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What is the PATH Study?
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The PATH Study is a nationally representative, longitudinal study that looks at tobacco product use trajectories, changes in attitudes and beliefs towards tobacco products, and associated health outcomes over time. |
The study is funded by CTP and is administered by the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA) with additional financial support from other NIH institutes and centers. The PATH Study assesses changes over individuals’ lifetimes and between people in a large national cohort of participants aged 12 years and older. The study has collected information from roughly 40,000 participants through questionnaires and biospecimen collection.
Through questionnaires, researchers ask both youth and adult participants who have never used, currently use, or formerly used tobacco about their use and views of multiple tobacco products. Researchers also collect various types of biospecimens, including urine and blood, and can pair with reported tobacco use from questionnaires to observe health outcomes over time in subgroups of individuals defined by sex, age, race/ethnicity, and other risk factors.
Researchers have so far collected data in eight full “waves” over an 11-year period between 2013 and 2024. The next half wave of data collection (Wave 8.5) will begin in February 2025. The PATH Study adds new questions to the questionnaire portion during each wave. For example, for all interviews conducted in 2020 through 2023, the questionnaires included questions about impacts of the COVID-19 pandemic on tobacco use and views, and Wave 8 collected data on “long COVID” in 2024.
How is the PATH Study different from other tobacco studies?
The PATH Study has a longitudinal cohort study design, which means researchers gather information from the same individuals over multiple years. Because of this methodology, researchers can follow the tobacco use and health journeys of individual participants to observe whether they changed the types of tobacco products they used or any attempts to quit tobacco use. Although surveys like the National Youth Tobacco Survey also measure tobacco product use, they generally compare different samples of individuals with similar characteristics between years rather than the same individuals.
The longevity of the study has given researchers long-term data to follow product use trends. For example, researchers can follow participants on a large scale to determine whether the use of certain tobacco products, such as nicotine pouches, or characteristics of products, such as flavors, predict cessation or increased tobacco use over time. For example, the longitudinal data from the PATH Study showed that flavor use in tobacco products was associated with a higher risk of tobacco experimentation and subsequent tobacco use in youth and young adults.
What have researchers found using PATH Study data and how does that inform CTP’s work?
As of September 30, 2024, researchers have published over 830 scholarly articles using PATH Study data or on PATH Study methods. Over 300 of those publications were supported by CTP funding and more than 125 articles included CTP scientists as co-authors. These articles cover topics from harm reduction to health outcomes to dependence trends.
PATH Study-funded researchers have looked at the extent to which adults who smoke were switching to e-cigarettes using the PATH Study data. For example, Kasza et al. 2024 found that between 2018 and 2021, adults who used e-cigarettes stopped using cigarettes at a higher rate than those that did not use e-cigarettes. These data help in understanding the role e-cigarettes may play in quitting cigarettes among adults who smoke and ultimately support CTP’s evaluation of the overall public health impact of e-cigarettes.
PATH Study-funded researchers have also studied the connection between tobacco product use and health outcomes. For example, Sharma et al. 2024 found adults who smoke cigars, cigarettes, or both were more likely to report respiratory conditions, including asthma, uncontrolled asthma, or wheezing (functionally important respiratory symptoms) compared to those who never smoked cigars or cigarettes. Understanding health impacts associated with cigar use is important for developing rules and regulations and can further help in designing clinical interventions focused on quitting cigar smoking.
PATH Study data and findings often inform FDA’s tobacco regulatory activities—such as rules and guidance, enforcement actions, and application review—and help inform educational efforts. Some examples include:
- In December 2024, FDA sent warning letters to retailers for selling unauthorized Geek Bar products among other e-cigarette products. Before issuing these warning letters, FDA had identified preliminary data from the PATH Study that identified Geek Bar brand e-cigarette products as popular or youth appealing.
- The recent proposed rule regarding characterizing flavors in cigars was supported by PATH Study data and findings. Internal analyses, PATH Study Data Tables and Figures, and peer-reviewed literature on PATH Study data supported FDA’s development of the proposed rule and the preliminary regulatory impact analysis. Some public comments on the proposed rule also cited PATH Study data and findings.
- Data from the PATH Study add to the evidence base that flavored tobacco products appeal to youth and serve as starter products to established tobacco use. PATH Study data show that more than half of youth and young adults have reported that their first product was flavored, or they use a product because it “comes in flavors that I like.” These findings have informed FDA’s resources on vaping for teachers, students, and parents, among other education initiatives.
- For adults who smoke cigarettes, switching completely from cigarettes to e-cigarettes may reduce exposure to many harmful chemicals present in cigarettes. However, PATH Study data shows that some adults who do not perceive this relative risk are less likely to switch from cigarette smoking to exclusive e-cigarette use. CTP published an educational webpage about the relative risks of different tobacco products.
- FDA’s 2020 guidance on enforcement priorities for unauthorized e-cigarettes and other tobacco products cited PATH Study data and findings numerous times. Researchers have also used PATH Study data to examine changes in e-cigarette use among youth and adults before and after FDA shared this guidance.
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Are there any upcoming PATH Study presentations?
Join CTP’s Office of Science on its new date, January 16, 2025, for a webinar on key findings from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of tobacco use. Over its 10+ years of data collection, the study has followed significant changes in tobacco product use and the marketplace, including a dramatic rise and fall in youth e-cigarette use, the emergence of new products like nicotine pouches, and increasing concern about the concurrent use of multiple types of tobacco products. The talk will share an overview and history of the PATH Study and highlight how scientific evidence generated from this longitudinal study informs FDA’s regulatory activities and public health.
New PATH Study Data Files Available
CTP and NIDA are announcing the availability of the Wave 7 Public-Use File from the PATH Study. These Wave 7 files contain questionnaire data collected between January 2022 and April 2023.
The Public-Use Files are available for download. Additionally, the Master Linkage Files have each been updated to reflect the current availability of biospecimens in the Biospecimen Access Program.
Researchers are also encouraged to apply for access to the Restricted-Use Files and Biomarker Restricted-Use Files. In addition, the Biospecimen Access Program webpage 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), Wave 5 (2018-2019), and Wave 7 (2022-2023).
Selected Publications about PATH by CTP Researchers Published in 2024 and 2025
How to Learn More About the PATH Study?
If you want to learn more about the PATH Study and how you can use its restricted and public use data files for research, FDA has several resources available on the PATH Study, including:
In addition, you can review other resources about the PATH Study for researchers, including:
This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our CTP Connect newsletter and CTP News e-blasts.
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