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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.

Adolescents and young adults continue to use e-cigarettes, and communication campaigns are needed to decrease use among these populations. We developed and tested a point-of-sale communication campaign focused on e-cigarette chemical exposure. We developed messages based on formative research and tested them (versus text-only messages) in a nationally-representative online survey among adolescents and young adults (16–25) (Phase 1). Based on survey findings, we selected a message focused on nicotine and brain development for the point-of-sale trial (Phase 2). We then conducted a cluster-randomized trial at six gas stations with convenience stores, randomly assigned to the intervention (messages displayed) or no message control condition. We conducted intercept surveys with repeated cross-sectional samples of 50 participants (ages 16–25) per store, at baseline and a four-week follow-up. Phase 1 included 1,636 participants in the online study. Intervention messages were rated as more attention grabbing than plain text messages (p <.05), though were rated similarly on other outcomes. Exposure to intervention messages resulted in larger changes from pre- to posttest for beliefs about addiction and relative harms versus cigarettes (p <.05). Phase 2 included 586 participants in the point-of-sale study. Real-world campaign exposure was low (31.8%), and no differences were found between conditions. E-cigarette prevention messages focused on nicotine's impact on brain development show promise. However, garnering attention for communication campaigns in saturated point-of-sale environments, often dominated by tobacco advertising, is challenging. Future efforts should utilize additional communication channels to directly target adolescents and young adults. [ABSTRACT FROM AUTHOR]

Flavor additives are commonly used in combustible tobacco products to mask harshness and increase appeal. However, research on the availability of flavored waterpipe tobacco (WT) is lacking, yet is important to support implementation of policies. We completed a comprehensive online search in 2020 to identify WT brands and flavors sold online in the USA. We conducted a descriptive content analysis categorizing flavors as explicit (i.e., clear taste/flavor) or concept (i.e., no clear taste/flavor); and coded for 23 flavor descriptors (e.g., fruit, mint/menthol, tobacco). Flavor names were double-coded and discrepancies were resolved by a third coder. We identified 66 WT brands with 118 product lines (i.e., sub-brands). We found 2953 flavors, including 1871 unique flavors. Brands averaged 45 flavors (range: 1–183). Almost three quarters (73.5%, n = 2171) used explicit flavor names and 26.5% (n = 782) used concept flavor names. Concept flavors varied widely, and included names such as 1001 Nights and California Dream. The most common flavor descriptors were fruit (54.1%) and mint/menthol (12.5%). Tobacco was rarely (0.2%) used as a flavor descriptor. Flavor descriptors also included location (10.7%), color (11.1%), candy (6.3%), cool/ice (5.3%), and alcohol (5.5%). WT is available in 1871 unique flavors, likely contributing to product appeal and use. Like other tobacco products, fruit and mint/menthol are common flavors. Given the significant health consequences associated with WT smoking and the role of flavors in product use, regulatory action specifically targeting WT flavors is urgently needed. [ABSTRACT FROM AUTHOR]

Objective: Colleges have implemented policies to limit tobacco use on-campus; however, the off-campus environment is often overlooked in tobacco control efforts. We assessed availability, marketing, and promotion of cigarettes, snus, and traditional smokeless tobacco (SLT) in a sample of communities surrounding 11 college campuses in North Carolina and Virginia. Participants: Between January-March of 2011, 2012 and 2013, 481 tobacco-selling retailers, including convenience stores, pharmacies and supermarkets, located near campuses were assessed. Methods: Trained observers completed annual point-of-sale assessments. Results: The percentage of stores selling (81.4% to 58.6%; p < 0.0001) and advertising snus (80.1% to 53.11%; p < .0001) significantly decreased over time. Convenience stores increased promotions of cigarettes (65.4% to 72.8%; p = 0.04) and SLT (3.1% to 23.3%; p = 0.02). Conclusions: Off-campus environments have abundant tobacco availability and marketing. Colleges should collaborate with state and local tobacco control advocates to address tobacco promotion near campuses to potentially decrease product appeal and access among young adults.

Introduction We examined awareness and perceptions of the US Food and Drug Administration (FDA) JUUL marketing denial order (MDO) that occurred in June 2022 among a nationally representative sample of US adolescents. Aims and Methods Data were collected in August 2022 via an online survey (n = 1603). Adolescents were asked whether they had heard about the JUUL MDO, and, if yes, where they heard the news. Those who had heard were asked about the MDO's impact on their harm beliefs about JUUL and vape products in general. We examined correlates of awareness of the MDO and of increased JUUL and vape harm perceptions. Results Twenty-seven percent of adolescents had heard about the MDO. Older adolescents (adjusted odds ratio [aOR] = 1.13) and LGBTQ+ adolescents (aOR = 2.05) had significantly higher odds of having heard the news, while those who identified as Black or African American had significantly lower odds of having heard (aOR = 0.56). Most participants who were aware of the MDO indicated that they had higher harm perceptions about JUUL itself (77.9%) and vapes in general (79.6%). Youths susceptible to vaping and current users were less likely to report increased harm perceptions about JUUL (B = − 0.34 and − 0.46, respectively) and vapes in general (B = − 0.27 and − 0.43) compared with youth not susceptible to vaping. Conclusions The results of this nationally representative survey demonstrate that over one-quarter of US youth heard about the JUUL MDO and the vast majority of those indicated increased harm perceptions about vapes. Large-scale news events about vaping can reach youth audiences and may impact what youth think about the harms of vaping. Implications Analysis of a nationally representative survey of adolescents aged 13–17 revealed that more than 25% had heard about the marketing denial order issued to JUUL Labs by the FDA in June of 2022. We also found that the vast majority of adolescents reported increased JUUL and vape harm perceptions in response to hearing about the MDO. This indicates that news coverage about vaping—including coverage of regulatory actions—can reach and potentially impact adolescents. It is therefore important to monitor news coverage about vaping, how it is framed and discussed across media platforms, and its reach among priority populations. [ABSTRACT FROM AUTHOR]

Objective: Smokeless tobacco (SLT) use is associated with specific adverse health effects. Knowledge of student tobacco use, including SLT, may guide inquiry into other risky health behaviors, and provide opportunities for health education of students. Design: An incentivized email invitation to complete a web-based survey was sent to students at 11 colleges and universities in North Carolina and Virginia. Methods: In autumn 2010, emails were sent to all first-year students (n = 29,536) at 11 colleges and universities in North Carolina and Virginia, inviting them to participate in a brief web-based survey to be used to establish a cohort for the parent study evaluating tobacco use over 4 years. Survey items elicited demographic characteristics, tobacco use and other health behaviors. Results: A total of 10,520 (36%) students responded. Past 30 day smoking and SLT use were 12% and 3%, respectively. Logistic regression analysis revealed that male gender (Adjusted Odds Ratio [AOR] = 11.6, 95% Confidence Interval [CI] = 8.16-16.59); current smoking (AOR = 5.5, 95% CI = 4.21-7.10), ever use of alcoholic energy drinks (AOR = 4.8, 95% CI = 3.63--6.43), and = 5 days vs. < 3 days of physical activity a week (AOR = 1.5, 95% CI = 1.07-2.01) predicted risk of past 30 day SLT use. Conclusion: While SLT use is relatively uncommon, knowledge of significant correlations between student tobacco use, including SLT and other risky health behaviors, might guide clinicians' inquiry and provide opportunities for health education of students.

Background: Patient portals can be an innovative and efficient way to engage patients in advance care planning (ACP). However, comprehension and judgment in older adults with cognitive impairment presents several barriers and challenges to engaging in new technology. Our objective was to develop an ACP portal-based tool (ACPVoice) for community-dwelling persons living with cognitive impairment (PLCI) by engaging end-users in the design process. Methods: Two rounds of cognitive interviews were conducted to identify and resolve cognitive issues related to comprehension, judgment, response, and to assess content validity. Purposive sampling was used with the goal of enrolling 15 different participants (five with mild cognitive impairment and five dyads (those with mild dementia and their care partner) in each round to assess respondents' understanding of questions related to advance care planning to be administered via the patient portal. Results: Twenty PLCI (mean age 78.4, 10 females [50%]) and ten care partners (mean age 60.9, 9 females [90%]) completed cognitive interviews between May 2021 and October 2021. The mean Mini-Mental State Examination score for PLCI was 25.6 (SD 2.6). Unclear wording and undefined vague and/or unfamiliar terms were the major issues identified. Revisions to item wording, response options, and instructions were made to improve question comprehension and response as well as navigational ease. Conclusion: Minor changes to the wording, format, and response options substantially improved respondents' ability to interpret the item content of the ACPVoice tool. Dissemination and implementation of the ACPVoice tool could help to engage community-dwelling PLCI in ACP discussions. [ABSTRACT FROM AUTHOR]

Many adolescents and young adults hold erroneous beliefs that cigarillos and waterpipe tobacco (WT) are safer than cigarettes, contributing to use. Communication campaigns can correct misperceptions and increase risk beliefs. We tested point-of-sale (POS) communication campaigns focused on chemical exposure for cigarillos and WT. We conducted two cluster randomized trials at 20 gas stations with convenience stores (10 stores for cigarillos, 10 for WT) in North Carolina between June and November 2017. Within each trial, stores were randomly assigned to either the intervention (campaign messages displayed) or a no message control condition. We conducted intercept surveys with repeated cross-sectional samples of 50 adolescents and young adults (ages 16–25) per store, at baseline and follow-up. There were 978 participants (mean age = 20.9 years) in the cigarillo trial, and 998 participants (mean age = 21.0 years) in the WT trial. Rates of campaign exposure were low (26% for cigarillos; 24.3% for WT). The cigarillo campaign increased knowledge that ammonia is in cigarillo smoke (p <.01). There were also significant increases in knowledge about ammonia and cyanide in cigarillo smoke and arsenic in WT smoke (p <.05) in the sub-sample who reported exposure to the campaign. No differences were found in outcome expectancies, product attitudes, worry about chemical exposure, or behavioral intentions in either campaign. Garnering attention for communication campaigns in saturated POS environments, often dominated by tobacco advertising, is challenging. Our study demonstrates the feasibility of anti-tobacco campaigns at the POS and points to several lessons learned for future POS campaigns. [ABSTRACT FROM AUTHOR]

Objectives: To explore demographics, contextual factors, and health risk behaviors associated with nondaily smoking by college students. Methods: In fall 2005, a random sample of 4100 students completed an online survey. Results: Of those surveyed, 29% reported current smoking; of that 29%, 70% were nondaily smokers. Compared to daily smokers, nondaily smokers were younger, African American (compared to white), had mothers with higher education, belonged to Greek organizations, and attended private (vs public) schools. Nondaily smokers were less likely to have used illicit drugs. Conclusions: Nondaily and daily smokers differed on several demographic and contextual factors, but reported mostly similar health risk behaviors.

Objective: To examine use of and interest in cessation strategies among nondaily and daily college student smokers. Participants: 800 undergraduate student smokers aged 18 to 25. Methods: The authors examined nondaily versus daily smoking in relation to use of and interest in cessation strategies using an online survey. Results: Nondaily (65.8%) versus daily smokers (34.3%) were more likely to have made a quit attempt (p = 0.01) but less likely to have used any assistance (p less than 0.001). Nondaily smokers were less interested in pharmacotherapy and traditional behavioral interventions; however, there was no difference in interest in technology-based interventions among nondaily versus daily smokers. Controlling for covariates, there were no significant differences in interest in traditional or technology-based behavioral interventions. Higher motivation, lower confidence, and depressive symptomatology were related to interest in each intervention. Smoking for social reasons was related to interest in technology-based interventions. Conclusions: Different intervention strategies may be appropriate for nondaily and daily smokers. (Contains 3 tables.)

Objective: This study assessed college students' reports of tobacco screening and brief intervention by student health center providers. Participants: Participants were 3,800 students from 8 universities in North Carolina. Methods: Web-based survey of a stratified random sample of undergraduates. Results: Fifty-three percent reported ever visiting their student health center. Of those, 62% reported being screened for tobacco use. Logistic regression revealed screening was higher among females and smokers, compared to nonsmokers. Among students who were screened and who reported tobacco use, 50% reported being advised to quit or reduce use. Brief intervention was more likely among current daily smokers compared to current nondaily smokers, as well as at schools with higher smoking rates. Screening and brief intervention were more likely at schools with lower clinic caseloads. Conclusions: Results highlight the need to encourage college health providers to screen "every patient at every visit" and to provide brief intervention for tobacco users. (Contains 4 tables.)