The FDA's Diverse and Dynamic Activities in the Social and Behavioral Sciences: Advancing and Supporting Health Equity.

The U.S. encompasses a heterogenous mix of people and health disparities exist for various subpopulations, such as minorities, women, people with limited English proficiency, those with low socioeconomic status, and other underserved groups. Differences in health outcomes arise in part due to inequalities and injustices rooted in biological, social, and structural factors. Because the origins of health disparities are multifactorial, the approaches to reduce, or even eliminate them, must be multifactorial as well. The social and behavioral sciences are well poised to address the myriad and complex factors that affect health outcomes, including those at the individual level (eg, individuals' behaviors, attitudes, and beliefs), the neighborhood level (eg, housing), the community level (eg, cultural values and norms), and the policy level (eg, public policies that influence healthcare funding and access to healthcare resources and educational materials). In addition, the social and behavioral sciences (1) help equip government agencies with the perspectives and tools needed to promote health equity and (2) contribute to rigorous, evidence-based solutions for public health issues, such as disparities found in childhood vaccination rates, childhood obesity, tobacco use, and access to health information technology. The FDA, in particular, actively conducts social and behavioral sciences research to guide the Agency's efforts to advance and support health equity.

Menthol and Mint Cigarettes and Cigars: Initiation and Progression in Youth, Young Adults and Adults in Waves 1-4 of the PATH Study, 2013-2017.

INTRODUCTION: This study examined in youth (12-17 years), young adults (18-24 years), and adults (25+ years): (1) the prevalence of the first menthol cigarette and menthol/mint cigar use among new tobacco users; (2) association between the first menthol/mint use, subsequent tobacco use, and nicotine dependence ~1 year later compared with the first non-menthol/mint use. AIMS AND METHODS: Longitudinal analysis of data from Waves 1 to 4 of the Population Assessment of Tobacco and Health (PATH) Study (2013-2017; 10 086 youth and 21 281 adults). Main outcome measures were past 12-month and past 30-day cigarette and cigar use, and nicotine dependence. RESULTS: Youth and young adult new cigarette users are more likely to smoke a menthol cigarette or indicate that they do not know the flavor compared with adults aged 25+. A greater proportion of adults aged 25+ first used menthol/mint-flavored cigars (13.4%) compared with youth (8.5%) and young adults (7.4%). Among young adults, first use of a menthol cigarette is associated with past 12-month use of cigarettes at the subsequent wave and first use of any menthol/mint-flavored cigars is associated with past 30-day use of these products at the subsequent wave in both youth and young adults. In youth and adults, there were no significant relationships between first use of a menthol/mint cigarette or cigar and nicotine dependence scores at a subsequent wave in multivariable analyses. CONCLUSIONS: The first use of menthol/mint cigarettes and cigars is associated with subsequent cigarette and cigar use in young people aged 12-24. IMPLICATIONS: This study examined the relationship between initiation with menthol cigarettes and menthol/mint cigars, subsequent tobacco use, and nicotine dependence in US youth, young adults, and adults who participated in Waves 1-4 of the Population Assessment of Tobacco and Health study. New use of menthol cigarettes was associated with greater past 12-month cigarette use in young adults and new use of menthol/mint-flavored cigars was associated with greater past 30-day cigar use in youth and young adults compared with non-menthol use. Initiation with menthol/mint cigarette and cigar products may lead to subsequent use of those products.

Flavored Tobacco Product Use Among Middle and High School Students - United States, 2014-2018.

The 2009 Family Smoking Prevention and Tobacco Control Act prohibits the inclusion of characterizing flavors (e.g., candy or fruit) other than tobacco and menthol in cigarettes; however, characterizing flavors are not currently prohibited in other tobacco products at the federal level.* Flavored tobacco products can appeal to youths and young adults and influence initiation and establishment of tobacco-use patterns (1). The Food and Drug Administration (FDA) and CDC analyzed data from the 2014-2018 National Youth Tobacco Surveys (NYTS) to determine prevalence of current (past 30-day) use of flavored tobacco products, including electronic cigarettes (e-cigarettes), hookah tobacco, cigars, pipe tobacco, smokeless tobacco, bidis, and menthol cigarettes among U.S. middle school (grades 6-8) and high school (grades 9-12) students. In 2018, an estimated 3.15 million (64.1%) youth tobacco product users currently used one or more flavored tobacco products, compared with 3.26 million (70.0%) in 2014. Despite this overall decrease in use of flavored tobacco products, current use of flavored e-cigarettes increased among high school students during 2014-2018; among middle school students, current use of flavored e-cigarettes increased during 2015-2018, following a decrease during 2014-2015. During 2014-2018, current use of flavored hookah tobacco decreased among middle and high school students; current use of flavored smokeless tobacco, cigars, pipe tobacco, and menthol cigarettes decreased among high school students. Full implementation of comprehensive tobacco prevention and control strategies, coupled with regulation of tobacco products by FDA, can help prevent and reduce use of tobacco products, including flavored tobacco products, among U.S. youths (2,3).

Longitudinal associations between youth tobacco and substance use in waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: While evidence suggests bidirectional associations between cigarette use and substance (alcohol or drug) use, how these associations are reflected across the range of currently available tobacco products is unknown. This study examined whether ever tobacco use predicted subsequent substance use, and ever substance use predicted subsequent tobacco use among 11,996 U.S. youth (12-17 years) from Waves 1 (2013-2014) and 2 (2014-2015) of the Population Assessment of Tobacco and Health (PATH) Study. METHODS: Ever use of cigarettes, e-cigarettes, traditional cigars, cigarillos, filtered cigars, pipe, hookah, snus pouches, smokeless tobacco excluding snus pouches, dissolvable tobacco, bidis, kreteks, alcohol, marijuana, prescription drugs, and other drugs (cocaine and other stimulants, heroin, inhalants, solvents, and hallucinogens) was assessed at Wave 1 followed by past 12-month use assessments at Wave 2. The analyses included covariates (demographics, mental health, sensation seeking, prior use) to mitigate confounding. RESULTS: Ever tobacco use predicted subsequent substance use. The magnitude of the associations was lowest for alcohol, higher for marijuana, and highest for other drugs. Ever substance use also predicted subsequent tobacco use. Specifically, ever alcohol, marijuana, and non-prescribed Ritalin/Adderall use predicted tobacco-product use. Ever e-cigarette and cigarette use exclusively and concurrently predicted subsequent any drug (including and excluding alcohol) use. E-cigarette and cigarette use associations in the opposite direction were also significant; the strongest associations were observed for exclusive cigarette use. CONCLUSION: Tobacco and substance use prevention efforts may benefit from comprehensive screening and interventions across tobacco products, alcohol, and drugs, and targeting risk factors shared across substances.

Beliefs about FDA tobacco regulation, modifiability of cancer risk, and tobacco product comparative harm perceptions: Findings from the HINTS-FDA 2015.

Smokers who inaccurately believe that FDA evaluates cigarettes for safety hold lower harm perceptions of cigarettes compared to those who do not hold this belief. However, not much is known about associations between beliefs about FDA tobacco regulatory authority and comparative harm perceptions of tobacco products. Data were analyzed from the Health Information National Trends Survey, HINTS-FDA 2015 (N = 3738), which is a cross-sectional, probability-based, nationally representative survey of U.S. non-institutionalized civilian adults aged 18 years or older. Weighted multinomial and logistic regression analyses regressed comparative harm perceptions on sociodemographic factors, beliefs about FDA regulatory authority, perceptions of FDA credibility, and beliefs about modifiability of cancer risk (behavioral cancer causal beliefs and cancer fatalism). Findings indicate that, compared to non-users, current tobacco users are more likely to report believing that e-cigarettes are less harmful than cigarettes, to report believing that some cigarette types may be less harmful than others, and to report believing that tobacco products are safer now than they were five years ago. Awareness of FDA regulatory authority was associated with reporting the belief that tobacco products are safer now than five years ago, that e-cigarettes are less harmful than cigarettes, and that some cigarette types are less harmful than other cigarette types. Believing behavior as a cause of cancer and endorsing cancer fatalism were associated with uncertainty of comparative harm perceptions. Communication efforts can help target inaccurate beliefs by raising awareness about regulation of tobacco products as well as the risks of tobacco products.

E-cigarette curiosity among U.S. middle and high school students: Findings from the 2014 national youth tobacco survey.

Curiosity is a potential risk factor for electronic cigarette (e-cigarette) use, which has increased considerably among US youth in recent years. We examined the relationship between curiosity about e-cigarettes and perceived harm, comparative addictiveness, and e-cigarette advertisement exposure. Data came from the 2014 National Youth Tobacco Survey, a nationally representative survey of U.S. middle and high school students. In 2014, 2.5% of middle school and 9.2% of high school students currently used cigarettes, while 3.9% of middle school and 13.4% of high school students reported current e-cigarette use. Among never e-cigarette users (n=17,286), descriptive statistics assessed curiosity about e-cigarettes by combustible tobacco use, sex, race/ethnicity, and school level. Associations between curiosity and perceived harm (absolute and comparative to cigarettes), comparative addictiveness, and e-cigarette advertising exposure were explored using multivariate models in 2015. Among youth who never used e-cigarettes, 25.8% reported curiosity about e-cigarettes. Higher levels of perceived absolute harm and comparative harm were associated with lower levels of curiosity, while no association was observed between comparative addictiveness and curiosity. Among never combustible tobacco users, the odds of high curiosity were greater among non-Hispanic blacks (odds ratio (OR): 1.39; 95% confidence interval (CI):1.02-1.88), Hispanics (OR=1.79; 95% CI:1.48-2.16), and non-Hispanic 'Other' (OR=1.47; 95% CI:1.15-1.89) race/ethnicities than non-Hispanic whites. One-quarter of middle and high school students who have never used e-cigarettes are curious about the products, with greater curiosity among those with lower perceptions of harm from these products. These findings may help inform future strategies aimed at reducing curiosity about e-cigarettes among youth.