Tobacco Products

FDA and NIH Study: Population Assessment of Tobacco and Health

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

In October 2011, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new study called the Population Assessment of Tobacco and Health (PATH) Studydisclaimer icon. The study will examine tobacco use and how it affects the health of Americans. About 46,000 people aged 12 years and older will be invited to participate in the PATH Study. Some of them will be tobacco users; others won't. Interviewers will meet with each person once a year for at least three years.

The study will help scientists learn how and why people start using tobacco, quit using it, and start using it again after they've quit. They will also learn about how health is affected by tobacco use. Information from the PATH Study will help FDA and NIH to understand tobacco use behaviors and associated health conditions. Findings from the study may inform FDA's actions related to tobacco products, thereby helping to achieve the goals of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Specific 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 will help 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 tobacco product use;
  • Evaluate initiation and use patterns, including the use of new products, the use of multiple products concurrently, and the switch from one product to another;
  • Study patterns of tobacco product use, cessation and relapse;
  • Track potential behavioral and health impacts; and
  • Assess differences in tobacco-related attitudes, behaviors, and health conditions among racial/ethnic, gender, and age subgroups.

PATH Study Participants

PATH Study participants are a nationally representative sample from across the United States. Participants include youth, young adults, and adults who may or may not use tobacco products.

Learn more about this important research study.

Availability of Wave 1 Questionnaire Data

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) announce the availability of questionnaire data from the first wave of the Population Assessment of Tobacco and Health (PATH) Study. Qualified researchers are encouraged to apply for access to a restricted-use file (RUF). Wave 1 questionnaire data and documentation are also available to the public through an unrestricted public use file (PUF). The RUF and PUF are available through the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan.

The PATH Study is a household-based, nationally representative, longitudinal cohort study of 45,971 youth (12-17 years) 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 that was signed into law in 2009. Data in the first wave were collected from September 2013 to December 2014.


Page Last Updated: 02/01/2017
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