Analysis of FDA's Vuse market authorisation: limitations and opportunities.

This special communication provides a physicians' critique of the US Food and Drug Administration (FDA)'s decision to authorise the Vuse Solo (Vuse) Premarket Tobacco Application (PMTA). The PMTA authorisation represents the first time that FDA has authorised an Electronic Nicotine Delivery System (ENDS) for marketing in the USA. Using the FDA Decision Summary, the special communication identifies significant unanswered public health and scientific questions that prevent the authors from reaching FDA's conclusion that Vuse meets the Appropriate for the Protection of the Public Health (APPH) standard. The authors recommend FDA suspend the market authorisation and use these questions to re-evaluate the PMTA, and to prospectively monitor whether Vuse meets APPH standard. The special communication advances the ENDS harm reduction conversation because it calls for national tobacco regulators to develop an epidemiological prediction of ENDS impact on the population and to expand the scope of their analysis to evaluate the impacts of ENDS on congenital birth defects, abuse liability and non-flavour drivers of youth usage. Through learning from the American experience regulating Vuse, national tobacco regulators around the globe will be better equipped to evaluate the impact of ENDS on the public health.

Reducing attractiveness of e-liquids: proposal for a restrictive list of tobacco-related flavourings.

OBJECTIVE: Electronic cigarettes are addictive and harmful, and flavour is a key factor determining their abuse liability. Both adult smokers and young non-smokers like sweet and fruity flavours in particular. In order to discourage e-cigarette use among youth, the Dutch government announced in 2020 to only allow tobacco flavours in e-liquids. We propose a restrictive list of flavourings that will only enable the production of e-liquids with a tobacco flavour. METHODS: We used e-liquid ingredient data notified via the European Common Entry Gate system before the government's announcement. First, we classified all e-liquids into flavour categories, and continued with the set of flavourings present in tobacco e-liquids. Five selection criteria related to prevalence of use, chemical composition, flavour description and health effects were defined to compile a restrictive list of tobacco flavourings. RESULTS: E-liquids marketed as having tobacco flavour contained 503 different flavourings, some with tobacco flavour, but also other (such as sweet) flavours. We excluded (1) 330 flavourings used in <0.5% of e-liquids, (2) 77 used less frequently in tobacco than in all e-liquids, (3) 13 plant extracts, (4) 60 that are sweet or not associated with a tobacco flavour and (5) 7 flavourings with hazardous properties. This resulted in a final list of 16 flavourings. CONCLUSIONS: Implementing this restrictive list will likely discourage e-cigarette use among youth, but could also make e-cigarettes less attractive as smoking cessation aid.

Reasons for using e-cigarettes among adults who smoke: comparing the findings from the 2016 and 2020 ITC Korea Surveys.

INTRODUCTION: Dual use of e-cigarettes and cigarettes is a growing usage pattern in adults, but little is known about the motivations underlying this trend. We investigated the reasons for e-cigarette use among adults who smoke, considering variation in sociodemographic subgroups. METHODS: This repeated cross-sectional study analysed adults who smoked at least weekly and vaped at any frequency. Data were from the International Tobacco Control Korea Surveys conducted in 2016 (n=164) and 2020 (n=1088). Fourteen reasons for e-cigarette use were assessed in both waves. Subgroup analyses were performed by age, sex and educational level. RESULTS: The top reasons for e-cigarette use in 2020 were curiosity (62.8%), less harmful than smoking (45.4%) and taste (43.2%). Curiosity was the most cited across age, sex and education subgroups. Significant differences were observed in 2020 compared with 2016, with lower percentages in goal-oriented reasons: helping quit smoking (36.3% vs 48.9%; p=0.017), helping cut down smoking (35.3% vs 52.7%; p=0.001), less harmful to others (39.0% vs 54.6%; p=0.003) and more acceptable (31.6% vs 61.2%; p<0.001). By contrast, non-goal-oriented reasons showed higher percentages in 2020, such as curiosity (62.8% vs 27.9%; p<0.001), taste (43.2% vs 22.1%; p<0.001) and enjoyment (26.8% vs 8.6%; p<0.001). In 2020, a majority of adults who smoked and vaped (53.3%) reported no intention to quit or reduce smoking. CONCLUSIONS: E-cigarette use for curiosity and pleasure predominated among adults who smoked. The reasons for dual use in adults have shifted from goal-oriented to non-goal-oriented.

Hidden flaws in e-cigarette industry-funded studies.

Electronic cigarette (e-cigarette) use has increased since e-cigarettes were introduced to the market nearly 20 years ago. Researchers continue to conduct studies to understand the health risks and benefits of e-cigarettes to inform health education and promotion efforts as well as public policy. Studies funded by the tobacco industry examining the potential risks and benefits of e-cigarettes have also been conducted and are sometimes published in the scientific literature. Frequently, tobacco and e-cigarette industry-funded researchers report findings that contradict research funded by other sources. While many industry-funded studies may appear methodologically sound at first glance, in some cases, industry-funded studies include methodological flaws that result in misleading conclusions. The tobacco industry's use of biased research to influence tobacco-related policy decisions in the past is well-documented. This commentary provides specific examples of recent e-cigarette research funded by the tobacco/e-cigarette industry in which methodological flaws result in misleading conclusions that support industry goals. Given the long history of biased research conducted by the tobacco industry, there is a need to assess whether research funded by the e-cigarette industry similarly contains methodological flaws. We emphasise the need for tobacco and e-cigarette-funded research to be scrutinised by non-industry-funded subject matter experts and call for journals to not consider manuscripts that have received support from the tobacco or e-cigarette industry.

Perceptions of and responses of young adults who use e-cigarettes to flavour bans in China: a qualitative study.

BACKGROUND: China has banned all flavoured e-cigarettes to reduce e-cigarette use among young people, but little is known about the views and reactions of people who use e-cigarettes. This study explored the perceptions of, and responses by, young adults who use e-cigarettes to the flavour ban. METHODS: Semistructured interviews were conducted with 25 Chinese young adults aged 18-25 years who had used e-cigarettes daily in the past 3 months. Thematic analysis was used to analyse the interview data. FINDINGS: Four themes were identified from the data: (1) understanding of the public health benefits, (2) resistance to and misperceptions of the flavour ban, (3) circumvention of the flavour ban and (4) acceptance of the flavour ban. Some participants expressed support for the ban due to perceived public health benefits, while others who resisted the ban emphasised their right to choose preferred flavours and questioned the rationale behind the policy. Participants responded to the flavour ban by utilising a variety of adaptive strategies, including purchasing flavoured e-cigarettes through illegal channels or exploring alternative ways to obtain flavours. Those who complied with the ban responded with different strategies, including switching back to combustible cigarettes, using tobacco-flavoured e-cigarettes, or quitting vaping. CONCLUSIONS: The findings suggest the need for comprehensive regulatory measures, including stringent enforcement measures, transparent health communication and vigilant monitoring of e-cigarette manufacturers' tactics, to reduce e-cigarette use among young adults.

Understanding the nicotine dose delivered by electronic nicotine delivery systems in a single puff: the importance of nicotine flux and puff duration.

Electronic nicotine delivery systems (ENDS) may lead to public health benefit if they help people who smoke quit smoking, and may lead to public health harm if they recruit a new generation of nicotine-dependent people. Regulators intent on maximising ENDS' public health benefit and minimising harm may be interested in regulating the nicotine dose delivered by ENDS in a single puff. The per-puff nicotine dose is the product of ENDS nicotine emission rate (or 'nicotine flux') and the duration of the puff taken by the person using the ENDS (or 'puff duration'). Nicotine flux can be measured or predicted mathematically for any ENDS device/liquid combination. Puff duration can be controlled electronically, as demonstrated by several ENDS marketed today. Combining nicotine flux and puff duration regulation is feasible today and provides authorities the means to limit nicotine dose per puff to a level that may help people who smoke quit smoking while reducing the possibility that nicotine-naive individuals will engage in repeated ENDS use. Tobacco regulatory science and product regulation will both be improved by a rigorous approach to understanding, characterising, and reporting the nicotine dose emitted by ENDS.

Building consensus on a set of ENDS-specific pictorial health warnings: a Delphi study among a tobacco control expert panel.

BACKGROUND: This study reports on the development of pictorial health warning labels for electronic nicotine delivery system (ENDS) using the Delphi approach with a panel of tobacco control experts. Twenty-four evidence-based ENDS-specific warnings corresponding to three themes (toxicity, health risks and specific harm) were developed and used in the Delphi study. METHODS: We conducted a three-round online Delphi study among 60 experts (55% female) between June 2022 and April 2023. We balanced the panel in areas of expertise and positions relevant to ENDS (risks, benefits). In round 1, participants rated the warnings on attention, relevance to evidence and perceived effectiveness (harm perception, motivation to quit) and provided suggestions for improvement. In rounds 2 and 3, participants ranked the revised warnings based on importance in each theme. We assessed levels of agreement between participants using interquartile deviations and medians. RESULTS: Warnings in theme 1, toxicity, received the highest ratings for perceived effectiveness on harm perception and encouraging quitting ENDS (p<0.05). Experts recommended using clear and affirmative text paired with emotion-provoking pictures and avoiding the rare side effects of ENDS. Most of the top-ranked warnings were from theme 3, ENDS-specific harm, pertained to lung damage, dual use of ENDS and cigarettes, nicotine addiction among youth, anti-ENDS industry sentiment and toxicity. DISCUSSION: This study developed 24 evidence-based ENDS health warning labels using a systematic process that included several rounds of expert panel feedback. These warnings can be used to advance ENDS prevention and tobacco control policies and further target different populations.

Characteristics of and engagement with URL resources shared among online vaping communities on Reddit.

INTRODUCTION: Reddit is a popular social media platform for sharing information about vaping. Little is known about the types of external resources that Reddit users in vaping communities share and engage with. METHODS: We analysed 2315 posts containing uniform resource locators (URLs) published to vaping communities on Reddit between November 2021 and October 2022. We coded URLs into eight mutually exclusive domain types. A mixed-effects Poisson regression model examined whether domain type was associated with user engagement (ie, number of unique commenters). RESULTS: Posts contained links to social media (35%), image hosting (31%), vaping-related commerce (19%), eJuice (12%), general vaping (6%), news (2%) and research (1%) URL domains. There were 237 unique vaping-related commerce domains (eg, ziipstock.com). The average number of commenters per post was 5.43 (SD=8.04). The rate of commenters was higher for posts sharing research (adjusted rate ratio (aRR) 1.74, 95% CI 1.28 to 2.36) and news (aRR 1.56, 95% CI 1.02 to 2.38) domains compared with vape-related commerce domains. CONCLUSION: Reddit users in vaping communities share and interact with a variety of external resources. The >200 different vaping-related commerce domains in our sample speak to the breadth and availability of websites that Reddit users (perhaps even those underage) may be using to browse and purchase vaping devices.

Associations between tobacco 21 and state flavour restrictions with young adult tobacco use.

BACKGROUND: States have recently enacted tobacco-related age and flavour restrictions in addition to federal T21 laws. Little is known about the independent effects of these policies on young adult tobacco use. METHODS: Linking 2011-2022 Behavioural Risk Factor Surveillance System data on 2 696 870, 18-59 years from 50 states and DC with policy data, we conducted probit regression models to evaluate the associations between state and federal T21 laws and state flavour restrictions with cigarettes, electronic nicotine delivery system (ENDS) and smokeless tobacco use. Models were adjusted for sociodemographics, additional tobacco policies, COVID-19-related factors, year and state. We tested two-way and three-way interactions between age, state T21 and federal T21 laws. RESULTS: Although we did not find evidence that state T21 laws were associated with cigarette, smokeless tobacco or ENDS use overall, the federal T21 law was associated with lower use of all three tobacco products by 0.39-0.92 percentage points. State flavour restrictions were associated with lower use of cigarettes by 0.68 (-1.27 to -0.09) and ENDS by 0.56 (-1.11 to -0.00) percentage points, but not with smokeless tobacco. A three-way interaction revealed that state and federal T21 laws together were associated with a lower prevalence of ENDS use among 18-20 years, but there were no differences in cigarette use from both policies combined versus either alone. CONCLUSION: State and federal T21 laws are broadly effective at reducing adult tobacco use, while state flavour restrictions specifically lower use of cigarettes and ENDS.

Effects of liquid nicotine concentration and flavour on the acceptability of electronic nicotine delivery systems (ENDS) among people who smoke participating in a randomised controlled trial to reduce cigarette consumption.

BACKGROUND: Research is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking. METHODS: People who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction. RESULTS: Participants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups. CONCLUSIONS: Both nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.