Summary Commercial cigarettes were analyzed for harmful and potentially harmful constituents (HPHCs) in tobacco and smoke to investigate temporal product variability independent of analytical variability over one week, one year, and three years. Cigarettes from the worldwide market with various design features were collected over a 3-year period, stored, and tested concurrently for HPHCs to minimize analytical variability; repeat testing of reference cigarette 3R4F was included as an analytical control for the study design. Physical parameters were found to be relatively consistent. No trends in variability were noted based on blend type, smoke analyte matrix, or magnitude of an HPHC's yield. Combustion-related HPHCs generally showed low variation. Long-term batch-to-batch variability was found to be higher than short-term variability for tobacco-related compounds that have the potential to vary over time due to weather and agronomic practices. “Tar”, nicotine, and carbon monoxide were tested in multiple labs and showed greater lab-to-lab variability than batch-to-batch variability across all phases. Based on the results of this study, commercial cigarette products appear to have relatively low product variability. The low analyte variability noted in this study with products tested under unconventionally controlled analytical conditions serves to indicate that analytical variability may be a significant contributor to overall variability for general product testing over time and in interlaboratory studies. Laboratory controls and using a matched reference product across studies and between laboratories are important to assess testing differences and variability.
{"title":"HPHC Testing of Tobacco and Smoke to Examine Cigarette Temporal Variability","authors":"Rana Tayyarah, M. Morton, J. Flora","doi":"10.2478/cttr-2022-0012","DOIUrl":"https://doi.org/10.2478/cttr-2022-0012","url":null,"abstract":"Summary Commercial cigarettes were analyzed for harmful and potentially harmful constituents (HPHCs) in tobacco and smoke to investigate temporal product variability independent of analytical variability over one week, one year, and three years. Cigarettes from the worldwide market with various design features were collected over a 3-year period, stored, and tested concurrently for HPHCs to minimize analytical variability; repeat testing of reference cigarette 3R4F was included as an analytical control for the study design. Physical parameters were found to be relatively consistent. No trends in variability were noted based on blend type, smoke analyte matrix, or magnitude of an HPHC's yield. Combustion-related HPHCs generally showed low variation. Long-term batch-to-batch variability was found to be higher than short-term variability for tobacco-related compounds that have the potential to vary over time due to weather and agronomic practices. “Tar”, nicotine, and carbon monoxide were tested in multiple labs and showed greater lab-to-lab variability than batch-to-batch variability across all phases. Based on the results of this study, commercial cigarette products appear to have relatively low product variability. The low analyte variability noted in this study with products tested under unconventionally controlled analytical conditions serves to indicate that analytical variability may be a significant contributor to overall variability for general product testing over time and in interlaboratory studies. Laboratory controls and using a matched reference product across studies and between laboratories are important to assess testing differences and variability.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"58 1","pages":"112 - 126"},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85645798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Summary On May 10, 2016, the U.S. Food and Drug Administration (FDA) published a Final Rule that extended its regulatory authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (Deemed Products). Effective August 8, 2016, this decision greatly expanded the scope of tobacco products being regulated by FDA and introduced significant testing challenges that need to be addressed. The major challenge for cigars in particular is testing as well as generation of accurate and reliable data, in the absence of certified reference products and standardized methodology for a product category with significant complexity and high inherent variability. In this article, we provide an overview of recent studies as well as active opportunities and on-going challenges associated with regulating and testing cigars. To the best of our knowledge, this is the first comprehensive review of non-clinical research for this product category (cigars). We are therefore convinced that, tobacco scientists and farmers, analytical chemists, cigar consumers, tobacco legal counsels, state and federal regulatory authorities will find this review beneficial and insightful.
{"title":"Advancements and Challenges of Cigar Science, Testing and Regulation: A Review","authors":"R. Abrokwah, Rana Tayyarah","doi":"10.2478/cttr-2022-0008","DOIUrl":"https://doi.org/10.2478/cttr-2022-0008","url":null,"abstract":"Summary On May 10, 2016, the U.S. Food and Drug Administration (FDA) published a Final Rule that extended its regulatory authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (Deemed Products). Effective August 8, 2016, this decision greatly expanded the scope of tobacco products being regulated by FDA and introduced significant testing challenges that need to be addressed. The major challenge for cigars in particular is testing as well as generation of accurate and reliable data, in the absence of certified reference products and standardized methodology for a product category with significant complexity and high inherent variability. In this article, we provide an overview of recent studies as well as active opportunities and on-going challenges associated with regulating and testing cigars. To the best of our knowledge, this is the first comprehensive review of non-clinical research for this product category (cigars). We are therefore convinced that, tobacco scientists and farmers, analytical chemists, cigar consumers, tobacco legal counsels, state and federal regulatory authorities will find this review beneficial and insightful.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"16 1","pages":"73 - 89"},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90665771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Summary High lignin content of tobacco stem has been addressed as a drawback for its utilization on manufacture of reconstituted tobacco sheet. Therefore, the solvothermal method using ethylene glycol was investigated for the removal of lignin from tobacco stem. It was found that the removal efficiency of ethylene glycol on tobacco stem is much lower than that achieved on wheat straw and corncob, i.e., 13.9% vs. 39.3% and 44.1%, respectively. This can be rationalized in terms of the presence of solanesol in tobacco stem, which retards the strong hydrogen bond interaction between ethylene glycol and the free hydroxyl groups present in lignin. When solanesol was eliminated by applying an n-hexane extraction procedure, 40.5% of lignin was successfully dissolved from tobacco stem. The successful removal of lignin was further confirmed by the characterizing results of SEM, FT-IR and N2-sorption. The developed method provides a promising way to attenuate the negative effects of lignin on utilization of the otherwise wasted tobacco stem for production of reconstituted tobacco sheet.
{"title":"Investigation on the Lignin Removal From Tobacco Stem by a Solvothermal Method Using Ethylene Glycol as a Solvent","authors":"Zhihao Chen, Li Ding, Dong Li, Jiahui Chen, Lipeng Zhou, Jijun Zhao","doi":"10.2478/cttr-2022-0011","DOIUrl":"https://doi.org/10.2478/cttr-2022-0011","url":null,"abstract":"Summary High lignin content of tobacco stem has been addressed as a drawback for its utilization on manufacture of reconstituted tobacco sheet. Therefore, the solvothermal method using ethylene glycol was investigated for the removal of lignin from tobacco stem. It was found that the removal efficiency of ethylene glycol on tobacco stem is much lower than that achieved on wheat straw and corncob, i.e., 13.9% vs. 39.3% and 44.1%, respectively. This can be rationalized in terms of the presence of solanesol in tobacco stem, which retards the strong hydrogen bond interaction between ethylene glycol and the free hydroxyl groups present in lignin. When solanesol was eliminated by applying an n-hexane extraction procedure, 40.5% of lignin was successfully dissolved from tobacco stem. The successful removal of lignin was further confirmed by the characterizing results of SEM, FT-IR and N2-sorption. The developed method provides a promising way to attenuate the negative effects of lignin on utilization of the otherwise wasted tobacco stem for production of reconstituted tobacco sheet.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"45 1","pages":"106 - 111"},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90325411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Rytsar, S. Djurdjevic, Alexander K. Nussbaum, A. Kaul, Emanuel Bennewitz, P. N. Lee, J. Fry
Summary Background We previously estimated the impact of introducing heat-not-burn products and e-cigarettes in Germany on smoking-related disease mortality in men and women aged 30–79 years between 1995 and 2015. Here, we estimate the impact by socioeconomic group. Methods Individuals with a defined baseline cigarette smoking distribution were followed under a “Null Scenario” (no reduced-risk products) and “Alternative Scenarios” (reduced-risk products introduced). Transition probabilities allowed estimation of annual product use changes, with individual product histories used to estimate reductions in deaths and life-years lost. Here, however, individuals were classified into two socioeconomic groups defined by income and education, with allowance for variation by group in initial smoking prevalence and the probability of changing product use, or of changing socioeconomic group. Results With no allowance for socioeconomic group, deaths would have reduced by 217,000 (from 852,000 for continued smoking) had everyone immediately ceased smoking in 1995 and by 40,000 to 179,000 had one or two types of reduced-risk products – the heat-not-burn product and the e-cigarette – been adopted by smokers to varying extents. With such allowance, we estimate substantial drops in each socioeconomic group. Where all cigarette smokers switched immediately, half of them to heat-not-burn products, half to e-cigarettes, the estimated drops in deaths were 60,000 in group A (higher socioeconomic group) and 122,000 in group B (lower), about 82% of the drops associated with immediate cessation (73,000 in A and 148,000 in B). With more gradual conversion, the drops were 26,648 in A and 53,000 in B, about 35% of those from cessation. The drops in deaths and life-years saved were about 2 and 1.5 times higher in group B, respectively, associated with its greater numbers, older age, and higher smoking prevalence. The estimated reductions would increase upon considering more diseases, a wider age range, or longer follow-up. Methodological limitations would not affect the conclusion that introducing these products in 1995 in Germany could have substantially reduced deaths and life-years lost in both groups, more so in B. Conclusions Although cessation is optimal for reducing mortality, switching to reduced-risk products also provides substantial health gains. A public health approach encouraging lower socioeconomic group smokers to switch to reduced-risk products could diminish smoking-related health inequalities relative to continued smoking.
{"title":"Estimated Public Health Gains From Smokers in Germany Switching to Reduced-Risk Alternatives: Results From Population Health Impact Modelling by Socioeconomic Group","authors":"R. Rytsar, S. Djurdjevic, Alexander K. Nussbaum, A. Kaul, Emanuel Bennewitz, P. N. Lee, J. Fry","doi":"10.2478/cttr-2022-0005","DOIUrl":"https://doi.org/10.2478/cttr-2022-0005","url":null,"abstract":"Summary Background We previously estimated the impact of introducing heat-not-burn products and e-cigarettes in Germany on smoking-related disease mortality in men and women aged 30–79 years between 1995 and 2015. Here, we estimate the impact by socioeconomic group. Methods Individuals with a defined baseline cigarette smoking distribution were followed under a “Null Scenario” (no reduced-risk products) and “Alternative Scenarios” (reduced-risk products introduced). Transition probabilities allowed estimation of annual product use changes, with individual product histories used to estimate reductions in deaths and life-years lost. Here, however, individuals were classified into two socioeconomic groups defined by income and education, with allowance for variation by group in initial smoking prevalence and the probability of changing product use, or of changing socioeconomic group. Results With no allowance for socioeconomic group, deaths would have reduced by 217,000 (from 852,000 for continued smoking) had everyone immediately ceased smoking in 1995 and by 40,000 to 179,000 had one or two types of reduced-risk products – the heat-not-burn product and the e-cigarette – been adopted by smokers to varying extents. With such allowance, we estimate substantial drops in each socioeconomic group. Where all cigarette smokers switched immediately, half of them to heat-not-burn products, half to e-cigarettes, the estimated drops in deaths were 60,000 in group A (higher socioeconomic group) and 122,000 in group B (lower), about 82% of the drops associated with immediate cessation (73,000 in A and 148,000 in B). With more gradual conversion, the drops were 26,648 in A and 53,000 in B, about 35% of those from cessation. The drops in deaths and life-years saved were about 2 and 1.5 times higher in group B, respectively, associated with its greater numbers, older age, and higher smoking prevalence. The estimated reductions would increase upon considering more diseases, a wider age range, or longer follow-up. Methodological limitations would not affect the conclusion that introducing these products in 1995 in Germany could have substantially reduced deaths and life-years lost in both groups, more so in B. Conclusions Although cessation is optimal for reducing mortality, switching to reduced-risk products also provides substantial health gains. A public health approach encouraging lower socioeconomic group smokers to switch to reduced-risk products could diminish smoking-related health inequalities relative to continued smoking.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"237 1","pages":"52 - 67"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76941200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Summary 4-(N’-methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) is a potentially carcinogenic tobacco specific nitrosamine (TSNA) and an important compound in the Harmful and Potentially Harmful Constituents (HPHCs) list of U.S. Food and Drug Administration (FDA). For this reason, significant effort is being made for an understanding of the formation of this compound and for the reduction of its level in tobacco products. Formation of NNK is assumed to be the result of nitrosation of 4-(methylamino)-1-(3-pyridyl)-1-butanone (pseudooxynicotine or PON). Present study evaluated the correlation between the levels of NNK and those of PON in a variety of tobaccos and tobacco products. Since nicotine-1′-N-oxide can be involved in the formation of PON, the correlation of the levels of this compound with the levels of NNK was also evaluated. Two original methods were developed for the quantitation of PON in tobacco and tobacco products and a well-established method has been used for the analysis of NNK. The correlation between the levels of NNK with that of PON was proven to be very poor. The same result was obtained for the correlation between NNK levels and nicotine-1′-N-oxide. This indicated that a higher level of PON or of nicotine-1′-N-oxide in tobacco or tobacco products does not lead to a higher level of NNK. The study does not prove that NNK in tobacco or tobacco products is not generated via PON, but it demonstrated that the limiting factor in the formation of NNK in tobacco and tobacco products is not the level of PON or that of nicotine-1′-N-oxide, and other factors are responsible for the effectiveness of NNK formation.
4-(N′-甲基亚硝胺)-1-(3-吡啶基)-1-丁酮(NNK)是一种具有潜在致癌性的烟草特异性亚硝胺(TSNA)，是美国食品和药物管理局(FDA)有害和潜在有害成分(HPHCs)清单中的重要化合物。因此，正在作出重大努力，以了解这种化合物的形成并减少其在烟草制品中的含量。NNK的形成被认为是4-(甲胺)-1-(3-吡啶基)-1-丁酮(伪烟碱或PON)亚硝化的结果。本研究评估了各种烟草和烟草制品中NNK和PON水平之间的相关性。由于尼古丁-1′- n -氧化物可参与PON的形成，因此还评估了该化合物水平与NNK水平的相关性。开发了两种用于烟草和烟草制品中PON定量的原始方法，并采用了一种完善的方法来分析NNK。NNK水平与PON水平的相关性很差。NNK水平与尼古丁-1′- n -氧化物的相关性也得到了相同的结果。这表明烟草或烟草制品中较高水平的PON或尼古丁-1′- n -氧化物不会导致较高水平的NNK。本研究并没有证明烟草或烟草制品中的NNK不是通过PON产生的，但证明了烟草和烟草制品中NNK形成的限制因素不是PON或尼古丁-1′- n -氧化物的水平，其他因素对NNK形成的有效性负责。
{"title":"Does the Level of NNK in Tobacco and Tobacco Products Depend on the Level of Pseudooxynicotine or of Nicotine-1′-N-Oxide?","authors":"H. Ji, S. Moldoveanu","doi":"10.2478/cttr-2022-0003","DOIUrl":"https://doi.org/10.2478/cttr-2022-0003","url":null,"abstract":"Summary 4-(N’-methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) is a potentially carcinogenic tobacco specific nitrosamine (TSNA) and an important compound in the Harmful and Potentially Harmful Constituents (HPHCs) list of U.S. Food and Drug Administration (FDA). For this reason, significant effort is being made for an understanding of the formation of this compound and for the reduction of its level in tobacco products. Formation of NNK is assumed to be the result of nitrosation of 4-(methylamino)-1-(3-pyridyl)-1-butanone (pseudooxynicotine or PON). Present study evaluated the correlation between the levels of NNK and those of PON in a variety of tobaccos and tobacco products. Since nicotine-1′-N-oxide can be involved in the formation of PON, the correlation of the levels of this compound with the levels of NNK was also evaluated. Two original methods were developed for the quantitation of PON in tobacco and tobacco products and a well-established method has been used for the analysis of NNK. The correlation between the levels of NNK with that of PON was proven to be very poor. The same result was obtained for the correlation between NNK levels and nicotine-1′-N-oxide. This indicated that a higher level of PON or of nicotine-1′-N-oxide in tobacco or tobacco products does not lead to a higher level of NNK. The study does not prove that NNK in tobacco or tobacco products is not generated via PON, but it demonstrated that the limiting factor in the formation of NNK in tobacco and tobacco products is not the level of PON or that of nicotine-1′-N-oxide, and other factors are responsible for the effectiveness of NNK formation.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"223 1","pages":"25 - 34"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73352541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Summary Introduction Previous studies have shown that nicotine interacts in inflammatory pathways and may have both pro- and anti-inflammatory actions. The aim of this study was to carry out a systematic review of publications investigating the inflammatory effects of nicotine in models of human disease. Methods The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklists were followed during the design and implementation of this study. Searches were carried out across PubMed, Science Direct, and the Cochrane Library. Articles were included if they were published in English, in peer-reviewed journals, reported an effect of nicotine in the treatment of a clinical condition, experimental studies or clinical trials which investigated an effect of nicotine administration in patients with a clinical condition or epidemiological studies which investigated an effect of nicotine administration in patients with a clinical condition. Results Thirty-eight studies were identified and categorized into disease areas before systematic review. Nineteen studies were related to digestive diseases (primarily Crohn’s disease and ulcerative colitis), six to atherosclerosis, five to skin and healing, four to pain and infection, three to pulmonary sarcoidosis, and three to multiple sclerosis (one study reported data on three disease areas). Risk of bias assessment was not carried out, but the general quality of the studies was low, mostly offering preliminary data in small numbers of participants. No consistent effects of nicotine treatment (primarily through use of transdermal nicotine patches or nicotine chewing gums) were reported across any of the disease models. Conclusion No reliable evidence of a pro- or anti-inflammatory effect of nicotine was observed in patients with any of the diseases included in this study.
{"title":"Nicotine and Inflammatory Disease in Humans: A Systematic Review","authors":"L. Price, Keith Thompson, Javier Martínez","doi":"10.2478/cttr-2022-0002","DOIUrl":"https://doi.org/10.2478/cttr-2022-0002","url":null,"abstract":"Summary Introduction Previous studies have shown that nicotine interacts in inflammatory pathways and may have both pro- and anti-inflammatory actions. The aim of this study was to carry out a systematic review of publications investigating the inflammatory effects of nicotine in models of human disease. Methods The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklists were followed during the design and implementation of this study. Searches were carried out across PubMed, Science Direct, and the Cochrane Library. Articles were included if they were published in English, in peer-reviewed journals, reported an effect of nicotine in the treatment of a clinical condition, experimental studies or clinical trials which investigated an effect of nicotine administration in patients with a clinical condition or epidemiological studies which investigated an effect of nicotine administration in patients with a clinical condition. Results Thirty-eight studies were identified and categorized into disease areas before systematic review. Nineteen studies were related to digestive diseases (primarily Crohn’s disease and ulcerative colitis), six to atherosclerosis, five to skin and healing, four to pain and infection, three to pulmonary sarcoidosis, and three to multiple sclerosis (one study reported data on three disease areas). Risk of bias assessment was not carried out, but the general quality of the studies was low, mostly offering preliminary data in small numbers of participants. No consistent effects of nicotine treatment (primarily through use of transdermal nicotine patches or nicotine chewing gums) were reported across any of the disease models. Conclusion No reliable evidence of a pro- or anti-inflammatory effect of nicotine was observed in patients with any of the diseases included in this study.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"41 1","pages":"10 - 24"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76353389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
T. Jaunky, D. Thorne, Andrew Baxter, Simone Hadley, J. Frosina, D. Breheny, James J. Murphy, M. Gaca
Summary Tobacco heating products (THPs) have reduced toxicant emissions relative to cigarettes. THPs are continually evolving, but safety and efficacy studies on each new variant involve considerable resources. As employed by the pharmaceutical industry, a “bridging” process could be used to demonstrate product equivalence. Therefore, we investigated the feasibility of a bridging approach by evaluating aerosol emissions and in vitro cytotoxicity of five variant THPs in relation to a base product. All products were compared to a reference cigarette and a commercial benchmark. Relative to smoke, chemical reductions in THP aerosols were comparable among the THPs at 94–97%. The aerosols showed similar cytotoxicity in human lung tissues exposed at the air-liquid interface (p = 0.8378) but were significantly less toxic than smoke (p = 0.04). Relative to the THP benchmark, variant THPs showed lower cytotoxicity (p = 0.0141). Emissions and cytotoxicity data demonstrated that the variant THPs were comparable to the base THP, irrespective of consumable format or flavour. This dataset demonstrates the feasibility of a bridging approach and can inform an evidence-based strategy in developing sufficient data to predict similarity against an already established dataset. Therefore, avoiding repetition of vast data generation could ease authorisation requirements of newer products. Finally, we propose that more work is required to understand chemical, biological (in vitro), human consumption, and clinical data before the equivalence of these products (and others) can be definitively demonstrated. Future studies maybe needed to assess additional chemical and biological outputs and all data will need to be contextualised against human consumption data in terms of a bridging framework.
{"title":"An Experimental Analytical and In Vitro Approach to Bridge Between Different Heated Tobacco Product Variants","authors":"T. Jaunky, D. Thorne, Andrew Baxter, Simone Hadley, J. Frosina, D. Breheny, James J. Murphy, M. Gaca","doi":"10.2478/cttr-2022-0001","DOIUrl":"https://doi.org/10.2478/cttr-2022-0001","url":null,"abstract":"Summary Tobacco heating products (THPs) have reduced toxicant emissions relative to cigarettes. THPs are continually evolving, but safety and efficacy studies on each new variant involve considerable resources. As employed by the pharmaceutical industry, a “bridging” process could be used to demonstrate product equivalence. Therefore, we investigated the feasibility of a bridging approach by evaluating aerosol emissions and in vitro cytotoxicity of five variant THPs in relation to a base product. All products were compared to a reference cigarette and a commercial benchmark. Relative to smoke, chemical reductions in THP aerosols were comparable among the THPs at 94–97%. The aerosols showed similar cytotoxicity in human lung tissues exposed at the air-liquid interface (p = 0.8378) but were significantly less toxic than smoke (p = 0.04). Relative to the THP benchmark, variant THPs showed lower cytotoxicity (p = 0.0141). Emissions and cytotoxicity data demonstrated that the variant THPs were comparable to the base THP, irrespective of consumable format or flavour. This dataset demonstrates the feasibility of a bridging approach and can inform an evidence-based strategy in developing sufficient data to predict similarity against an already established dataset. Therefore, avoiding repetition of vast data generation could ease authorisation requirements of newer products. Finally, we propose that more work is required to understand chemical, biological (in vitro), human consumption, and clinical data before the equivalence of these products (and others) can be definitively demonstrated. Future studies maybe needed to assess additional chemical and biological outputs and all data will need to be contextualised against human consumption data in terms of a bridging framework.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"1 1","pages":"1 - 9"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90786989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Rytsar, S. Djurdjevic, Alexander K. Nussbaum, Ashok Kaul, Emanuel Bennewitz, P. N. Lee, J. Fry
Summary Background Smoking is associated with cancer and cardio-respiratory mortality. Reducing smoking prevalence will lead to fewer deaths and more life-years. Here, we estimate the impact of hypothetical introduction of reduced-risk products (heat-not-burn products and e-cigarettes) in Germany from 1995 to 2015 on mortality from lung cancer, chronic obstructive pulmonary disease, ischaemic heart disease, and stroke in men and women aged 30–79 years. Methods We used a previously described population health impact model, with individuals with a defined baseline cigarette smoking distribution followed under a “Null Scenario”, with reduced-risk products never introduced, and various “Alternative Scenarios” where they are. Transition probabilities allow product use to change annually, with the individual product histories allowing estimation of risks, relative to never users, which are then used to estimate reductions in deaths and life-years lost for each Alternative Scenario. Results In the Null Scenario, we estimated 852,000 deaths from cigarette smoking (42,600 per year), with 8.61 million life-years lost. Had everyone ceased smoking in 1995, and with no use of reduced-risk products, these numbers would reduce by 217,000 and 2.88 million. Compared to the Null Scenario, the estimated reductions would be 159,000 and 2.06 million with an immediate complete switch to heat-not-burn products and 179,000 and 2.34 million with 50% of smokers immediately switching to heat-not-burn products and 50% to e-cigarettes. In four Scenarios with a more gradual switch, the estimated decreases were 39,800–81,000 deaths and 0.50–1.05 million life-years, representing 17.5%–37.5% of the effect of immediate cessation in 1995. These estimates assume that switching to heat-not-burn products and e-cigarettes involves risk decreases of 80% and 95% of those from quitting, respectively. The reductions in mortality would be greater with more diseases and a wider age range considered or with a longer follow-up period, as the decreases increased markedly with time. Various limitations are discussed, none affecting the conclusion that introducing these new products into Germany in 1995 could have substantially reduced deaths and life-years lost. Conclusions Deaths from cigarette smoking could be substantially reduced not only by cessation but additionally by switching to reduced-risk products. Respective public health campaigns might increase such switching.
{"title":"Estimated Public Health Gains From German Smokers Switching to Reduced-Risk Alternatives: Results From Population Health Impact Modelling","authors":"R. Rytsar, S. Djurdjevic, Alexander K. Nussbaum, Ashok Kaul, Emanuel Bennewitz, P. N. Lee, J. Fry","doi":"10.2478/cttr-2022-0004","DOIUrl":"https://doi.org/10.2478/cttr-2022-0004","url":null,"abstract":"Summary Background Smoking is associated with cancer and cardio-respiratory mortality. Reducing smoking prevalence will lead to fewer deaths and more life-years. Here, we estimate the impact of hypothetical introduction of reduced-risk products (heat-not-burn products and e-cigarettes) in Germany from 1995 to 2015 on mortality from lung cancer, chronic obstructive pulmonary disease, ischaemic heart disease, and stroke in men and women aged 30–79 years. Methods We used a previously described population health impact model, with individuals with a defined baseline cigarette smoking distribution followed under a “Null Scenario”, with reduced-risk products never introduced, and various “Alternative Scenarios” where they are. Transition probabilities allow product use to change annually, with the individual product histories allowing estimation of risks, relative to never users, which are then used to estimate reductions in deaths and life-years lost for each Alternative Scenario. Results In the Null Scenario, we estimated 852,000 deaths from cigarette smoking (42,600 per year), with 8.61 million life-years lost. Had everyone ceased smoking in 1995, and with no use of reduced-risk products, these numbers would reduce by 217,000 and 2.88 million. Compared to the Null Scenario, the estimated reductions would be 159,000 and 2.06 million with an immediate complete switch to heat-not-burn products and 179,000 and 2.34 million with 50% of smokers immediately switching to heat-not-burn products and 50% to e-cigarettes. In four Scenarios with a more gradual switch, the estimated decreases were 39,800–81,000 deaths and 0.50–1.05 million life-years, representing 17.5%–37.5% of the effect of immediate cessation in 1995. These estimates assume that switching to heat-not-burn products and e-cigarettes involves risk decreases of 80% and 95% of those from quitting, respectively. The reductions in mortality would be greater with more diseases and a wider age range considered or with a longer follow-up period, as the decreases increased markedly with time. Various limitations are discussed, none affecting the conclusion that introducing these new products into Germany in 1995 could have substantially reduced deaths and life-years lost. Conclusions Deaths from cigarette smoking could be substantially reduced not only by cessation but additionally by switching to reduced-risk products. Respective public health campaigns might increase such switching.","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"1 1","pages":"35 - 51"},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82697033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Deng Qixin, Xie Wei, L. Zechun, Liu Jiangsheng, Zhang Tingui, Lian Fenyan, Chen Kunyan, X. Jianping, Liu Huimin, Nie Cong, Yan Quanping
Summary A method for simultaneous identification and quantitative determination of 30 organic acids was established. The smoke yields and filter retentions of organic acids and routine smoke components, total particulate matter (TPM), nicotine-free dry particulate matter (NFDPM), nicotine and carbon monoxide (CO) at different filter ventilation levels were determined under both International Organization for Standardization (ISO) and Health Canadian Intense (HCI) smoking regimes. As a result of smoke dilution during filter ventilation, the yields of all organic acids were reduced in mainstream cigarette smoke. The spatial distribution pattern of the concentration of each organic acid in the filter was investigated at different ventilation levels and their filter retention determined. On one hand, the concentration of organic acids with a lower boiling point (BP) and lower molecular weight (MW) was relatively higher at the smoking end and the periphery part of the filter and spatial concentration distributions within the filter were significantly affected by smoke diffusion. On the other hand, those acids with high BPs and high MW were mainly distributed at the tobacco rod end and central part of the filter and spatial concentration distributions were only slightly influenced by their smoke diffusion within the filter whilst air compression around the filter vents also led to less change. This way, different acids in mainstream cigarette smoke were reduced to different extents which can also influence the acid-base equilibrium and sensory quality of the smoke. Compared with ISO smoking regime, the vent blocking and more intense smoking HCI regime led to different extents of yield increase for each of the studied acids. The effect of filter ventilation in the HCI smoking regime was not investigated, as the HCI smoking regime requires blocked ventilation holes. [Contrib. Tob. Nicotine Res. 30 (2021) 199–211]
{"title":"The Effects of Cigarette Filter Ventilation on Delivery and Retention of Organic Acids","authors":"Deng Qixin, Xie Wei, L. Zechun, Liu Jiangsheng, Zhang Tingui, Lian Fenyan, Chen Kunyan, X. Jianping, Liu Huimin, Nie Cong, Yan Quanping","doi":"10.2478/cttr-2021-0015","DOIUrl":"https://doi.org/10.2478/cttr-2021-0015","url":null,"abstract":"Summary A method for simultaneous identification and quantitative determination of 30 organic acids was established. The smoke yields and filter retentions of organic acids and routine smoke components, total particulate matter (TPM), nicotine-free dry particulate matter (NFDPM), nicotine and carbon monoxide (CO) at different filter ventilation levels were determined under both International Organization for Standardization (ISO) and Health Canadian Intense (HCI) smoking regimes. As a result of smoke dilution during filter ventilation, the yields of all organic acids were reduced in mainstream cigarette smoke. The spatial distribution pattern of the concentration of each organic acid in the filter was investigated at different ventilation levels and their filter retention determined. On one hand, the concentration of organic acids with a lower boiling point (BP) and lower molecular weight (MW) was relatively higher at the smoking end and the periphery part of the filter and spatial concentration distributions within the filter were significantly affected by smoke diffusion. On the other hand, those acids with high BPs and high MW were mainly distributed at the tobacco rod end and central part of the filter and spatial concentration distributions were only slightly influenced by their smoke diffusion within the filter whilst air compression around the filter vents also led to less change. This way, different acids in mainstream cigarette smoke were reduced to different extents which can also influence the acid-base equilibrium and sensory quality of the smoke. Compared with ISO smoking regime, the vent blocking and more intense smoking HCI regime led to different extents of yield increase for each of the studied acids. The effect of filter ventilation in the HCI smoking regime was not investigated, as the HCI smoking regime requires blocked ventilation holes. [Contrib. Tob. Nicotine Res. 30 (2021) 199–211]","PeriodicalId":10723,"journal":{"name":"Contributions to Tobacco & Nicotine Research","volume":"4 1","pages":"199 - 211"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87895785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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