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The Food and Drug Administration has the authority to reduce the nicotine content of cigarettes. In this randomized trial, participants assigned to reduced-nicotine cigarettes smoked fewer cigarettes than those assigned to standard-nicotine cigarettes. Twenty years ago, Benowitz and Henningfield published a landmark commentary that coincided with initial attempts by the Food and Drug Administration (FDA) to regulate tobacco products. 1 They reasoned that if the nicotine content of cigarettes were limited to approximately 0.5 mg per cigarette (approximately 0.7 mg per gram of tobacco), cigarettes would be rendered nonaddictive. Although a reduction in nicotine content was endorsed by representatives of the medical community, 2 in 2000, the FDA lost its initial argument to regulate cigarettes in a hearing before the Supreme Court, and the proposal ultimately languished. 3 In the past 8 years, the prospect of . . .

Abstract Introduction The Global Adult Tobacco Survey (GATS) is the global standard for systematically monitoring adult tobacco use and tracking key tobacco control indicators. Methods Using a multistage stratified cluster design, 9856 households were sampled, and one individual was randomly selected from each household. Standard GATS questionnaire was used to collect information on tobacco use, cessation, second-hand smoke, knowledge, attitudes, and perceptions. Data were analyzed per standard GATS protocol. Results Of 9856 individuals, 7831 individuals completed the interview. The response rate was 81%. Overall, 19.1% adults were currently using tobacco products and among them, 12.4% smoked tobacco, and 7.7% smokeless tobacco. Exposure to second-hand smoke was seen in 86% in a restaurant while it was 76% on public transportation. A total of 24.7% smokers made a quit attempt in the past 12 months. Anticigarette smoking information was observed by 37.7% adults, while 29.7% current smokers thought about quitting after reading health warning labels on cigarette packages. Most (85%) adults favored no smoking in public places, and 74.8% favored increasing taxes on tobacco products. Current cigarette smokers spent Pakistani Rupees 767.3 per month (7.78 USD) on manufactured cigarettes and consumed 4500 cigarette sticks (225 packs) annually. Conclusions Besides 19.1% tobacco users, the majority (86%) were exposed to second-hand smoke at public places indicating that ban on tobacco use in public places is not being followed. A quarter of current smokers wants to quit smoking who may be provided assistance to reduce tobacco burden. Implications This study provides national-level data about tobacco use and its burden and also indicates weak implantation of tobacco control laws. There is need to devise a strategy for proper implementation of these laws to reduce the tobacco burden in the country.

Abstract Introduction The menthol Tobacco Heating System 2.2 (mTHS) is a newly developed candidate modified-risk tobacco product intended to reduce exposure to the harmful and potentially harmful constituents (HPHCs) of conventional cigarette (CC) smoke. This study examined the impact of switching to mTHS on biomarkers of exposure to HPHCs relative to menthol CCs (mCCs) and smoking abstinence (SA). Methods In this three-arm, parallel-group study, 160 Japanese adult smokers (23–65 years; smoking ≥10 mCCs per day) were randomized to mTHS (n = 78), mCC (n = 42), or SA (n = 40) for 5 days in confinement and 85 days in ambulatory settings. Endpoints included biomarkers of exposure to HPHCs, human puffing topography, safety, and subjective effects of smoking measures. Results After 5 days of product use, the concentrations of carboxyhemoglobin, 3-hydroxypropylmercapturic acid, monohydroxybutenyl mercapturic acid, and S-phenylmercapturic acid were 55%, 49%, 87%, and 89% lower (p < .001), respectively, in the mTHS group than in the mCC group. Other biomarkers of exposure (measured as secondary endpoints) were 50%–94% lower in the mTHS group than in the mCC group on day 5. These reductions in the mTHS group were maintained at day 90, similar to the SA group. Switching to mTHS was associated with changes in human puffing topography (shorter puff intervals and more frequent puffs). The urge-to-smoke and smoking satisfaction levels on day 90 were similar in the mTHS and the mCC groups. Conclusion Switching from mCCs to mTHS significantly reduced exposure to HPHCs relative to continuing smoking mCCs with concentrations similar to those observed following SA in Japanese adult smokers. Implications This randomized study compared the impact of switching to a modified-risk tobacco product candidate mTHS on biomarkers of exposure to HPHCs of cigarette smoke relative to continuing smoking cigarettes or abstaining from smoking in sequential confinement and ambulatory settings. The study showed that switching to mTHS was associated with significant biomarker reductions within 5 days in confinement, these reductions being maintained throughout the ambulatory setting up to day 90. The results provide evidence that switching to mTHS reduces real-life exposure to HPHCs in adult smokers.

Abstract Introduction Modified-risk tobacco products are expected to reduce exposure to harmful and potentially harmful constituents of cigarette smoke, and ultimately reduce the health burden of smoking-related diseases. Clinically relevant risk markers of smoking-related diseases inform about the risk profile of new tobacco products in the absence of in-market epidemiological data. The menthol Tobacco Heating System 2.2 (mTHS) is a modified-risk tobacco product in development as an alternative to cigarettes (conventional cigarettes [CCs]). Methods In this parallel-group study, Japanese adult smokers (23–65 years; ≥10 mCCs/day) were randomized to mTHS, menthol CCs (mCC), or smoking abstinence (SA) for 5 days in confinement and 85 days in ambulatory settings. Endpoints included biomarkers of exposure to harmful and potentially harmful constituents and clinically relevant risk markers of smoking-related diseases. Results One-hundred and sixty participants were randomized to the mTHS (n = 78), mCC (n = 42), and SA (n = 40) groups. Switching to the mTHS was associated with reductions in biomarkers of exposure compared with continuing mCCs. Reductions in 8-epi-prostaglandin F2α (biomarker of oxidative stress), 11-dehydro-thromboxane B2 (biomarker of platelet activation), soluble intracellular adhesion molecule-1 (biomarker of endothelial function), and an increase in high-density lipoprotein cholesterol (biomarker of lipid metabolism) and forced expiratory volume in 1 second (biomarker of lung function) occurred in the mTHS group compared with the mCC group. The changes in the mTHS group approached those in the SA group. Conclusions Switching from mCCs to mTHS was associated with improvements in clinically relevant risk markers linked to mechanistic pathways involved in smoking-related diseases. Implications In this three-way randomized study, switching from menthol cigarettes to mTHS for 5 days in confinement and 85 days in ambulatory settings was associated with reductions in biomarkers of exposure to cigarette smoke, and changes were observed in clinically relevant biomarkers of oxidative stress (8-epi-prostaglandin F2α), platelet activity (11-dehydro-thromboxane B2), endothelial function (soluble intracellular adhesion molecule-1), lipid metabolism (high-density lipoprotein cholesterol) and lung function (forced expiratory volume in 1 second), similar to the SA group. The results suggest that switching to the mTHS has the potential to reduce the adverse health effects of conventional cigarettes.

Tobacco use prevalence has been commonly estimated on a product by product basis and the extent of polytobacco use among current users of each tobacco product is not well understood. This study aimed to examine the prevalence, trends, and correlates of polytobacco use among current users of cigarettes, cigars, chewing tobacco, and snuff in US adults aged ≥18. We used pooled data from the 1998, 2000, 2005, and 2010 Cancer Control Supplements of the National Health Interview Survey (N = 123 399 adults). Multivariate logistic regression models were estimated to determine significant factors associated with polytobacco use. In 2010, the prevalence of polytobacco use was 8.6% among current cigarette smokers, 50.3% among current cigar users, 54.8% among current chewing tobacco users, and 42.5% among current snuff users. After controlling for other covariates, gender and race/ethnicity did not show consistent associations with poly-use across these four groups of current tobacco users; however, a positive association of young adulthood, less than high school education, and binge drinking with poly-use was consistently found among all these groups. Polytobacco use is extremely popular among current users of non-cigarette tobacco products. Polytobacco use patterns differ across sociodemographic subpopulations, and the gender and racial/ethnic profiles in poly-users vary across different groups of current tobacco users. Tobacco control strategies need to consider the interrelationships in the use of different tobacco products and the diverse profiles of poly-users in order to develop tailored tobacco prevention and intervention policies to further reduce the burden of tobacco use.

Smoking is a leading cause of numerous human disorders including pulmonary disease, cardiovascular disease, and cancer. Disease development is primarily caused by exposure to cigarette smoke constituents, many of which are known toxicants. Switching smokers to modified risk tobacco products (MRTPs) has been suggested as a potential means to reduce the risks of tobacco use, by reducing such exposure. This randomized, controlled study investigated whether biomarkers of toxicant exposure (BoE) were reduced when smokers switched from smoking combustible cigarettes to using a novel (glo™/THP1.0) or in-market comparator (iQOS/THS) tobacco heating product (THP). One hundred eighty Japanese smokers smoked combustible cigarettes during a 2-day baseline period, followed by randomization to either continue smoking cigarettes, switch to using mentholated or non-mentholated variants of glo™, switch to using a non-mentholated variant of iQOS, or quit nicotine and tobacco product use completely for 5 days. Baseline and post-randomization 24-h urine samples were collected for BoE analysis. Carbon monoxide was measured daily in exhaled breath (eCO). On day 5 after switching, urinary BoE (excluding for nicotine) and eCO levels were significantly (p < .05) reduced by medians between 20.9% and 92.1% compared with baseline in all groups either using glo™ or iQOS or quitting tobacco use. Between-group comparisons revealed that the reductions in the glo™ groups were similar (p > .05) to quitting in many cases. glo™ or iQOS use for 5 days reduced exposure to smoke toxicants in a manner comparable to quitting tobacco use. THPs are reduced exposure tobacco products with the potential to be MRTPs. This clinical study demonstrates that when smokers switched from smoking combustible cigarettes to using tobacco heating products their exposure to smoke toxicants was significantly decreased. In many cases, this was to the same extent as that seen when they quit smoking completely. This may indicate that these products have the potential to be reduced exposure and/or reduced risk tobacco products when used by smokers whose cigarette consumption is displaced completely. ISRCTN14301360 and UMIN000024988.

Heated tobacco products (HTPs) are a form of nicotine delivery intended to provide an alternative to traditional cigarettes. The aim of this systematic review was to present the current state of knowledge on HTPs with an emphasis on the potential impact of HTP use on human health. During the preparation of this systematic review, the literature on HTPs available within Medline/PubMed, EMBASE, CINAHL, ScienceDirect, and Google Scholar was retrieved and examined. In the final review, 97 research papers were included. The authors specifically assessed the construction and operation of HTPs, as well as the chemical composition of HTP tobacco sticks and the generated aerosol, based on evidence from experimental animal and cellular studies, and human-based studies.Heated tobacco products were found to generate lower concentrations of chemical compounds compared to traditional cigarettes, except for water, propylene glycol, glycerol, and acetol. The nicotine levels delivered to the aerosol by HTPs were 70-80% as those of conventional combustion. The results of in vitro and in vivo assessments of HTP aerosols revealed reduced toxicity, but these were mainly based on studies sponsored by the tobacco industry. Independent human-based studies indicated that there was a potentially harmful impact of the active and passive HTP smoking on human health. Currently, a large body of knowledge on HTP exposures and health effects is provided by the tobacco industry (52% of identified studies). Based on the available evidence, HTPs produce lower levels of toxic chemicals, compared to conventional cigarettes, but they are still not risk-free. Int J Occup Med Environ Health. 2019;32(5):595-634.

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.

IntroductionModified risk tobacco product (MRTP) claims for heated tobacco products (HTPs) that convey reduced exposure compared with conventional cigarettes may promote product initiation and transition among young people. We assessed the effects of a hypothetical MRTP claim for HTPs on young adults’ intention and perceptions of using HTPs and whether these effects differed by their current cigarette and e-cigarette use.MethodsWe embedded a randomised between-subjects experiment into a web-based survey administered among a cohort of 2354 Southern California young adults (aged 20–23) in 2020. Participants viewed depictions of HTPs with an MRTP claim (n=1190) or no claim (n=1164). HTP use intention and HTP-related harm and use perceptions relative to cigarettes and e-cigarettes were assessed.ResultsOverall, participants who viewed versus did not view the claim did not differ in HTP use intention (28.5% vs 28.7%) but were more likely to perceive HTPs as less harmful than cigarettes (11.4% vs 7.0%; p<0.001). The experimental effect on HTP use intention did not differ among past 30-day cigarette smokers versus non-smokers (interaction adjusted OR (AOR)=0.78, 95% CI 0.36 to 1.76) but differed among past 30-day e-cigarette users versus non-users (interaction AOR=1.67, 95% CI 1.02 to 2.68).DiscussionThe hypothetical MRTP claim may lower young adults’ HTP harm perceptions compared with cigarettes but may not change HTP use intention overall or differentially for cigarette smokers. The larger effect on HTP use intention among e-cigarette users than non-users raises the question of whether MRTP claims may promote HTP use or HTP and e-cigarette dual use among young e-cigarette users.

Despite widespread knowledge of the dangers of cigarette consumption, smoking continues to be a public health concern. One compound that has shown potential for treatment in preclinical models is the neuropeptide oxytocin (OT). The purpose of the present study was to examine the effects of intranasal oxytocin on cigarette craving, behavioral economic demand for cigarettes, and cigarette consumption, in regular smokers after 18 hours of abstinence. Otherwise healthy daily smokers (n = 35) completed two sessions where they received OT (40 IU intranasal) or placebo (PBO) and completed measures of craving and cigarette demand, and they were given six opportunities to smoke partial cigarettes in exchange for money. On average participants smoked few cigarettes after receiving OT than after receiving PBO, and they reported less desire for additional cigarettes during the smoking period. OT did not affect cigarette demand or standardized measures of cigarette craving. This study suggests that OT decreases some indices of smoking desire and consumption, providing modest support for the idea that OT might be effective for reducing cigarette smoking. This study provides new evidence that oxytocin might have clinical value in the treatment of addictive disorders, in this case tobacco addiction. The study adds to a growing literature suggesting that this neuropeptide, which is mainly known for its role in social bonding and attachment, may also affect mood and motivational states relevant to addiction.