 Latest News
PATH Study: Location Characteristics Data Files from Waves 1 to 5 Released
CTP and the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA) announced the availability of the adult and youth/parent location characteristics restricted use files from Wave 1 (2013) through Wave 5 (2019) of the Population Assessment of Tobacco and Health (PATH) Study. These newly released variables characterize a respondent's neighborhood of residence as one of four basic locale types: city, suburban, town, or rural. Providing an enhanced measure of a respondent’s location as more urban or rural improves the ability of researchers to understand relationships between tobacco use behaviors, health equity, and community characteristics. Researchers may apply for access to the restricted-use files.
In addition, the PATH Study biomarker restricted-use files have been updated to include additional assays from youth and young adults at Wave 4 (oxidative stress) and Wave 5 (hydroxy polycyclic aromatic hydrocarbons). Other updates to Wave 7 restricted use files include tobacco universal product code (UPC) data, state design, and state identifier data. The master linkage files have been updated to reflect the new files and the current availability of biospecimens in the Biospecimen Access Program.
NYTS Study Data Shows Youth E-Cigarette Use Drops to Lowest Level in a Decade
On Sept. 5, FDA, in conjunction with the U.S. Centers for Disease Control and Prevention, published new data from the National Youth Tobacco Survey (NYTS) that showed half a million fewer U.S. youth reported current use of e-cigarettes in 2024 compared to 2023. The study also showed that youth nicotine pouch use remained low at 1.8%. The nationally representative data featured in Morbidity and Mortality Weekly Report (MMWR) includes more findings on e-cigarette and nicotine pouch use among U.S. youth.
Funding Awarded to Study Messaging about the Continuum of Risk for Tobacco Products
In August, CTP and the National Institutes of Health (NIH) awarded a cooperative agreement grant (U01) titled, “From Perceptions to Behaviors: A Comprehensive Approach to Examine the Impact of Public Health Communication Messaging about the Continuum of Risk for Tobacco Products.” The principal investigators, Drs. Meghan Moran of Johns Hopkins University and Andy Tan of the University of Pennsylvania, will conduct health communication studies to better understand the impact that messaging about the continuum of risk for tobacco products may have on various segments of the population.
Current research in this area has been limited, and this project aims to fill this gap by collecting data to optimize public health communication on the topic. To educate adults who smoke about the existing research on the topic, in April 2024, the agency released a new website on the relative risk of tobacco products, including e-cigarettes. This cooperative agreement is the latest award from Tobacco Regulatory Science Program (TRSP), a long-standing interagency partnership between FDA and NIH to foster tobacco regulatory research. TRSP is part of FDA’s comprehensive and scientifically rigorous research portfolio.
New Tobacco Data Standards Implementation Guide Released
In June, in partnership with the Clinical Data Interchange Standards Consortium (CDISC), CTP released the Tobacco Implementation Guide – a new resource for stakeholders to use to help facilitate tobacco product research and scientific review. The resource–which includes data standards that can help optimize scientific accuracy and review efficiency–was created by a multidisciplinary team from CTP, tobacco industry stakeholders, and CDISC, and included public/community review.
CDISC created the Tobacco Implementation Guide to serve as a comprehensive resource for the collection, analysis, and exchange of tobacco product data for submissions to CTP, including tobacco product applications and research findings. Examples of tobacco product application submissions include premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, and modified risk tobacco product (MRTP) applications, and examples of research include epidemiology studies, toxicology reports, and behavioral studies.
FDA Posts Two New Science Policy Memos on PMTAs for E-Cigarettes
On Aug. 5, FDA posted the following two regulatory science policy memos related to the agency’s review of PMTAs for new e-cigarette products:
- June 03, 2024: Genotoxicity Hazard Identification and Carcinogenicity Tiering of Constituents in ENDS [Electronic Nicotine Delivery System] Premarket Tobacco Product Applications
- June 03, 2024: Calculating Excess Lifetime Cancer Risk in ENDS Premarket Tobacco Product Applications
In general, the science policy memos provide a snapshot of FDA’s internal thinking on a specific topic at a certain point in time. Therefore, the information contained in the memos is subject to change, for example, based on changes in policy, the regulatory framework, or regulatory science. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation.
FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products and Seven Tobacco-Flavored E-Cigarette Pods
In June, following an extensive scientific review, the FDA authorized the marketing of four menthol-flavored e-cigarette products through the PMTA pathway. The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products, which are the first non-tobacco flavored e-cigarette products to be authorized by the FDA.
In July, the FDA also authorized the marketing of seven e-cigarette products in the United States through the PMTA pathway. Following an extensive scientific review, FDA issued marketing granted orders to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable.
FDA evaluates PMTAs based on a public health standard that considers, among other things, the risks and benefits of the product to the population as a whole. After reviewing the company’s applications, FDA determined there was sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
PMTA Decisions
FDA continues to make decisions on PMTAs, including the following:
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July 18, 2024: Marketing Granted Orders for R.J. Reynolds Vapor Company (Vuse Alto Power Unit and Vuse Alto tobacco-flavored pods)
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June 21, 2024: Marketing Granted Orders for NJOY LLC (NJOY DAILY Menthol and NJOY ACE Menthol)
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June 6, 2024: Update on FDA's Scientific Review of JUUL Product Applications
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