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Spotlight on Science - Summer 2020

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In This Issue…

FDA authorizes reduced exposure marketing for the IQOS Tobacco Heating System and Tobacco Control publishes a special issue on PATH data. Learn more in this latest issue of Spotlight on Science, a quarterly research and science digest from FDA’s Center for Tobacco Products.

FDA Completes Scientific Review and Authorizes Reduced Exposure Marketing for IQOS Heated Tobacco System

On July 7, 2020, FDA authorized the marketing of “IQOS Tobacco Heating System” products as modified risk tobacco products (MRTPs). This includes the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks. 

FDA previously authorized the marketing of these products in April 2019 via the premarket tobacco application (PMTA) pathway. To limit youth access to the products and to limit youth exposure to IQOS advertising and promotion, the PMTA authorization placed stringent restrictions on how the products are marketed – particularly via websites and through social media platforms – by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.

Person walking on straight with arrow pointing in multiple directions

With this new action, FDA issued exposure modification orders authorizing Philip Morris Products S.A. to use the following information in their advertising and marketing of the products:


  • The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals." 

Even with this action, these products are neither safe nor "FDA approved" as there are no safe tobacco products. The exposure modification orders do not permit the company to make express or implied statements that convey or could mislead consumers into believing that the product is endorsed or approved by FDA, or that FDA deems the product to be safe for use by consumers.

The company must request and receive authorization from FDA to continue marketing the products with the same modified exposure information after the initial order expires in 4 years. FDA also may withdraw the initial and any potential subsequent exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole, for example as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.

More information about modified risk tobacco products (MRTPs), including the application process and a summary of past MRTP application actions, is available on the FDA website.

PATH Study Update: Special Issue of Tobacco Control on Tobacco Transition Behaviors

A special issue of Tobacco Control, titled “Patterns of Tobacco Product Use in the United States: Transitions across Three Waves of the PATH Study (2013-2016),” examines how tobacco product use changes over time, including transitions within and between product types. The issue includes a series of peer-reviewed papers analyzing tobacco product use transitions among U.S. youth, young adults, and adults using data from the Population Assessment of Tobacco and Health (PATH) Study – a collaboration between FDA and the National Institutes of Health (NIH). 

PATH - Population Assessment of Tobacco and Health

The special issue features five articles that focus on transitions among current users of various tobacco products (cigarette, e-cigarette, hookah, cigar, and smokeless). The papers also consider complex transition patterns, including exclusive tobacco product use and the use of two or more tobacco product types (polytobacco use). In addition, the issue includes papers that assess initiation, cessation and relapse for each of the assessed tobacco products.

Tobacco Control is an international peer-reviewed journal covering many aspects of tobacco policy implications. This special issue is a collaboration between FDA, NIDA, CDC, Westat and Roswell Park Comprehensive Cancer Center. The PATH Study is a large, long-term study of tobacco use and health in the United States. About 46,000 people aged 12 years and older, including tobacco users and non-users, are included in the PATH Study.


Researchers Encouraged to Access PATH Data Files 

CTP and the National Institutes of Health (NIH) announce the availability of the second in a series of restricted-use biomarker data files from the third wave of the Population Assessment of Tobacco and Health (PATH) Study. This latest addition to the PATH Study’s Biomarker Restricted-Use Files contains data collected during Wave 3 (October 2015 – October 2016). Qualified researchers may apply for access through the PATH Study Biomarker Restricted-Use Files webpage

In addition to the release of these biomarker restricted-use files, there will be a release of (1) a state design restricted-use file (SDRUF) that includes the state identifier for study participants at the time of selection and recruitment for the PATH Study at Wave 1 or Wave 4; (2) Wave 2 – Wave 4 state identifier restricted-use files (SIRUF) that include variables for linking the state identifier to the questionnaire and biomarker data, and variables designating the state (state FIPS, state abbreviation, and full name of the state); and (3) Wave 1 – Wave 4 tobacco universal product code (UPC) restricted-use files that contain UPC values on the packages of tobacco products used or in the possession of adult respondents, which may be used to identify and validate the specific products used by respondents and augment the analyses of the characteristics of tobacco products used by respondents. Qualified researchers may apply for access to these restricted-use files through the PATH Study Restricted-Use Files webpage.

The complete list of newly released files includes the following:

  • Wave 3 Biomarker Restricted Use Files (BRUF) (Part 2)
  • State Design Data
  • Wave 1: Tobacco Universal Product Code (TUPCRUF) Data
  • Waves 2-4:
    • Tobacco Universal Product Code (TUPCRUF) Data
    • Adult State Identifier Data (SIRUF)
    • Youth/Parent State Identifier Data (SIRUF)


In addition, the Biospecimen Access Program webpage provides information on how to access biospecimens collected from adult PATH Study participants. These include urine, serum, plasma, and genomic DNA collected during Wave 1 and urine collected during Wave 2.

Please also see this current funding opportunity for secondary data analysis.


FDA Shares Resources for Tobacco Product Applications Due Sept. 9, 2020

The deadline for manufacturers and importers to submit tobacco product applications to FDA for deemed new tobacco products on the market as of Aug. 8, 2016 is Sept. 9, 2020. FDA recently launched an informational resource that houses all information related to Submitting Tobacco Product Applications. This webpage compiles information on a variety of topics related to the applications.

FDA has also created a limited email and social media series of “FDA Tobacco Application Tips.” This series highlights application tips that will be helpful to companies preparing to submit their premarket review applications to FDA by Sept. 9 and will conclude at that time. To subscribe to the email, visit Sign Up for Email Updates from CTP and select CTP News. All tweets related to the series are available at @FDATobacco. 


CTP Director’s Op-Ed and Podcast on FDA’s Approach to Youth E-Cigarette Use

On May 6, 2020, CTP Director Mitch Zeller published an editorial in the American Journal of Public Health (AJPH) on FDA’s multifaceted approach to protecting youth from the dangers of e-cigarettes. The article outlines FDA’s January 2020 guidance that it will now prioritize enforcement against these illegally marketed ENDS products: 

  • Any flavored cartridge-based ENDS products (other than tobacco- or menthol-flavored) 
  • All other ENDS products for which a manufacturer fails to take adequate measures to prevent minors’ access 
  • Any ENDS products targeted to minors

The policy is just one of many steps that the FDA is taking to combat youth e-cigarette use. FDA’s multifaceted strategy includes public education, compliance and enforcement, research, and science-based regulation to ensure U.S. youth are protected from the harms of tobacco products.


Director Zeller also spoke to AJPH in a podcast. He described FDA’s approach to strike a careful balance between making flavored tobacco products less accessible to kids and maintaining potentially less harmful options for adult smokers looking to quit cigarettes. Hear directly from Director Zeller as he discusses the ways FDA uses data and research to create science-based regulation and to ensure e-cigarettes are not marketed to, sold to, or used by kids.


More About CTP Research 

Recent Publications by CTP Researchers

For recent research publications, please follow this link.

Research Opportunities to Explore

In support of its mission to develop regulation rooted in science, CTP seeks new research to address key areas of tobacco regulatory science such as: 

  • Toxicity
  • Addiction
  • Health effects
  • Behavior
  • Communications
  • Marketing influences
  • Impact analysis of regulatory actions 

Featured below are some current CTP funding opportunities. You can find more information by clicking on the appropriate funding opportunity announcement (FOA) number. 

More information on CTP-funded research can be found on the center’s website.

NIH Tobacco Regulatory Science Program

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. 

Tobacco Regulatory Science (R01 Clinical Trial Optional)
Application due date: February 13, 2021, by 5:00 PM local time of applicant organization.

The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Notice of Special Interest: Research to Advance the Understanding of Tobacco Product Pharmacokinetic Research (NOT-OD-20-081)
Application due date: February 13, 2021, by 5:00 PM local time of applicant organization.

The purpose of this notice is to invite R01 applications focused on tobacco product pharmacokinetic research to support biomedical and behavioral research that will provide scientific data to inform the regulation of tobacco products to protect public health.

Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed) (RFA-OD-19-021)
Application due dates: August 7, 2020, March 8, 2021, by 5:00 PM local time of applicant organization.

This Funding Opportunity Announcement (FOA) invites R21 applications to stimulate exploratory research relevant to the mission of the FDA Center for Tobacco Products (CTP) using existing (publicly available) biospecimens currently stored in repositories in the United States. This will include, but not be limited to, collections associated with the Population Assessment of Tobacco and Health (PATH) Study, the National Health and Nutrition Examination Survey (NHANES), the National Heart, Lung and Blood Institute’s (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), and the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Proposed research should seek to maximize the scientific value of these stored collections and to provide researchers with an opportunity to generate preliminary data for subsequent research proposals. While other publicly available repositories would be considered, depending on analyses to be conducted, nationally representative analyses will receive priority. These applications need to provide justification why the data set is unique, and the research questions cannot be answered from a publicly available, nationally representative, data set. 

Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed) (RFA-OD-19-022)
Application due dates: March 8, 2021, by 5:00 PM local time of applicant organization.

This Funding Opportunity Announcement (FOA) invites R21 applications proposing the innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data, to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to the FDA Center for Tobacco Products (CTP). Other publicly available data sets would be considered depending on the analyses to be conducted; however, nationally representative analyses will receive priority. Applications not using nationally representative data sets will need to provide justification why the data set is unique, and why the research questions cannot be answered from a (publicly available) nationally representative data set. This FOA encourages the analyses of public use datasets that may inform tobacco regulatory actions in the United States. 

FDA Support for Conferences and Scientific Meetings (R13)
Application due dates: Oct. 13, 2020; April 12, 2021; October 12, 2021; April 12, 2022; and October 11, 2022 by 11:59 p.m. EST. 

FDA recognizes the value of supporting high quality, small scientific conferences. A small scientific conference is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern that impact the public's health within the scope of FDA's mission.

Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01; RFA-OD-20-008 or RFA-OD-20-011)
Application due dates: Feb. 8, 2021, Oct. 8, 2021, and July 8, 2022 by 5:00 p.m. local time of applicant organization.

This award provides support for an intensive, supervised career development experience of three, four, or five protected years in biomedical, behavioral, and social science research. This experience will inform the development and evaluation of tobacco regulation and will foster research independence. Projects must address one of FDA’s research priority areas. 

Pathway to Independence Award in Tobacco Regulatory Research (K99/R00; RFA-OD-20-009 or RFA-OD-20-010)
Application due dates: Feb. 8, 2021, Oct. 8, 2021, and July 8, 2022 by 5:00 p.m. local time of applicant organization.

This FOIA aims to increase and maintain a strong cohort of talented independent investigators conducting research that will inform the development and evaluation of tobacco product regulations. This program is designed to facilitate the timely transition of outstanding postdoctoral researchers from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. This program will provide NIH research support during this transition in order to help awardees launch competitive, independent research careers.

Spotlight on Science is a quarterly science and research digest from FDA’s 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.

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