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Correspondence to Professor Sven Eric Jordt, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA; sven.jordt@duke.edu Background In February 2021, the popular vaping company, PuffBar, started selling disposable e-cigarettes in the USA containing synthetic nicotine, claiming to be exempt from federal and state laws regulating products containing tobacco-derived nicotine.1 US lawmakers responded to the emerging synthetic nicotine market by clarifying that synthetic nicotine products are subject to the US Food and Drug Administration’s (FDA) regulatory regimen for tobacco products.1–3 As of 14 April 2022, the FDA has been authorised to regulate tobacco products containing nicotine from any source, including laboratory synthesis, requiring manufacturers to submit a premarket tobacco product application (PMTA).3 In October 2022, the FDA sent a warning letter to the company, alerting the owners that its products are ‘marketed unlawfully and are subject to enforcement action at FDA’s discretion’.4 5 Currently, the company appears to be selling Puffbar-branded e-cigarette products without nicotine only.6 While many countries have updated their tobacco product laws to cover synthetic nicotine, or are in the process of doing so, a recent WHO report warned that non-nicotine tobacco alkaloids or synthetic nicotine analogues could be used by manufacturers to bypass regulatory schemes focusing on nicotine alone.2 Non-nicotine tobacco alkaloids such as anabasine, nornicotine, anatabine and myosmine have well-known addictive and reinforcing effects.7–10 Starting in the 1970s, tobacco companies also developed various synthetic nicotine analogues and studied whether they could be used to dissociate nicotine’s central and peripheral effects, to create more desirable products, to circumvent regulation or to develop pharmaceuticals.11 The tobacco companies, however, never used these synthetic nicotine analogues in commercial products until now. Another patent, assigned to Shanghai Lingnuo Biotech, includes human studies in which e-cigarette users were asked to rate the ‘throat hit’ and other psychophysical qualities of e-cigarette aerosol containing 6-methyl nicotine.20 In one of these studies, 1 mg/mL 6-methyl nicotine was found to be as satisfying as 3 mg/mL nicotine and to produce a similar ‘throat hit’, with the authors concluding that ‘6-methyl nicotine can be used for replacing nicotine in electronic aerosolisation’.20 Only 10 test subjects participated in this study, with unknown background, with puffing protocols not mentioned, and with no statistical analysis provided. An abstract presented by a US-based chemical analytical services company at a recent tobacco industry conference describes a method for the quantification of 6-methyl nicotine and detected its presence in e-liquids, confirming efforts by the industry to market such products.33 Given the growing activity from several industry groups, we expect that additional 6-methyl nicotine-containing products will be marketed in the USA soon. 6-methyl nicotine: regulatory challenges and solutions Are products containing 6-methyl nicotine, differing from nicotine by a methyl group, subject to the PMTA requirement and the other provisions of the US Tobacco Control Act (TCA), or are they indeed ‘PMTA exempt’? If the FDA concludes that 6-methyl nicotine is a ‘complex’ of nicotine and takes enforcement action against Spree Bar or other similar products, the manufacturers would likely challenge that determination in court.36 Other jurisdictions define the term

IntroductionIllicit smokeless tobacco (ST) trade has seldom been documented despite ST use in at least 127 countries across the world. Based on non-compliance with packaging regulations, we report the proportion of illicit ST products from samples on sale in Bangladesh, India and Pakistan where 85% of global ST users reside.MethodsWe purchased unique ST products from tobacco sellers in two purposively selected administrative areas (division/district) in each of the three countries. The criteria to determine illicit ST products were based on country-specific legal requirements for ST packaging and labelling. These requirements included: ‘market retail price disclosure’, ‘sale statement disclosure’, ‘pictorial health warning (PHW) pertinence’, ‘appropriate textual health warning’ and ‘using misleading descriptors (MDs)’. Non-compliance with even one of the legal requirements was considered to render the ST product illicit.ResultsAlmost all ST products bought in Bangladesh and India were non-compliant with the local packaging requirements and hence potentially illicit, all products in Pakistan lacked desirable features. The most common feature missing was health warnings: 84% packs in Bangladesh, 93% in India, and 100% in Pakistan either did not have PHW or their sizes were too small. In Bangladesh, 61% packs carried MDs. In India and Pakistan, the proportions of such packs were 32% and 42%, respectively.ConclusionsWeak and poorly enforced ST control policies may be slowing the progress of tobacco control in South Asia. Standardised regulations are required for packaging and labelling ST. Improving compliance and reducing sale of cheap illicit products may require business licensing and market surveillance.

BackgroundThe endgame literature recommends that, for a tobacco sales ban to be successful, several demand-side preconditions (eg, low prevalence and effective cessation support) should be in place. The South African Government imposed a ban on the sale of all tobacco and vaping products between 27 March and 17 August 2020, as part of the COVID-19 lockdown.ObjectivesTo assess how cigarette smokers responded to the sales ban, to evaluate how the ban impacted the cigarette market in South Africa and to use the South African experience to inform endgame planning.MethodsRegular preban cigarette smokers completed an online questionnaire from 4 to 19 June 2020 (n=23 631), in which they reported on their prelockdown cigarette smoking patterns, quitting behaviour (if relevant) and smoking behaviour during the ban.ResultsAbout 9% of prelockdown smokers in the sample successfully quit smoking. 93% of continuing smokers purchased cigarettes despite the sales ban. The average price of cigarettes increased by 250% relative to prelockdown prices. Most respondents purchased cigarettes through informal channels.ConclusionsThe demand-side preconditions for an effective sales ban were not in place in South Africa, making a sales ban inappropriate. The South African experience suggests that supply-side factors are also important in ensuring the success of a sales ban. These are: (1) the illicit market must be under control before implementing a sales ban; and (2) an effective sales ban needs to be synchronised with a ban on the manufacture, transport and distribution of cigarettes.

BackgroundIllicit trade in tobacco products is a menace to the goal of eliminating tobacco consumption. Although tax policy is very effective in reducing consumption, illicit trade can reduce (though not eliminate) its effectiveness.MethodsThis article discusses the recent evolution of illicit trade and the context in which it occurred; the new methods that have been developed to measure it and, finally, the challenges in the next phase in the control of illicit trade.ResultsThere has been a remarkable stability in the penetration of cigarette illicit trade in the past decade. Such a stability, however, occurred in a world of shrinking tobacco consumption, implying a decreasing absolute illicit trade. Most countries have progressed in increasing tobacco taxes and changing tax structures. Prices of illicit cigarettes follow legal cigarette prices. Concomitantly, many new studies, independent from the tobacco industry, have been conducted allowing for better understanding of the illicit trade and providing inputs to its solution. The entry into force of the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products provides both a global and a national policy framework to further curb illicit trade. Instruments such as track-and-trace systems must be promoted and adopted to maximise reductions in illicit trade.ConclusionsGlobal efforts to curb the illicit trade in tobacco products are gaining momentum and progress has been made in many parts of the world. The next decade can witness a decisive decrease in tobacco consumption, both licit and illicit, if countries further engage in international collaboration.

ObjectiveTo examine the features of markets for loose cigarettes in several low-income and middle-income countries and their effects on tobacco control policies, particularly taxation.DesignAn analysis of survey data targeting people who smoke in two African, one Southeast Asian and two South Asian countries and retailers across 16 African countries to study loose cigarette markets and examine how prices in these markets move relative to the prices for cigarette packs.ResultsMarkets for loose cigarettes are large, and their consumer base tends to differ from the wider population of people who smoke. Loose cigarette prices are on average higher than those of cigarettes bought in packs, and they respond differently to tax increases, at least partially due to a denomination effect.ConclusionsThe features of the loose cigarette markets present a challenge for tobacco control policy, especially tobacco tax policy. One way to overcome this challenge is to aim for large, rather than incremental, tax increases.

BackgroundMenthol cigarettes have been banned in Great Britain (GB) since May 2020. Still, menthol accessories and unlabelled cigarettes perceived as mentholated are available, and people can buy menthol cigarettes overseas or illicitly. This study assessed: trends in smoking menthol cigarettes among all adults and 18–24-year-olds in GB between October 2020 and March 2023; trends in and differences between England, Scotland and Wales during the same period and purchase sources among people smoking menthol versus non-flavoured cigarettes.MethodsPopulation-weighted data were from a monthly cross-sectional survey of adults in GB. Among people smoking cigarettes, we calculated the proportion smoking menthol cigarettes across all adults and 18–24-year-olds, and prevalence ratios (PR) between the first and last quarter. We also calculated the proportions of people smoking menthol/non-flavoured cigarettes by purchase source (including illicit sources).ResultsIn the first quarter, 16.2% of adults smoking cigarettes reported menthol cigarette smoking with little to no decline throughout the study (PR 0.85, 95% CI 0.71 to 1.01), while it declined among 18–24-year-olds (PR 0.75, 95% CI 0.63 to 0.89). The prevalence of menthol cigarette smoking fell by two-thirds in Wales (PR 0.36, 95% CI 0.19 to 0.62) but remained relatively stable in England (PR 0.88, 95% CI 0.72 to 1.06) and Scotland (PR 0.94, 95% CI 0.59 to 1.53). The main purchasing sources were licit (93.9%), 14.8% reported illicit sources and 11.5% cross-border purchases, without notable differences from people smoking non-flavoured cigarettes.ConclusionsRoughly one million adults in GB still smoke menthol cigarettes and, with the exception of Wales and young people, there were no noteworthy changes in the post-ban period. There was no indication that the overall persistence of menthol smoking was driven by illicit purchases.

ObjectiveThe aim of this work is to present possible applications of the systems of tobacco traceability for guiding local enforcement against illicit trade.MethodsThe proposed three-step strategy relies on a robust regression technique and Local Moran’s I, a local indicator of spatial association, and aims at identifying retail outlets with significantly low sales compared to normal market conditions, which can indicate illegal sales activities. The ability of the method to produce alerts pointing to areas subject to illicit trade is tested on synthetic data in terms of precision and accuracy in different scenarios. Other metrics are also provided.ResultsOur approach performs well under different metrics and across various levels of illicit trade prevalence, achieving a precision of 94% under the main scenario and method parametrisation.ConclusionsThe proposed strategy provides high-quality leads for investigations into geographical areas disproportionately susceptible to illicit trade, potentially unveiling any form of illegal sales, including those involving products that have never entered the legal supply chain. Therefore, it can be a valuable tool for law enforcement agencies to tackle illegal sales activities. The findings of this study support also the argument in favour of expanding tobacco traceability systems downstream to the full length of the supply chain.

ObjectivesIn the USA, tobacco product free samples (FS) are prohibited, except for smokeless tobacco samples distributed under certain conditions in qualified adult-only facilities. We examined prevalence and frequency of FS receipt among adults who use tobacco, channels of FS distribution and the potential effect of FS use on subsequent product purchase.MethodsFrom 15 April through 12 July 2020, a total of 1989 adult participants in the National Panel of Tobacco Consumer Studies completed a mixed-mode survey on receipt and use of FS of cigarettes, cigars, smokeless tobacco, e-cigarettes and hookah tobacco. We estimated weighted proportions, population totals and 95% CIs. We used χ2 tests to assess differences between FS recipients and non-recipients.ResultsAn estimated 11.0% of US adults who use tobacco received an FS in 2020. Similar proportions received FS of cigarettes (3.8%), cigars (3.3%), smokeless tobacco (3.2%) and e-cigarettes (2.7%). Approximately 60.0% of FS recipients used it, and 68.1% of those who used FS said they were likely to purchase the product. More than half (54.2%) received FS on two or more occasions in the past 12 months, most commonly at retail outlets and tobacco specialty stores.ConclusionsWhile prevalence of adults who use tobacco receiving FS is relatively low, findings indicate that FS distribution continues to occur for cigarettes, cigars, smokeless tobacco and e-cigarettes, though in-person FS of smokeless tobacco may be legally distributed under certain conditions in qualified adult-only facilities. Findings suggest that FS are often used by recipients, which can affect future purchase decisions.

BackgroundIncreasing cigarette excise taxes is widely recognised as the most effective measure to reduce the demand for cigarettes. The presence of illicit trade undermines the effectiveness of tax increases as both a public health and a fiscal measure, because it introduces cheaper alternatives to legal, full-priced cigarettes.ObjectiveTo assess trends in the size of the illicit cigarette market in South Africa from 2002 to 2017 using gap analysis.MethodsTax-paid cigarette sales are compared with consumption estimates from two nationally representative surveys: the All Media and Products Survey and the National Income Dynamics Study. We explore the size of the illicit cigarette market and its changes over the period 2002–2017.ResultsSince 2009, illicit trade has increased sharply. We estimate that illicit trade is between 30% and 35% of the total market in 2017. The acceleration in the growth of the illicit market since 2015 corresponds with a turbulent time at the South African Revenue Service, when many of the enforcement functions were greatly reduced.ConclusionsThe current levels of illicit trade are extremely high and need to be addressed urgently by implementing effective control mechanisms such as a track and trace system to monitor the production, taxation, and sale of cigarettes.

ObjectiveTo examine the quality of tobacco industry-funded data on the illicit tobacco trade (ITT) through a systematic review of existing assessments of industry-funded data on ITT.Data sourcesPapers and reports assessing tobacco industry-funded data on ITT were obtained via searches of 8 academic databases, Google searches and correspondence with ITT experts.Study selectionInclusion criteria identified 35 English-language papers containing an original assessment of tobacco industry-funded data.Data extractionUsing a coding framework, information was extracted from the assessments regarding the quality of tobacco industry data. Documents were second-coded, achieving 94% intercoder reliability with all disagreements resolved.Data synthesisOf the 35 assessments reviewed, 31 argued that tobacco industry estimates were higher than independent estimates. Criticisms identified problems with data collection (29), analytical methods (22) and presentation of results (21), which resulted in inflated ITT estimates or data on ITT that were presented in a misleading manner. Lack of transparency from data collection right through to presentation of findings was a key issue with insufficient information to allow replication of the findings frequently cited.ConclusionsTobacco industry data on ITT are not reliable. At present, the tobacco industry continues to fund and disseminate ITT research through initiatives such as PMI IMPACT. If industry data on ITT cannot meet the standards of accuracy and transparency set by high-quality research publications, a solution may be to tax tobacco companies and administer the resulting funds to experts, independent of the tobacco industry, who use previously developed reliable models for measuring ITT.