Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-Menthol Cigarettes

Introduction The Food and Drug Administration (FDA) announced its intention to reduce the nicotine content in cigarettes as a strategy to promote cessation and reduce smoking-related harm. A low nicotine product standard will apply to all cigarettes on the market, including menthol cigarettes. In December 2021, the FDA approved a modified risk tobacco product application for menthol and non-menthol flavoured very low nicotine cigarettes (VLNC) from the 22nd Century Group. Notably, experimentation with menthol cigarettes is linked to smoking progression, as well as greater nicotine dependence relative to non-menthol cigarette use. If menthol VLNCs are perceived as more appealing than non-menthol VLNCs, this would indicate that some aspect of menthol may maintain smoking even in the absence of nicotine and FDA’s regulatory authority to ban or restrict the sale of menthol cigarettes should apply to reduced nicotine content of cigarettes. In April 2022, the FDA announced proposed rulemaking to prohibit menthol cigarettes, however it is unclear if a menthol prohibition would apply to VLNCs. Methods and analysis This study will recruit 172 young adult menthol smokers (with a specific subsample of n=40 sexual and gender minority young adults) and measure appeal for smoking experimental menthol and non-menthol VLNCs, and the impact of proposed product standards on tobacco product purchasing behaviour using an Experimental Tobacco Marketplace. Appeal across product standards will be assessed in a controlled laboratory and using ecological momentary assessment. Ethics and dissemination The protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#11865). Findings will examine the effects of a reduced nicotine standard and a menthol ban on young adult smoking and will be disseminated through peer-reviewed journal articles and presentations at scientific conferences. Trial registration number NCT04340947

Effects of Very Low Nicotine Content Cigarettes on Smoking Behavior and Biomarkers of Exposure in Menthol and Non-menthol Smokers.

IntroductionBecause 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a nicotine reduction policy.MethodsIn a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low nicotine cigarettes (VLNC; 0.4 mg nicotine/g tobacco) or normal nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of nicotine content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence.ResultsAt baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps < .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition.ConclusionsAlthough menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers.ImplicationsResults of this analysis suggest that smokers of menthol cigarettes may respond to a nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes

Longitudinal latent class analysis of tobacco use and correlates among young adults over a 10-year period.

INTRODUCTION: We assessed patterns and correlates, including demographic characteristics, psychological factors, and social role transitions, of young adults tobacco use over time. METHODS: In the fall of 2010, we recruited a cohort of 3146 students from 11 colleges in North Carolina and Virginia. Participants completed baseline and at least two survey waves between 2010 and 2019. RESULTS: The sample was 49.8% female, 15.7% non-white, and 6.6% Hispanic. Longitudinal latent class analysis revealed a five-class model with distinct patterns and correlates of tobacco use. Limited Use (52.6% of sample) had minimal use. College-Limited Combustible Tobacco Users (18.6%) had moderate probability of cigarette, cigar, and waterpipe smoking, which decreased to no use post-college. Intermittent Sustained Polytobacco Users (10.9%) had low probability of use that continued post-college. College Polytobacco with Continued Cigarette and E-Cigarette Users (14.5%) had high probability of use of cigarette smoking and increasing probability of e-cigarette, both of which continued post-college. Sustained Polytobacco Users (5.7%) had moderate probability of use of tobacco products across all waves. CONCLUSIONS: Patterns of tobacco use varied considerably. In most classes, tobacco use was highest during freshman year and in three classes, use continued post-college. Prevention activities should focus on first-year students and target those at risk for post-college tobacco use

Reactions to using other nicotine and tobacco products instead of menthol cigarettes: A qualitative study of people who smoke menthol cigarettes in the United States

The US Food and Drug Administration is considering banning menthol cigarettes, which could result in some people who smoke menthol cigarettes switching to other tobacco products (OTPs). This qualitative study explored reactions to using OTPs instead of menthol cigarettes. People who smoke menthol cigarettes (N=40) completed a behavioral economic assessment of the effects of menthol cigarette price increases on OTP purchasing. At the highest price, most participants could not afford menthol cigarettes. Instead, they could purchase non-menthol cigarettes, little cigars/cigarillos (LCCs), e-cigarettes, smokeless tobacco, or medicinal nicotine, or they could abstain from tobacco use. Participants used the OTPs they purchased for three days. During follow-up sessions, participants (n=35) completed semi-structured interviews discussing their purchasing-decisions and experiences using OTPs instead of menthol cigarettes. Interviews were analyzed using reflexive thematic analysis methods. Factors influencing purchasing decisions included flavor, price, prior use of OTPs, interest in trying new OTPs, and perceived ability to satisfy nicotine cravings. Participants described positive experiences using e-cigarettes including the “refreshing” menthol flavor, ability to use in places where cigarettes are prohibited, and convenience of use relative to smoking. Among those using non-menthol cigarettes, many reported they were acceptable but less satisfying products compared to menthol cigarettes while others reported negative reactions to them such as tasting like “cardboard”. Reactions to smoking LCCs were mostly unfavorable but participants said it gave them “something to light”. Multiple considerations may affect switching to OTPs in light of pending menthol cigarette regulation including the availability of menthol-flavored alternatives and (dis)satisfaction with OTPs

Psychometric Analysis of a Microenvironment Secondhand Smoke Exposure Questionnaire

Background: We conducted a psychometric analysis of an adapted secondhand smoke (SHS) questionnaire by testing the three-component structure of the original scale that measures SHS exposure in home, work and social environments. Methods: The 15-item questionnaire was administered to 839 daily smokers participating in a multi-site randomized controlled trial. Following parallel analysis, we conducted a confirmatory factor analysis specifying a three-factor structure. Cronbach’s alphas and fit indices were calculated to assess internal consistency. Criterion validity was assessed by comparing the Social environments subscale to the Brief Wisconsin Inventory of Smoking Dependence Motives Social/Environmental Goads subscale. Predicative validity of the questionnaire was assessed using linear regressions and tobacco biomarkers of harm; NNAL, expired carbon monoxide and total cotinine. Results: Five items did not load onto any factor and were dropped, resulting in a 10-item questionnaire. The Cronbach’s alphas were (0.86), (0.77) and (0.67) for the Work, Social, and Home subscales, respectively. The WISDM subscale was moderately correlated with scores on the Social subscale (r = 0.57, p < 0.001). The questionnaire demonstrated predictive validity of smoke exposure above individual’s own reported use as measured by cigarettes smoked per day. Conclusions: Three constructs emerged; results indicate that a shortened 10-item scale could be used in future studies

Risk Perceptions of Low Nicotine Cigarettes and Alternative Nicotine Products across Priority Smoking Populations

Background: As the U.S. Food and Drug Administration considers a low nicotine product standard for cigarettes, it is important to examine how people who smoke, especially individuals from priority populations disproportionately affected by smoking, perceive low nicotine content (LNC) cigarettes and their relative risk perceptions of alternative nicotine delivery system (ANDS) products, including e-cigarettes and snus, and medicinal nicotine. Methods: Data are from Wave 4 (2016–2017) of the adult Population Assessment of Tobacco Use and Health (PATH) Study. We examined respondents’ absolute risk perceptions about nicotine, LNC cigarettes, ANDS products and medicinal nicotine; their relative risk perceptions of LNC cigarettes and ANDS products compared to conventional cigarettes; and their relative risk perceptions of medicinal nicotine compared to ANDS products. Results: The majority of respondents across priority smoking populations indicated snus, e-cigarettes, and LNC cigarettes were ‘about the same’ level of harmfulness or addictiveness as conventional cigarettes. The majority of respondents indicated e-cigarettes to be ‘about the same’ harmfulness as medicinal nicotine. Conclusions: Our study indicates that adults who smoke cigarettes generally have misperceptions about the harms of nicotine and the relative risks of ANDS products and such misperceptions exist regardless of their racial/ethnic identity, sexual orientation, and gender identity

“I actually finally feel like the cigarettes aren’t controlling me.” – Interviews with participants smoking very low nicotine content cigarettes during a residential study

BackgroundThe U.S. Food and Drug Administration (FDA) is considering a low-nicotine product standard for cigarettes. The purpose of this qualitative study was to explore participants' experiences after 72 hours of exclusively smoking very low nicotine content (VLNC) cigarettes.MethodsWe conducted a residential study during which participants who smoked cigarettes (N = 16) stayed in a smoking-friendly hotel for 5 days/4 nights. Participants only had access to VLNC cigarettes and were told the cigarettes had 97% less nicotine compared to conventional cigarettes. We conducted individual interviews with participants to assess their initial expectations about VLNC cigarettes, subjective experiences when smoking VLNC cigarettes, opinions regarding a low-nicotine product standard, and predicted use behavior if only VLNC cigarettes were available. Interviews were transcribed verbatim and analyzed using thematic analysis methods.ResultsSeveral participants expected, prior to trying VLNC cigarettes, to compensate for the reduced nicotine levels by smoking more cigarettes but were surprised when they did not increase their smoking. A subset of participants reported experiencing minor withdrawal symptoms, such as irritability and fatigue. Several participants reported feeling less dependent after exclusively smoking VLNC cigarettes. Most participants said they would smoke VLNC cigarettes if they were the only cigarettes available to purchase. Some also said that smoking VLNC cigarettes could help people taper down or quit smoking.ConclusionsHealth communication strategies are needed to inform people who smoke about what to expect from a low-nicotine product standard for cigarettes in order to maximize the public health impact of the policy and increase support

Effects of Very Low Nicotine Content Cigarettes on Smoking Behavior and Biomarkers of Exposure in Menthol and Non-menthol Smokers.

INTRODUCTION: Because 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a nicotine reduction policy. METHODS: In a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low nicotine cigarettes (VLNC; 0.4 mg nicotine/g tobacco) or normal nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of nicotine content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence. RESULTS: At baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps < .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition. CONCLUSIONS: Although menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers. IMPLICATIONS: Results of this analysis suggest that smokers of menthol cigarettes may respond to a nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes