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FDA and NIH Study: Population Assessment of Tobacco and Health

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PATH - Population Assessment of Tobacco and Health - A collaboration between the NIH and FDA

About the PATH Study

The Population Assessment of Tobacco and Health (PATH) Study is a uniquely large, long-term study of tobacco use and health in the United States. A collaboration between the U.S. Food and Drug Administration (FDA) Center for Tobacco Products and the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA), the study was launched in 2011 and started the first wave of data collection in 2013. For updates on PATH Study data collection, see “PATH Study FAQs for Researchers.” 

By following study participants over time, the PATH Study helps scientists learn how and why people start using tobacco, quit using it, and start using it again after they’ve quit, as well as how different tobacco products affect health (such as cardiovascular and respiratory health) over time. Findings from the study may also inform FDA’s actions related to tobacco products, thereby helping to achieve the goals of the Family Smoking Prevention and Tobacco Control Act.

The PATH Study is conducted via a contract awarded to Westat and involves researchers from:

  • Centers for Disease Control and Prevention 
  • Center for Tobacco Products, FDA
  • Dartmouth College
  • National Institute on Drug Abuse, NIH
  • New York University
  • Roswell Park Cancer Institute
  • Rutgers, The State University of New Jersey
  • Truth Initiative (formerly Legacy)
  • The Medical University of South Carolina
  • The University of California, San Diego
  • The University of Minnesota
  • The University of Waterloo

To learn more, view the “PATH Study 101” video, developed or view the PATH Study Fact Sheet, developed to provide an orientation to the study.

Research Goals for the PATH Study

By monitoring and assessing behaviors, attitudes, biomarkers, and health outcomes associated with tobacco use in the United States, the PATH Study helps enhance the evidence base available to inform FDA’s regulatory activities related to tobacco. Specifically, the study aims to:

  • Examine what makes people susceptible to using a tobacco product
  • Evaluate initiation and use patterns, including the:
    • use of newer products, such as  e-cigarettes or ENDS (electronic nicotine delivery systems)
    • use of multiple products
    • switching from one product to another
  • Study patterns of tobacco product use, cessation, and relapse
  • Track potential behavioral and health impacts, including biomarkers of exposure and harm
  • Assess differences in tobacco-related attitudes, behaviors, and health conditions among racial/ethnic, gender, and age subgroups

Data Access and Availability

Data and documentation (questionnaires, codebooks) related to the PATH Study are available on the National Addiction & HIV Data Archive Program (NAHDAP) website including:

  • PATH Study Fact Sheet Available
  • PATH Study Data Tables and Figures: Waves 1 - 5 (2013 – 2019)
  • Public-use files (PUFs)from Wave 1 (Sep. 2013–Dec. 2014), Wave 2 (Oct. 2014–Oct. 2015), Wave 3 (Oct. 2015–Oct. 2016), Wave 4 (Dec. 2016—Jan. 2018), Wave 5 (Dec. 2018–Nov. 2019), and Wave 6 (Mar. 2021-Nov. 2021).
  • Restricted-use files (RUFs)from Wave 1 (Sep 2013–Dec 2014), Wave 2 (Oct 2014–Oct 2015), Wave 3 (Oct 2015–Oct 2016), Wave 4 (Dec. 2016 – Jan. 2018), Wave 5 (Dec. 2018–Nov. 2019), Wave 6 (Mar. 2021-Nov. 2021), and Wave 7 (Jan. 2022 – Apr. 2023). Updated State Design Data and Tobacco Universal Product Codes (Wave 1 – Wave 7). Enhanced Urbanicity/Rurality variable (Wave 1-Wave 5). Qualified researchers are encouraged to apply for access through the NAHDAP website.
  • Biomarker Restricted-use files (BRUFs)from Wave 1 (Sep 2013–Dec 2014), Wave 2 (Oct. 2014 – Oct. 2015), Wave 3 (Oct 2015— 2016), and Wave 4 (Dec. 2016 – Jan. 2018), Wave 5 (Dec. 2018-Nov. 2019), and Wave 7 (Jan. 2022 – April 2023)
  • Biospecimen Access Program (BAP) which provides the research community with access to urine, serum, and plasma collected from adult PATH Study participants from Wave 1 (Sep. 2013 – Dec. 2014), Wave 2 (Oct. 2014 – Oct. 2015), Wave 3 (Oct. 2015 – Oct. 2016), Wave 4 (Dec. 2016 – Jan. 2018), Wave 5 (Dec. 2018 – Nov. 2019), and Wave 7 (Jan. 2022 – Apr. 2023). 
  • Special Collection Restricted-use files (SCRUFs) from Wave 4.5 Youth Only Data Collection; Wave 5.5 Youth and Young Adults ages 13-19 and the PATH Study Adult Telephone Survey (PATH-ATS), ages 20+
  • Special Collection Public-use files (SCPUFs) from Wave 4.5 Youth Only Data Collection; Wave 5.5 Youth and Young Adults ages 13-19; and the PATH Study Adult Telephone Survey (PATH-ATS), ages 20+

Researchers interested in the PATH Study are encouraged to create an account to join the PATH Study Data User Forum. The forum enables researchers using PATH Study data to submit and answer questions. Announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users are also posted to the forum.

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

NOTE: This email address is not for questions about statistical analysis or analytic guidance. For analytic questions, researchers may wish to consult with statisticians and analysts at their institutions. Additionally, the PATH Study User Forum can be used to obtain feedback and engage in discussion with other PATH Study data users.

PATH Study Publications

Listed below is a selection of peer-reviewed journal articles from the PATH Study. See the NAHDAP website or search PubMed.gov for a complete list of publications.

Note: The following publications are highlighted for illustrative purposes only. The information in these highlighted publications is not a formal dissemination of information by FDA and does not represent agency position or policy. The contents of the publications are the responsibility of the authors alone.

  • Brunette MF, Halenar MJ, Edwards KC, Taylor KA, Emond JA, Tanski SE, et al. Association between tobacco product use and asthma among US adults from the Population Assessment of Tobacco and Health (PATH) Study waves 2-4. BMJ Open Respir Res. 2023;10(1).
  • Kasza, K. A., Tang, Z., Xiao, H., Marshall, D., Stanton, C., Gross, A., Jackson, K., Kelley, D., Schroeder, M., Vivar, J., & Hyland, A. (2023). National longitudinal tobacco product discontinuation rates among US youth from the PATH Study: 2013–2019 (waves 1–5). In Tobacco Control (p. tc-2022-057729). BMJ. https://doi.org/10.1136/tc-2022-057729
  • Gardner, L.D.; Liu, S.T.; Xiao, H.; Anic, G.M.; Kasza, K.A.; Sharma, E.; Hyland, A.J. Electronic Nicotine Delivery System (ENDS) Device Types and Flavors Used by Youth in the PATH Study, 2016–2019. Int. J. Environ. Res. Public Health 2022, 19, 5236. https://doi.org/10.3390/ijerph19095236
  • Kasza, K. A., Tang, Z., Xiao, H., Marshall, D., Stanton, C., Gross, A. L., Jackson, K. M., Kelley, D., Schroeder, M. J., Vivar, J. C., & Hyland, A. (2022). National longitudinal tobacco product cessation rates among US adults from the PATH Study: 2013–2019 (waves 1–5). In Tobacco Control (p. tobaccocontrol-2022-057323). BMJ. https://doi.org/10.1136/tc-2022-057323
  • Silveira, M. L., Everard, C. D., Sharma, E., Lauten, K., Alexandridis, A. A., Duffy, K., Taylor, E. V., Tolliver, E. A., Blanco, C., Compton, W. M., Kimmel, H. L., Iafolla, T., Hyland, A., & Chaffee, B. W. (2022). Tobacco Use and Incidence of Adverse Oral Health Outcomes Among US Adults in the Population Assessment of Tobacco and Health Study. JAMA network open, 5(12), e2245909. https://doi.org/10.1001/jamanetworkopen.2022.45909
  • Stanton, C. A., Tang, Z., Sharma, E., Seaman, E., Gardner, L. D., Silveira, M. L., Hatsukami, D., Day, H. R., Cummings, K. M., Goniewicz, M. L., Limpert, J., Everard, C., Bansal-Travers, M., Ambrose, B., Kimmel, H. L., Borek, N., Compton, W. M., Hyland, A. J., & Pearson, J. L. (2022). Predictors of e-cigarette and cigarette use trajectory classes from early adolescence to emerging adulthood across four years (2013-2017) of the PATH Study. In Nicotine & Tobacco Research. Oxford University Press (OUP). https://doi.org/10.1093/ntr/ntac119
  • Christensen, C. H., Chang, J. T., Rostron, B. L., Hammad, H. T., van Bemmel, D. M., et al. (2021). Biomarkers of Inflammation and Oxidative Stress Among Adult Former Smoker, Current E-Cigarette Users Results from Wave 1 PATH Study. Cancer Epid Biomarkers & Prevention, cebp.0140.2021. https://doi.org/10.1158/1055-9965.epi-21-0140

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