rss_2.0Sciendo RSS Feed for Contributions to Tobacco & Nicotine Researchhttps://sciendo.com/journal/CTTRhttps://www.sciendo.comhttps://sciendo-parsed.s3.eu-central-1.amazonaws.com/6471a90a215d2f6c89dac465/cover-image.jpghttps://sciendo.com/journal/CTTR140216https://sciendo.com/article/10.2478/cttr-2025-0004<abstract> <title style='display:none'>Summary</title> <p>Exclusive use of Swedish snus is associated with a reduction in associated health risks as compared with cigarette smoking. Similar to Swedish snus but without tobacco, modern oral nicotine pouches are smokeless nicotine products with the potential to offer similar or greater reductions of risks associated with tobacco use. Currently, little is known about the use prevalence of these products in established markets for Swedish snus. In this descriptive study, two market research surveys were conducted in 2019 among 18–64-year-olds in Sweden (n = 7003; male, 51.1%) and Denmark (n = 4402; male, 50.5%) on use of these oral tobacco and nicotine products in order to explore basic user demographics and average daily consumption (ADC) of oral nicotine products. In Sweden, 18.5% of participants reported currently using oral products (17.1% snus; 1.4% nicotine pouch), while only 11.0% smoked cigarettes. In Denmark, by contrast, 20.5% of participants reported currently using cigarettes, whereas 3.2% used oral products (0.8% snus; 2.4% nicotine pouch). More men than women reported using oral products in both countries, and most oral product users were younger than 45 years. The ADC of all oral products was 11.1 pouches/day in Sweden, but only 5.6 pouches/day in Denmark, where nicotine pouch use was predominant. In summary, Swedish snus continues to account for most oral tobacco or nicotine product use in Sweden, but nicotine pouch use has surpassed snus use (2.4% <italic>vs.</italic> 0.8%) in Denmark. Tobacco users who switch to nicotine pouches may reduce their health risks as compared to continuing tobacco product use, and nicotine pouches can contribute to tobacco harm reduction for the population as a whole.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2025-00042025-02-12T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2025-0002<abstract> <title style='display:none'>Summary</title> <p>Providing data on usage patterns is key to assessing the reduced-risk potential of novel tobacco and nicotine products as compared to conventional cigarettes at a population level. A pilot cross-sectional survey was conducted in 2018 across 3 areas of Japan (Tokyo, Osaka, and Sendai) to assess tobacco and nicotine product use after the introduction of Heated Tobacco Products (HTPs). Following successful completion of the pilot study, two nationwide cross-sectional surveys were conducted using the general population in Japan to assess use patterns after the introduction of HTPs. The first (Wave 1) was conducted in 2019, and the second in 2020. In Wave 2, the concern of this publication, additional population-level data was obtained on use patterns and behaviour relating to tobacco and nicotine products in Japan. Eligible participants were Japanese residents, aged 20 years or older who consented to complete the survey. A 3-stage probability sampling method was applied that was geographically stratified by street blocks proportionate to population density. Respondents self-reported patterns of product use and reasons for HTP use. Complete responses were available from 5307 individuals, of whom 889 (16.7%) were current users, 1012 (19.1%) were former users, and 3407 (64.2%) were never users of tobacco products (weighted respondent totals). Of current tobacco users, 63.5% smoked cigarettes exclusively and 17.9% used HTPs exclusively. HTP dual use in combination with conventional cigarettes was 12.7%. The remaining 5.9% of users were categorised as poly users (i.e., use of 2 or more tobacco products). The most common reasons reported for HTP use were perceived reduction in harm to others and self - compared to cigarettes. These findings are consistent across pilot and Wave 1 conducted in Japan as part of this survey programme. Cigarettes were still the most frequent tobacco product used (13.4% in the pilot to 15.5% in Wave 1) within the general population, the usage prevalence for HTPs (5.3% to 5.4%) being considerable in comparison to other tobacco or nicotine-containing products like cigars, cigarillos, pipe, kiseru, and oral tobacco, where usage prevalence was close to zero. As with the previous Waves, no gateway effect (use of non-traditional combustible tobacco use – such as e-cigarettes and in this case HTP use – leading to subsequent tobacco smoking) was observed in this study.</p> <p>The findings presented here are indicative of the results from the initial study in 2018 and the nationwide Wave 1 study in 2019 but with a larger population, where the market is now more established with new-generation products. In conclusion, the prevalence of cigarette use in Japan is decreasing and HTPs seem to be increasingly used as an alternative to cigarette smoking.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2025-00022025-01-30T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2025-0003<abstract> <title style='display:none'>Summary</title> <p><italic>In vivo</italic> testing is a crucial part of product development. Most <italic>in vivo</italic> toxicology studies are conducted in a heavily regulated environment, in accordance with sound scientific principles, and in an ethical manner. Statistical methods are an important component of these scientific principles, and many regulatory authorities provide guidelines or recommendations for statistical analyses and reporting. We propose a rigorous and comprehensive statistical approach to assess the impact of smoke exposure during <italic>in vivo</italic> comparative studies using statistical equivalence with variable equivalence limits based on historical data. The analysis enables comparison of the effect of a new/test aerosol to its reference/control while leveraging information about reference item variation across multiple studies. This approach is helpful in assessing the relevance of observed effects while incorporating sources of variability estimated using data from the current and previous experiments. The proposed method was used to analyze an OECD (Organization for Economic Co-operation and Development) 90-day inhalation study to determine the effects of exposure to smoke emitted by the new 1R6F reference cigarette as compared to the older 3R4F reference cigarette. Data from previous OECD 90-day <italic>in vivo</italic> studies using 3R4F cigarette smoke were used to improve our assessment of the effects observed in the current study.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2025-00032025-01-30T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2025-0001<abstract> <title style='display:none'>Summary</title> <p>Evaluating the reduced-risk potential of novel tobacco and nicotine products, as compared to cigarettes, requires consideration not only of individual risk but also the impact on the population as a whole. Where the reduction in health risk for smokers who switch to the product instead of continuing to smoke, but also the product’s potential effects and rate of uptake among non-smokers must be taken into account.</p> <p>Computational models have proven to be a valuable tool to enable evaluation of long-term population health effects, in the absence of epidemiological data. Most population health models projecting the health impact of novel tobacco and nicotine products have primarily focussed on potential population harm or benefit using premature ‘all cause’ mortality rates attributable to cigarette smoking as the key output indicator. This study expands on previous mortality projections for the introduction of tobacco heated products (THPs) in Japan, using an enhanced systems dynamics model including non-mortality outcomes. This enables investigation of additional projections for person-years lived with disabilities, tobacco related disease incidence, tobacco use prevalence and tobacco user behaviour, such as average smoker age, the number of years smoked and the age at which individuals ceased smoking. Disease specific projections are provided for the main smoking related diseases, lung cancer, CVD and COPD, and also for esophageal cancer and lower extremity peripheral arterial disease as examples of the potential wider application of this modelling approach.</p> <p>Modelling estimates based on the available data, indicate that the introduction of THPs into the Japanese marketplace will reduce future smoking prevalence, smoking-related premature deaths and the burden of smoking related disabilities, compared to a scenario where THPs had not been introduced. The resulting projections demonstrate the ability to investigate population health impacts beyond all-cause mortality to provide further insight into the harm reduction potential of alternative nicotine products such as THPs.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2025-00012025-01-30T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0010<abstract> <title style='display:none'>Summary</title> <p>Analytical research relevant to cigar products is relatively limited compared to other tobacco product categories and very few standardized methods are in place. In recent years, scientific and regulatory interests in cigar testing have increased. Thus, there is a need for increased foundational knowledge in the product space. The objective of this work was to characterize cigars across a range of design features to understand relative magnitude of results and to evaluate analytical variability among and between three laboratories using their own practices and methodology.</p> <p>Commercial cigars across a broad range of design characteristics were evaluated for tobacco and smoke harmful or potentially harmful constituents (HPHCs) typically applied to cigarettes and smokeless tobacco products (i.e., FDA-Center for Tobacco Product’s abbreviated list). Design features such as size, manufacturing technique (machine <italic>vs.</italic> hand), and tipping (untipped, filtered, and mouthpiece designs) were included in the study matrix. For smoke analytes, a currently accepted regime for cigar smoking was employed. Cigars from the same lots were tested by three independent laboratories using their own methodologies to assess lab-to-lab differences across 5 physical parameter measures, 10 tobacco analytes, and 21 smoke analytes. Thus, the overall study was a randomized design with a two-factor arrangement: cigar type (with six levels) and laboratory (with three levels). Calculation of Lab Product Range (LPR) allowed for a comparison of magnitude in results across the product set. Data analysis included determination of relative variability (% RSD, Relative Standard Deviation) for replicate testing among the products. Lab Range (LR) was calculated to compare spread in results among the laboratories for each product. Low LR and similar LPR among the labs is an indicator of laboratory consistency.</p> <p>LPR results ranged from 45% for length to 445% for smoke ammonia. For example, tobacco weight, at approximately 260% LPR, ranged from 1 g/cigar to 18 g/cigar. Tobacco NNN, LPR 328%, ranged from 2000 ng/g to 27,000 ng/g. Replicate variability (% RSD) of physical characteristics, tobacco, and smoke analytes was much higher for the cigar products than previously reported for typical cigarette products. For example, tobacco weight % RSD was as high as 11%. Commercial factory-made cigarettes are typically reported at &lt; 1% RSD.</p> <p>Lab Range was as low as &lt; 1% for cigar length and as high as 247% for tobacco NNK. Smoke nicotine, one of the few analytes tested using standard methodology and subject to routine collaborative studies, had an LR as high as 73%. Tobacco BaP and carbonyls LR results were very inconsistent between labs. For example, acetaldehyde for Sample D was reported as 0.29, 0.81, and &lt; 0.10 µg/g for Lab 1, Lab 2, and Lab 3, respectively.</p> <p>Cigars with a broad range of design features were shown to have relatively high variability, a wide magnitude in analyte levels and smoking characteristics, and in some cases quite distinct results from lab-to-lab. Some analytes, such as BaP and crotonaldehyde, were determined to be inadequate for characterization in cigar tobacco due to a lack of quantifiable results. Based on LR results, smoke ammonia and carbonyls were found to lack robust methodology.</p> <p>The results of this study support the need for increased standardization for smoking analyte methods and the use of reference products across studies to improve understanding of product differences and the contribution of analytical variability. Additionally, in the absence of foundational data, the results are cautionary regarding using isolated data sets for characterization <italic>via</italic> HPHC testing for cigars, especially hand rolled products.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00102025-01-07T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0008<abstract> <title style='display:none'>Summary</title> <p>The objective of this study was to create a North American e-cigarette, or electronic nicotine delivery system (ENDS), market map representative of the 2020 and 2021 commercial market for analysis of harmful and potentially harmful constituents (HPHCs) and other chemicals in aerosol. The study consisted of 14 brands (seven closed pod-based, four open (refillable) pod-based, two cigalike, one disposable) and analyzed multiple e-liquid formulations per brand with varying labelled nicotine concentrations and flavors, equating to 35 unique tested ENDS. Aerosol was generated using two puffing regimes (ISO 27068 and intense) and analyzed for primary constituents, metals, carbonyls, and glycidol in a head-to-head comparison in the same testing laboratory. Nicotine yields per puff ranged from 0.045 mg/puff for the lowest yielding ENDS under the ISO 27068 puffing regime to 1.11 mg/puff for the highest yielding ENDS under intense puffing conditions. For carbonyls, all ENDS generated quantifiable amounts of acetaldehyde, acrolein, and formaldehyde in collected aerosol, irrespective of puffing regime, with an increase in yields observed under intense puffing compared to ISO 27068 puffing for the majority of tested ENDS. For metals, the ENDS aerosol yielded nickel (Ni) ranging from below limits of detection (BLOD) to &gt;30 ng/puff, while quantifiable levels of chromium (Cr), copper (Cu), and lead (Pb) were only associated with select ENDS. All tested ENDS aerosol contained quantifiable glycidol ranging from 0.003 to &gt;1.00 µg/puff for ISO 20768 and 0.005 to 1.10 µg/puff for intense puffing regimes. As a category, ENDS aerosol showed significantly reduced levels of HPHCs compared to 1R6F combustible cigarette (CC) smoke on a per nicotine basis. However, there was variability among ENDS and the aerosol of some ENDS products produced increased levels of specific HPHCs (e.g., formaldehyde and nickel) compared to 1R6F CC smoke. The observed HPHC variations appear to be primarily dependent on device design. In summary, this work is one of the most comprehensive analyses of HPHCs for North American ENDS using validated analytical methods in the same test facility for a head-to-head comparison.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00082024-10-15T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0009<abstract> <title style='display:none'>Summary</title> <p>In recent years, the tobacco- and/or nicotine-containing product (TNP) portfolio has expanded to include products such as e-vapor products, heated tobacco products, and nicotine pouches. Although scientific papers and regulatory requirements/recommendations related to the assessment of product use behavior and exposure to product use have been published for these novel TNPs, there is great diversity in the terminology used to characterize and assess these types of products. The aim of this paper is to define the terms and methods used for assessing product use behavior and exposure, with the objective to suggest a uniform application of terms used by scientists working in this field of research. This publication is the work product of a cross-industry work item commissioned by the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) Product Use Behaviour and Biomarkers Subgroups.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00092024-10-15T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0007<abstract> <title style='display:none'>Summary</title> <p>The nicotine pharmacokinetics (PK) of non-combustible tobacco and nicotine products, including e-cigarettes, have been extensively studied, with lower or similar nicotine exposure reported for most products compared with combustible cigarettes (CC). We conducted two clinical studies to evaluate nicotine PK and assess nicotine consumption when using two types of e-cigarettes with different flavor variants in U.S. healthy adults who smoke, under similar study protocols.</p> <p>Study 1 was a randomized, 6-period crossover study conducted in healthy adults who smoke. The primary objective was to evaluate nicotine PK following use of a cig-a-like e-cigarette (eDNC1.0a) with three flavor variants, subjects’ own brand of CC, a nicotine gum, and a reference e-cigarette. Study 2 was a randomized, 7-period crossover study conducted in healthy adults who smoke. The primary objective was to evaluate nicotine PK following use of a closed-tank e-cigarette (eDNC2.0a) with four flavor variants, subjects’ own brand of CC, a nicotine inhaler, and a reference e-cigarette.</p> <p>In summary, the results of the present studies indicate that nicotine exposure from eDNC1.0a with three flavor variants and eDNC2.0a with four flavor variants was less than that from subjects’ own brand of CC, similar to or less than that from reference e-cigarettes, but similar to or greater than that from pharmaceutical nicotine replacement products. It was observed that the nicotine consumption, estimated based on e-liquid consumption, was generally directly proportional to the level of nicotine exposure as indicated by nicotine PK parameter measurements in each study. Furthermore, linear relationships were found between estimated nicotine consumption and plasma nicotine PK parameters following e-cigarette use. Our findings suggest that mixed effects modelling can be used as a noninvasive method to provide insights of nicotine PK parameters (AUC and C_max) from e-liquid nicotine consumption data.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00072024-08-21T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0005<abstract> <title style='display:none'>Summary</title> <p>This study describes the dissolution release profiles of nicotine and flavor markers from three loose moist smoke-less tobacco (MST) products, same brand, each made with a distinct flavor. The US Pharmacopeia flow-through cell dissolution apparatus 4 (USP-4) was employed, following a previously published method that was validated to study the nicotine release from MST products. Herein, we expanded the scope of the analytical method by incorporating three flavor markers including methyl salicylate, ethyl salicylate, and glycyrrhizic acid to provide an understanding of the dissolution release profiles of not only nicotine but also of flavor markers. The dissolution release profiles of nicotine were found to be equivalent across all three tobacco products. In contrast, the release profiles of the studied flavor markers exhibited distinct differences, primarily influenced by their chemical properties, particularly polarity. Notably, glycyrrhizic acid demonstrated the most rapid release rate, while ethyl salicylate exhibited the slowest release rate. This study serves as a valuable resource for researchers, manufacturers, and regulatory bodies involved in the evaluation of MST products attributes and performance.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00052024-08-10T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0006<abstract> <title style='display:none'>Summary</title> <p>Cigarette draw resistance and filter pressure drop are both critical physical indicators for the tobacco industry, which use testing equipment to measure the two parameters. Pressure drop standards are used as transfer standards to ensure the accuracy and reliability of the testing equipment. Pressure drop standards are generally cylindrical rods having a certain number of parallel capillaries. To address the issue of how to design and fabricate pressure drop standards quickly and conveniently, this paper proposes a design method for pressure drop standards based on structural parameters. The method uses a mathematical model of the internal airflow of the standard including the entrance effect into a circular capillary and uses an iterative calculation algorithm accordingly. By iterative calculation, the structural parameters of the pressure drop standard, namely, diameter and length of the capillaries, were obtained, along with the relationship between the draw resistance of the standard and the flow rate in each capillary. The accuracy of the mathematical model was validated by comparing and analyzing the experimental and theoretical draw resistance of standards with different structural parameters. The experimental results showed that the relative error between the measured draw resistance and the calculated draw resistance was below 8%, which proves the reliability and validity of the mathematical model, and provides theoretical support for the design and fabrication of pressure drop standards.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00062024-08-10T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0003<abstract> <title style='display:none'>Summary</title> <p>With the improvement of irrigation and transportation infrastructures, single tobacco cultivation has been converted into tobacco–vegetable double cultivation in Yunnan Province. High residual nitrogen (N) levels in soil before tobacco transplanting induced by the excessive N input during the vegetable cultivation season resulted in a reduction of economic income and the quality of flue-cured tobacco. Therefore, the objective of this paper is to describe the optimization of N management and to provide a better understanding of the mechanism of optimal N application rate on the economic benefit and quality of tobacco. A field experiment with six N application rates (0, 45, 60, 75, 90, and 105 kg N ha⁻¹) was carried out with a randomized block design in 2021 and 2022 in Yunnan Province. The economic value and yield, intrinsic chemical and processing quality, leaf growth rate and agronomic characters were determined.</p> <p>Compared with the currently recommended 105 kg N ha⁻¹ rate, 75 kg N ha⁻¹ significantly increased the total economic value and superior tobacco yields, improved the integrated grade of chemical compounds and resulted in leaf midrib proportions in an appropriate range. The total economic value positively correlated with the superior tobacco leaf yields (R² = 0.91, p &lt; 0.001), while not with medium and inferior leaf yield. The daily leaf growth rate in prosperous growth stage significantly correlated with the yield of superior tobacco and reached its maximum at a N rate of 75 kg N ha⁻¹. The sum of N application rate and soil residual N before transplanting correlated with the total economic value (R² = 0.66, p &lt; 0.05) and superior leaf yield (R² = 0.64, p &lt; 0.05), respectively. Based on the amount of soil residual N before transplanting, the optimal N application rate was 66 kg N ha⁻¹ which was 39 kg N ha⁻¹ lower than the currently recommended N rate (105 kg N ha⁻¹). Our results highlighted that the technical consultants and farmers should adjust the N application rate appropriately according to the residual N amount before transplanting and optimize the water and fertilizer management especially in the prosperous growth stage. An optimized N rate is not only of economic benefit and the improvement of quality of tobacco cultivation, but also environment friendly.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00032024-06-09T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0002<abstract> <title style='display:none'>Summary</title> <p>Tobacco smoke consists of over 5000 chemical components, most of them are carcinogenic, respiratory toxicants, cardiovascular toxicants, addictive, etc. In 2006 the Working Group on Tobacco Control identified substances in tobacco smoke, which are harmful and potentially harmful for human health (Priority List) and encouraged the development of methods for the analysis of these components. This review focuses on the different methods of evaluation of harmful and potentially harmful components in tobacco smoke used by the International Agency for Research on Cancer (IARC) and the U.S. Food and Drug Administration (FDA) and furthermore on the official methods proposed by the World Health Organization (WHO) and the Cooperation Center for Scientific Research Relative to Tobacco (CORESTA) for analysing these constituents. The various methods for the determination of the substances in tobacco smoke included in the Priority List are compared. In addition, the different evaluation of components from the Priority List is presented. The authors hope that this review will acquaint readers with the harmful components in tobacco smoke. Also, that it will help accredited or scientific laboratories to compare the different methods and to choose appropriate methods depending on their laboratory equipment and laboratory chemicals available.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00022024-06-09T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0004<abstract> <title style='display:none'>Summary</title> <p>The compositions of waterpipe tobaccos available for retail sale on the US market are relatively unknown compared with more popular products such as cigarettes. Indeed, the phrase “waterpipe tobaccos” is used only in some governmental regulations and in journal articles dealing with regulatory aspects of those products. Commercially, the terms “shisha”, “hookah tobaccos”, and “flavored tobaccos” are used. In addition to the differences in commercial terminology, there is also confusion about the composition of such tobaccos, with the term “waterpipe tobacco” also being applied to products on the market that do not contain enough glycerol to prevent combustion during use. Therefore, during the past several years, 40 samples of shisha products on the US market were sent to an ISO 17025 accredited laboratory for the determination of glycerol, propylene glycol, fructose, glucose, and sucrose, in addition to the usual tobacco analytes and water using the Karl Fischer method. Moreover, two surrogate samples of shisha tobacco, one based on flue-cured tobacco and the other based on dark air-cured tobacco, were analyzed by the same laboratory along with samples of the starting tobaccos. The main finding from these analyses was that there were two very different types of shisha tobaccos on the market. One type was based on dark air-cured tobacco and the other type was based on flue-cured tobacco. Among the brand-styles based on flue-cured tobacco, some had higher levels of glycerol and lower levels of added sugars than others that had higher added sugars and lower levels of glycerol. Another important point of differentiation was that the products based on dark air-cured tobacco had much smaller tobacco particle sizes than did those based on flue-cured tobacco. The results of this research as well as other research that will be presented in two subsequent reports showed that waterpipe tobaccos cannot be considered as a single product category. This is particularly true for the determination of emissions using the instrumentation specified in ISO 22486:2019 (Water pipe tobacco smoking machine — Definitions and standard conditions).</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00042024-06-09T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2024-0001<abstract> <title style='display:none'>Summary</title> <sec><title style='display:none'>Background</title> <p>Next generation of nicotine/tobacco products (NGPs) include electronic cigarettes (ECs), heated tobacco products (HTPs), oral nicotine pouches (NPs) and smokeless tobacco (SLT) products (in particular snus). These products commonly contain nicotine and are intended to replace combustible cigarettes (CCs) and thus can be regarded as tobacco harm reduction products. To fulfill this role, it is essential that nicotine, which has well established addictive properties, is not causally related to health risks upon chronic use.</p> </sec> <sec><title style='display:none'>Objectives</title> <p>The purpose of this review is to evaluate the scientific literature to answer the question, whether nicotine is involved in the development of any diseases or disorders associated with the acute, short, mid- and long-term use of NGPs. Appropriate results from studies with nicotine replacement therapy (NRT) products (gum, patches, inhalers, lozenges) are included as reference basis for inferring the health effects of NGPs. Furthermore, suggestions for filling identified gaps and for avoiding or minimizing limitations and weaknesses in study design are provided.</p> </sec> <sec><title style='display:none'>Methods</title> <p>Literature databases such as MEDLINE, Google Scholar and an in-house ABF library (containing about 180,000 articles) were searched for relevant articles. Furthermore, pertinent monographs (such as the US Surgeon General Reports) and recent reviews were screened for further publications. Inclusion criteria were: all human studies investigating the association between use (preferably chronic use) of the nicotine/tobacco products mentioned above and health effects, including diseases, disorders, changes in biomarkers of biological effect (BOBEs). <italic>In vivo</italic> (animal) and <italic>in vitro</italic> studies were also considered, provided effects of NGPs in the presence and absence of nicotine or in relation to the nicotine exposure dose were reported. Also, reference lists of recent suitable articles were screened. In total, about 500 articles were retrieved by this approach. The role of nicotine was evaluated by considering the article authors’ statements and their cited references as well as by own judgement of reported results. Human studies are presented in a standardized table format.</p> </sec> <sec><title style='display:none'>Results</title> <p>In total, 183 human studies were evaluated, with cardiovascular diseases (CVD) ranking highest (N = 75 studies), followed by respiratory diseases (43), oral health disorders (23), cancer (10), metabolic syndrome (7), reproduction disorders (5) and several other diseases (&lt; 5). The majority of studies do not provide evidence for a participation of nicotine in the pathogenesis. Some (weak) evidence was found that nicotine might be involved in some CVD-related effects and metabolic syndrome. This would be also supported by results from animal and <italic>in vitro</italic> studies.</p> </sec> <sec><title style='display:none'>Discussion</title> <p>Human studies showed some severe limitations and weaknesses with respect to the study design and time of availability of NGPs on the market. A severe flaw is the insufficient consideration of dual use (NGP + CC), particularly in studies on chronic use, which could have led to erroneously increased risks for NGPs with direct consequences also for the role of nicotine. Additionally, prior effects from using CC have an impact. Both circumstances could have led to inaccurate conclusions in terms of elevated risk levels, which require changes in method designs. Suggestions for methodological improvements are provided for future studies.</p> </sec> <sec><title style='display:none'>Conclusions</title> <p>A final evaluation of the role of nicotine in disease development in NGP users is currently not possible because use durations are too short. Chronic studies often suffer from insufficient separation between NGP only and dual use together with CCs, which may falsely increase the observed health risk. There is some limited evidence that nicotine may be involved in CVD-related effects, which, however, has to be verified in well controlled long-term studies. The potential involvement of nicotine in other patho-mechanisms also requires further research.</p> </sec> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2024-00012024-04-05T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2023-0018<abstract> <title style='display:none'>SUMMARY</title> <p>Heated tobacco products (HTPs) are a recent category of tobacco products, with their relative safety compared to cigarette smoking and potential to help smokers to quit being two reasons why regulators may consider their market approval. Designed to heat tobacco rather than to burn in order to produce aerosol, different heating techniques are applied to commercial HTPs, which may result in differing aerosol formation. Therefore, each product requires separate assessment. This work focuses on a closed-end HTP (coded as HTP-A), which is electrically heated and designed to allow puffing air flow to bypass its tobacco section, resulting in reduced oxygen concentration within the tobacco section during heating and aerosol forming. To provide a preliminary aerosol chemistry and <italic>in vitro</italic> toxicological screening, this study assessed HTP-A against a commercial electrically heated HTP (IQOS^TM, coded as HTP-B) and a 3R4F reference cigarette. Under Health Canada Intense (HCI) smoking regime, the levels of 9 regulatory priority toxicants in the aerosol of HTP-A were either reduced or comparable to those in HTP-B on a per-stick basis. Additionally, both HTPs showed significant reduction (greater than 90%) in comparison to those measured in mainstream smoke of 3R4F cigarette for these toxicants. Using a set of standard <italic>in vitro</italic> toxicological assays (Ames, Micronucleus and Neutral Red Uptake), the two HTPs showed no observable responses while significant toxicity responses were recorded for 3R4F’s total particulate matter. Based on these preliminary results, the novel closed-end HTP-A design may provide similar toxicological profiles to the comparator HTP-B. Further toxicological and clinical assessments are warranted to evaluate HTP-A’s potential for exposure or disease risk reduction. [Contrib. Tob. Nicotine Res. 32 (2023) 146–156]</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2023-00182023-12-16T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2023-0015ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2023-00152023-12-16T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2023-0017<abstract> <title style='display:none'>SUMMARY</title> <p>The airtightness of heated tobacco product (HTP) packs is a very important indicator for the product quality and is also of great importance during the conditioning process. A method for evaluation of the airtightness was developed based on the air pressure difference in a constant pumping configuration. The essential feature of this method is that the pressure difference between the inside and the outside of the HTP packs during the deflation process is used to characterize the sealing quality of HTP packs. The detailed setup, the principle as well as the determination procedure are described. The accuracy and the repeatability of the method were assessed, and the effect of airtightness on the conditioning process was also investigated. The developed method is proven to be reliable with a standard deviation less than 0.09 kPa and repeatability less than 0.30 kPa. In addition, it was found that, although the transmission of moisture between HTPs and atmosphere could not be entirely prevented by the packs, airtightness still plays a significant role during the conditioning process, especially if the airtightness was at a relatively low level (e.g., lower than 1.5 kPa under a pumping flow rate of 200 mL/min). The method provides a promising way to assess and monitor the sealing quality of HTP packs, and it is suggested that the airtightness of the pack should not be lower than 2 kPa under a pumping flow rate of 200 mL/min. [Contrib. Tob. Nicotine Res. 32 (2023) 140–145]</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2023-00172023-12-16T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2023-0014ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2023-00142023-12-16T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2023-0016<abstract> <title style='display:none'>SUMMARY</title> <sec> <title style='display:none'>Background</title> <p>In recent years several nicotine products have been introduced that aim to offer smokers an alternative to cigarettes. As well as having fewer toxicants than combustible cigarettes, such nicotine products must be able to deliver nicotine efficiently. The aim of this study was to determine and compare the pharmacokinetics of nicotine absorption from nine oral tobacco-free smokeless nicotine pouches with varying nicotine content and flavours.</p> </sec> <sec> <title style='display:none'>Methods</title> <p>In a randomised, open-labelled, controlled, crossover clinical study, nicotine pharmacokinetics and product-liking were compared between nine nicotine pouches (<italic>Velo</italic>, BAT; 4- or 7-mg nicotine per pouch and in eight flavours). During a 10-day confinement period, 42 healthy adult participants, who were current smokers of combustible cigarettes, used a single study product once each day during a 45-min use period following overnight nicotine abstinence.</p> </sec> <sec> <title style='display:none'>Results</title> <p>Maximum plasma nicotine concentration and area under curve for nicotine concentration <italic>versus</italic> time 180 min after the start of study product use were significantly greater for the 7-mg than for the 4-mg <italic>Velo</italic> pouches <italic>(p</italic> &lt; 0.0001). These values did not differ between flavours among the 7-mg <italic>Velo</italic> nicotine pouches after adjustment for multiple comparisons (both <italic>p</italic> &gt; 0.003). The median time to maximum plasma nicotine concentrations and mean product-liking scores were similar regardless of nicotine content and flavour.</p> </sec> <sec> <title style='display:none'>Conclusions</title> <p>Regardless of flavour, nicotine pouches with the same nicotine content and formulation produce similar pharmacokinetic parameters and can deliver nicotine efficiently. Nicotine pouches could be a satisfying alternative for smokers switching from conventional cigarettes. [Contrib. Tob. Nicotine Res. 32 (2023) 130–139]</p> </sec> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2023-00162023-12-16T00:00:00.000+00:00https://sciendo.com/article/10.2478/cttr-2022-0012<abstract> <title style='display:none'>Summary</title> <p>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.</p> </abstract>ARTICLEtruehttps://sciendo.com/article/10.2478/cttr-2022-00122022-08-15T00:00:00.000+00:00en-us-1