 Latest News
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
On April 28, FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit all characterizing flavors (other than tobacco) in cigars. The public may provide comments on these proposed rules through July 5.
When submitting a comment, FDA recommends a person state whether they support or oppose the proposed rule and include data, research, or other information that shows why they take that position, identify any part of a proposed rule that may be confusing, or provide suggestions for different wording.
Comments can be submitted online at Regulations.gov or mailed to FDA’s Division of Dockets Management.
PMTA Decisions
FDA continues to make decisions on premarket tobacco product applications (PMTAs), including the following:
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June 10, 2022: Marketing Granted and Denial Orders NJOY LLC (NJOY Daily)
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May 12, 2022: Marketing Granted and Denial Orders R.J. Reynolds Vapor Company (Vuse Vibe, Vuse Ciro)
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April 26, 2022: Marketing Granted and Denial Orders NJOY LLC (NJOY Ace)
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April 8, 2022: Marketing Denial Orders Fontem, US, LLC (myblu)
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March 24, 2022: Marketing Granted and Denial Orders Logic, LLC (Logic Vapeleaf, Logic Pro, Logic Power)
Population Assessment of Tobacco and Health (PATH) Study Updates
Latest Data Files Released
Researchers can now access new and updated data files from the PATH Study:
New data sets:
Updated datasets:
The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Additionally, Restricted Use Files have been updated to include Wave 5 Ever/Never Reference Data, and the Restricted-Use and Public-Use Master Linkage Files (MLFs) have been updated.
PATH Data Tables and Figures
In March, FDA and NIH released the first set of widely available PATH Study online tables and figures that provide information on tobacco use among youth (aged 12-17), young adults (aged 18-24), and adults (aged 25+). These online data tables and figures offer streamlined information about the PATH Study that can only be found by analyzing the data. The online tables and figures include cross-sectional and longitudinal data from Waves 1-5 (2013-2019) of the PATH Study.
The content, which is available for public use, may be accessed from the FDA PATH Study webpage along with important information about the analytic methods used to generate the tables and figures and other PATH Study resources.
New Law Clarifies FDA Authority to Regulate Synthetic Nicotine
New legislation enacted on March 15, makes clear that FDA can regulate tobacco products containing nicotine from any source. This law took effect on April 14, 2022.
Manufacturers, distributors, importers, and retailers of tobacco products containing non-tobacco nicotine (NTN)—that is, nicotine not made or derived from tobacco, such as synthetic nicotine—must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from this law.
For manufacturers of NTN products to continue marketing their products, they were required to submit a premarket application by May 14, 2022 and must obtain FDA authorization or by law they will be subject to FDA enforcement.
More About CTP Research
Current Funding Opportunities
NIH Tobacco Regulatory Science Program (TRSP) Funding Opportunity Announcements
- Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54; RFA-OD-22-004)
- Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54, RFA-OD-22-003)
- 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)
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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