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The 2001 report by the US National Academy of Sciences titled "Clearing the Smoke: assessing the Science Base for tobacco harm reduction" examined the potential of tobacco harm reduction (THR) and found that abstaining from smoking could reduce many negative health effects. Since then, cigarette smoking rates in the US have decreased, and new tobacco products like e-cigarettes and oral nicotine products have emerged, which aim to reduce tobacco-related cancers and cardiovascular diseases while maintaining nicotine addiction. The report emphasized the need for research on the effectiveness and public health implications of these reduced-exposure products (PREPs) and expressed concerns about their marketing and use. The debate on tobacco harm reduction continues, with differing opinions on the safety and effectiveness of products like e-cigarettes. The text also discusses the use of snus, a treated tobacco product that has shown success in reducing smoking rates and tobacco-related cancers in Sweden and Norway. It mentions the emergence of nicotine pouches as a new oral nicotine product and criticizes opponents of e-cigarettes for opposing all oral tobacco and nicotine products, despite evidence of their effectiveness in reducing tobacco-related diseases. The author of the text is solely responsible for its content. [Extracted from the article]

Background: Scientific evidence clearly demonstrates that inhaling the smoke from the combustion of cigarettes is responsible for most of the harm caused by smoking, and not the nicotine. However, a majority of U.S. adults who smoke inaccurately believe that nicotine causes cancer which may be a significant barrier, preventing switching to potentially reduced risk, non-combustible products like electronic nicotine delivery systems (ENDS) and smokeless tobacco (ST). We assessed the population health impact associated with nicotine perceptions. Methods: Using a previously validated agent-based model to the U.S. population, we analyzed nationally representative data from the Population Assessment of Tobacco and Health (PATH) study to estimate base case rates of sustained (maintained over four waves) cessation and switching to non-combustible product use, by sex. Nicotine perception scenarios were determined from PATH data. The overall switch rate from smoking in Wave 4 to non-combustible product use in Wave 5 (3.94%) was stratified based on responses to the nicotine perception question "Do you believe nicotine is the chemical that causes most of the cancer caused by smoking cigarettes?", (four-item scale from "Definitely not" to "Definitely yes"). The relative percent change between the overall and stratified rates, corresponding to each item, was used to adjust the base case rates of switching, to determine the impact, if all adults who smoke exhibited switching behaviors based on responses to the nicotine perceptions question. The public health impact of nicotine perceptions was estimated as the difference in all-cause mortality between the base case and the four nicotine perception scenarios. Results: Switch rates associated with those who responded, "Definitely not" (8.39%) resulted in a net benefit of preventing nearly 800,000 premature deaths over an 85-year period. Conversely switch rates reflective of those who responded, "Definitely yes" (2.59%) resulted in a net harm of nearly 300,000 additional premature deaths over the same period. Conclusions: Accurate knowledge regarding the role of nicotine is associated with higher switch rates and prevention of premature deaths. Our findings suggest that promoting public education to correct perceptions of harm from nicotine has the potential to benefit public health. [ABSTRACT FROM AUTHOR]

Smoking cessation reduces the risk of developing smoking-related diseases. Although smoking prevalence has declined, many continue smoking cigarettes. Switching completely to smoke-free alternatives like the Tobacco Heating System (THS) 2.2—a heated tobacco product for which there is evidence demonstrating significantly reduced formation and exposure to harmful chemicals compared to cigarettes—has the potential to reduce the harm caused by continuing to smoke cigarettes. We conducted a 6-month clinical study (NCT02396381) with a 6-month extension (NCT02649556), initially randomizing 984 adult smokers to continue smoking or switch to THS (non-mentholated), of which 672 continued into the extension study. Endpoints were evaluated at baseline and at 3, 6, and 12 months. We longitudinally assessed biomarkers of potential harm (BoPHs) known to be reversible upon smoking cessation as indicators of pathways involved in the pathogenesis of cardiovascular or respiratory diseases and carcinogenicity. The need to cough and safety profile were also assessed. Impact on eight key BoPHs was used as a proxy to evaluate harm reduction potential. At 12 months, comparison of BoPH levels between the predominant THS use and cigarette smoking groups showed a positive effect in favor of switching, partially or in full, to THS. These results provide additional evidence of the harm reduction potential of THS for smokers who would otherwise continue smoking, but they need to be verified in long-term confirmatory studies. Clinicaltrials.gov Identifier: NCT0264955. Date of registration: January 7, 2016 [ABSTRACT FROM AUTHOR]

Abstract Background Scientific evidence clearly demonstrates that inhaling the smoke from the combustion of cigarettes is responsible for most of the harm caused by smoking, and not the nicotine. However, a majority of U.S. adults who smoke inaccurately believe that nicotine causes cancer which may be a significant barrier, preventing switching to potentially reduced risk, non-combustible products like electronic nicotine delivery systems (ENDS) and smokeless tobacco (ST). We assessed the population health impact associated with nicotine perceptions. Methods Using a previously validated agent-based model to the U.S. population, we analyzed nationally representative data from the Population Assessment of Tobacco and Health (PATH) study to estimate base case rates of sustained (maintained over four waves) cessation and switching to non-combustible product use, by sex. Nicotine perception scenarios were determined from PATH data. The overall switch rate from smoking in Wave 4 to non-combustible product use in Wave 5 (3.94%) was stratified based on responses to the nicotine perception question “Do you believe nicotine is the chemical that causes most of the cancer caused by smoking cigarettes?”, (four-item scale from “Definitely not” to “Definitely yes”). The relative percent change between the overall and stratified rates, corresponding to each item, was used to adjust the base case rates of switching, to determine the impact, if all adults who smoke exhibited switching behaviors based on responses to the nicotine perceptions question. The public health impact of nicotine perceptions was estimated as the difference in all-cause mortality between the base case and the four nicotine perception scenarios. Results Switch rates associated with those who responded, “Definitely not” (8.39%) resulted in a net benefit of preventing nearly 800,000 premature deaths over an 85-year period. Conversely switch rates reflective of those who responded, “Definitely yes” (2.59%) resulted in a net harm of nearly 300,000 additional premature deaths over the same period. Conclusions Accurate knowledge regarding the role of nicotine is associated with higher switch rates and prevention of premature deaths. Our findings suggest that promoting public education to correct perceptions of harm from nicotine has the potential to benefit public health.

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BackgroundE-cigarettes are often marketed as a less harmful alternative to traditional tobacco cigarettes. Despite their popularity, the evidence regarding their effects on human health remains unclear and is filled with complexities.ObjectivesThis systematic review aims to elucidate the direct effects of electronic cigarette use on human health, carefully distinguishing between the specific characteristics of the populations studied.MethodologyAdhering to the PRISMA guidelines, we conducted a comprehensive search in PubMed/Medline, Web of Science, Scopus, and Google Scholar databases without date restrictions, including articles in both Spanish and English. This approach enabled the identification and analysis of primary studies to understand the direct effect of electronic cigarettes on human health.ResultsA total of 33 studies were included that evaluated cardiovascular, pulmonary, renal, weight and fertility effects. Only five studies analyzed e-cigarettes in healthy populations and seven studies compared healthy individuals against smokers. The effects evaluated on smokers or former tobacco smokers were apparently positive, however, among healthy individuals, increased heart rate, mean arterial pressure, oxidative stress, alteration of respiratory epithelial cells and increased airflow resistance were found.ConclusionSmokers or former smokers who switch to e-cigarettes may reduce their exposure to carcinogens and lower their risk of developing severe health issues associated with conventional smoking. However, in healthy individuals who have never smoked traditional cigarettes, the use of e-cigarettes introduces several cardiovascular and respiratory adverse effects. These findings suggest that while e-cigarettes can be a strategic harm reduction tool for smokers, they are not a safe option for non-smokers.

Abstract Background According to a recently published study, approximately half of those who currently smoke in Norway have little or no desire to quit despite a hostile regulatory and socio-cultural climate for smoking. On this background, we discuss some challenges that regulators will face in a further tightening of structural measures to curb smoking. Main body Central to our discussion is the research literature concerned with the concept of state-paternalism in tobacco control—the line between an ethically justified interference with the freedom of those who smoke and an exaggerated infringement disproportionate to the same people’s right to live as they choose. In countries with an already advanced infrastructure for tobacco control, this dilemma might become quite intrusive for regulators. We ask that if people, who smoke are aware of and have accepted the risks, are willing to pay the price, smoke exclusively in designated areas, and make decisions uninfluenced by persuasive messages from manufacturers—is a further tightening of anti-smoking measures still legitimate? Strengthening of the infrastructure for tobacco control can be seen as a “help” to people who—due to some sort of “decision failure”—continue to smoke against their own will. However, for those who want to continue smoking for reasons that for them appear rational, such measures may appear unwanted, punitive, and coercive. Is it within the rights of regulators to ignore peoples’ self-determination for the sake of their own good? We problematize the “help” argument and discuss the authorities' right to elevate the zero-vision of smoking as universally applicable while at the same time setting up barriers to switching to alternative nicotine products with reduced risk. Conclusion We recommend that a further intensification of smoking control in countries that already have a well-developed policy in this area requires that regulators start to exploit the opportunity that lies in the ongoing diversification of the recreational nicotine market.

Abstract Background As part of its comprehensive plan to significantly reduce the harm from tobacco products, the US Food and Drug Administration is establishing a product standard to lower nicotine in conventional cigarettes to make them “minimally addictive or non-addictive". Many clinical studies have investigated the potential impact of such a standard on smoking behavior and exposure to cigarette constituents. These ambulatory studies required participants who smoke to switch to reduced nicotine study cigarettes. In contrast to clinical trials on pharmaceuticals or medical devices, participants had ready access to non-study conventional nicotine cigarettes and high rates of non-study cigarette use were consistently reported. The magnitude of non-compliance, which could impact the interpretation of the study results, was not adequately assessed in these trials. Methods We conducted a secondary analysis of data from a large, randomized trial of reduced nicotine cigarettes with 840 participants to estimate the magnitude of non-compliance, i.e., the average number of non-study cigarettes smoked per day by study participants assigned to reduced nicotine cigarettes. Individual participants’ non-study cigarette use was estimated based on his/her urinary total nicotine equivalent level, the nicotine content of the study cigarette assigned and the self-reported number of cigarettes smoked, using a previously published method. Results Our analysis showed that (1) there is a large variation in the number of non-study cigarettes smoked by participants within each group (coefficient of variation 90–232%); (2) participants in reduced nicotine cigarette groups underreported their mean number of non-study cigarettes smoked per day by 85–91%; and (3) the biochemical-based estimates indicate no reduction in the mean number of total cigarettes smoked per day for any group assigned to reduced nicotine cigarettes after accounting for non-study cigarettes. Conclusions High levels of non-compliance, in both the rate and magnitude of non-study cigarette use, are common in ambulatory reduced nicotine cigarette trials where participants have access to conventional nicotine non-study cigarettes. The potential impact of high non-compliance on study outcomes should be considered when interpreting the results from such ambulatory studies.

Abstract Background Pakistan is one of most vulnerable low- and middle-income countries with 29 million adult active tobacco users. Smoking cessation services are lacking as the tobacco control initiatives have largely failed to address the smoking endemic. Over the last 5 years, Pakistan has witnessed the use of innovative tobacco harm reduction (THR) products such as e-cigarettes and nicotine pouches. However, their use remains limited. THR products are imported legally as consumer goods and are taxable. The lack of sufficient data for THR and its application is a challenge in gauging their effectiveness in assisting smokers quit combustible smoking. Evidence-based studies can help in measuring the effectiveness of e-cigarettes and nicotine pouches as smoking cessation aids. Method Keeping in view the study objectives, a sample size of 600 participants will be sufficient to assess the effectiveness of e-cigarettes and nicotine pouches for smoking cessation in Pakistan. Of these, 200 participants each will receive e-cigarettes and nicotine pouches along with basic care counselling, while the remaining 200 participants will only receive basic care counselling for 48 weeks. The association of participants’ characteristics with smoking and health status will be based on the bivariate and multivariate analysis. The simple t-test and variance analysis will assess the differences in intervention indicators between the control and treatment groups. For the inferential analysis, the average treatment impact will be based on the quasi-experimental techniques such as difference in difference (DID) or propensity score matching (PMS). Discussion The study will evaluate the participants at the baseline as they decide the quit date. After every 12 weeks, a follow-up survey with the participants will be conducted. Results are anticipated to inform the public, decision-makers, and researchers about the effects of using e-cigarettes and nicotine pouches in the short- and medium-term periods. Critically, the potential of e-cigarettes and other alternative nicotine delivery systems as smoking cessation aid will be assessed. Trial registration ClinicalTrials.gov NCT05715164 . Registered on February 6, 2023. Protocol version. Protocol version 1.0, 14-12-2022 Trial in progress and not yet recruiting participants. Estimated primary data collection date—April 2024

Abstract Background Media campaigns targeting young people are a valuable tool for promoting awareness about tobacco harm reduction (THR). Advocacy and communication efforts that inform about the risks of tobacco use, THR strategies, and smoking cessation methods can enhance policy compliance, minimize tobacco-related damages, and motivate individuals to quit smoking. This study investigates the understanding, perceptions, and capabilities of burgeoning public health advocates in effectively communicating smoking cessation and THR strategies in Africa. Methods This research adopts a concurrent explanatory sequential design. The target demographic population consists of public health enthusiasts, healthcare students, health communicators, and budding journalists aged 18–30 in Nigeria. The questionnaire, validated through an extensive literature review, was distributed via Google Forms. From 450 individuals expressing interest in the THRjourno project, 415 agreed to participate, responding to open-ended questions on smoking cessation and THR among young people. Data were analysed with Microsoft Excel and IBM SPSS for quantitative aspects, while Atlas.ti was used for the qualitative interpretation of open-ended responses. Results Of the 415 participants, 73.7% lacked prior knowledge or proper understanding of THR. Most respondents (60.0%) regarded Nicotine Replacement Therapy (NRT) as the most effective THR strategy, with 26.7% favoring e-cigarettes. A majority (73.3%) perceived NRT to be safer than smoking, while 48.3% believed e-cigarettes were safer. Approximately 70.8% agreed that THR products aid in smoking cessation. However, 38.3% were uncertain if these products are addictive. Participants referenced strategies/activities for creating awareness for THR, which include, “More advocacy and sensitization programs should be organized”, and “These programs should engage people who smoke tobacco and nicotine products themselves as champions.”Ambassadorial roles in public Universities should be granted to students as a medium to proliferate the central message of the THR. Conclusion Identified barriers to effective THR communication included misinformation propagated by health professionals and the media, religious and cultural constraints, and challenges in reaching remote areas. Strategies to enhance THR communication encompass increased advocacy and communication, government engagement and policy development, simplification of THR messages, and capacity building and engagement of advocates and stakeholders.

Stopping smoking is crucial for public health and especially for individuals with diabetes. Combustion-free nicotine alternatives like e-cigarettes and heated tobacco products are increasingly being used as substitutes for conventional cigarettes, contributing to the decline in smoking prevalence. However, there is limited information about the long-term health impact of those products in patients with diabetes. This randomized controlled trial aims to investigate whether switching from conventional cigarettes to combustion-free nicotine alternatives will lead to a measurable improvement in cardiovascular risk factors and metabolic parameters over a period of 2 years in smokers with type 2 diabetes. The multicenter study will be conducted in seven sites across four countries. A total of 576 smokers with type 2 diabetes will be randomly assigned (1:2 ratio) to either standard of care with brief cessation advice (Control Arm) or combustion-free nicotine alternatives use (Intervention Arm). The primary end point is the change in the proportion of patients with metabolic syndrome between baseline and the 2-year follow-up. Additionally, the study will analyze the absolute change in the sum of the individual factors of metabolic syndrome at each study time point. Patient recruitment has started in September 2021 and enrollment is expected to be completed by December 2023. Results will be reported in 2026. This study may provide valuable insights into cardiovascular and metabolic health benefits or risks associated with using combustion-free nicotine alternatives for individuals with type 2 diabetes who are seeking alternatives to tobacco cigarette smoking. The study protocol, informed consent forms, and relevant documents were approved by seven ethical review boards. Study results will be disseminated through articles published in high-quality, peer-reviewed journals and presentations at conferences. [ABSTRACT FROM AUTHOR]

Background: As part of its comprehensive plan to significantly reduce the harm from tobacco products, the US Food and Drug Administration is establishing a product standard to lower nicotine in conventional cigarettes to make them "minimally addictive or non-addictive". Many clinical studies have investigated the potential impact of such a standard on smoking behavior and exposure to cigarette constituents. These ambulatory studies required participants who smoke to switch to reduced nicotine study cigarettes. In contrast to clinical trials on pharmaceuticals or medical devices, participants had ready access to non-study conventional nicotine cigarettes and high rates of non-study cigarette use were consistently reported. The magnitude of non-compliance, which could impact the interpretation of the study results, was not adequately assessed in these trials. Methods: We conducted a secondary analysis of data from a large, randomized trial of reduced nicotine cigarettes with 840 participants to estimate the magnitude of non-compliance, i.e., the average number of non-study cigarettes smoked per day by study participants assigned to reduced nicotine cigarettes. Individual participants' non-study cigarette use was estimated based on his/her urinary total nicotine equivalent level, the nicotine content of the study cigarette assigned and the self-reported number of cigarettes smoked, using a previously published method. Results: Our analysis showed that (1) there is a large variation in the number of non-study cigarettes smoked by participants within each group (coefficient of variation 90–232%); (2) participants in reduced nicotine cigarette groups underreported their mean number of non-study cigarettes smoked per day by 85–91%; and (3) the biochemical-based estimates indicate no reduction in the mean number of total cigarettes smoked per day for any group assigned to reduced nicotine cigarettes after accounting for non-study cigarettes. Conclusions: High levels of non-compliance, in both the rate and magnitude of non-study cigarette use, are common in ambulatory reduced nicotine cigarette trials where participants have access to conventional nicotine non-study cigarettes. The potential impact of high non-compliance on study outcomes should be considered when interpreting the results from such ambulatory studies. [ABSTRACT FROM AUTHOR]

Background: According to a recently published study, approximately half of those who currently smoke in Norway have little or no desire to quit despite a hostile regulatory and socio-cultural climate for smoking. On this background, we discuss some challenges that regulators will face in a further tightening of structural measures to curb smoking. Main body: Central to our discussion is the research literature concerned with the concept of state-paternalism in tobacco control—the line between an ethically justified interference with the freedom of those who smoke and an exaggerated infringement disproportionate to the same people's right to live as they choose. In countries with an already advanced infrastructure for tobacco control, this dilemma might become quite intrusive for regulators. We ask that if people, who smoke are aware of and have accepted the risks, are willing to pay the price, smoke exclusively in designated areas, and make decisions uninfluenced by persuasive messages from manufacturers—is a further tightening of anti-smoking measures still legitimate? Strengthening of the infrastructure for tobacco control can be seen as a "help" to people who—due to some sort of "decision failure"—continue to smoke against their own will. However, for those who want to continue smoking for reasons that for them appear rational, such measures may appear unwanted, punitive, and coercive. Is it within the rights of regulators to ignore peoples' self-determination for the sake of their own good? We problematize the "help" argument and discuss the authorities' right to elevate the zero-vision of smoking as universally applicable while at the same time setting up barriers to switching to alternative nicotine products with reduced risk. Conclusion: We recommend that a further intensification of smoking control in countries that already have a well-developed policy in this area requires that regulators start to exploit the opportunity that lies in the ongoing diversification of the recreational nicotine market. [ABSTRACT FROM AUTHOR]

Background: Media campaigns targeting young people are a valuable tool for promoting awareness about tobacco harm reduction (THR). Advocacy and communication efforts that inform about the risks of tobacco use, THR strategies, and smoking cessation methods can enhance policy compliance, minimize tobacco-related damages, and motivate individuals to quit smoking. This study investigates the understanding, perceptions, and capabilities of burgeoning public health advocates in effectively communicating smoking cessation and THR strategies in Africa. Methods: This research adopts a concurrent explanatory sequential design. The target demographic population consists of public health enthusiasts, healthcare students, health communicators, and budding journalists aged 18–30 in Nigeria. The questionnaire, validated through an extensive literature review, was distributed via Google Forms. From 450 individuals expressing interest in the THRjourno project, 415 agreed to participate, responding to open-ended questions on smoking cessation and THR among young people. Data were analysed with Microsoft Excel and IBM SPSS for quantitative aspects, while Atlas.ti was used for the qualitative interpretation of open-ended responses. Results: Of the 415 participants, 73.7% lacked prior knowledge or proper understanding of THR. Most respondents (60.0%) regarded Nicotine Replacement Therapy (NRT) as the most effective THR strategy, with 26.7% favoring e-cigarettes. A majority (73.3%) perceived NRT to be safer than smoking, while 48.3% believed e-cigarettes were safer. Approximately 70.8% agreed that THR products aid in smoking cessation. However, 38.3% were uncertain if these products are addictive. Participants referenced strategies/activities for creating awareness for THR, which include, "More advocacy and sensitization programs should be organized", and "These programs should engage people who smoke tobacco and nicotine products themselves as champions."Ambassadorial roles in public Universities should be granted to students as a medium to proliferate the central message of the THR. Conclusion: Identified barriers to effective THR communication included misinformation propagated by health professionals and the media, religious and cultural constraints, and challenges in reaching remote areas. Strategies to enhance THR communication encompass increased advocacy and communication, government engagement and policy development, simplification of THR messages, and capacity building and engagement of advocates and stakeholders. [ABSTRACT FROM AUTHOR]

Background: Pakistan is one of most vulnerable low- and middle-income countries with 29 million adult active tobacco users. Smoking cessation services are lacking as the tobacco control initiatives have largely failed to address the smoking endemic. Over the last 5 years, Pakistan has witnessed the use of innovative tobacco harm reduction (THR) products such as e-cigarettes and nicotine pouches. However, their use remains limited. THR products are imported legally as consumer goods and are taxable. The lack of sufficient data for THR and its application is a challenge in gauging their effectiveness in assisting smokers quit combustible smoking. Evidence-based studies can help in measuring the effectiveness of e-cigarettes and nicotine pouches as smoking cessation aids. Method: Keeping in view the study objectives, a sample size of 600 participants will be sufficient to assess the effectiveness of e-cigarettes and nicotine pouches for smoking cessation in Pakistan. Of these, 200 participants each will receive e-cigarettes and nicotine pouches along with basic care counselling, while the remaining 200 participants will only receive basic care counselling for 48 weeks. The association of participants' characteristics with smoking and health status will be based on the bivariate and multivariate analysis. The simple t-test and variance analysis will assess the differences in intervention indicators between the control and treatment groups. For the inferential analysis, the average treatment impact will be based on the quasi-experimental techniques such as difference in difference (DID) or propensity score matching (PMS). Discussion: The study will evaluate the participants at the baseline as they decide the quit date. After every 12 weeks, a follow-up survey with the participants will be conducted. Results are anticipated to inform the public, decision-makers, and researchers about the effects of using e-cigarettes and nicotine pouches in the short- and medium-term periods. Critically, the potential of e-cigarettes and other alternative nicotine delivery systems as smoking cessation aid will be assessed. Trial registration: ClinicalTrials.gov NCT05715164. Registered on February 6, 2023. Protocol version. Protocol version 1.0, 14-12-2022 Trial in progress and not yet recruiting participants. Estimated primary data collection date—April 2024 [ABSTRACT FROM AUTHOR]

Introduction: Tobacco harm reduction (THR) discourse has been divisive for the tobacco control community, partially because it sometimes aligns public health and tobacco industry interests. Industry funding is contentious as it influences study outcomes, and is not always disclosed in scientific publications. This study examines the role of disclosed and undisclosed industry support on THR publications via social network analysis.Methods: We reviewed 826 English-language manuscripts (1992-2016) to determine disclosed and undisclosed industry (pharmaceutical, tobacco and e-cigarette) and non-industry (including government) support received by 1,405 authors. We used social network analysis to identify the most influential authors in THR discourse by assessing the number of their collaborators on publications, the frequency of connecting other authors in the network, and tendency to form groups based on the presence of sponsorship disclosures, sources of funding and THR stance.Results: 284 (20%) out of 1,405 authors were supported by industry. Industry-sponsored authors were more central and influential in the network: with twice as many publications (Median = 4), 1.25 as many collaborators on publications (Median = 5), and higher likelihood of connecting other authors and thus having more influence in the network, compared to non-industry-sponsored authors. E-cigarette industry-sponsored authors had the strongest association with undisclosed industry support.Conclusions: Authors with industry support exerted stronger influence on the THR scientific discourse than non-industry-supported authors. Journals should continue adhering to strict policies requiring conflicts of interest disclosures. An increase in public health spending on tobacco control research may be necessary to achieve funding parity. [ABSTRACT FROM AUTHOR]

The article examines the perceived harm of e-cigarettes compared to conventional cigarettes among Ukrainian adults, revealing that a significant proportion believe e-cigarettes are more harmful, indicating a need for improved risk communication. Topics include survey methodology, trends in tobacco product usage, and implications for public health messaging regarding safer nicotine products.

LMICs bear an inexplicably larger share of the burden of tobacco-related death globally due to rising tobacco consumption. Understanding and conducting RCTs in the context of LMICs is mandatory to use THR products as an effective smoking cessation strategy for controlling rising tobacco consumption in these countries. The study is a two-arm, parallel RCT with a 12-week treatment period and a 52-week followup period which plans to enroll 258 smokers from general adult population. The participants after meeting eligibility criteria and providing informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counseling (2) Nicotine patches (21mg) with individual counseling. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face-toface interactions at the trial site as well as follow-up on the telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence. [ABSTRACT FROM AUTHOR]

Some smokers switch away from smoking using e‐cigarettes, but guidelines recommend trying approved medications first. We analyzed switching in adult smokers using JUUL by their recent history of quit attempts and use of smoking cessation medications. Participants were 8511 adult (21+) established smokers (at baseline), in which 50.3% are daily smokers, in a longitudinal observational study who completed a survey 12 months after first purchasing a JUUL Starter Kit. At baseline, participants reported attempts to quit smoking in the prior year and use of pharmacotherapy (nicotine replacement therapy [NRT] or prescription medication) in their most recent attempt. The outcomes were switching (self‐reported no past‐30‐day smoking) and 50%+ reductions in cigarette consumption. Multivariable analyses were adjusted for baseline covariates. Two thirds of the participants had made a quit attempt in the year before purchasing JUUL. Overall, 59% [58%, 60%] had switched at 12 months. Switching was more likely in those who had used NRT and who attempted quitting without medication versus those who used prescription medications or made no quit attempt. In adjusted multivariable analyses, only making a past‐year quit attempt (vs. not) was associated with higher odds of switching (OR = 1.15 [1.04, 1.28]). Over 60% of dual users reduced cigarette consumption by ≥50%. These associations were largely similar in daily smokers. Twelve months after purchasing JUUL, almost all smokers reported either switching or reducing their smoking by 50%+, including those who had recently failed to quit smoking with approved pharmacotherapies. E‐cigarettes provide an alternative route to abstinence from smoking for smokers with a history of cessation and cessation treatment failure. [ABSTRACT FROM AUTHOR]

Despite efforts to eliminate smoking, more than 1 billion people worldwide continue to use combustible cigarettes through choice or inability to quit. With an associated 8 million deaths, the provision of noncombustible tobacco and nicotine products that smokers will accept to replace combustible cigarettes can lessen harm. However, most of these products have entered the market only in the past 20 years. Therefore, particularly for some smoking‐related diseases, epidemiological studies to test harm reduction potential are only now becoming feasible. For cancer and chronic obstructive pulmonary disease, around two decades of data might be required. In this article, we discuss how the use of biomarkers might be applied to supplement epidemiological research for regulators. We further discuss how health providers and insurers can keep up with the rapid changes in biomarker research and recognize these reduced risks. [ABSTRACT FROM AUTHOR]

Decades of research show that constituents other than nicotine are the harmful agents in tobacco products. This knowledge is incorporated into the nicotine regulatory policies of countries leading in tobacco control, such as the UK and New Zealand. Alternative nicotine products, such as nicotine replacement therapy and e‐cigarettes, are now endorsed in the UK by a number of healthcare bodies in a tobacco harm reduction approach that encourages tobacco users to completely switch to a less risky nicotine‐containing product. The potential role of 'clean' nicotine alternatives to reduce the harms from tobacco is, however, not being translated into practice. Many healthcare practitioners still bundle tobacco, cigarettes, smoking, cancer and nicotine into one, thus preventing them from supporting their patients to make informed choices on safer nicotine alternatives. This misperception among healthcare professionals, in turn, is a hurdle to effective tobacco control policymaking in many low‐ and middle‐income countries and effective cessation support everywhere in the world. Nicotine confidence based on nicotine literacy among the key decision‐makers should start with reforming medical curricula and myth‐busting in the lay media to include factual statements about nicotine and public health policy discussions on the principles of harm reduction. [ABSTRACT FROM AUTHOR]

Electronic cigarette (EC) aerosol emissions generally contain fewer and lower concentrations of harmful and potentially harmful constituents, compared with cigarette smoke. Further studies are needed to establish whether decreased emissions translate to reduced health risks for EC users. In a cross-sectional study, biomarkers of exposure (BoE) to certain tobacco smoke toxicants and biomarkers of potential harm (BoPH), associated with biological processes linked to the potential development of smoking-related diseases and oxidative stress, were assessed in solus Vuse ECs users and current, former, and never smokers. In total, 213 participants were enrolled, and smoking status was confirmed by urinary cotinine, exhaled carbon monoxide, and N-(2-cyanoethyl)valine levels (EC users and former smokers only). During confinement participants used their usual product (EC or cigarette) as normal and BoE and BoPHs were assessed via blood, 24-h urine, and physiological assessment. Significantly lower levels of all urinary BoE; MHBMA, HMPMA, 3-HPMA, NNN, 3-OH-B[a]P, S-PMA, NNAL (all p < 0.0001), and TNeq (p = 0.0074) were observed in EC users when compared with smokers. Moreover, significantly lower levels were observed in EC users for 3 of the 7 BoPH measured, carboxyhaemoglobin (p < 0.0001), soluble intercellular adhesion molecule-1 (p = 0.0028), and 11-dehydrothromboxane B2 (p = 0.0012), when compared with smokers. As compared with smokers, solus Vuse EC users have significantly lower exposure to tobacco toxicants for the BoE, and 3 BoPH measured. These results add to the weight of evidence supporting EC as part of a tobacco harm reduction strategy. [ABSTRACT FROM AUTHOR]

Abstract Background Tobacco-free nicotine pouches is a novel category of oral nicotine-delivery products. Among current tobacco users such pouches may serve as a low-risk alternative to cigarettes or conventional, tobacco-based oral products e.g., snus and moist snuff. In the United States (U.S.), the market leading nicotine-pouch brand is ZYN®. However, no data on the chemical characteristics of ZYN have been published. Methods We screened for 43 compounds potentially present in tobacco products in seven oral nicotine-delivery products: ZYN (dry and moist), snus (General®), moist snuff (CRP2.1 and Grizzly Pouches Wintergreen), and two pharmaceutical, nicotine replacement therapy products (NRTs, Nicorette® lozenge and Nicotinell® gum). Thirty-six of the tested compounds are classified as harmful and potentially harmful constituents (HPHCs) by the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA-CTP). Five additional compounds were included to cover the GOTHIATEK® product standard for Swedish snus and the last two compounds were chosen to include the four primary tobacco specific nitrosamines (TSNAs). Results The tested products contained nicotine at varying levels. The two ZYN products contained no nitrosamines or polycyclic aromatic hydrocarbons (PAHs) but low levels of ammonia, chromium, formaldehyde, and nickel. In the NRT products we quantified low levels of acetaldehyde, ammonia, cadmium, chromium, lead, nickel, uranium-235, and uranium-238. The largest number (27) and generally the highest levels of HPHCs were quantified in the moist snuff products. For example, they contained six out of seven tested PAHs, and seven out of ten nitrosamines (including NNN and NNK). A total of 19 compounds, none of which were PAHs, were quantified at low levels in the snus product. NNN and NNK levels were five to 12-fold lower in snus compared to the moist snuff products. Conclusions No nitrosamines or PAHs were quantified in the ZYN and NRT products. Overall, the number of quantified HPHCs were similar between ZYN and NRT products and found at low levels.

Abstract Tobacco Harm Reduction (THR) offers a promising approach to addressing the significant burden of smoking in Afghanistan. Over three million Afghans smoke daily, making it a leading cause of preventable deaths in the country. While the previous Afghan government implemented various tobacco cessation policies and strategies, these measures were only partially effective in reducing the number of smokers or smoking-related deaths. In 2021, community-based initiatives in Kabul and Herat started advocating for Tobacco Harm Reduction (THR) as a novel, realistic, and practical approach proven to promote smoking abstinence and minimize tobacco harm. However, implementing THR strategies in Afghanistan faces numerous challenges, including a lack of governmental support, funding issues, unfavorable market conditions, the high cost-effectiveness of THR products, and misconceptions about these products. To effectively promote THR in Afghanistan and overcome these challenges, it will be necessary to implement THR policies that support THR products for smokers, regulate the market for these products, produce them locally with healthcare professional oversight, conduct more engaging advocacy campaigns, and secure domestic sponsors.

Background: Tobacco-free nicotine pouches is a novel category of oral nicotine-delivery products. Among current tobacco users such pouches may serve as a low-risk alternative to cigarettes or conventional, tobacco-based oral products e.g., snus and moist snuff. In the United States (U.S.), the market leading nicotine-pouch brand is ZYN®. However, no data on the chemical characteristics of ZYN have been published. Methods: We screened for 43 compounds potentially present in tobacco products in seven oral nicotine-delivery products: ZYN (dry and moist), snus (General®), moist snuff (CRP2.1 and Grizzly Pouches Wintergreen), and two pharmaceutical, nicotine replacement therapy products (NRTs, Nicorette® lozenge and Nicotinell® gum). Thirty-six of the tested compounds are classified as harmful and potentially harmful constituents (HPHCs) by the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA-CTP). Five additional compounds were included to cover the GOTHIATEK® product standard for Swedish snus and the last two compounds were chosen to include the four primary tobacco specific nitrosamines (TSNAs). Results: The tested products contained nicotine at varying levels. The two ZYN products contained no nitrosamines or polycyclic aromatic hydrocarbons (PAHs) but low levels of ammonia, chromium, formaldehyde, and nickel. In the NRT products we quantified low levels of acetaldehyde, ammonia, cadmium, chromium, lead, nickel, uranium-235, and uranium-238. The largest number (27) and generally the highest levels of HPHCs were quantified in the moist snuff products. For example, they contained six out of seven tested PAHs, and seven out of ten nitrosamines (including NNN and NNK). A total of 19 compounds, none of which were PAHs, were quantified at low levels in the snus product. NNN and NNK levels were five to 12-fold lower in snus compared to the moist snuff products. Conclusions: No nitrosamines or PAHs were quantified in the ZYN and NRT products. Overall, the number of quantified HPHCs were similar between ZYN and NRT products and found at low levels. [ABSTRACT FROM AUTHOR]

Background: Oral nicotine pouches (NPs) are smokeless, tobacco-free products that have a potential role in tobacco harm reduction strategies. Methods: In a cross-sectional study in Sweden/Denmark, several recognised biomarkers of potential harm (BoPHs) linked to smoking-related diseases/their initiating biological processes, and biomarkers of exposure (BoEs) to tobacco/tobacco smoke toxicants were compared among exclusive adult users of Velo NPs and current/former/never smokers. Over 24 h, participants used their usual product (Velo NP or cigarette) as normal, and BoEs/BoPHs were assessed via blood/24-h urine/exhaled breath/physiological assessments. Results: Among the primary endpoints, total NNAL (16.9 ± 29.47 vs 187.4 ± 228.93 pg/24 h), white blood cell count (5.59 ± 1.223 vs 6.90 ± 1.758 × 109/L), and COHb (4.36 ± 0.525 vs 8.03 ± 2.173% saturation) were significantly lower among Velo users than among smokers (91%, 19% and 46% lower, respectively, all P < 0.0001), while fractional exhaled NO, previously shown to be lower in smokers, was significantly higher (23.18 ± 17.909 vs 11.20 ± 6.980 ppb) among Velo users (107% higher, P < 0.0001). Furthermore, sICAM-1 tended to be lower (185.9 ± 42.88 vs 204.5 ± 64.85 ng/mL) among Velo users than smokers (9% lower). Several secondary endpoints, including six BoEs (3-HPMA (246.7 ± 91.07 vs 1165.7 ± 718.35 μg/24 h), 3-OH-B[a]P (82.4 ± 217.58 vs 258.3 ± 190.20 pg/24 h), HMPMA (135.1 ± 77.85 vs 368.8 ± 183.15 μg/24 h), MHBMA (0.22 ± 0.166 vs 3.39 ± 2.943 μg/24 h), S-PMA (0.10 ± 0.059 vs 3.53 ± 2.736 µg/24 h) and total NNN (7.5 ± 24.84 vs 9.7 ± 5.93 ng/24 h)), were significantly lower among Velo users (78.8%, 68.1%, 63.4%, 93.5%, 97.2% and 22.7% lower, respectively, P < 0.0001–0.0011), while total nicotine equivalents was significantly higher among Velo users (22.6 ± 12.69 vs 12.1 ± 7.92 mg/24 h, P < 0.0001), although Velo user levels are comparable to those previously reported among oral tobacco users, and Velo user and smoker mean levels were similar in Denmark. Conclusion: As compared with smokers, exclusive users of Velo NPs have significantly less exposure to tobacco toxicants and more favourable BoPHs associated with initiating biological processes of smoking-related diseases. International Standard Registered Clinical Trial number: ISRCTN16988167 [ABSTRACT FROM AUTHOR]

Tobacco Harm Reduction (THR) offers a promising approach to addressing the significant burden of smoking in Afghanistan. Over three million Afghans smoke daily, making it a leading cause of preventable deaths in the country. While the previous Afghan government implemented various tobacco cessation policies and strategies, these measures were only partially effective in reducing the number of smokers or smoking-related deaths. In 2021, community-based initiatives in Kabul and Herat started advocating for Tobacco Harm Reduction (THR) as a novel, realistic, and practical approach proven to promote smoking abstinence and minimize tobacco harm. However, implementing THR strategies in Afghanistan faces numerous challenges, including a lack of governmental support, funding issues, unfavorable market conditions, the high cost-effectiveness of THR products, and misconceptions about these products. To effectively promote THR in Afghanistan and overcome these challenges, it will be necessary to implement THR policies that support THR products for smokers, regulate the market for these products, produce them locally with healthcare professional oversight, conduct more engaging advocacy campaigns, and secure domestic sponsors. [ABSTRACT FROM AUTHOR]

Abstract Introduction The study investigated the role and activities of organizations that advocate for the adoption of and access to safer nicotine products (SNPs), such as nicotine vaping products (e‐cigarettes), Swedish‐style snus, nontobacco nicotine pouches, and heated tobacco products, as safer alternatives to combustible cigarettes and other high‐risk tobacco products, following a harm reduction approach. The aim was to map the number and locations of nicotine consumer organizations globally and describe their history, legal status, membership, structure, objectives, working methods and activities, and funding. Methods We identified active organizations through the use of existing networks and referrals. All identified organizations were contacted and asked to fill in an online self‐completion survey through the representatives of the organizations. The data collected were cleaned and anonymized. Categorization and analysis of variable distributions were carried out. Responses to open–ended questions were analyzed qualitatively. Results A total of 52 active organizations were identified: 13 in Latin America, 8 in Africa, 24 in Europe, 5 in the Asia‐Pacific region, and 2 in North America. Most were established from 2016 onward, and 39 were legally incorporated. Their reported objectives were to raise awareness about SNP, promote rights to access SNP, and advocate for a legal and regulatory environment in which SNPs are available. They are small organizations: Most are operated with volunteers, with only 7 having any contracted or paid staff, and only 13 persons globally with a paid position. A total of 31 organizations had not received any funding support. The total global funding for all organizations was US$ 309,810. None reported receiving funding from tobacco or pharmaceutical companies. All pointed to important achievements in the public debate about SNP and tobacco harm reduction. Conclusion The organizations are run by enthusiastic individuals, most of whom have successfully quit smoking with the help of SNP. Organizations depend on the input of a small number of core workers, all organizations are under‐resourced and potentially fragile, and yet, they report significant activity and success. The challenge for these groups is to gain recognition at national and international level as legitimate stakeholders in the development of tobacco control policy with respect to safer alternatives to smoking.

Tobacco harm reduction (THR) involves providing adult smokers with potentially reduced harm modes of nicotine delivery as alternatives to smoking combustible cigarettes. Heated tobacco products (HTPs) form a category with THR potential due to their ability to deliver nicotine and flavours through heating, not burning, tobacco. By eliminating burning, heated tobacco does not produce smoke but an aerosol which contains fewer and lower levels of harmful chemicals compared to cigarette smoke. In this study we assessed the in vitro toxicological profiles of two prototype HTPs’ aerosols compared to the 1R6F reference cigarette using the 3D human (bronchial) MucilAir™ model. To increase consumer relevance, whole aerosol/smoke exposures were delivered repeatedly across a 28 day period (16, 32, or 48 puffs per exposure). Cytotoxicity (LDH secretion), histology (Alcian Blue/H&E; Muc5AC; FoxJ1 staining), cilia active area and beat frequency and inflammatory marker (IL-6; IL-8; MMP-1; MMP-3; MMP-9; TNFα) levels were assessed. Diluted 1R6F smoke consistently induced greater and earlier effects compared to the prototype HTP aerosols across the endpoints, and in a puff dependent manner. Although some significant changes across the endpoints were induced by exposure to the HTPs, these were substantially less pronounced and less frequently observed, with apparent adaptive responses occurring over the experimental period. Furthermore, these differences between the two product categories were observed at a greater dilution (and generally lower nicotine delivery range) for 1R6F (1R6F smoke diluted 1/14, HTP aerosols diluted 1/2, with air). Overall, the findings demonstrate the THR potential of the prototype HTPs through demonstrated substantial reductions in toxicological outcomes in in vitro 3D human lung models.

New approach methodologies (NAMs) are emerging chemical safety assessment tools consisting of in vitro and in silico (computational) methodologies intended to reduce, refine, or replace (3R) various in vivo animal testing methods traditionally used for risk assessment. Significant progress has been made toward the adoption of NAMs for human health and environmental toxicity assessment. However, additional efforts are needed to expand their development and their use in regulatory decision making. A virtual symposium was held during the 2021 Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) Smoke Science and Product Technology (SSPT) conference (titled "Advancing New Alternative Methods for Tobacco Harm Reduction"), with the goals of introducing the concepts and potential application of NAMs in the evaluation of potentially reduced-risk (PRR) tobacco products. At the symposium, experts from regulatory agencies, research organizations, and NGOs shared insights on the status of available tools, strengths, limitations, and opportunities in the application of NAMs using case examples from safety assessments of chemicals and tobacco products. Following seven presentations providing background and application of NAMs, a discussion was held where the presenters and audience discussed the outlook for extending the NAMs toxicological applications for tobacco products. The symposium, endorsed by the CORESTA In Vitro Tox Subgroup, Biomarker Subgroup, and NextG Tox Task Force, illustrated common ground and interest in science-based engagement across the scientific community and stakeholders in support of tobacco regulatory science. Highlights of the symposium are summarized in this paper. [ABSTRACT FROM AUTHOR]

Background: Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy. Objective: This 2-center, cross-sectional confinement study conducted in Denmark and Sweden aimed to determine whether biomarkers of exposure (BoEs) to tobacco toxicants and biomarkers of potential harm (BoPHs) in exclusive users of NPs show favorable differences compared with current smokers. Methods: Participants were healthy NP users (target n=100) and current, former, or never smokers (target n=40 each), as confirmed by urinary cotinine and exhaled carbon monoxide concentrations. During a 24-hour confinement period, participants were asked to use their usual product (NP or cigarette) as normal, and BoEs and BoPHs were measured in blood and 24-hour urine samples, with compliance determined using anabasine, anatabine, and N-(2-cyanoethyl)valine. BoEs and BoPHs were compared between NP users and current, former, and never smokers. Urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (BoE to nicotine-derived nitrosamine ketone) and urinary 8-epi-prostaglandin F2α type III, exhaled nitric oxide, blood carboxyhemoglobin, white blood cell count, soluble intercellular adhesion molecule-1, and high-density lipoprotein cholesterol (BoPHs) were evaluated as primary outcomes. Other measures included urinary 11-dehydrothromboxane B2, forced expiratory volume, carotid intima-media thickness, self-reported quality of life, and oral health. Results: The results of this study were received in mid-2022 and will be published in late 2022 to early 2023. Conclusions: The results of this study will provide information on toxicant exposure and biomarkers associated with the development of smoking-related diseases among users of NPs compared with smokers, as well as on the potential role of NPs in THR. [ABSTRACT FROM AUTHOR]

Background: Numerous smoke-free tobacco or nicotine-containing product (TNP) alternatives have been introduced to support individual- and population-level harm reduction relative to continued cigarette smoking. This article details the nationwide prevalence and patterns of TNP use between 2016 and 2019 in Japan following the commercialization of IQOS™, a smoke-free heated tobacco product (HTP). Methods: Cross-sectional surveys were conducted over a period of three study years (2016/2017, 2017/2018, and 2018/2019) in representative samples of the Japanese general adult population and samples of Japanese adult IQOS users registered in the IQOS owner database of Philip Morris International’s affiliate in Japan. Results: Across the three study years (Y1-Y3), the prevalence of overall current TNP use (Y1-Y3: 18.5%, 18.9%, and 18.2%) and overall TNP use by age and sex remained similar. However, there was a growing shift from cigarette smoking to smoke-free TNP use across the three study years. While the cigarette smoking prevalence (Y1-Y3: 17.6%, 17.3%, and 16.0%) decreased, the use prevalence of smoke-free TNPs, including the HTP IQOS ™ (Y1-Y3: 1.8%, 3.2%, and 3.3%) and e-cigarettes (Y1-Y3, 0.7%, 1.6%, and 2.0%) increased. At the same time, TNP initiation, TNP relapse, and TNP reinitiation with IQOS were all very low across the three study years. Across Y1-Y3, exclusive use of only one type of TNP (Y1-Y3: 82.3%, 75.0%, and 70.4%) decreased, while dual use of two types of TNPs (Y1-Y3: 14.3%, 17.2%, and 16.7%) increased, and poly-TNP use (Y1-Y3: 2.1%, 6.1%, and 10.0%) increased markedly. Moreover, the majority of adult IQOS users were exclusive IQOS users. Conclusions: These trends in IQOS use behavior suggest that IQOS™ has the potential to switch adult smokers from cigarettes to smoke-free tobacco products, which presents a harm reduction opportunity, and that HTPs are effective tools for complementing current tobacco control measures.

Abstract Introduction The objective was to systematically review studies on health outcomes from smokeless tobacco (SLT) products. Methods We analysed published literature on the health outcomes from SLT use between 01/01/2015 to 01/02/2020, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol using PubMed, Embase, Scopus, and Google Scholar. Results Of 53 studies included, six were global, 32 from Asia, Middle East and Africa (AMEA), nine from USA and six from Europe. ‘Poor’-rated studies predominated (23;43%), in particular, for global (4;66%) and AMEA (16;50%). Health outcomes differed between SLT-products and regions; those in AMEA were associated with higher mortality (overall, cancer, Coronary heart disease (CHD), respiratory but not cardiovascular disease (CVD)), and morbidity (CVD, oral and head and neck cancers), with odds ratios up to 38.7. European studies showed no excess mortality (overall, CVD, from cancers) or morbidity (ischemic heart disease (IHD), stroke, oral, head and neck, pancreatic or colon cancers) from several meta-analyses; single studies reported elevated risk of rectal cancer and respiratory disorders. Pooled study data showed protection against developing Parkinson’s disease. US studies showed mixed results for mortality (raised overall, CHD, cancer and smoking-related cancer mortality; no excess risk of respiratory or CVD mortality). Morbidity outcomes were also mixed, with some evidence of increased IHD, stroke and cancer risk (oral, head and neck). No studies reported on switching from cigarettes to SLT-products. Conclusion Our review demonstrates stark differences between different SLT-products in different regions, ranging from zero harm from European snus to greatly increased health risks in AMEA. The literature on the safety profile for SLT-products for harm reduction is incomplete and potentially misinforming policy and regulation.

Abstract Background The combustion of tobacco is the main cause of tobacco-related morbidity and mortality. E-cigarettes are potentially disruptive innovations with considerable potential for population health. A key question is whether e-cigarettes are replacing tobacco cigarettes, which requires mapping their prevalence. Collecting information on nicotine use is difficult for many countries due to cost. The objective of this study was to derive a global estimate of e-cigarette use (vaping). Methods Since 2018 we have collected information on the prevalence of e-cigarette use. To estimate the prevalence of vaping in countries lacking information, we used the method of assumed similarity between countries in the same region and economic condition. Based on surveys, we calculated the average prevalence of vaping for each WHO region, World Bank income classification group, and the legal status of e-cigarettes in each country. For each of these groups the average prevalence of vaping was calculated. These values were used as substitutes for the prevalence figures in the countries with absent data. The number of vapers was calculated by taking as the denominator the adult population. Results Survey data on e-cigarette users were available for 49 countries covering 2.8 b of the adult population in 2018 and unavailable for 2.9 b. Information on vaping was lacking for half of the world's population. We estimated a total of 58.1 m vapers worldwide in 2018. By reference to market growth the data were adjusted to arrive at estimates for 2020. Results were fitted to revenue data at the 2018. For the year 2020, the projection is for 68 m vapers globally. Conclusions Many global epidemiological studies use the method of assumed similarity between countries with shared characteristics in order to estimate missing data. The methodological limitations are likely to overestimate the global number of vapers. Our estimate of 68 m vapers indicates considerable uptake given that: e-cigarettes have been available on most markets for only a decade; there is either no support, or there is opposition to vaping in many countries; and countries which regulate e-cigarettes have controls over advertising and promotion. However, given the global scale of tobacco smoking (at 1.1 billion people), progress in adoption of alternative products is slow. Those using e-cigarettes are still a small fraction of those who smoke.

As compared with cigarette smoking, use of Swedish snus is associated with significantly fewer health risks. Nicotine pouches (NPs), a new form of oral nicotine product, are smokeless and tobacco-free, comprising a nicotine-containing cellulose matrix inside a fiber pouch. NPs are similar in appearance/use to snus, but without tobacco, have the potential to further reduce tobacco-related harm. This study aimed to evaluate toxicant levels of NPs to estimate their position on the tobacco/nicotine product continuums of toxicant delivery and risk. NPs, snus and nicotine replacement therapy products (NRTs) were analyzed for 24–26 compounds applicable to oral tobacco, and their levels were compared. Twenty of these compounds were further used to compare the toxicant profile of NPs, as well as estimated daily toxicant exposure from NP use, with that of tobacco/nicotine products spanning the risk continuum. Of the compounds measured, 22 (NPs), 22 (lozenge NRT), 20 (gum NRT), and 11 (snus) were not quantifiable. Compared with snus, NPs had lower levels of 10 HPHCs and comparable/undetectable levels of a further 13. Across the product categories, NPs and NRTs had the lowest toxicant profiles and estimations of relative toxicant exposure. Based on the present chemical analysis and estimated exposure, use of NPs appears likely to expose users to lower levels of toxic compounds than Swedish snus, which is recognized to offer reduced levels of harm than associated with tobacco smoking. We conclude that NPs should be placed close to NRTs on the tobacco/nicotine product toxicant delivery continuum, although further studies will be needed to confirm this. [ABSTRACT FROM AUTHOR]

Rationale: Tobacco harm reduction (THR) involves encouraging adult smokers who would otherwise continue to smoke to transition to less harmful forms of nicotine delivery. These products must offer adult smokers reduced exposure to chemicals associated with tobacco combustion, satisfactory blood plasma nicotine levels and serve as an acceptable alternative. The most recent THR innovation is tobacco-free oral nicotine pouches. Objectives: This study aimed to compare pharmacokinetic, pharmacodynamic and safety and tolerability profiles of two nicotine pouch variants (ZoneX #2 (5.8 mg nicotine/pouch); ZoneX #3 (10.1 mg nicotine/pouch)) with cigarette to assess the pouches' THR potential. Methods: This was a controlled use, randomised, open-label, cross-over clinical study with 24 healthy adult traditional tobacco users. Pharmacokinetic (plasma nicotine levels; up to 8 h post-use), pharmacodynamic (urge to smoke, product liking; up to 4 h post-use) and short-term safety and tolerability profiles were assessed. Results: Distinct nicotine pouch pharmacokinetic profiles indicated nicotine absorption via the oral mucosa. Plasma nicotine levels were lower, and time to peak slower, for the nicotine pouches compared to cigarette (Cmax cigarette: 11.6 ng/ml vs. #2: 5.2 ng/ml, p < 0.0001; #3: 7.9 ng/ml, p < 0.0003) (Tmax cigarette: 8.6 min vs. #2: 26 min; #3: 22 min). All products effectively reduced subjects' urge to smoke and presented favourable product liking scores; nicotine pouches were also well tolerated following short-term use (no serious adverse events). Conclusions: Overall, the assessed ZoneX nicotine pouches may offer an acceptable alternative for adult smokers to achieve satisfactory levels of nicotine delivery and, based on the pharmacokinetic parameters and under the study conditions, likely have a lower abuse liability and addictive potential for current adult smokers compared to continued cigarette smoking. Clinical trial identifier: NCT04891406 (clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Heated tobacco products (HTPs) are electronic devices that heat tobacco sticks to temperatures much lower than those which cause pyrolysis and combustion in cigarettes. While this electrical heating causes the formation of an inhalable aerosol which contains nicotine, the aerosol from HTPs contains significantly fewer and lower levels of the harmful and potentially harmful chemicals found in cigarette smoke. As a result, HTP use potentially conveys reduced risks to health compared to cigarette smoking. While this relative reduction in individual health risk is becoming clearer, what is less certain is the impact of HTPs on overall population‑level health, taking into account both the potential positive impact on adult smokers who completely switch to using HTPs and any unintended impacts such as use by tobacco non‑users and particularly by youth. The aim of this scoping review was to collate and evaluate the published scientific evidence to date, with a cut‑off of 1 January 2024, investigating the impact of HTPs on population‑level health. This evaluation suggests that HTP use is almost exclusively observed among those with a history of cigarette smoking, and there is a growing body of evidence for the ability of HTPs to provide support for adult smokers to transition away from cigarette smoking, in the absence of any significant "gateway" into tobacco use initiation. Many studies have reported a significant degree of dual use of cigarettes and HTPs, and efforts to assess the reasons for such patterns of use, whether these provide overall exposure reductions, and whether dual use acts as a bridge towards a complete transition away from cigarette smoking, requires further investigation. In addition, correction of the widespread and increasing misperceptions of HTPs among adult smokers is recommended to promote HTP uptake as a potentially less harmful alternative to smoking in this population., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: This writing of this review was funded by Imperial Brands PLC, a manufacturer of tobacco and nicotine products including heated tobacco products. Financial relationships: Ian M. Fearon declare(s) personal fees from Imperial Brands PLC. Ian M. Fearon declare(s) personal fees from LA Clinical Trials, LLC. Ian M. Fearon declare(s) personal fees from Cheerain HK Ltd. Ian M. Fearon declare(s) personal fees and stock/stock options from British American Tobacco. Ian M. Fearon declare(s) personal fees from RAI Services Company. Ian M. Fearon declare(s) personal fees from Shenzhen Smoore Technology, Ltd. Ian M. Fearon declare(s) personal fees from Advanced Inhalation Rituals, Ltd. Ian M. Fearon is a Non-Executive Director with Advanced Inhalation Rituals, Ltd., a manufacturer of waterpipe tobacco and electronic waterpipe products. Ian M. Fearon declare(s) personal fees and stock/stock options from Qnovia, LLC. Ian M. Fearon is a consultant to, and Scientific Advisory Board Member of, Qnovia, LLC, an inhaled nicotine pharmaceutical smoking cessation product manufacturer. Thomas Nahde declare(s) employment and stock/stock options from Reemtsma Cigarettenfabriken GmbH. Employed by Reemtsma Cigarettenfabriken GmbH, an Imperial Brands PLC company. Sarah F. Cordery, Martin Fitzpatrick, Sarah Weaver, Matthew Stevenson, Erika Grandolfo, and Layla Malt declare(s) employment and stock/stock options from Imperial Brands PLC. Ian M. Fearon declare(s) personal fees from Tobacco and nicotine product manufacturers and CROs. Ian M. Fearon is an independent consultant to tobacco and nicotine product manufacturers, and CROs, and provides scientific support for clinical and behavioural studies and general regulatory support. These manufacturers/CROs are unspecified for confidentiality reasons. Ian M. Fearon declare(s) employment from Broughton Life Sciences, Ltd. Ian M. Fearon declare(s) personal fees from E-Alternative Solutions, LLC. Ian M. Fearon declare(s) personal fees from Shenzhen JWEI Electronics Co., Ltd. Ian M. Fearon declare(s) personal fees from JUUL Labs and JUUL Labs UK Holdco, Ltd. Ian M. Fearon declare(s) employment from McKinney Regulatory Science Advisors, LLC. Ian M. Fearon declare(s) Travel expenses from Messe Dortmund GmbH. To attend and present at a tobacco expo. Keith Thompson declare(s) employment from Elucid8 Holdings Ltd. Employed by Elucid8 Holdings Ltd. and is acting as an independent scientific consultant to Imperial Brands PLC. Keith Thompson is a former employee of Gallaher Ltd. and Japan Tobacco International UK Ltd. Imperial Brands and Japan Tobacco International produce the electrically heated tobacco products ‘Pulze’ and ‘Ploom’, respectively. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Fearon et al.)

Background: E-cigarettes are often marketed as a less harmful alternative to traditional tobacco cigarettes. Despite their popularity, the evidence regarding their effects on human health remains unclear and is filled with complexities., Objectives: This systematic review aims to elucidate the direct effects of electronic cigarette use on human health, carefully distinguishing between the specific characteristics of the populations studied., Methodology: Adhering to the PRISMA guidelines, we conducted a comprehensive search in PubMed/Medline, Web of Science, Scopus, and Google Scholar databases without date restrictions, including articles in both Spanish and English. This approach enabled the identification and analysis of primary studies to understand the direct effect of electronic cigarettes on human health., Results: A total of 33 studies were included that evaluated cardiovascular, pulmonary, renal, weight and fertility effects. Only five studies analyzed e-cigarettes in healthy populations and seven studies compared healthy individuals against smokers. The effects evaluated on smokers or former tobacco smokers were apparently positive, however, among healthy individuals, increased heart rate, mean arterial pressure, oxidative stress, alteration of respiratory epithelial cells and increased airflow resistance were found., Conclusion: Smokers or former smokers who switch to e-cigarettes may reduce their exposure to carcinogens and lower their risk of developing severe health issues associated with conventional smoking. However, in healthy individuals who have never smoked traditional cigarettes, the use of e-cigarettes introduces several cardiovascular and respiratory adverse effects. These findings suggest that while e-cigarettes can be a strategic harm reduction tool for smokers, they are not a safe option for non-smokers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Izquierdo-Condoy, Naranjo-Lara, Morales-Lapo, Hidalgo, Tello-De-la-Torre, Vásconez-Gonzáles, Salazar-Santoliva, Loaiza-Guevara, Rincón Hernández, Becerra, González, López-Cortés and Ortiz-Prado.)

Background: This article analyzes the professional stress at healthcare professionals (HCP), related to their job. Health care providers can serve as role models in promoting healthy lifestyles; however, HCP commitment to help individuals to quit smoking may be influenced by their own smoking behavior. Material and methods: In order to determine the level of perceptual stress, the Perceived Stress Questionnaire (PSQ) was applied, PSQ developed by Levenstein et al. In order to determine the level of addiction to smoking, the Fagerstorm nicotine addiction test was applied. The research was attended by 210 subjects from 5 medical institutions: doctors, nurses, and resident doctors. Confidentiality is maintained. Results: The doctors accumulated 32% on the scale of severe dependence, 8% moderate dependence and only 9% mild dependence, after calculating the score and interpreting the data. The resident doctors have accumulated the maximum score on the scale of mild dependence, 7% moderate dependence and only 3% severe dependence, which speaks of the fact that they are the youngest category of medical workers at the beginning of their careers and still do not have good defense mechanisms. The nurses, who represent 9% of the entire group of subjects, accumulated 0% on the scale of severe dependence, 8% moderate dependence and 1% mild dependence. Conclusions: Comparative data on smoking dependence levels in doctors of 32% according to the perceived stress level 71% confirm this. Stressed health workers are more likely to smoke, have different social problems and are males. The results of research have shown that the prevalence of smokers among health care professionals is high (51%), implying the ineffectiveness of the current government anti-tobacco strategy. Introducing new pillar – Harm Reduction in National Antismoking Action Plan, along with prevention, cessation and protection from second-hand smoking, can improve current smoking situation in general. It would be helpful to implement training programs about Tobacco Harm Reduction for healthcare workers to improve their ability in smoking cessation counselling techniques to provide active support to their patients.

Background: Head and neck squamous cell carcinomas (HNSCCs) are particularly aggressive epithelial tumors, that affect more than half a million patients worldwide each year. They represent a multi-factorial group of tumors caused by: alcohol, tobacco, and human papillomavirus (HPV) infections. Over the last ten years the overall 5-year survival rate of HNSCCs remained ~40–50%, inspite of significant improvement in clinical outcome of many tumor types. There are recent data that claim how some of these cells fulfill a suppressive role in the antitumor immune response. It is interesting that new clinical studies demonstrated that HPV (+) HNSCCs were among tumors with the highest immune infiltrates, while HPV (-) presented a reduced number of immune infiltrating cells. Conclusions: Recent researches prove that tumor microenvironment of HNSCC has an important role in tumor progression, aggressivity, metastasis process, in addition to genetic aberrations and molecular alterations of cancer cells. New researches in stromal composition of the HNSCC may be useful in understanding of mechanisms of different responses to therapy, also can be used as a target for therapeutic purposes. Cancer-associated fibroblasts and immune cells, as well as their products found in neck squamous cell carcinoma significantly influence the biological properties of this tumor. Smoking is one of the risk factors of occurrence of most HPV-associated tumors. Promoting smoking cessation should become an essential contributor to the treatment of cancer in all oncologic pathologies. In cases when patients can’t quit smoking completely within the shortest possible period of time, doctors should focus on harm reduction strategies – tobacco harm reduction.

Background: Numerous smoke-free tobacco or nicotine-containing product (TNP) alternatives have been introduced to support individual- and population-level harm reduction relative to continued cigarette smoking. This article details the nationwide prevalence and patterns of TNP use between 2016 and 2019 in Japan following the commercialization of IQOS TM , a smoke-free heated tobacco product (HTP). Methods: Cross-sectional surveys were conducted over a period of three study years (2016/2017, 2017/2018, and 2018/2019) in representative samples of the Japanese general adult population and samples of Japanese adult IQOS users registered in the IQOS owner database of Philip Morris International’s affiliate in Japan. Results: Across the three study years (Y1-Y3), the prevalence of overall current TNP use (Y1-Y3: 18.5%, 18.9%, and 18.2%) and overall TNP use by age and sex remained similar. However, there was a growing shift from cigarette smoking to smoke-free TNP use across the three study years. While the cigarette smoking prevalence (Y1-Y3: 17.6%, 17.3%, and 16.0%) decreased, the use prevalence of smoke-free TNPs, including the HTP IQOS (Y1-Y3: 1.8%, 3.2%, and 3.3%) and e-cigarettes (Y1-Y3, 0.7%, 1.6%, and 2.0%) increased. At the same time, TNP initiation, TNP relapse, and TNP reinitiation with IQOS were all very low across the three study years. Across Y1-Y3, exclusive use of only one type of TNP (Y1-Y3: 82.3%, 75.0%, and 70.4%) decreased, while dual use of two types of TNPs (Y1-Y3: 14.3%, 17.2%, and 16.7%) increased, and poly-TNP use (Y1-Y3: 2.1%, 6.1%, and 10.0%) increased markedly. Moreover, the majority of adult IQOS users were exclusive IQOS users. Conclusions: These findings suggest that current IQOS use behavior trends are in line with the principles of tobacco harm reduction and that HTPs are effective tools for complementing current tobacco control measures.

This study aimed to determine the knowledge and perceptions of dentists regarding the tobacco harm reduction program in West Java, Indonesia. A survey was conducted to dentists in West Java with an online questionnaire. The questionnaire contained various closed-ended questions covering the knowledge and perceptions of dentists regarding tobacco harm reduction. The respondents’ knowledge score was calculated by giving 1 point for each correct answer. A total of 290 responses were included in the analysis. The results showed that the majority of the respondents believed combining nicotine replacement therapies (NRT) with counseling results in a high success rate in smoking cessation (75.5%). However, only a small percentage stated that one of the tobacco harm reduction products, namely e-cigarettes, is effective in replacing conventional cigarettes (25.9%). Although the majority of the respondents still had low knowledge related to the program (67.2%), they agreed that tobacco control activities are the duty of dentists (69.5%) and that their practice is an ideal place to conduct these events (72.0%). The perception of dentists regarding tobacco control in West Java was generally quite good. However, their lack of knowledge concerning the reduction program could be a barrier to effectively implementing the program. [ABSTRACT FROM AUTHOR]

Heated tobacco products represent a novel category of tobacco products in which a tobacco consumable is heated to a temperature that releases nicotine from the tobacco leaf but not to a temperature sufficient to cause combustion. Heated tobacco products may therefore have the potential to be a less harmful alternative for adult smokers that would otherwise continue to smoke conventional cigarettes. Given the rapid development of this product category, the aim of this review was to examine the available peer-reviewed scientific evidence related to heated tobacco products and highlight any research gaps. In recent years, manufacturers of heated tobacco products have published a number of studies on their respective heated tobacco products. Whilst there is limited research that is independent of commercial interests, the available scientific evidence indicates that heated tobacco products produce a much simpler aerosol than conventional cigarette smoke, with fewer and substantially lower levels of harmful toxicants. Toxicology assessments indicate these reductions in aerosol toxicants translate to reduced biological effects. Biomarker and clinical data from studies in which product use is controlled within a clinical setting, indicate changes in biomarker levels and clinical end-points similar to observations in cessation studies, indicating the potential for reduced harm. The scientific evidence also indicates that exposure of non-users to emissions from heated tobacco products in indoor environments is significantly reduced compared to exposure resulting from smoking conventional cigarettes. Overall, the available scientific evidence indicates that heated tobacco products hold promise as a less harmful alternative to conventional cigarettes, but more independent data is required to validate industry findings. As a growing product category, epidemiological studies and independent population modelling studies are outstanding, and empirical data on how dual tobacco product category use by consumers affects their risk profile is lacking.

Abstract Background In preparation for the 2021 revision of the European Union Tobacco Products Directive, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has posted its Preliminary Opinion on Electronic Cigarettes. They concluded that e-cigarettes only achieve a sub-optimal level of protection of human health. In this paper, we provide evidence that the Opinion’s conclusions are not adequately backed up by scientific evidence and did not discuss the potential health benefits of using alternative combustion-free nicotine-containing products as substitute for tobacco cigarettes. Methods Searches for articles were conducted in PubMed and by citation chasing in Google Scholar. Articles were also retrieved with a review of references in major publications. Primary data from World Health Organization surveys, the conclusions of reviews, and peer-reviewed non-industry studies were cited to address errors and omissions identified in the Opinion. Results The Opinion omitted reporting on the individual and population health benefits of the substitution of e-cigarettes (ENDS) for cigarette smoking. Alternative hypotheses to the gateway theory were not evaluated. Its assessment of cardiovascular risk is contradicted by numerous reviews. It cites ever-use data that do not represent current patterns of use. It did not report non-nicotine use. It presented erroneous statements on trends in ENDS prevalence. It over-emphasized the role of flavours in youth ENDS initiation. It did not discuss cessation in sufficient length. Conclusions For the delivery of a robust and comprehensive final report, the members of the Working Group of the Scientific Committee on Health, Environmental and Emerging Risks will need to consider (1) the potential health benefits of ENDS substitution for cigarette smoking, (2) alternative hypotheses and contradictory studies on the gateway effect, (3) its assessment of cardiovascular risk, (4) the measurements of frequency of use, (5) non-nicotine use, (6) the role of flavours, and (7) a fulsome discussion of cessation.

Abstract Background This interventional-cohort study tried to answer if people who smoke and choose an e-cigarette in the context of smoking cessation treatment by tobacco counselors in Flanders are achieving smoking abstinence and how they compare to clients who opt for commonly recommended (or no) aids (nicotine replacement therapy, smoking cessation medication). Methods Participants were recruited by tobacco counselors. They followed smoking cessation treatment (in group) for 2 months. At several times during treatment and 7 months after quit date, participants were asked to fill out questionnaires and to perform eCO measurements. Results One third of all participants (n = 244) achieved smoking abstinence 7 months after the quit date, with e-cigarette users having higher chances to be smoking abstinent at the final session compared to NRT users. Point prevalence abstinence rates across all follow-up measurements, however, as well as continuous and prolonged smoking abstinence, were similar in e-cigarette users and in clients having chosen a commonly recommended (or no) smoking cessation aid. No differences were obtained between smoking cessation aids with respect to product use and experiences. Conclusions People who smoke and choose e-cigarettes in the context of smoking cessation treatment by tobacco counselors show similar if not higher smoking cessation rates compared to those choosing other evidence-based (or no) smoking cessation aids.

Introduction Worldwide, tobacco smoking is one of the leading causes of avoidable deaths. In Nigeria, there is currently no clinical guidelines for tobacco dependence treatment. However, globally, pharmacy-based smoking cessation intervention has been associated with improved cessation rates and quality of life. This study aims at assessing the knowledge and perception of community pharmacists about smoking cessation and tobacco harm reduction as well as barriers to the practice of pharmacybased smoking cessation intervention. Methods A cross-sectional survey was carried out among 104 community pharmacists, between August and December 2019, using a self-administered paper questionnaire. Data entering, cleansing, and analysis were done using IBM SPSS (version 23). Descriptive statistics including frequencies and percentages were used to summarize the data. Results Thirteen pharmacists (12.5%) were providing smoking cessation services. One-tenth (10.6%) of the pharmacists were aware of tobacco harm reduction. The majority (89.4%) were willing to attend smoking cessation training. Among the respondents, 65 (62.5%) had poor knowledge regarding smoking cessation and tobacco harm reduction. Lack of knowledge and skills were reported by all (100%) as a barrier to providing the service. However, 101 (97.1%) community pharmacists agreed that smoking cessation treatment is an important role of pharmacists. Conclusions A suboptimal level of knowledge of smoking cessation and tobacco harm reduction was noted among the community pharmacists. However, they believed smoking cessation intervention is an important role of pharmacists. It is advocated that smoking cessation training should be included as part of the Pharmacists’ Council of Nigeria Mandatory Continuing Professional Development Training. Thus, it is imperative to establish basic national smoking cessation guidelines that can be functional towards reducing mortality and morbidity associated with tobacco smoking in Nigeria.