scientific Conference Grant Program recognizes the value of small, high-quality conferences and scientific meetings that are relevant to FDA’s mission and to public health.
R13—Support for Conferences and Scientific Meetings
FOA Number: PAR-16-378
Next Application Due Date: April 12, 2019
Letter of Intent Due Date: Eight weeks before application due date
Tobacco Regulatory Science
The Tobacco Regulatory Science Program, FDA’s partnership with NIH to foster tobacco regulatory research, offers funding for scientists whose research can inform CTP’s regulatory activities.
R01—Tobacco Regulatory Science Research Project Grant
FOA Number: RFA-OD-18-002
Next Application Due Date: Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date
R21—Tobacco Regulatory Science Exploratory/Developmental Research Grant
FOA Number:- RFA-OD-18-003
Next Application Due Date: Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date
R03—Tobacco Regulatory Science Small Grant Program for New Investigators
FOA Number: RFA-OD-18-001
Next Application Due Date: February 13, 2019
Letter of Intent Due Date: 60 days before application due date