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The Tobacco Regulatory Science Program is a collaborative research effort between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). In 2013, the NIH funded 14 Tobacco Centers of Regulatory Science (TCORS), which serve as partners in establishing research, training, and professional development programs to guide FDA. Each of the fourteen TCORS, and two other NIH-funded research programs, the Center for the Evaluation of Nicotine in Cigarettes (CENIC) and the Consortium on Methods Evaluating Tobacco (COMET), pursued specific research themes relevant to FDA's priorities. A key mandate for FDA is to reduce tobacco use among young people. This article is a review of the peer-reviewed research, including published and in-press manuscripts, from the TCORS, CENIC, and COMET, which provides specific data or other findings on youth (ages 10-18 years) and/or young adults (ages 18-34 years), from 2013 to 2018. Citations of all TCORS, CENIC, and COMET articles from September 2013 to December 2017 were collected by the TCORS coordinating center, the Center for Evaluation and Coordination of Training and Research. Additional citations up to April 30, 2018 were requested from the principal investigators. A scoring rubric was developed and implemented to assess study type, primary theme, and FDA priority area addressed by each article. The major subareas and findings from each priority area are presented. There were 766 articles in total, with 258 (34%) focusing on youth and/or young adults. Findings relevant to FDA from this review concern impact analysis, toxicity, health effects, addiction, marketing influences, communications, and behavior.ImplicationsThe Tobacco Centers of Regulatory Science, CENIC, and COMET have had a high output of scientific articles since 2013. These Centers are unique in that the FDA supports science specifically to guide future regulatory actions. The 258 articles that have focused on youth and/or young adults are providing data for regulatory actions by the FDA related to the key priority areas such as the addictiveness of non-cigarette products, the effects of exposure to electronic cigarette marketing on initiation and cessation, and the impact of flavored products on youth and young adult tobacco use. Future regulations to reduce tobacco use will be guided by the cumulative evidence. These Centers are one innovative mechanism to promote important outcomes to advance tobacco regulatory science.

Background: Although use of Electronic Nicotine Delivery Systems (ENDS) is increasingly prevalent among young adults, little is known about predictors of ENDS initiation among this population. Aims: We examined the roles of the social environment (i.e., peer ENDS use and household ENDS use), normative beliefs (i.e., social acceptability of ENDS use), and attitudes (i.e., inclination to date someone who uses ENDS) in prospectively predicting initiation of ENDS over a 1-year period among 18- to 29-year-old college students. Method: Participants were 2,110 (18- to 29-year-old) students (M = 20.27, SD = 2.17) from 24 colleges in Texas who participated in a three-wave online survey, with 6 months between each wave. All participants reported never using ENDS at baseline. A multivariable, multilevel logistic regression model, accounting for clustering of students within colleges, was used to assess if students' social environment, normative beliefs, and attitudes predicted subsequent initiation of ENDS up to 1 year later, adjusting for various sociodemographic factors and number of other tobacco products used. Results: In all, 329 college students (16%) initiated ENDS within 1 year. Results from the logistic regression indicated that college students who were younger (18-24 years old), ever used other tobacco products, indicated a more dense peer network of ENDS users, and had a higher inclination to date someone who uses ENDS had higher odds of initiating ENDS than their peers. Conclusion: Preventing ENDS initiation should be included in college health promotion programs, which should highlight the roles of students' social environment and attitudes regarding ENDS use.

This study examined multiple risk behaviors (violence, delinquency, and substance use) among 240 African American and 262 Hispanic preadolescent boys from urban schools in the Midwest United States. Latent transition analysis allowed patterns of multivariate risk to emerge uniquely within and across these ethnic groups, highlighting patterns for subgroups that are overlooked by common aggregate statistics. Results revealed four risk classes for each ethnic group, with nuanced probabilities of endorsement and transition across classes and ethnic groups. Involvement with police and more severe use of substances were distinguishing factors of higher risk classes. African American boys showed a tendency to transition between risk classes over time, while Hispanic boys tended to exhibit stability. Personal involvement in school and community action among parents were highlighted as protective factors. Suggestions for prevention programming based on results include early timing, addressing criminal justice involvement, providing academic enrichment programs, and promoting community action among parents.

Objective: The purpose of this study is to examine differences between current and non-current cigarette users, focusing on sociodemographic factors, non-cigarette tobacco product use, parental and friend use, and alcohol and marijuana use; and to identify predictors of cigarette use six months later. Participants: Participants included young adults (n = 4,296) from 24 Texas colleges, participating in a young adult cohort study, beginning in fall 2014. Methods: Mixed effects logistic regressions were conducted accounting for school-level variability. Results: Cigarette users were older, more likely to report use of non-cigarette tobacco products and peer use of cigarettes than non-current users. Wave 1 cigarette and non-cigarette tobacco product use, marijuana use and binge drinking, and peer use all uniquely predicted cigarette use at wave 2. Conclusions: Colleges need prevention programs targeting multiple tobacco products, because non-cigarette tobacco use and other risky behaviors appear to be independent risk factors for cigarette use in young adults.

The Minnesota Drug Abuse Resistance Education (DARE) Plus project augmented the DARE curriculum with community, parent involvement, and extracurricular activity components. Of the 24 schools in the DARE Plus project, the 8 receiving the DARE Plus intervention are examined in this study. The association of participation in the extracurricular activities component of the DARE Plus project with adolescent substance use is investigated. The intervention targeted the class of 2005 from seventh to eighth grade (1999-2001). As part of the intervention, students participated in extracurricular activities planned by peer leaders, and annual surveys measured substance use and psychosocial outcomes. After 2 years students overall and boys participating in extracurricular activities had significantly less alcohol use and fewer intentions to use alcohol than did nonparticipants. Asian American participants had significantly less tobacco use and fewer intentions to use tobacco compared with nonparticipants. The results suggest an association between extracurricular activity participation in DARE Plus and lower rates of substance use, especially among boys, and suggest that such participation can be helpful for youth of varying ethnicities. Further research is needed to more rigorously evaluate this association using an experimental design. (Contains 2 tables and 1 figure.)

Background: Computerized surveys present many advantages over paper surveys. However, school-based adolescent research questionnaires still mainly rely on paper-and-pencil surveys as access to computers in schools is often not practical. Tablet-assisted self-interviews (TASI) present a possible solution, but their use is largely untested. This paper presents a method for and our experiences with implementing a TASI in a school setting. Methods: A TASI was administered to 3907 middle and high school students from 79 schools. The survey assessed use of tobacco products and exposure to tobacco marketing. To assess in-depth tobacco use behaviors, the TASI employed extensive skip patterns to reduce the number of not-applicable questions that nontobacco users received. Pictures were added to help respondents identify the tobacco products they were being queried about. Results: Students were receptive to the tablets and required no instructions in their use. None were lost, stolen, or broken. Item nonresponse, unanswered questions, was a pre-administration concern; however, 92% of participants answered 96% or more of the questions. Conclusions: This method was feasible and successful among a diverse population of students and schools. It generated a unique dataset of in-depth tobacco use behaviors that would not have been possible through a paper-and-pencil survey.

Background: As conventional cigarette use is declining, electronic cigarette ("e-cigarette") use is rising and is especially high among college students. Few studies examine dual use of e-cigarettes and cigarettes among this population. This study explores the relationship between dual and exclusive e-cigarette / cigarette use and perceptions of harm and addictiveness of both products. Methods: This is a cross-sectional analysis of data from students attending 24 colleges in Texas (n = 5,482). Multinomial logistic regression was employed to test the association between current e-cigarette / cigarette use and perceived harm and addictiveness of both products. Three tobacco groups were included: cigarette only users, e-cigarette only users, and dual users. Results: Dual users reported lower perceived harm of e-cigarettes most consistently (p<0.001, all comparisons). Perceived harm of cigarettes was significantly lower among cigarette only and dual users only, compared to non-users (p<0.001, all comparisons). Compared to non-users, all three groups reported significantly lower perceived addictiveness of e-cigarettes (p<0.001, all comparisons). The same finding was observed for perceived addictiveness of cigarettes, though findings were less consistent for the e-cigarette only group (p<0.02, all comparisons except one). Conclusion: Findings demonstrate that among college students, perceptions of harm and addictiveness of e-cigarettes are lower than those for conventional cigarettes. For both products, perceptions of harm and addictiveness were lower among exclusive and dual users, compared to non-users.

Objective: To examine the associations between sensation seeking and ever and current e-cigarette use in Texas young adults (18-29 years old). Current cigarette use was examined as a potential effect modifier of the associations. Participants: Participants included college students enrolled in four-year and two-year colleges in four metropolitan areas in Texas (n = 5,418) who completed the survey between November 2014 and February 2015. Methods: This cross-sectional study utilized mixed effects logistic regression to determine the associations between mean sensation seeking scores and ever and current e-cigarette use after controlling for covariates. Results: After controlling for covariates, significant associations between sensation seeking and both ever and current e-cigarette use were observed; however, these associations were significant for noncurrent smokers only (adjusted odds rations [AOR] = 1.55, 95% confidence interval (CI) = 1.39, 1.73; AOR = 1.82, 95% CI = 1.54, 2.15, respectively). Conclusions: Sensation seeking is an important factor in identifying college students who may be at increased risk for e-cigarette use behaviors.

To test the efficacy of an intervention to reduce tobacco use among youth (10-19 years old) in slum communities in Delhi, India. This community-based cluster-randomized trial included 14 slums composed of purposely built resettlement colonies and adjacent inhabitant-built Jhuggi Jhopris. Youth in the intervention received a 2 year multiple-component intervention: (a) youth and adult leader training; (b) peer-led interactive activities and outreach; (c) tobacco cessation camps; and (d) enforcement of India's Tobacco Control Law (smoke-free environments and youth access). Overall, no differences between the intervention and control conditions were observed over time; self-reported tobacco use declined in both groups. However, when stratified by type of residence, a significant decrease was observed among youth in the resettlement colonies in the intervention group for overall tobacco use (slope = -0.69) and cigarette and bidi smoking (slope = -0.66), compared to an increase in the control group (slope = 0.24 and 0.12, respectively) (P < 0.001). No differences in smokeless tobacco (SLT) use were observed for either group. Comprehensive community-based interventions that engage youth can be effective in reducing smoking among disadvantaged youth in India. More intensive interventions, like tax increases or large-scale media campaigns, appear warranted for the most marginalized in this context and for SLT products.