A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol.

BACKGROUND: Menthol cigarette use remains a large public health problem and disproportionately affects Black adults in the United States. The Food and Drug Administration has proposed prohibiting menthol flavor in cigarettes to protect public health. However, e-cigarettes are available in menthol flavor and are a popular alternative product adults might switch to if menthol is prohibited in cigarettes. Research is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes could impact cigarette use among adults who smoke menthol cigarettes. METHODS: We will recruit 150 adults who currently smoke menthol cigarettes and will randomize them to 1 of 3 conditions modeling different regulatory scenarios. We will recruit equal numbers of participants identifying as Black vs. non-Black and will stratify randomization by race. To promote standardization and adherence, cigarette and e-cigarette products will be provided for 8 weeks based on the assigned condition: (A) no menthol restriction (menthol cigarette and menthol flavored e-cigarette), (B) menthol prohibited in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), (C) menthol prohibited in both cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up visit will occur at week 12 to assess tobacco use status. The study aims are to (1) examine the impact of prohibiting menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) investigate whether outcomes differ by race to understand the impact of menthol policies on Black (vs. non-Black) individuals given high rates of menthol cigarette use in this population. The primary outcome will evaluate changes in the number of cigarettes smoked per day during the 8-week study period and will examine differences by regulatory scenario. Secondary outcomes will compare percent days smoke-free, changes in nicotine dependence, and motivation, confidence, and intentions to quit smoking by the regulatory scenarios. We will examine whether changes in the outcomes differ by Black vs. non-Black participants to compare the magnitude of the effect of the various menthol policy scenarios by race. DISCUSSION: Results will contribute critical information regarding menthol in cigarettes and e-cigarettes to inform regulatory policies that maximize reductions in cigarette smoking and reduce tobacco-related health disparities. TRIAL REGISTRATION: NCT05259566. Yale IRB protocol #2000032211, last approved 12/8/2023.

The Scientific Basis for the Regulation of Flavors in Tobacco Products.

Effective tobacco policies are important for reducing the harm of tobacco use and can have a broad impact at the population level. This review provides an overview of how clinical science can inform tobacco policies with a focus on policies related to flavored tobacco products, using menthol cigarettes as an illustrative example. Specifically, this review summarizes the role of flavors in tobacco use and the history of regulation of flavored tobacco products by the US Food and Drug Administration (FDA), provides an overview of clinical research methods used to contribute to the scientific evidence to inform FDA tobacco policies, discusses key findings related to menthol tobacco products using these methods, and proposes future directions for clinical research. As the tobacco marketplace continues to evolve with new products and flavor chemicals, ongoing clinical science will be essential for establishing evidence-based policies to protect public health and reduce tobacco-related health disparities.

Importance of Various E-Cigarette Device and E-Liquid Characteristics by Smoking Status among Young Adults Who Vape.

BACKGROUND: E-cigarette product characteristics are known to influence appeal among young adults. Understanding which characteristics appeal to individuals with (vs. without) a history of combusted tobacco use is essential for developing effective tobacco control policies. METHODS: Anonymous, self-report data were collected from young adults (18-30 years) who had used e-cigarettes in the past 30 days (n = 295) online via Prolific from September-October 2019. Using a visual analogue scale (range: 0-100), participants rated the importance of ten e-cigarette device and nine e-liquid characteristics. Adjusted linear regression models were used to evaluate the association of combusted tobacco use status (never, former, current) with mean rating scores for each of the nineteen characteristics. RESULTS: The most important e-cigarette device characteristics were price (Mean = 81.1; [SD = 17.9]), size (Mean = 75.5 [SD = 20.9]), and hit strength (Mean = 73.8 [SD = 20.4]) while the most important e-liquid characteristics were flavor (M = 85.1 [SD = 16.3]), price (M = 80.9 [SD = 18.4]), and nicotine level (M = 77.8 [18.9]). Differences by combusted tobacco use status were observed for device brand, temperature/voltage, customizability, color, and popularity, with the highest ratings generally observed among those concurrently using combustible tobacco products. For e-liquids, differences by use status were observed for flavor, price, and bottle type. Notably, those concurrently using combusted products rated flavor as less important than those with no history of combustible tobacco use (B=-5.01[95%CI=-9.97, -0.05]). CONCLUSIONS: The self-rated importance of e-cigarette device and e-liquid attributes varies by combustible tobacco use status among young adults which may be used to inform regulatory decisions regarding e-cigarette product characteristics.

A review of research on cigarette smoking in Preventive Medicine in recognition of the journal's 50th anniversary.

This report reviews the literature on cigarette smoking published in Preventive Medicine over the past 50 years. The goal is twofold. First, to acknowledge the 50th anniversary of Preventive Medicine and its role in disseminating research on cigarette smoking by providing an abridged summary of smoking research published in the journal from inception through June 23, 2022. Second, to review experimental reports to identify contributions to innovations in tobacco control and regulatory efforts to reduce cigarette smoking. We searched PubMed using the search terms cigarette/cigarettes, tobacco products, smoking, smoking cessation, Preventive Medicine. Titles and abstracts were reviewed in duplicate, excluding reports not addressing cigarette smoking. Included reports were categorized by study type (original study, commentary, review). Experimental articles were assessed for impact using iCite, a National Institutes of Health web application that provides bibliometric information for articles in defined topic areas. The review identified 1181 articles on cigarette smoking: 1018 original studies (86.2%), 107 literature reviews (9.1%), and 56 commentaries (4.7%); 166 of the 1018 original studies (16%) were experimental reports. In the iCite analysis these 166 experimental articles received 6366 total citations, a mean (standard error) citation rate/article of 38.35 (±3.21) and mean relative citation ratio of 1.85 (±0.17) which is at the 73rd percentile for NIH-funded field- and time-normalized reports. Overall, this review demonstrates an ongoing and impactful contribution of Preventive Medicine to efforts to reduce cigarette smoking, the most preventable cause of premature death.

Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes.

The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.

Behavior change, health, and health disparities 2022: Innovations in tobacco control and regulatory science to decrease cigarette smoking.

This Special Issue of Preventive Medicine (PM) is the 9th in a series on behavior change, health, and health disparities. This topic is critically important to improving population health. Unhealthy lifestyles including substance misuse, unhealthy food choices, physical inactivity, and non-adherence with medical regimens are important preventable causes of chronic disease and premature death. This year we focus on cigarette smoking, which continues to have devastating health impacts including more than 8 million annual premature deaths globally and 480,000 in the U.S. where most of the research reported in this Special Issue was conducted. While the introduction of new tobacco products into the marketplace like electronic nicotine delivery systems (ENDS) demands attention, it is essential that we remain focused on the enormous challenges involved in eliminating cigarette smoking. This Special Issue examines innovations in tobacco control and regulatory science aimed towards reducing cigarette smoking. Discussion of new tobacco products is largely limited to their role in this overarching aim of reducing combusted cigarette use. We discuss important innovations in tobacco control (e.g., digital text-based interventions, ENDS-assisted cessation, financial incentives) and regulatory science (e.g., nicotine reduction in cigarettes, flavor bans). Throughout, attention is given to the important topic of disparities in terms of understanding the uneven adverse impacts of cigarette smoking and efforts to eliminate it, and the critical importance of researching vulnerable populations. Across these topics we have recruited contributions from accomplished investigators, clinicians, and policymakers to acquaint readers with recent advances while also noting knowledge gaps and unresolved challenges.

Leveraging the cigarette purchase task to understand relationships between cumulative vulnerabilities, the relative reinforcing effects of smoking, and response to reduced nicotine content cigarettes.

We examined if the relative-reinforcing effects of smoking increase with greater cumulative vulnerability and whether cumulative vulnerability moderates response to reduced nicotine content cigarettes. Participants were 775 adults from randomized clinical trials evaluating research cigarettes differing in nicotine content (0.4, 2.4, 15.8 mg/g). Participants were categorized as having low (0-1), moderate (2-3), or high (≥4) cumulative vulnerability. Vulnerabilities included rural residence, opioid use disorder, affective disorder, low educational attainment, poverty, unemployment, and physical disability. We used the cigarette purchase task (CPT) to assess the relative-reinforcing effects of participants' usual-brand cigarettes at baseline and study cigarettes during the 12-week trial. The CPT is a behavioral-economic task wherein participants estimate likely smoking (demand) over 24 h under escalating cigarette price. Demand is characterized by two factors: Amplitude (demand volume at zero/minimal price) and Persistence (demand sensitivity to price). Greater cumulative vulnerability was associated with greater demand Amplitude (F[2709] = 16.04,p < .0001) and Persistence (F[2709] = 8.35,p = .0003) for usual-brand cigarettes. Demand Amplitude for study cigarettes increased with increasing cumulative vulnerability (F[2619] = 19.59, p < .001) and decreased with decreasing nicotine content ([4879] = 5.45, p < .001). The only evidence of moderation was on demand Persistence (F[8867] = 2.00,p = .04), with larger reductions at the 0.4 mg/g compared to 15.8 mg/g doses among participants with low compared to moderate or high cumulative vulnerability. The relative-reinforcing effects of smoking clearly increase with greater cumulative vulnerability. Reducing nicotine content would likely reduce demand Amplitude across cumulative-vulnerability levels but reductions in demand Persistence may be more limited among those with greater cumulative vulnerability.

Preliminary evidence on cigarette nicotine reduction with concurrent access to an e-cigarette: Manipulating cigarette nicotine content, e-liquid nicotine content, and e-liquid flavor availability.

The reinforcing characteristics of e-cigarettes could moderate the impact of reducing cigarette nicotine content. In this study, people who smoke daily were recruited from North Carolina and Pennsylvania (US) in 2018 and 2019. Within a randomized 2 × 2 × 2 factorial design, participants received investigational cigarettes and an e-cigarette for 12 weeks. Cigarette nicotine content was very low (0.4 mg/g of tobacco; VLNC) or normal (15.8 mg/g; NNC). E-liquids were 0.3% ("low") or 1.8% ("moderate") freebase nicotine, and available in tobacco flavors or tobacco, fruit, dessert and mint flavors. Study recruitment concluded before reaching the planned sample size (N = 480). Fifty participants were randomized and 32 completed the study. We found that randomization to VLNC, relative to NNC cigarettes, reduced self-reported cigarettes per day (CPD; mean difference: -12.96; 95% CI: -21.51, -4.41; p = 0.005); whereas e-liquid nicotine content and flavor availability did not have significant effects. The effect of cigarette nicotine content was larger in the moderate vs. low nicotine e-liquid groups and in the all flavors versus tobacco flavors e-liquid groups; tests of the interaction between e-liquid characteristics and cigarette nicotine content were not significant. Biomarkers of smoke exposure at Week 12 did not differ across conditions, which may reflect variability in adherence to only using VLNC cigarettes. In conclusion this study offers preliminary evidence that the extent to which cigarette nicotine reduction decreases smoking may depend on the reinforcing characteristics of alternative products, including the available nicotine contents and flavors of e-cigarettes.

The actual and anticipated effects of restrictions on flavoured electronic nicotine delivery systems: a scoping review.

OBJECTIVE: To synthesize the outcomes of policy evaluations of flavoured electronic nicotine delivery systems (ENDS) restrictions. DATA SOURCES: PubMed, Scopus, Embase and Web of Science before May 3, 2022. STUDY SELECTION: Studies that report sales, behaviour, or compliance outcomes related to implemented or hypothetical ENDS flavour restrictions. DATA EXTRACTION: Restriction details, whether implemented or hypothetical, whether additional products were restricted, jurisdictional level, study locations, and outcomes classified by sales, behaviour, and compliance. DATA SYNTHESIS: We included 30 studies. Of those, 26 were conducted exclusively in the US, two in India, and two surveyed respondents in multiple countries, including the US. Twenty-one evaluated implemented restrictions, while nine considered hypothetical restrictions. Five studies evaluated product sales, 17 evaluated behaviour, and 10 evaluated compliance, with two studies reporting multiple outcomes. Two studies reported an increase and one a reduction in cigarette sales following restrictions, while three reported reductions in ENDS sales. Behavioural studies presented a mixed view of the impacts of regulations on ENDS and cigarette use. However, the use of disparate outcomes limits the comparability of studies. Studies of hypothetical restrictions suggest decreased ENDS use, increased cigarette use, and increased use of illicit markets. Studies of compliance with flavoured product restrictions that included ENDS found that 6-39% of stores sold restricted flavoured products post-restrictions. Online stores remain a potential source of restricted products. CONCLUSION: Our findings highlight the need for additional research on the impacts of ENDS restrictions. Research should further evaluate the impact of restrictions on youth and adult use of nicotine and tobacco products in addition to the effects of restrictions in countries beyond the US to enable a robust consideration of the harm-benefit trade-off of restrictions.

A review of tobacco regulatory science research on vulnerable populations.

In 2013 the U.S. Food and Drug Administration and National Institutes of Health established fourteen Tobacco Centers of Regulatory Science (TCORS) to advance scientific knowledge relevant to conducting evidence-based tobacco regulation. This report reviews TCORS-funded research with adult vulnerable populations. The literature search included a list of all TCORS-funded publications compiled by the TCORS coordinating center; all TCORS were requested to share publications not in the coordinating-center's list. Only TCORS-funded reports describing an empirical study with an adult vulnerable population published in a peer-reviewed journal between September 2013 and June 2018 were included. 71 reports met inclusion criteria; 39% (28/71) examined tobacco use among those with mental health and medical comorbidities, 34% (24/71) socioeconomic disadvantage, 31% (22/71) women of reproductive age, 30% (21/71) racial/ethnic minorities, 18% (13/71) rural residents, and 3% (2/71) each among active military/veterans and sexual/gender minorities. Regarding scientific domains, 63% (45/71) investigated behavior, 37% (26/71) addiction, 24% (17/71) health effects, 20% (14/71) impact analyses, 18% (13/71) toxicity, 8% (6/71) marketing influences, and 7% (5/71) communications. Totals exceed 100% because some reports addressed multiple populations/domains. TCORS funding has generated a substantial, multidisciplinary body of new scientific knowledge on tobacco use in adult vulnerable populations. However, considerable variability was noted in the amount of research conducted across the various vulnerable populations and scientific domains. Most notably, relatively few studies focused on active military/veterans or sexual/gender minorities, and the scientific domains of marketing influences and communications were conspicuously underrepresented. These are important knowledge gaps to address going forward.

Young adult dual combusted cigarette and e-cigarette users' anticipated responses to hypothetical e-cigarette market restrictions.

Introduction: The aim of this exploratory study was to assess young adult dual e-cigarette (EC) and combusted cigarette (CC) users' anticipated responses to hypothetical market restrictions regarding key EC characteristics. Methods: Data came from 240 young adult dual EC and CC users recruited via Amazon Mechanical Turk in June 2017. Descriptive statistics were used to report sociodemographic, CC smoking, and EC use characteristics. McNemar's chi-square tests and chi-square tests were used to assess differences between groups in terms of anticipated responses to hypothetical EC market restrictions. Results: Hypothetical regulations resulted in reported intentions to reduce EC use and increase CC use; the greatest impact was found for restrictions regarding e-liquid nicotine content, followed by flavor and ability to modify EC devices. Moreover, individuals reporting use of flavored e-liquid, high nicotine content e-liquid, and customizable EC were most likely to report intentions to reduce EC use and increase CC use. Conclusions: This work provides preliminary evidence that restrictive regulations regarding key EC characteristics may increase intentions to increase CC use among young adult dual EC and CC users.

Editorial: 5th Special Issue on behavior change, health, and health disparities.

This Special Issue of Preventive Medicine (PM) is the 5th in a series on behavior change, health, and health disparities. Unhealthy behavior patterns (i.e., lifestyle choices) including cigarette smoking and other substance abuse, physical inactivity, unhealthy food choices, and non-adherence with recommended medical regimens, undermine U.S. population health by increasing risk for chronic disease and premature death. This Special Issue brings together scholarly contributions from the emerging area of tobacco regulatory science to examine current topics of critical importance to reducing the burden of cigarette smoking on U.S. population health. More specifically, three related topics are examined including (a) the potential for reducing smoking by adopting a national policy that would cap the nicotine content of cigarettes at minimally-addictive levels; (b) increasing scientific understanding of cigarette smoking and other tobacco use among populations that are especially vulnerable to initiating smoking, tobacco addiction, and its adverse health consequences; and (c) the potential of a harm-reduction strategy for reducing the burden of smoking by advocating that those who are unwilling or unable to quit nicotine use substitute electronic cigarettes or other non-combusted sources of nicotine for cigarettes in order to avoid exposure to the other toxins in tobacco smoke that are most responsible for smoking morbidity and mortality. While tremendous progress has been made in reducing overall U.S. smoking prevalence and its adverse health impacts, more needs to be done. This Special Issue offers some ideas that have the potential to make a substantive contribution towards that goal.

Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.

Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation.

Editorial: 3rd Special Issue on behavior change, health, and health disparities.

This Special Issue of Preventive Medicine (PM) is the 3rd that we have organized on behavior change, health, and health disparities. This is a topic of critical importance to improving U.S. population health. There is broad scientific consensus that personal behaviors such as cigarette smoking, other substance abuse, and physical inactivity/obesity are among the most important modifiable causes of chronic disease and its adverse impacts on population health. Hence, effectively promoting health-related behavior change needs to be a key component of health care research and policy. There is also broad recognition that while these problems extend throughout the population, they disproportionately impact economically disadvantaged populations and other vulnerable populations and represent a major contributor to health disparities. Thus, behavior change represents an essential step in curtailing health disparities, which receives special attention in this 3rd Special Issue. We also devote considerable space to the longstanding challenges of reducing cigarette smoking and use of other tobacco and nicotine delivery products in vulnerable populations, obesity, and for the first time food insecurity. Across each of these topics we include contributions from highly accomplished policymakers and scientists to acquaint readers with recent accomplishments as well as remaining knowledge gaps and challenges.

Examining longitudinal associations between initial perceptions and experiences with electronic nicotine delivery system (ENDS) use and use patterns among adults who smoke and recently initiated ENDS.

INTRODUCTION: Limited data exist on factors associated with concurrent use patterns of electronic nicotine delivery systems (ENDS) and cigarettes. We examined longitudinally perceptions and experiences with ENDS in relationship to concurrent use patterns among established, recent smokers who recently initiated ENDS. METHODS: Participant recruitment took place using paid digital advertisements on social media. Between December 2020 and October 2021, 303 adults aged ≥21 years from across the US who currently or recently smoked and had initiated ENDS use within the past 30 days or reinitiated ENDS use after more than one year of non-use were surveyed. Multinomial logistic regressions were conducted to analyze association between the outcome of current use pattern at follow-up at 1 month [rejectors (discontinued ENDS, continued smoking), primary smokers (concurrent users, mostly smoke), dual user (similar smoking and ENDS use), primary vapers (concurrent users, mostly vape), and switchers (discontinued smoking, continued using ENDS) or quitters (discontinued both smoking and ENDS] and perceptions of and experiences with ENDS predictors at baseline. RESULTS: At follow-up at 1 to 2 months after initiating ENDS, 20% were rejectors, 31% were primary smokers, 13% were dual users, 19% were primary vapers, and 17% were switchers/quitters. Perceiving ENDS as less harmful than smoking or being uncertain and as equally or more enjoyable smoking, experiencing a lot or complete reduction in cravings to smoking and in irritability with ENDS use, liking the taste of ENDS, and being satisfied with vaping were associated with higher odds of quitting smoking compared to rejecting ENDS or mostly smoking at follow-up at 1 month. CONCLUSIONS: Findings highlight the importance of initial ENDS perceptions and experiences when examining tobacco outcomes and potentially for developing policies and interventions targeting smoking cessation. ENDS initiators are differentiating into distinct use patterns based on these factors within a short period of time.

Restrictions of cigarette and e-cigarette flavor and filter ventilation on demand and substitution in the Experimental Tobacco Marketplace.

SIGNIFICANCE: Tobacco product design features, including flavors and cigarette filter ventilation, are subject to regulation. This study examined the effects of cigarette and e-cigarette flavors on demand and substitution by preferred cigarette flavor and ventilation in the Experimental Tobacco Marketplace (ETM). METHODS: In a mixed between-group (usual cigarette flavor and ventilation)/within-subject design (policy conditions), individuals who use tobacco (n=176 cigarette (60.5 % female); n=91 multiple products (26.7 % female)) were recruited using Ipsos and InnovateMR, completed purchasing trials with increasing cigarette prices in the ETM. Participants were exposed to four conditions in a 2×2 factorial design with cigarette flavors restricted or unrestricted and e-cigarette flavors restricted or unrestricted. RESULTS: In individuals who exclusively smoke cigarettes: 1) Cigarette menthol restrictions decreased willingness to purchase cigarettes (OR: 0.001; 95 % CI: 0.00002, 0.015) for individuals that prefer menthol cigarettes and increased willingness to purchase NRT (OR: 4.02; 95 % CI: 1.47, 11.0), 2) cigarette menthol restrictions reduced demand for cigarettes in individuals who smoke menthol cigarettes (p<0.001), 3) e-cigarette flavor restrictions reduced the degree of e-cigarette substitution in individuals who smoke menthol cigarettes (p=0.028), and 4) preference for higher cigarette filter ventilation was associated with higher demand for cigarettes (p=0.003) and lowered substitution of smokeless tobacco products (p=0.028). In individuals who use multiple tobacco products, restrictions did not impact product purchasing. CONCLUSION: Strategies to reduce flavored product sales and increase cessation resource accessibility may improve population health by reducing smoking and increasing NRT use in individuals who use menthol cigarettes.

Menthol preference moderates the relationship between cigarette nicotine content choice and reactions in young adults who smoke infrequently.

BACKGROUND: Half of young adults who smoke use menthol cigarettes, which is associated with continued smoking and greater nicotine dependence. Additionally, early subjective reactions to cigarettes predict future use. Menthol may blunt the sensory effects of nicotine. We investigated the moderating role of menthol on subjective reactions to, and choice of varied nicotine content cigarettes in young adults who smoke infrequently. METHODS: In three counterbalanced, double-blinded sessions, young adults who smoke ≤ 15 days/month smoked fixed doses from very low (VLNC), intermediate (INC), and normal (NNC) nicotine content cigarettes, which were menthol or non-menthol depending on preference. Participants chose their preferred cigarette in a final session. Positive and negative subjective reactions were measured in each session. ANOVA tests investigated the relationship between menthol preference, nicotine content, and subjective reactions. RESULTS: Participants (N = 87) were 18-25 years old and reported smoking 15.2 cigarettes per month over 8 days (35 % menthol). Non-menthol preferring participants had increased negative reactions with greater nicotine content (F(1, 55)= 10.76, p < .001); menthol preferring participants did not. Choice of higher nicotine cigarettes was associated with having reported a greater difference in positive reactions to NNC and VLNC for non-menthol preferring participants (F(1, 55)= 12.72, p < .001) but not for menthol preferring participants. CONCLUSIONS: Young adults who smoke infrequently are a priority tobacco control population given their high risk of transitioning to daily smoking. Results from this study in the form of subjective reactions indicate that a menthol ban is required for a nicotine reduction standard to be maximally effective in this vulnerable group.

Cognitive and emotional responses to pictorial warning labels and their association with quitting measures after continued exposure.

OBJECTIVE: Previous research has highlighted the role of cognitive and affective mediators in facilitating the effectiveness of pictorial warning labels (PWLs). This study examines smokers' responses towards PWLs after 10 days of use and their associations with changes in quitting attitudes, beliefs, and intentions during this period. METHODS: Non-treatment-seeking, daily smokers completed a randomized, parallel design trial. Participants were randomized to either a PWL or control (i.e., text only or no warning label) group and received their preferred brand cigarettes affixed with their assigned label for 10 days. We assessed quitting attitudes, intentions, and beliefs at the onset and end of the study. At study end, smokers rated their PWL on a 5-point scale for 8 cognitive and emotional attributes: memorable, understandable, shocking, informative, offensive, boring, relevant, and interesting. RESULTS: Mean ratings of the PWLs were high for memorable, understandable, informative, relevant, and interesting (range = 3.4 to 4.0), moderate for shocking (2.9), and low for offensive (1.7), and boring (1.5). Among the PWLs, quitting-related attitudes, positive beliefs, and intentions increased over the study period (p < .001) and these changes were positively associated with most attributes except offensive and boring (p < .05). For the text-only label group, attitudes and intentions increased significantly but these changes were not associated with any attributes. CONCLUSION: Smokers generally have favorable evaluations of PWLs following repeated exposures. Further, these evaluations are associated with increased quitting attitudes and intentions, which may facilitate cessation attempts over longer periods of exposure.

Fostering Tobacco Regulatory Team Science through a multisite, virtual fellowship program for early-career researchers.

INTRODUCTION: In an era of complex, multi-institutional, team-based science, there is little guidance for the successful creation of effective, collaborative, multisite training programs. OBJECTIVE: We designed, implemented, and evaluated a multi-institutional Tobacco Regulatory Science (TRS) fellowship representing a scalable program that may be customized for other research areas. METHODS: Using a mixed-methods approach, we analyzed program evaluations from trainees enrolled in the first 7 years of the American Heart Association (AHA) Tobacco Regulation and Addiction Center (A-TRAC) fellowship (2014-2021). We also reported the program outcomes, including published TRS manuscripts, independent grant funding, Food and Drug Administration (FDA) Docket comments submitted on TRS topics, TRS oral and poster presentations, research awards, and promotions in the TRS field. RESULTS: Thirty-five unique trainees (49% [n = 17] female, 29% [n = 10] Black) from eight institutions within the A-TRAC network participated in the fellowship since its inception. The trainees reported 74 TRS publications, 78 TRS oral or poster presentations, 25 FDA Docket comment submissions, and 13 funded grant awards. Participant evaluations indicated six areas of programmatic strength: 1) blended instruction medium with webinars and in-person meetings, 2) curricular emphasis on theories of experiential learning, 3) focus on career and professional development, 4) integrated mentorship model, 5) culture of feedback and feedforward to foster successful learning, and 6) focus on recruiting diverse participants. The A-TRAC model stresses experiential education, feedback and feedforward, and peer learning. CONCLUSIONS: Our resource-effective, needs-driven program is a reproducible model for institutions interested in developing multisite, virtual research education programs in the era of team science.

Examining the potential role of e-cigarettes to reduce health disparities associated with menthol cigarette use: Characterizing e-cigarette use, flavors, and reasons for use among US adults smoking menthol cigarettes.

INTRODUCTION: Menthol cigarette use contributes to disproportionate tobacco-related health disparities amongst minoritized race/ethnic groups. E-cigarettes are available in flavors such as menthol and may be a less harmful substitute among adults who smoke. Yet little is known about e-cigarette flavor preference and reasons for use by race/ethnicity among adults who smoke menthol cigarettes. METHODS: Nationally representative PATH wave 4 adult data (Dec. 2016-Jan. 2018) were used to examine how menthol cigarette status and race/ethnicity were associated with past 30-day e-cigarette use, flavors used, and reasons for use with adjusted logistic regression models. RESULTS: Menthol (vs. non-menthol) cigarette use was associated with higher odds of e-cigarette use (AOR=1.33, 95%CI=1.16-1.52). However, non-Hispanic (NH) Black and Hispanic individuals (vs. NH White) had lower odds of e-cigarette use (p's ≤ 0.004). In terms of flavor used, adults smoking menthol cigarettes and NH Black and Hispanic individuals had greater odds of using menthol/mint-flavored e-cigarettes (p's ≤ 0.02), and older adults (vs. 18-24-year-olds) had lower odds of using sweet-flavored e-cigarettes (p's < 0.0001). Regarding reasons for use, adults smoking menthol cigarettes had higher odds of reporting using e-cigarettes due to liking flavors (AOR=1.63, 95%CI=1.30-2.04), while NH Black adults had lower odds of liking flavors (AOR=0.64, 95%CI=0.43-0.96), and Hispanic adults had lower odds of using e-cigarettes to cut down on cigarette smoking (AOR=0.59, 95%CI=0.42-0.83). CONCLUSIONS: Findings suggest menthol flavored e-cigarettes may be important for adults who smoke menthol cigarettes, although racial disparities in current e-cigarette use and reasons for use may exacerbate tobacco-related health disparities.