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Spotlight on Science - Winter 2021

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In This Issue…

According to results from the latest National Youth Tobacco Survey (NYTS), 1.73 million fewer middle and high school students are using tobacco products in 2020 compared to 2019. Learn more in this latest issue of Spotlight on Science, a quarterly research and science digest from FDA’s Center for Tobacco Products (CTP).

Youth Overall Tobacco Use and ENDS Use Both Declined in 2020

FDA and the Centers for Disease Control and Prevention (CDC) released findings on youth overall tobacco use from the 2020 National Youth Tobacco Survey (NYTS), which show 1.73 million fewer middle and high school students are using tobacco products in 2020 compared to 2019. A decrease in youth use of e-cigarettes (1.80 million) accounted for a large portion of the decline in overall youth tobacco use, although the number of current e-cigarette users remains disconcertingly high (3.58 million). Additionally, from 2019 to 2020, teen use of combustible tobacco products, multiple tobacco products, cigars, and smokeless tobacco decreased significantly.

Despite the declines in youth use of combustible tobacco products, there was no change in teen cigarette smoking from 2019 to 2020. Nor was there a change in youth use of hookah, pipe tobacco, or heated tobacco products from 2019 to 2020. Furthermore, rates of combustible tobacco use remain concerningly high: among youth who use any tobacco product in 2020, about 42 percent smoke combustible products. The data also show an alarming surge in the number of youth who use disposable e-cigarettes and flavored products.

FDA and CDC published detailed information on the 2020 NYTS in a December 2020 article on youth overall tobacco use and a September 2020 article on youth e-cigarette use. FDA has published a web feature on youth tobacco use and an infographic on youth e-cigarette use to promote these findings further.

Current Use of Select Tobacco Products Among High School Students 2019 and 2020


Though FDA is encouraged by the declines in overall tobacco product use from 2019 to 2020, it remains very concerned about the 24 percent of high schoolers and 7 percent of middle schoolers who currently use tobacco products. Notably, 3.58 million youth currently using e-cigarettes is still far too many.

Teen e-cigarette use has increased alarmingly in the United States in recent years. Though only a small percentage of teens used e-cigarettes in 2011, 28 percent of high school students and 11 percent of middle school students used e-cigarettes by 2019. In 2020, these numbers declined to about 20 percent of high schoolers and 5 percent of middle schoolers currently using e-cigarettes. While this is progress from last year, youth use of e-cigarettes remains a public health issue that is affecting children, families, schools and communities.

National Youth Tobacco Survey Current E-cig Use


Read More

FDA Issues Marketing Order for IQOS 3 System Holder and Charger 

On Dec. 7, FDA issued a marketing order to Philip Morris Products S.A. authorizing the sale of the IQOS 3 System Holder and Charger. Compared to the previous version authorized in April 2019, the newly authorized version has minor design differences, including how the holder inserts into the charger, changes to the charging connectors and LED indicator lights, a new touch feedback feature, and an option to reduce the perceived heat from the tobacco aerosol inhaled by users.

Data on product use in international markets suggest no differences among user populations from the previous version of the device holder and charger, including no new concerns regarding product initiation or use among youth and young adults. Following FDA’s scientific review of the application, the agency found, among other things, that the modifications to the device do not raise new concerns related to safety, health effects, product quality, or product misuse.

Importantly, this action does not mean this product is safe or “FDA-approved.” There are no safe tobacco products, and those who do not use tobacco products should not start.

The previous version of the IQOS System Holder and Charger was initially allowed for sale in the United States following FDA’s issuance of a marketing order via the premarket tobacco product application (PMTA) pathway in April 2019. The company later submitted another PMTA to FDA in April 2020 requesting authorization to market an updated version of the device holder and charger.

This is the first “supplemental” PMTA received by FDA. Such applications seek authorization to modify a tobacco product that previously received a marketing order via the PMTA pathway. “Supplemental” PMTAs must still contain the information required by section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act, but they may meet these requirements by cross-referencing content from the relevant previously authorized PMTA and by providing new information related to the product modifications.

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, and impact analysis of regulatory actions. 

CTP encourages research studies to include, where appropriate to the research question, populations of special relevance, including (but not limited to): youth, socioeconomically disadvantaged populations, racial/ethnic minorities, underserved rural populations, people with co-morbid mental health conditions and/or substance use disorders, military/veteran populations, pregnant women or women of reproductive age, and sexual and gender minorities.

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: 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: 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 FOA 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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