FDA CTP & NIH News

Today, FDA posted additional regulatory science policy memos related to the agency’s review of premarket applications. This release includes thirteen memos developed between 2020 and 2023 that describe the process and prioritization methods used to conduct filing and review of PMTAs for flavored e-cigarettes and other PMTAs, as well as the bases to support specific actions related to environmental assessments.

In April, FDA resumed the posting of regulatory science policy memos. This is now the fourth batch of released memos in 2024, and including those posted today, FDA has released a total of 26 memos. The release of these latest memos reflects the center’s commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation. Visit the FDA website to read more about FDA’s actions in response to the evaluation.

Read the Full Statement

NIH’s National Institute on Drug Abuse and FDA’s Center for Tobacco Products are announcing the release of the Wave 7 Biomarker Restricted-Use File (BRUF) from the Population Assessment of Tobacco and Health (PATH) Study. This release is the first to include biomarker data from Wave 7, which were collected between January 2022 and April 2023. Researchers may apply for access to the Biomarker Restricted-Use Files (BRUF). 

In addition, the Wave 1 BRUF has been updated to include expanded samples from Wave 1 adults who had former experimental use or long-term former use of any tobacco product. The Restricted-Use and Public-Use Master Linkage Files have been updated to reflect the new files and the current availability of biospecimens in the Biospecimen Access Program. 

Researchers are encouraged to apply for access to the Restricted-Use Files. Public-Use Files are also available for download. In addition, the Biospecimen Access Program webpage provides information on how to access the urine, serum, plasma, and genomic DNA 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),Wave 5 (2018-2019), and Wave 7 (2022-2023).

In addition, the PATH Study has posted a new training video entitled “Modelling with the PATH Study Data – Survival Analysis” available in the PATH Study playlist.

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

On Monday, October 21, from 9 a.m. to 4:30 p.m. EDT, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will host a joint public meeting entitled, “Advancing Smoking Cessation: FDA and NIH Priorities.” The focus of the meeting is on advancing innovation of smoking cessation products to help both adults and youth.

The meeting will feature presentations and panel discussions on several smoking cessation-focused topics, including:

• Clinical and community perspectives
• Promising target areas for development
• Regulatory paths forward

The meeting will include an opportunity for public comment on several topics related to cessation.

The meeting is free, and can be attended virtually or in-person at the FDA’s White Oak campus in Silver Spring, Maryland. Additional information about the meeting, including specific questions for which public comment is being sought, is found in the Federal Register notice announcing the meeting. Deadlines for registration, including for public comment, are as follows:

• In-person registration is required by October 15, 2024, while virtual registration is open through 9:00 a.m. EDT on the day of the meeting.
• Registration to speak in-person during the public comment portion of the meeting is required by October 1 at 5:00 p.m. EDT. Please note that public comments during the meeting will only be accepted in person and not virtually. Every effort will be made to accommodate as many speakers as possible; however, speaking spots are limited and not guaranteed.
• Written comments must be submitted by November 21, 2024 via the meeting's public docket on Regulations.gov [Docket No. FDA-2024-N-4085].

Tobacco product use remains the single most preventable cause of disease, disability and death in the United States, and each year, an estimated 480,000 Americans die prematurely from smoking or from exposure to second-hand smoke. The U.S. Department of Health and Human Services (HHS) Framework to Support and Accelerate Smoking Cessation includes a stated goal to promote ongoing and innovative research in the area of cessation. The FDA and NIH’s joint October meeting is in support of these efforts, as the Department advances our collective efforts to improve the nation’s health.

NIH’s National Institute on Drug Abuse (NIDA) and NIH and FDA’s Center for Tobacco Products (CTP) are announcing 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 RUF at https://doi.org/10.3886/ICPSR36231.

In addition, the PATH Study Biomarker Restricted-Use Files (RUF) have been updated to include additional panel assays from Wave 4 and Wave 5, which can be accessed at https://doi.org/10.3886/ICPSR36840. The PATH Study Restricted-Use Files (RUF) have been updated to include Wave 7 state identifier, state design, and Tobacco Universal Product (UPC) data. The Restricted-Use and Public-Use Master Linkage Files have each been updated to reflect the new RUF files and the current availability of biospecimens in the Biospecimen Access Program. Master Linkage Files can be accessed at https://doi.org/10.3886/ICPSR38008.

Members of the research community are encouraged to apply for access to the Restricted-Use Files through https://doi.org/10.3886/ICPSR36231 and Biomarker Restricted-Use Files at https://doi.org/10.3886/ICPSR36840. Public-Use Files are also available for download at https://doi.org/10.3886/ICPSR36498. 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), 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. It was launched in 2011 to inform the FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. Questions regarding accessing the PATH Study can be sent to NAHDAP@icpsr.umich.edu. 

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).

The NIH’s Office of Science Policy, through an NIH-wide collaboration, has developed and releasedInformed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language.  This resource presents general points to consider, instructions for use, and optional sample language for the research community. This resource will best be used to inform research teams and Institutional Review Board (IRB) members who are planning, reviewing, or conducting research that studies or uses digital health technologies.

On June 10, in partnership with the Clinical Data Interchange Standards Consortium (CDISC), FDA’s Center for Tobacco Products (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.

CTP awarded a grant to CDISC to expedite the development of data standards and terminologies to facilitate tobacco research, scientific review, and information exchange. Specifically, 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.

This initial version of the Guide implements several data models, including Clinical Data Acquisition Standards Harmonization, Study Data Tabulation Model, and Analysis Data Model.

Comments and feedback to this guide can help inform future updates to the Tobacco Implementation Guide. CDISC posts public review comments and resolutions to ensure transparency and show implementers how comments were addressed.

The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. 

Along with the FDA and the Justice Department, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth. Additional agencies may join the task force in the coming weeks and months. 

“Enforcement against illegal e-cigarettes is a multi-pronged issue that necessitates a multi-pronged response,” said Dr. Brian King, director of the FDA’s Center for Tobacco Products. “This ‘All Government’ approach – including the creation of this new Task Force – will bring the collective resources and experience of the federal government to bear on this pressing public health issue.”   

NIH’s National Institute on Drug Abuse (NIDA) and NIH and FDA’s Center for Tobacco Products (CTP) announce the release of the Wave 7 Restricted-Use File (RUF) from the Population Assessment of Tobacco and Health (PATH) Study.  Wave 7 files contain data collected between January 2022 and April 2023, including questionnaire data, tobacco Universal Product Code (UPC) data, and state identifier data. Researchers may apply for access to the RUF at https://doi.org/10.3886/ICPSR36231.

In addition, the PATH Study Biomarker Restricted-Use Files (BRUF) have been updated to include additional assays from Wave 4 and Wave 5. The PATH Study Restricted-Use Files (RUF) have been updated to include Wave 6 Ever/Never reference data for all participants, which can be accessed at https://doi.org/10.3886/ICPSR36231. The Restricted-Use and Public-Use Master Linkage Files have each been updated to reflect the new RUF files and the current availability of biospecimens in the Biospecimen Access Program. Master Linkage Files can be accessed at https://doi.org/10.3886/ICPSR38008.

Members of the research community are encouraged to apply for access to the Restricted-Use Files through https://doi.org/10.3886/ICPSR36231 and Biomarker Restricted-Use Files at https://doi.org/10.3886/ICPSR36840. Public-Use Files are also available for download at https://doi.org/10.3886/ICPSR36498. 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), 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. Questions regarding accessing the PATH Study can be sent to NAHDAP@icpsr.umich.edu. 

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).
 

Today, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to-use search capabilities. The database, which can be accessed at www.fda.gov/searchtobacco, will be updated on a monthly basis.  

Within the database, FDA provides information on three categories of products: 1) new tobacco products that received marketing authorization through one of FDA’s three pathways to market a new tobacco product; 2) pre-existing tobacco products established through a voluntary determination program (commercially marketed as of Feb. 15, 2007); and 3) provisional tobacco products that were removed from review. 

“CTP remains committed to enhanced transparency in a way that is useful, timely, and user-friendly,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We hope that this database will be an asset to stakeholders—including retailers—that will be used to help facilitate compliance with the law.”

Read the Statement

TUS-CPS September 2022 Data and Brief Now Available 
Code Now Available in Stata, R, and SAS Programming Languages

The National Cancer Institute (NCI) is pleased to announce that the initial release from the 2022-2023 Tobacco Use Supplement to the Current Population Survey (TUS-CPS), consisting of September 2022 data, is now publicly available. A subsequent data release will include the remaining two time points of data (January 2023 and May 2023) and is expected to be available later in 2024.

A Data Brief presenting a synopsis of the early September 2022 results is available on NCI’s website. The brief details current use of a variety of tobacco products, smoking frequency, recent quit attempts, and e-cigarette device types and flavors.

Download Data Brief 

Also, supporting code (i.e., programs to read in the data files) is now available in both Stata and R programming languages for the 2018-2019 survey wave. The new Stata and R supporting code is available here. The addition of both Stata and R supporting code to existing SAS code should make TUS-CPS data available for use by an even greater range of researchers interested in analyzing key tobacco use behaviors, attitudes, and policies in the United States. 

The Tobacco Use Supplement represents a unique opportunity to track long-term trends and conduct complex analyses within the Current Population Survey, at both the national and state levels.

For questions about the TUS-CPS, contact us at ncidccpsbrpadvances@mail.nih.gov.

The TUS-CPS is co-sponsored by NCI’s Behavioral Research Program in the Division of Cancer Control and Population Sciences and the Food and Drug Administration, Center for Tobacco Products. For more information, visit cancercontrol.cancer.gov/tus-cps.

Subscribe to TUS-CPS email updates and news at cancercontrol.cancer.gov/TUSsubscribe.

NIH’s National Institute on Drug Abuse (NIDA) and FDA’s Center for Tobacco Products (CTP) announced the continuation of the Population Assessment of Tobacco and Health (PATH) Study through the award of a contract to Westat. The continuation of the PATH Study, through this third contract, provides further opportunities for researchers to use study data to advance knowledge about tobacco and health. Since the launch of Wave 1 in 2013, the PATH Study has been in the field continually, conducting 7 main waves of data collection (Waves 1-7), as well as, 3 additional special data collections (Waves 4.5, 5.5/Adult Telephone Survey, and 7.5). Wave 8 data collection is currently underway and this new contract supports at least four additional waves of main data collection, as well as other special data collections.

The continuing objectives of the PATH Study are to enhance the evidence base to inform FDA's regulatory actions under the Tobacco Control Act by examining tobacco product use behaviors and trajectories, assessing health outcomes, evaluating the impacts of CTP regulations on those outcomes, as well as conducting additional data collections in response to emerging regulatory needs as appropriate. The PATH Study provides longitudinal data on the impact of tobacco products on the health of the population, including data on the potential of tobacco products to encourage cessation among people who currently use tobacco, and the potential to prevent relapse/reuptake by those with former use, and initiation of tobacco use, particularly youth.

Members of the research community are encouraged to learn more about the PATH Study and to apply for access to the PATH Study Restricted-Use Files (RUFs) or to download the Public-Use Files (PUFs) at Population Assessment of Tobacco and Health (PATH) Study Series (umich.edu). This site also provides information about how to apply to the Biospecimen Access Program for access to the urine, serum, plasma, and genomic DNA (gDNA) collected from a subsample of PATH Study participants.

On Dec. 18, CTP Director Brian King published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.

CTP’s Strategic Plan defines five goals, 10 outcomes, and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products. We will also continue to invest in our staff—our greatest resource—by advancing operational enhancements and supporting the further development of our highly qualified, inclusive, and high-performing workforce.

In conjunction with the strategic plan, today CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. This policy agenda will create a more efficient approach to meeting CTP’s strategic plan and will be updated annually.