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On March 10, FDA and CDC published a report based on data from the 2021 National Youth Tobacco Survey (NYTS). The study assessed youth tobacco product use and associated factors and estimated that in 2021, approximately, 2.55 million (9.3%) students reported current (past 30-day) use of a tobacco product: 2.06 million (13.4%) high school students and 470,000 (4.0%) middle school students.
Because of the changes in the way the survey was conducted this year, results of the 2021 NYTS cannot be compared with findings from previous NYTS surveys. Nonetheless, the 2021 NYTS provides crucial information about youth use of tobacco, including factors associated with tobacco use, to inform public health policy and practice and guide regulatory activities.
National Academies Releases Report on Premium Cigars Health Effects
On March 10, the National Academies of Sciences, Engineering, and Medicine (NASEM) published an independent report on the health effects of “premium” cigars. The report was commissioned by FDA and the National Institutes of Health (NIH), and it provides a comprehensive review of the scientific literature on these products.
PATH: Latest Data Files Released
CTP and NIH’s National Institute on Drug Abuse (NIDA) announced the release of new Population Assessment of Tobacco and Health (PATH) Study Biomarker Restricted-Use File (BRUF) data files:
- Wave 5 BRUF on Urinary Nicotine Metabolites (Cotinine and Hydroxycotinine) (UNICM), Metals (Metals), Enzymatic Urinary Creatinine (CREAU) and Volatile Organic Compounds Metabolites (VOCM)
- Wave 3 BRUF: Oxidative Stress (F2PG2a)
Updated versions of several previously released data files are also available now. These include:
- Wave 5 Public-Use File (PUF): Adult & Youth Questionnaire Data
- Wave 5 Restricted-Use File (RUF): Adult & Youth Questionnaire Data
- Wave 4 Biomarker Restricted-Use File (BRUF)
- Wave 1-Wave 4 Biomarker Restricted-Use File (BRUF): Volatile Organic Compounds Metabolites (VOCM)
New Law Clarifies FDA Authority to Regulate Synthetic Nicotine
On March 15, President Biden signed H.R. 2471 – the Consolidated Appropriations Act, 2022. As a result, the Federal Food, Drug, and Cosmetic Act (FD&C Act) now includes specific language that makes clear the U.S. Food and Drug Administration can soon regulate tobacco products containing nicotine from any source, which includes synthetic nicotine. This new provision of the law takes effect on April 14, 2022. Manufacturers of tobacco products containing nicotine not derived from tobacco will soon need to submit a premarket tobacco product application (PMTA) to the FDA and obtain authorization from the Agency to market their product under the FD&C Act as amended by this legislation, or they will be subject to FDA enforcement.
The FDA will provide additional information about the implementation of this new law and the PMTA process for these types of products in the near future.
CTP Director Discusses Upcoming FDA Actions to Address Tobacco-Related Health Disparities
FDA’s Center for Tobacco Products (CTP) Director Mitch Zeller has authored a new FDA Voices blog titled “FDA on Track to Take Actions to Address Tobacco-Related Health Disparities.”
This past April, FDA announced its commitment to advancing two tobacco product standards — one prohibiting menthol as a characterizing flavor in cigarettes and another prohibiting all characterizing flavors (including menthol) in cigars. The product standards aim to reduce tobacco product initiation, increase quitting and promote health equity.
In this new blog, Director Zeller describes how:
- Certain populations have been targeted and disproportionately impacted by tobacco use, especially when it comes to characterizing flavors that entice them to start and keep smoking;
- Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally; and
- These actions to advance these two product standards represent powerful, science-based approaches that will have an extraordinary public health impact.
Webinar on FDA’s Rulemaking Process and Upcoming Tobacco Product Standards
On Thurs., Feb. 10, CTP hosted a webinar on FDA’s plans to advance the two tobacco product standards and how stakeholders can participate in the rulemaking process. The webinar and materials are now available on the FDA website.
Please note: This webinar is not intended to communicate contents of the proposed rules or additional details about the timeline for their release.
CTP’s Tobacco Education Resource Library
CTP’s Exchange Lab is now the FDA Tobacco Education Resource Library (TERL). While the FDA Tobacco Education Resource Library has a new name, it continues to provide the same FREE science-based tobacco education information.
More About CTP Research
Current Funding Opportunities
NIH Tobacco Regulatory Science Program (TRSP) Funding Opportunity Announcements
- Notice of Intent to Publish a Funding Opportunity Announcement for Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54; NOT-OD-22-017)
- Notice of Intent to Publish a Funding Opportunity Announcement for Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54, NOT-OD-22-011)
- Center for Rapid Surveillance of Tobacco (CRST) to Assess Changes in Use Behaviors, Product Marketing, and the Marketplace (U01, RFA-OD-22-002)
- Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21; RFA-OD-21-004)
- Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21; RFA-OD-21-003)
- Tobacco Regulatory Science (R01; RFA-OD-21-002)
- Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01; RFA-OD-20-008 or RFA-OD-20-011)
- Pathway to Independence Award in Tobacco Regulatory Research (K99/R00; RFA-OD-20-009 or RFA-OD-20-010)
FDA-wide Funding Opportunity Announcements
- FDA Support for Conferences and Scientific Meetings (R13; PAR-19-306)
- FY22 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science (contract; FDABAA-22-00123)
Recent Publications by CTP Researchers
This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our CTP Connect newsletter and CTP News e-blasts.
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