FDA CTP & NIH News

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.

On Sept. 9, 2021, FDA Center for Tobacco Products (CTP) Director Mitch Zeller published a perspective piece discussing the progress that the agency has made on the premarket applications submitted to FDA by the Sept. 9, 2020 application deadline and what to expect after Sept. 9, 2021.

The piece covers several important topics, including:

• The latest status of FDAs review of applications for deemed tobacco products
• A summary of the marketing decisions that have been taken to-date
• FDAs plans on compliance and enforcement

This perspective piece follows updates provided by FDA in May and February, as well as the initial perspective published in August 2020.

Acting FDA Commissioner Janet Woodcock and CTP Director Mitch Zeller have also issued an FDA statement on this topic.

FDA issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

This action represents a significant step toward making progress on the unprecedented number of applications received by the Sept. 9, 2020 court-ordered deadline for submission of premarket applications for deemed new tobacco products, and addressing youth use of flavored ENDS products.

FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. Although the agency has issued other negative actions for some applications, this is the first set of MDOs FDA has issued for applications that have reached the substantive scientific review portion of premarket review. The agency is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that they are appropriate for the protection of the public health.

The 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. The MDOs announced today do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration.

On June 11, FDA announced the withdrawal of the Unified Agenda entry pertaining to the advance notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018, as well as a related request for information (RFI). The agency has posted a web statement that includes background information on the ANPRM and RFI as well as FDAs rationale for this action.

FDA expects to update the public in spring of 2022 following the completion of an ongoing review being conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM) under contract with FDA. The study findings are expected to further inform the agency�s regulatory policy.

On May 20, 2021, FDA posted the list of deemed new tobacco products for which a premarket application was submitted to FDA via the Premarket Tobacco Product Application (PMTA) pathway by Sept. 9, 2020. The list includes over 6 million products.

In February, FDA posted the list of deemed new tobacco products with timely applications submitted to FDA via the Substantial Equivalence (SE) and Exemption from SE Request (EX REQ) pathways.�At the time, the PMTA list was still being compiled due to the large number of applications, size of applications, and other factors. FDA also had to ensure that the development and posting of the list was done in accordance with applicable laws; for example, FDA needed to contact each individual applicant to request the dates of initial marketing and current marketing status of each product for which an application was submitted by the Sept. 9, 2020 deadline. FDA used this information to determine if the existence of the pending application could be disclosed to the public. Please note that FDA has not independently verified the information provided by applicants about the current marketing status of their products.

The process is now complete for the deemed new tobacco products with timely applications submitted through the PMTA pathway, and updates to the SE and EX REQ lists have been made to reflect final actions taken since their initial posting. Now, all lists of deemed new tobacco products with timely submitted applications are available.�It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement. The agency will be updating these lists regularly as positive or negative actions are issued on these products.