FDA CTP & NIH News

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative, longitudinal cohort study of tobacco use and how it affects the health of people in the United States. A collaboration between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), the PATH Study was launched in 2011 and the first wave of data collection started in 2013. It is one of the first large tobacco research efforts undertaken by the NIH and the FDA since Congress gave the FDA authority to regulate tobacco products in 2009. Learn more about the PATH Study at https://doi.org/10.3886/Series606.

In March 2022, the first set of widely available PATH Study Data Tables and Figures were released, featuring a series of cross-sectional and longitudinal tables and figures providing national estimates on tobacco use among youth (aged 12-17), young adults (aged 18-24), and adults (aged 25+) using data from Waves 1-5 (2013-2019) of the PATH Study. These tables and figures are available for public use at PATH Study Data Tables and Figures: Wave 1-5 (2013-2019). Please review the Methodology document for important information about the analytic methods used to generate tables and figures.

 These data tables and figures offer streamlined information about the PATH Study that can only be found by analyzing the data. Some features that users may find particularly useful are:

 1. These data tables and figures provide nationally representative tobacco use prevalence estimates that are generalizable to the CNP (Civilian Noninstitutional Population) of the United States. They can be accessed easily and are targeted toward a wide audience that can include students, researchers, and other interested groups.

 2. These data tables and figures present an easy and quick reference for prevalence of tobacco use among youth (aged 12-17), young adults (aged 18-24) and adults (aged 25+) across different products, starting from Wave 1 (2013/2014) and up to Wave 5 (2018/2019).

 3. These data tables and figures provide overall prevalence of flavored tobacco product use, as well as estimates stratified by age, sex, race/ethnicity, and educational attainment to provide information on differences in tobacco use patterns across these important demographic subgroups.

 4. These data tables and figures provide longitudinal transitions stratified by age, sex, race/ethnicity, and education to provide information on tobacco product initiation and discontinued cigarette use over time. 

 Researchers using these files are asked to use the recommended citation below:

 United States Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, and United States Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products. (2021). [INSERT PDF TITLE]. In PATH Study Data Tables and Figures. Inter-university Consortium for Political and Social Research [distributor]. Retrieved on [INSERT DATE] from [INSERT DOI/URL TO THE SPECIFIC PDF].

On March 10, 2022, 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 provides a comprehensive review of the scientific literature on these products. For example, the report includes information on short-term and long-term health effects, patterns of use, marketing and perceptions, and product characteristics of premium cigars. The NASEM report provides valuable knowledge and adds to the FDA’s scientific understanding of premium cigars. Read the full report HERE.

Findings from the 2021 National Youth Tobacco Survey (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. Click here to read the full report and key findings.

The Navajo Nation has recently passed one of the most comprehensive bans on commercial tobacco products on American Indian tribal lands. Learn more about the research that helped pass this ban, which covers conventional cigarettes, e-cigarettes, cigars, and similar products. More information: Navajo Nation Enacts Commercial Tobacco Ban - National Cancer Institute

Effective Date of Final Rule

On Feb. 10, 2022, the U.S. District Court for the Eastern District of Texas issued an order in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule. The new effective date of the final rule is April 9, 2023. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, FDA strongly encourages entities to submit cigarette plans (as required by 21 CFR 1141.10(g)) as soon as possible, and in any event by June 10, 2022. More information: Cigarette Labeling and Health Warning Requirements | FDA 

The FDA’s Center for Tobacco Products (CTP) and the NIH’s National Institute on Drug Abuse (NIDA) announce the release of the first in a series of restricted-use biomarker data files from Wave 5 of the Population Assessment of Tobacco and Health (PATH) Study collected December 2018 – November 2019. This latest addition to the PATH Study’s Biomarker Restricted-Use Files (BRUF) includes urine panel assay data files, namely urinary nicotine metabolites (UNICM), creatinine (CREAU), metals, and volatile organic compounds metabolites (VOCM). The release also includes datafiles containing urine biomarkers of oxidative stress (F2PG2a) at Wave 3. Qualified researchers may apply for access through the PATH Study Biomarker Restricted-Use Files webpage at https://doi.org/10.3886/ICPSR36840.  

In addition, updates were made to the Wave 5 Public-Use File (PUF), the Wave 5 Restricted-Use File (RUF), Wave 4 BRUF, the Wave 1 – Wave 4 VOCM BRUFs. Researchers may apply to access the RUF at https://doi.org/10.3886/ICPSR36231, and the PUF can be accessed at https://doi.org/10.3886/ICPSR36498. Restricted-Use Master Linkage Files were also updated and are available at https://doi.org/10.3886/ICPSR38008.

The Biospecimen Access Program webpage at http://bit.ly/2wBFOtc provides information on how to access the urine, serum, plasma, and genomic DNA (gDNA) collected from adult PATH Study participants during Wave 1 (2013-2014) and urine collected during Wave 2 (2014-2015), Wave 3 (2015-2016), Wave 4 (2016-2018), and Wave 5 (2018-2019).

The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. For the latest announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users, join the PATH Study Data User Forum. The forum enables researchers using PATH Study data to submit and answer questions.

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com (not to be used for questions about statistical analysis or analytic guidance).

On Oct. 12, FDA announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by FDA through the PMTA pathway. FDA issued Marketing Granted Orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today's authorization allows these products to be legally sold in the U.S. This action does not mean these products are safe or FDA approved. All tobacco products are harmful and addictive and those who do not use tobacco products should not start.

FDA also issued 10 Marketing Denial Orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company's application for menthol-flavored products under the Vuse Solo brand.

The FDA’s Center for Tobacco Products (CTP) and the NIH’s National Institute on Drug Abuse (NIDA) announce the release of the Wave 5 Public-Use File (PUF) from the Population Assessment of Tobacco and Health (PATH) Study. In addition to the Wave 5 data files, an updated Master Linkage File will also be available for use by the public and researchers.  The Wave 5 files consist of data collected through the PATH Study (from December 2018 through November 2019) and may be downloaded from https://doi.org/10.3886/ICPSR36498.v13. The Master Linkage Files for the PATH Study may be downloaded from https://doi.org/10.3886/ICPSR38008.v3.

The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. For the latest announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users, join the PATH Study Data User Forum. The forum enables researchers using PATH Study data to submit and answer questions. 

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com (not to be used for questions about statistical analysis or analytic guidance).

In addition, the Biospecimen Access Program webpage at http://bit.ly/2wBFOtc provides information on how to access the urine, serum, plasma, and genomic DNA (gDNA) collected from adult PATH Study participants during Wave 1 (2013 – 2014) and urine collected during Wave 2 (2014 – 2015).

FDAs Center for Tobacco Products (CTP) and NIHs National Institute on Drug Abuse (NIDA) announce the release of the Wave 5 Public-Use Files (PUF) from the Population Assessment of Tobacco and Health (PATH) Study. The Wave 5 files consist of data collected through the PATH Study from December 2018 through November 2019.

In addition to the Wave 5 data files updated Master Linkage Files will also be available for use by the public and researchers.

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

Since Sept. 2, FDA has issued an additional 134 marketing denial orders (MDOs) for more than 637,000 flavored electronic nicotine delivery system (ENDS) products. These MDOs follow others the agency has issued starting in August. Now, in total, the agency has issued 168 MDOs for more than 992,000 flavored ENDS products.

Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.

Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), we cannot release additional information about those actions.

Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.

FDA continues to make substantial progress reviewing the unprecedented number of applications received by the Sept. 9, 2020, court-ordered deadline for submission of premarket applications for deemed new tobacco products.�

The aggregate information on these actions will be provided within our regular updates on the Tobacco Product Applications: Metrics and Reporting page.