In This Issue... FDA has committed to advance two product standards: one to ban menthol as a characterizing flavor in cigarettes and another to ban all characterizing flavors (including menthol) from cigars. Learn more in this latest issue of Spotlight on Science, a quarterly research and science digest from FDA's Center for Tobacco Products (CTP). FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers On April 29, FDA announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products – the leading cause of preventable death in the U.S. FDA is working toward issuing proposed product standards within the next year: one to ban menthol as a characterizing flavor in cigarettes and another to ban all characterizing flavors (including menthol) in cigars. The authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. The decision to advance these product standards is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.  |
The agency is taking urgent action to reduce tobacco addiction and curb deaths. There is strong evidence that a menthol ban will help people quit. Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults. Menthol masks unpleasant flavors and harshness of tobacco products, making them easier to start using. Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine. PATH Study Update: Researchers Encouraged to Access Latest Files, Including Wave 5 Data (2018 – 2019) Researchers can now access five new data sets from the Population Assessment of Tobacco and Health (PATH) Study, including the following: - Wave 5 Restricted-Use File (RUF)
- Wave 5 State Identifier Restricted-Use File (SIRUF)
- Wave 5 Tobacco Universal Product Code Restricted-Use File (TUPCRUF)
- Special Collection Wave 4.5 Youth State Identifier Restricted-Use File (SIRUF)
- Special Collection Wave 4.5 Ever/Never Reference Data File
Instructions for requesting access to the new content along with other PATH Study resources can be found on the PATH Study webpage. Qualified researchers may also apply for access to the updated biomarker data restricted-use files (BRUFs) for Waves 2 and 3, and the Wave 4 BRUF, through the PATH Study Biomarker Restricted-Use Files webpage. To learn more, please view a video that provides an orientation to the study. Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com. Letter to the Editor Highlights Data on Youth Disposable ENDS Use FDA and CDC researchers published a Letter to the Editor of the New England Journal of Medicine. The letter summarizes findings from the latest National Youth Tobacco Survey about youth use of disposable ENDS, including some new findings not previously published in the report on youth e-cigarette use in the Morbidity and Mortality Weekly Report (MMWR). Some highlights from the letter to the editor include: - Among middle school students currently using any type of e-cigarette, disposable e-cigarette use was reported by 3.0 percent (30,000 students) in 2019 and by 15.2 percent (80,000 students) in 2020.
- Among high school students currently using any type of e-cigarettes, disposable e-cigarettes use was reported by 4 percent (90,000 students) in 2019 and 26.5 percent (790,000 students) in 2020.
- Among all middle school students, use of disposable e-cigarettes was reported by 0.3 percent in 2019 and by 0.7 percent in 2020; 0.7 percent and 5.1 percent of all high school students reported disposable cigarette use in 2019 and 2020, respectively.
- Prefilled pods or cartridges remained the most commonly used device type in 2020, as reported by 220,000 middle school students and 1.45 million high school students.
New FDA & AAP Video Series: Pediatricians Discuss Youth E-Cigarette Use FDA and the American Academy of Pediatrics (AAP) collaborated to develop a video series featuring pediatricians answering common questions about youth e-cigarette use. Click below to watch the videos. FDA also created a new webpage that includes tobacco education resources for parents and educators. Parents and teachers can use these resources to learn more and to start an honest conversation with youth about the dangers of tobacco use. Did You Know… … you can request a speaker from CTP's Speakers Bureau, a centralized place to request expert speakers on CTP's regulatory actions and public education initiatives? To request a speaker from CTP's Speakers Bureau, submit the following to CTPSpeakerRequests@fda.hhs.gov: - A completed speaker request form;
- A formal invitation on organization letterhead, and;
- A program agenda with all invited speakers and topics.
For more information, please visit our Speakers Bureau webpage or contact us at CTPSpeakerRequests@fda.hhs.gov. 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. Data Standards for Tobacco Research and Scientific Review Program (U24 Clinical Trial Not Allowed) (RFA-FD-22-002)
Letter of Intent due date: May 1, 2021.
Application due date: June 1, 2021 by 11:59 PM EST. Tobacco Regulatory Science (R01 Clinical Trial Optional) (RFA-OD-21-002) Application due date: July 14, 2021, February 15, 2022, July 14, 2022, and February 14, 2023 by 5:00 p.m. local time of applicant organization. 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. 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. 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. 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. 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. 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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