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Smoking is responsible for more U.S. deaths annually than the acquired immunodeficiency syndrome, use of alcohol and illegal drugs, motor vehicle accidents, murders, and suicides combined.1 With recent data suggesting higher smoking-attributable mortality than previously estimated,2 the medical community is urged to make tobacco control a high priority.3 The prevalence of current use of cigarettes has declined during the past 50 years, from 42% of adults in 1965 to less than 20% in 2014,4,5 but disparities in cigarette smoking across demographic subgroups (particularly according to race or ethnic group, educational attainment, and socioeconomic status) have widened during the past several decades,5,6 and smoking prevalence remains exceptionally high among members of sexual minorities.5,7,8 Furthermore, noncigarette tobacco products are rapidly evolving, and their effect on population-level health is unknown.9–11 Use of electronic cigarettes (e-cigarettes), cigars, smokeless tobacco, and hookah (waterpipe) has risen sharply in the past decade,12–15 and the use of two or more tobacco products has increased in recent years, especially among young adults.16–19
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) broad regulatory authority over the manufacture, marketing, and distribution of regulated tobacco products to protect the health of the U.S. population.20 The FDA Center for Tobacco Products uses a robust scientific evidence base to inform and assess the effect of its tobacco regulatory activities.21 In 2011, the Population Assessment of Tobacco and Health (PATH) Study was established to generate longitudinal epidemiologic data on tobacco-use behavior and health in the U.S. population.
In contrast to other national studies that have been used for the surveillance of tobacco use,22–27 the PATH Study uses a detailed assessment of tobacco-use behaviors, the inclusion of biomarkers, and a longitudinal design in a comprehensive effort to document tobacco use. Specifically, the design of the PATH Study will allow for examination of between-person differences and within-person changes over time in patterns of use of existing and emerging tobacco products, exposures and related biomarkers, risk perceptions, and health conditions potentially related to tobacco use.28 An additional feature of the PATH Study is the...