Background This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration’s (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. Methods The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study’s design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. Conclusions The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA’s regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation’s burden of tobacco-related death and disease.

BACKGROUND Noncigarette tobacco products are evolving rapidly, with increasing popularity in the United States. METHODS We present prevalence estimates for 12 types of tobacco products, using data from 45,971 adult and youth participants (≥12 years of age) from Wave 1 (September 2013 through December 2014) of the Population Assessment of Tobacco and Health (PATH) Study, a large, nationally representative, longitudinal study of tobacco use and health in the United States. Participants were asked about their use of cigarettes, e-cigarettes, traditional cigars, cigarillos, filtered cigars, pipe tobacco, hookah, snus pouches, other smokeless tobacco, dissolvable tobacco, bidis, and kreteks. Estimates of the prevalence of use for each product were determined according to use category (e.g., current use or use in the previous 30 days) and demographic subgroup, and the prevalence of multiple-product use was explored. RESULTS More than a quarter (27.6%) of adults were current users of at least one type of tobacco product in 2013 and 2014, although the prevalence varied depending on use category. A total of 8.9% of youths had used a tobacco product in the previous 30 days; 1.6% of youths were daily users. Approximately 40% of tobacco users, adults and youths alike, used multiple tobacco products; cigarettes plus e-cigarettes was the most common combination. Young adults (18 to 24 years of age), male adults and youths, members of racial minorities, and members of sexual minorities generally had higher use of tobacco than their counterparts. CONCLUSIONS During this study, 28% of U.S. adults were current users of tobacco, and 9% of youths had used tobacco in the previous 30 days. Use of multiple products was common among tobacco users. These findings will serve as baseline data to examine between-person differences and within-person changes over time in the use of tobacco products. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration.)

BACKGROUND AND OBJECTIVES: Non-cigarette tobacco marketing is less regulated and may promote cigarette smoking among adolescents. We quantified receptivity to advertising for multiple tobacco products and hypothesized associations with susceptibility to cigarette smoking.

IMPORTANCE Cigarette marketing contributes to initiation of cigarette smoking among young people, which has led to restrictions on use of cigarette advertising. However, little is known about other tobacco advertising and progression to tobacco use in youth and young adults. OBJECTIVE To investigate whether receptivity to tobacco advertising among youth and young adults is associated with progression (being a susceptible never user or ever user) to use of the product advertised, as well as conventional cigarette smoking. DESIGN, SETTING, AND PARTICIPANTS The Population Assessment of Tobacco and Health (PATH) Study at wave 1 (2013-2014) and 1-year follow-up at wave 2 (2014-2015) was conducted in a US population-based sample of never tobacco users aged 12 to 24 years from wave 1 of the PATH Study (N = 10 989). Household interviews using audio computer-assisted self-interviews were conducted. EXPOSURES Advertising for conventional cigarettes, electronic cigarettes (e-cigarettes), cigars, and smokeless tobacco products at wave 1. MAIN OUTCOMES AND MEASURES Progression to susceptibility or ever tobacco use at 1-year follow-up in wave 2. RESULTS Of the 10 989 participants (5410 male [weighted percentage, 48.3%]; 5579 female [weighted percentage, 51.7%]), receptivity to any tobacco advertising at wave 1 was high for those aged 12 to 14 years (44.0%; 95% confidence limit [CL], 42.6%-45.4%) but highest for those aged 18 to 21 years (68.7%; 95% CL, 64.9%-72.2%). e-Cigarette advertising had the highest receptivity among all age groups. For those aged 12 to 17 years, susceptibility to use a product at wave 1 was significantly associated with product use at wave 2 for conventional cigarettes, e-cigarettes, cigars, and smokeless tobacco products. Among committed never users aged 12 to 17 years at wave 1, any receptivity was associated with progression toward use of the product at wave 2

The PATH Study Adult Wave 1 Questionnaire provided psychometrically valid measures of TD that enables future regulatory investigations of nicotine dependence across tobacco products.

Regardless of the tobacco product used, findings reveal high co-occurrence of substance use and mental health problems among youth tobacco users, especially poly-tobacco users. These findings suggest the need to address comorbidities among high risk youth in prevention and treatment settings.

Key PointsQuestionWhat is the association between first flavored use of a given tobacco product and subsequent tobacco use, including progression of tobacco use, among US youth (aged 12-17 years), young adults (aged 18-24 years), and adults (aged ≥25 years)?FindingsIn this cohort study of 11 996 youth and 26 447 adults who participated in waves 1 and 2 of the Population Assessment of Tobacco and Health Study, most youth and young adult new tobacco users first tried a flavored product. First use of flavored tobacco products was positively associated with subsequent product use compared with first use of a nonflavored product.MeaningFirst use of flavored tobacco products may place youth and adults at risk of subsequent tobacco use.

Background Although non-cigarette tobacco product use is increasing among U.S. adults, their associations with substance use and mental health problems are unclear. This study examined co-occurrence of tobacco use, substance use, and mental health problems, and its moderation by gender, among 32,202 U.S. adults from Wave 1 (2013–2014) of the nationally representative longitudinal Population Assessment of Tobacco and Health (PATH) Study. Methods Participants self-reported current cigarette, e-cigarette, traditional cigar, cigarillo, filtered cigar, hookah, smokeless tobacco and other tobacco product use; past year alcohol, marijuana, and other drug use; and past year substance use, internalizing and externalizing problems. Results Compared to non-current tobacco users, current users were more likely to report alcohol or drug use (adjusted odds ratio (AOR)=2.6; 95% confidence interval (CI): 2.3, 2.9), with the strongest associations observed for cigarillo and hookah users. Across all tobacco product groups, users were more likely to report internalizing (AOR=1.9; 95% CI: 1.7, 2.1), externalizing (AOR=1.6; 95% CI: 1.5, 1.8), and substance use (AOR=3.4; 95% CI: 2.9, 4.1) problems than non-users. Gender moderated many of these associations and, of these, all non-cigarette tobacco product associations were stronger among females. Conclusions This nationally representative study of U.S. adults is the first to comprehensively document tobacco use, substance use, and mental health comorbidities across the range of currently available tobacco products, while also demonstrating that female tobacco users are at increased risk for substance use and mental health problems. These findings may point to gender differences in vulnerability and suggest that interventions incorporate gender-specific approaches.