FDA and NIH Study: Population Assessment of Tobacco and Health
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, started the first wave of data collection in 2013, and is currently in its fourth wave.
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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.
Dr. Andrew Hyland, Roswell Park Cancer Institute, Scientific Director of the PATH Study
The PATH Study is conducted via a contract awarded to Westat and involves researchers from:
- Center for Tobacco Products, FDA
- National Institute on Drug Abuse, NIH
- Centers for Disease Control and Prevention
- Roswell Park Cancer Institute
- Dartmouth College
- Truth Initiative (formerly Legacy)
- The Medical University of South Carolina
- The University of California, San Diego
- The University of Waterloo
- The University of Minnesota
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
About 46,000 people aged 12 years and older, including tobacco users and non-users, are included in the first wave of the PATH Study.
Initial data on adult and youth tobacco use, published January 2017 in the New England Journal of Medicine, showed that more than 25 percent of American adults were current users of tobacco in 2013-14 and roughly 9 percent of youth reported using tobacco in the past 30 days. Multiple product use was common among tobacco users, accounting for roughly 40 percent of adult and youth tobacco users, with cigarettes and e-cigarettes being the most common combination among both age groups.
Among tobacco users who reported using more than one product:
- 23 percent of adults and 15 percent of youth used cigarettes and e-cigarettes
- 6 percent of adults and 4 percent of youth used cigarettes and hookah
- 2 percent of adults and 5 percent of youth used e-cigarettes and hookah
- 5 percent of adults and 10 percent of youth used cigarettes and cigarillos
The study reports prevalence for more product combinations used by study participants.
Data and documentation (questionnaires, codebooks) related to the PATH Study are available on the National Addiction & HIV Data Archive Program (NAHDAP) website including:
- Public-use files (PUFs) from Wave 1 (Sep 2013–Dec 2014) and 2 (Oct 2014–2015) of data collection.
- Restricted-use files (RUFs) from Wave 1 (Sep 2013–Dec 2014), Wave 2 (Oct 2014–Oct 2015), Wave 3 (Oct 2015–Oct 2016), and Wave 4 (Dec 2016–Jan 2018). Qualified researchers are encouraged to apply for access through the NAHDAP website.
- Biomarker Restricted-use files (BRUFs) from Wave 1 (Sep 2013–Dec 2014) and Wave 2 (October 2014 – October 2015).
- Biospecimen Access Program (BAP) which provides the research community with access to urine, serum, and plasma collected from adult PATH Study participants during Wave 1 (Sep 2013–Dec 2014).
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.
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.
- Goniewicz ML, Smith DM, Edwards KC, et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes. JAMA Netw Open. 2018;1(8):e185937. doi:10.1001/jamanetworkopen.2018.5937.
- Villanti AC, Johnson AL, Ambrose BK, et al. Flavored tobacco product use in youth and adults: findings from the first wave of the PATH Study (2013–2014) [published online March 13, 2017]. Am J Prev Med. doi:10.1016/j.amepre.2017.01.026
- Kasza KA, Ambrose BK, Conway KP, et al. Tobacco-product use by adults and youths in the United States in 2013 and 2014. N Engl J Med. 2017;376(4):342-353.
- Hyland A, Ambrose BK, Conway KP, et al. Design and methods of the Population Assessment of Tobacco and Health (PATH) Study [published online August 8, 2016]. Tob Control. doi:10.1136/tobaccocontrol-2016-052934.
- Ambrose BK, Day HR, Rostron B, et al. Flavored tobacco product use among US youth aged 12-17 years, 2013-2014. JAMA. 2015;314(17):1871-1873.