Awareness and use of nicotine pouches in a nationwide sample of adults in Poland.

INTRODUCTION: Nicotine pouches are a new type of nicotine-containing product that have been marketed in many countries worldwide, generating growing acceptance among consumers. The aim of this study was to assess factors associated with public awareness and use of nicotine pouches among adults in Poland. METHODS: A cross-sectional survey was conducted with a nationally representative sample of 1080 adults in Poland (February 2024). Awareness of nicotine pouches, history of use, current (past 30-day) use of nicotine pouches, as well as perception of harm was assessed using a purpose-designed questionnaire. RESULTS: Awareness of nicotine pouches was reported by 24% of the sample, while 9.2% reported ever having used a nicotine pouch product, and 4.3% using a nicotine pouch in the past 30 days. Among all respondents, 60.7% perceived nicotine pouches as harmful as combustible cigarettes, 28.2% perceived nicotine pouches as less harmful, and 11% as more harmful than combustible cigarettes. In multivariable logistic regression model, women (adjusted odds ratio, AOR=1.40; 95% CI: 1.03-1.91; p<0.05), individuals aged <60 years (p<0.05), current tobacco smokers (AOR=2.59; 95% CI: 1.75-3.82; p<0.001), former tobacco smokers (AOR=1.53; 95% CI: 1.01-2.32; p<0.05) and ever users of e-cigarette or heated tobacco (AOR=2.90; 95% CI: 2.07-4.05; p<0.001) were more likely to declare that had ever heard of nicotine pouches. Moreover, individuals aged <60 years (p<0.05), occupationally active individuals (AOR=1.82; 95% CI: 1.01-3.31; p<0.05), current tobacco smokers (AOR=2.71; 95% CI: 1.48-4.97; p<0.01), and ever users of e-cigarette or heated tobacco (AOR=5.29; 95% CI: 2.96-9.44; p<0.001) were more likely to declare ever use of nicotine pouches. CONCLUSIONS: This study provides the first national data on public awareness and use (ever and current) of nicotine pouches in Poland. Young adults, current smokers, and ever e-cigarette and heated tobacco users are at higher risk of ever use of nicotine pouches, so policy interventions are needed to protect young people from nicotine pouch marketing and nicotine initiation.

Oral mucosal changes caused by nicotine pouches: case series.

Oral nicotine pouches are the latest products in the tobacco industry. They are manufactured by large tobacco companies and entice tobacco or nicotine addicts, although the products are presented as a 'harmless choice.' Nevertheless, dentists and oral health specialists worry about oral mucosal changes due to product interactions with the oral mucosa. Unfortunately, there are no case reports of oral mucosal changes from nicotine pouches that are also investigated histopathologically. The aim of the present study was to visually and histopathologically investigate oral mucosal changes in nicotine pouch users. An online retrospective survey regarding medical and dental health, dietary habits, and tobacco consumption habits was conducted (n = 50). Respondents were selected for further intraoral and histopathological investigation based on the inclusion criteria. All five respondents had oral lesions that were histopathologically analyzed. Visually, the lesions varied in form and intensity, but all appeared white at the location where the pouches were placed. Histopathological analyses revealed parakeratosis with acanthotic epithelium, intraepithelial and connective tissue oedema, and chronic inflammatory infiltration with lymphocytes and macrophages. Participants received information about nicotine cessation and oral health recommendations. In conclusion, nicotine pouches significantly impacted oral mucosa with white lesions that revealed important changes at the cellular level.

Patterns of nicotine pouch use among young Australians.

BACKGROUND: Despite increasing interest in the use of nicotine pouches in Australia - where retail sale of the products is illegal - research exploring patterns of pouch use and reasons for use is lacking. Accordingly, this study explored young Australians' experiences with nicotine pouches. METHODS: An online survey was administered to 1598 Australians aged 16-39 years (53 % women). We assessed (i) awareness and use (lifetime and past 30-day) of nicotine pouches, (ii) patterns of use (e.g., flavours and nicotine strength used), (iii) product source, and (iv) reasons for use. Regression analyses were conducted to assess socio-demographic predictors of awareness and use. RESULTS: Just over three-quarters (77 %) of the sample reported being aware of nicotine pouches. Lifetime use was reported by 26 % of respondents and past 30-day use by 19 %. Among those who reported past 30-day use, fruit (35 %) and menthol/mint (34 %) flavours were most commonly used. In terms of pouch source, one-third (33 %) reported obtaining the product from a tobacconist. The most common reasons for use were "they come in flavours I like" (34 %) and "to help me quit smoking" (32 %). Awareness, lifetime use, and past 30-day use of nicotine pouches were more likely among men, those who reported current use of tobacco products, and those who reported current use of e-cigarettes. CONCLUSIONS: Awareness and use of nicotine pouches among young Australians may be substantial enough to warrant the inclusion of items measuring pouch use in national surveys. Efforts should be made to better enforce existing laws regarding the sale of nicotine pouches.

Sales of tobacco and nicotine replacement therapy products, especially nicotine pouches, increased in Finland during the COVID-19 pandemic.

Aim: Some previous studies suggest that the consumption of tobacco and nicotine products overall declined during the COVID-19 pandemic, but the results are mixed. We investigated tobacco and nicotine product sales in Finland, including the sales of nicotine replacement therapy (NRT). Our particular focus was on nicotine pouches used as NRT. We aimed to evaluate the effect of the COVID-19 pandemic on the sales of tobacco and NRT products in 2020 by comparing the sales to the previous year. Methods: The data were derived from a large sales group (S group) in Finland, representing 46% of the market share in grocery trade in 2020. The gross weekly sales of tobacco (cigarettes, loose tobacco) and NRT (patches, inhalers, tablets, gum and "other", consisting mainly of nicotine pouches) were retrieved from February to December 2020 from 1062 points of sale throughout the country and compared to the same period in 2019. Results: During this period, there was a significant increase in cigarette sales. Moreover, the sales of NRT were significantly higher throughout 2020 compared with 2019. Specifically, the sales of nicotine pouches sold as NRT increased, especially after the travel restrictions in Finland were initiated and the national boundaries closed in the spring of 2020. Conclusions: During the COVID-19 pandemic in Finland, the sales of cigarettes and NRT products increased, especially those of nicotine pouches sold as NRT. Our findings call for further research to reveal the factors leading to this increase and to determine whether the situation is long-standing.

The Effects of Nicotine Pouches and E-Cigarettes on Oral Microbes: A Pilot Study.

It remains uncertain whether nicotine pouches and electronic cigarettes alter the oral environment and result in a high presence of periodontopathogenic bacteria in saliva, compared to that among cigarette users or non-tobacco users. In this study, saliva samples were collected from respondents using nicotine pouches, electronic cigarettes, and conventional cigarettes, alongside a control group of non-tobacco users. Polymerase chain reaction was used to identify clinical isolates of the following periodontal bacteria: Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Fusobacterium nucleatum, Fusobacterium periodonticum, Porphyromonas endodontalis, and Rothia mucilaginosa. The presence of some periodontal pathogens was detected in the saliva samples from users of nicotine pouches, electronic cigarettes, and conventional cigarettes but not in samples taken from the control group. Therefore, the initial results of this pilot study suggest that the presence of periodontopathogenic bacteria in the saliva of nicotine pouch and electronic cigarette users could alter the oral microbiome, leading to periodontal diseases. However, further quantitative investigation is needed.

The potential of new nicotine and tobacco products as tools for people who smoke to quit combustible cigarettes - a systematic review of common practices and guidance towards a robust study protocol to measure cessation efficacy.

New types of nicotine and tobacco products like electronic cigarettes (ECs), heated tobacco products or nicotine pouches have been discussed as less harmful alternatives to combustible cigarettes and other toxic forms of tobacco products. Their harm reduction potential lay in the efficient transition away from smoking to those new products. Numerous studies addressing the cessation efficacy of ECs have been published with contradictory outcomes. Yet, a comprehensive Cochrane review concluded with high certainty on the cessation efficacy of ECs. This prompted us to perform a review to identify weaknesses in common study designs and to summarize best practices for the study design on the potential of new nicotine products as cessation aids. 120 articles retrieved from Medline were found to be eligible. Most of the studies in the field were interventional trials while observational studies played a minor role in the evaluation of smoking cessation. Efficacy was predominantly assessed for ECs in 77% of the reports while heated tobacco (17%) and non-combustible products (11%) were less frequently investigated up to now. Measures to determine the efficacy were questionnaire-based assessments as well as use documentation/prevalence and abstinence rates. Studies varied largely in their duration and sample size with medians of 3 months and 156.5 participants, respectively.With the help of this review, we identified several weaknesses in the common study designs. One major limitation in longitudinal trials was the lack of compliance measures suited to verify the use status over longer time periods, relying solely on self-reports. Moreover, the motivation of the participants to quit was rarely defined and a profound familiarization period was not taken into account for the majority of the studies. To what extent such weaknesses influence the outcome of the studies was beyond the scope of this review. We encourage researchers to consider the recommendations which resulted from this review in order to determine the abuse liability and cessation efficacy of the products in a more robust manner. Finally, we like to call attention to the missing data for low- and middle-income countries which would require quitting strategies most urgently to combat the tobacco smoking epidemic.

Effect of Flavored on! Nicotine Pouch Products on Smoking Behaviors: Protocol for a Sequential, Multiple Assignment, Randomized Controlled Trial.

BACKGROUND: Cigarette smoking is a leading cause of morbidity and mortality. For adults who smoke cigarettes and cannot or will not quit smoking, smoke-free products, such as nicotine pouches, have been recognized as a potential alternative to smoking combusted cigarettes to reduce harm due to cigarette smoking. The role of flavors in these smoke-free products in tobacco harm reduction has not been fully understood. OBJECTIVE: This study evaluates the effect of flavors in on! nicotine pouch products (research products) in the reduction of cigarette smoking among adults who smoke cigarettes in their natural environment. METHODS: This study uses a sequential, multiple assignment, randomized trial design. Approximately 400 eligible adults who smoke cigarettes will be enrolled and randomized to have access to either the Original (unflavored) on! nicotine pouch product only or a complete flavor profile (ie, Berry, Cinnamon, Citrus, Coffee, Mint, Original, and Wintergreen) of on! nicotine pouch products. After 3 weeks, participants in the Original-only arm will be randomized again, with half remaining in the Original-only arm and half having access to the complete flavor profile for another 3 weeks. Primary outcomes are expired-air carbon monoxide (CO) levels. Secondary outcomes are self-reported cigarette consumption and CO-verified cigarette abstinence. RESULTS: Recruitment and data collection started in September 2023 and is projected to last until March 2025. We anticipate completing the data analysis in 2025. As of May 2024, we have enrolled 314 participants. CONCLUSIONS: This study will provide empirical evidence about the effect that flavor availability in smoke-free products may have in reducing cigarette smoking. TRIAL REGISTRATION: ClinicalTrials.gov NCT06072547; https://clinicaltrials.gov/study/NCT06072547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56565.

Small pouches, but high nicotine doses-nicotine delivery and acute effects after use of tobacco-free nicotine pouches.

Tobacco-free nicotine pouches are new nicotine products for oral consumption. They can contain very high nicotine amounts that have not been addressed with clinical studies yet. Thus, nicotine delivery, effects on craving, and side effects were assessed using pouches with up to 30 mg nicotine. In this single-center, five-arm, crossover study, 15 regular cigarette smokers consumed tobacco-free nicotine pouches from different brands with 6, 20, and 30 mg for 20 min. Comparators were nicotine-free pouches and tobacco cigarettes. At baseline and predefined time points over a study period of 240 min, plasma nicotine concentrations, effects on cigarette craving, and side effects were assessed. Cardiovascular parameters including arterial stiffness were measured using a MobilOGraph. Consumption of 30 mg nicotine pouches has led to a higher nicotine uptake compared with the cigarette (Cmax: 29.4 vs 15.2 ng/mL; AUC: 45.7 vs 22.1 ng/mL × h). Nicotine uptake in the acute phase was rapid during use of the 30 mg pouch and cigarette. Extraction rate of nicotine differed between pouches. Use of all products has reduced acute cigarette craving, even the nicotine-free pouch. During consumption of the cigarette and the pouches with 20 and 30 mg, heart rate increased about 27, 12, and 25 bpm, respectively. Parameters for arterial stiffness were elevated and all pouches have induced mouth irritations. The pouches with 30 mg nicotine had overall the strongest side effects and may induce addiction. As craving was also reduced by products with less nicotine, it is questionable whether such high nicotine contents should be allowed on the market. A limit of nicotine content is warranted. The nicotine release rate varies across products and needs to be known to estimate the nicotine delivery.

Multi-endpoint in vitro toxicological assessment of snus and tobacco-free nicotine pouch extracts.

'Modern' oral tobacco-free nicotine pouches (NPs) are a nicotine containing product similar in appearance and concept to Swedish snus. A three-step approach was taken to analyse the biological effects of NPs and snus extracts in vitro. ToxTracker was used to screen for biomarkers for oxidative stress, cell stress, protein damage and DNA damage. Cytotoxicity, mutagenicity, and genotoxicity were assessed in the following respective assays: Neutral Red Uptake (NRU), Ames and Mouse Lymphoma Assay (MLA). Targeted analysis of phosphorylation signalling and inflammatory markers under non-toxic conditions was used to investigate any potential signalling pathways or inflammatory response. A reference snus (CRP1.1) and four NPs with various flavours and nicotine strengths were assessed. Test article extracts was generated by incubating one pouch in 20 mL of media (specific to each assay) with the inclusion of the pouch material. NP extracts did not induce any cytotoxicity or mutagenic response, genotoxic response was minimal and limited signalling or inflammatory markers were induced. In contrast, CRP1.1 induced a positive response in four toxicological endpoints in the absence of S9: Srxn1 (oxidative stress), Btg2 (cell stress), Ddit3 (protein damage) and Rtkn (DNA damage), and three endpoints in presence of S9: Srxn1, Ddit3 and Rtkn. CRP1.1 was genotoxic when assessed in MLA and activated signalling pathways involved in proliferation and cellular stress and specifically induced phosphorylation of c-JUN, CREB1, p53, p38 MAPK and to a lesser extent AKT1S1, GSK3α/ß, ERK1/2 and RSK1 in a dose-dependent manner. CRP 1.1 extracts resulted in the release of several inflammatory mediators including cytokines IL-1α, IL5, IL6, IL8, IL-1RA, MIF and TNF-ß, receptor IL-2RA, and growth factors FGF-basic, VEGF and M-CSF. In conclusion these assays contribute to the weight of evidence assessment of the potential comparative health risks of NPs and snus.

Tobacco-Free Nicotine Pouches and Their Potential Contribution to Tobacco Harm Reduction: A Scoping Review.

Tobacco harm reduction (THR) refers to strategies designed to reduce the health risks associated with tobacco smoking but may involve continued use of nicotine and/or tobacco. Next-generation products (NGPs) are a THR alternative as they do not burn tobacco or produce smoke and deliver nicotine and have fewer and substantially lower levels of harmful chemicals compared to cigarettes. Tobacco­free nicotine pouches (TFNPs) are an emerging category of nicotine­containing oral products that do not combust or contain tobacco leaf. Similar to Swedish snus, TFNPs are placed between a user's lip and gum, and nicotine is absorbed through the oral mucosa rather than being inhaled. The aim of this scoping review was to systematically collate and evaluate published scientific evidence (cut­off of 31 May 2023) identified from bibliometric databases investigating the potential of TFNPs to contribute to THR. Overall, studies examining chemical constituents indicated that the use of TFNPs may result in lower exposure to toxicants than other tobacco or nicotine-containing products, both combustible and non­combustible. This reduction in toxicant exposure has been demonstrated by multiple human biomarker studies and in vitro toxicological assessments to translate to harm reduction potential in smokers switching to TFNPs. However, further study is warranted. At present, there is some evidence from human behavioral research that TFNPs can support either transitioning away from smoking or reducing cigarette consumption. Furthermore, TFNP use appears very much limited to current users of traditional tobacco products, and youth uptake has been limited. In conclusion, the findings of this review indicate that TFNPs have the potential to support THR efforts and may help inform evidence­based regulation.

Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study.

BACKGROUND AND AIMS: Oral nicotine pouches (ONPs) probably offer reduced harm compared with cigarettes, but independent data concerning their misuse liability are lacking. We compared nicotine delivery and craving relief from ONPs with different nicotine concentrations to cigarettes. DESIGN: This was a single-blind, three-visit (≥ 48-hour washout), randomized-cross-over study. Participants were encouraged to complete all study visits in less than 1 month. SETTING: The study took place in Rural/Appalachian Ohio. PARTICIPANTS: Participants comprised 30 adults who smoke cigarettes. Participants (meanage = 34.5) were 60% men and 90% White. INTERVENTION: Participants who were ≥ 12-hour tobacco-abstinent used: (1) a 3-mg nicotine concentration ONP, (2) a 6-mg nicotine concentration ONP and (3) usual brand cigarette in separate visits. ONPs (wintergreen Zyn) were used for 30 minutes; cigarettes were puffed every 30 sec for 5 minutes. MEASUREMENTS: Plasma nicotine and self-reported craving were assessed at t = 0, 5, 15, 30, 60 and 90 minutes. The primary outcome was plasma nicotine concentration at t = 30 minutes. A secondary outcome was craving relief at t = 5 minutes. FINDINGS: At t = 30, mean [95% confidence interval (CI)] plasma nicotine was 9.5 ng/ml (95% CI = 7.1, 11.9 ng/ml) for the 3 mg nicotine ONP, 17.5 ng/ml (95% CI = 13.7, 21.3) for the 6 mg nicotine ONP and 11.4 ng/ml (95% CI = 9.2, 13.6 ng/ml) for the cigarette. Mean plasma nicotine at t = 30 minutes differed between the 3- and 6-mg nicotine ONPs (P = 0.001) and between the 6-mg nicotine ONP and cigarette (P = 0.002). Mean (95% CI) craving at t = 5 minutes was lower for the cigarette (mean = 1.00, 95% CI = 0.61, 1.39) than either the 3 mg (mean = 2.25, 95% CI = 1.68, 2.82; P < 0.0001) or 6 mg nicotine (mean = 2.19, 95% CI = 1.60, 2.79; P < 0.0001) ONP. CONCLUSIONS: Among adult smokers, using 6-mg nicotine concentration oral nicotine pouches (ONPs) was associated with greater plasma nicotine delivery at 30 minutes than 3-mg ONPs or cigarettes, but neither ONP relieved craving symptoms at 5 minutes as strongly as a cigarette. Accelerating the speed of nicotine delivery in ONPs might increase their misuse liability relative to cigarettes.

Prioritizing common terminology and measures to advance research on oral nicotine product use.

This commentary calls for consistent measurement of oral nicotine product use by the scientific community, recommends specific measures where possible, and emphasizes areas in need of further research. We hope to expedite the use of consistent measures of oral nicotine product use so that this area of tobacco research can advance quickly.

Oral nicotine pouches with an aftertaste? Part 2: in vitro toxicity in human gingival fibroblasts.

Nicotine pouches contain fewer characteristic toxicants than conventional tobacco products. However, the associated risks in terms of toxicity and addiction potential are still unclear. Therefore, endpoints of toxicity and contents of flavoring substances were investigated in this study. The in vitro toxicity of five different nicotine pouches and the reference snus CRP1.1 were studied in human gingival fibroblasts (HGF-1). Cells were exposed to product extracts (nicotine contents: 0.03-1.34 mg/mL) and sampled at different time points. Cytotoxicity, total cellular reactive oxygen species (ROS) levels, and changes in the expression levels of inflammatory and oxidative stress genes were assessed. Flavor compounds used in the nicotine pouches were identified by GC-MS. Cytotoxicity was observed in two nicotine pouches. Gene expression of interleukin 6 (IL6) and heme oxygenase 1 (HMOX1) was upregulated by one and three pouches, respectively. ROS production was either increased or decreased, by one pouch each. CRP1.1 caused an upregulation of IL6 and elevated ROS production. Toxicity was not directly dependent on nicotine concentration and osmolarity. A total of 56 flavorings were detected in the five nicotine pouches. Seven flavorings were classified according to the harmonized hazard classification system as laid down in the European Classification, Labelling and Packaging regulation. Nine flavorings are known cytotoxins. Cytotoxicity, inflammation, and oxidative stress responses indicate that adverse effects such as local lesions in the buccal mucosa may occur after chronic product use. In conclusion, flavorings used in nicotine pouches likely contribute to the toxicity of nicotine pouches.

Nicotine pouch awareness, use and perceptions among young adults from six metropolitan statistical areas in the United States.

INTRODUCTION: Nicotine pouches, which emerged in the US in 2016 and are marketed as 'tobacco-free', may appeal to young adults. This study examined young adults' nicotine pouch awareness, use, use intentions, and related factors. METHODS: We analyzed Spring 2022 survey data from 942 young adults recruited via social media from six US cities (mean age=27.61 years, 34.3% men, 33.1% racial/ethnic minority) to characterize nicotine pouch awareness, ever use, use intentions, exposure, and perceptions. RESULTS: Nicotine pouch awareness and ever use were reported by 34.6% and 9.8%, respectively. Males (AOR=1.79; 95% CI: 1.33-2.38), non-White participants (vs White; AOR=1.64; 95% CI: 1.04-2.61), and those using cigarettes (AOR=2.67; 95% CI: 1.63-4.38), e-cigarettes (AOR=2.28; 95% CI: 1.57-3.31), and smokeless tobacco (SLT) (AOR=14.46; 95% CI: 1.81-115.61) had greater odds of awareness. Among those aware of nicotine pouches, males (AOR=2.27; 95% CI: 1.33-3.85), White participants (vs Asian; AOR=0.40; 95% CI: 0.17-0.94), and SLT users (AOR=4.90; 95% CI: 1.26-18.98) had greater odds of ever use; being male (B=0.39; 95% CI: -0.67 - -0.12) and using SLT (B=1.73; 95% CI: 1.10-2.36) predicted greater use intentions. Overall, 31.4% reported past-month advertising exposure, most often via tobacco retailers (67.3%). Ever users most commonly purchased them at gas stations (46.7%). The most frequently reported use motives were to quit combusted tobacco (16.8%) and reduce tobacco smell (15.4%). Nicotine pouches were perceived as less harmful and less addictive than cigarettes, e-cigarettes, and SLT, and more socially acceptable than cigarettes and SLT. CONCLUSIONS: Young adults were exposed to advertising, accessed nicotine pouches via various sources, and perceived these products favorably. Marketing and use surveillance is needed to monitor their impact on those likely to use them (e.g. males, SLT users).

Oral nicotine pouches with an aftertaste? Part 1: screening and initial toxicological assessment of flavorings and other ingredients.

Nicotine pouches are oral products that deliver nicotine without containing tobacco. Previous studies mainly focused on the determination of known tobacco toxicants, while yet no untargeted analysis has been published on unknown constituents, possibly contributing to toxicity. Furthermore, additives might enhance product attractiveness. We therefore performed an aroma screening with 48 different nicotine-containing and two nicotine-free pouches using gas chromatography coupled to mass spectrometry, following acidic and basic liquid-liquid extraction. For toxicological assessment of identified substances, European and international classifications for chemical and food safety were consulted. Further, ingredients listed on product packages were counted and grouped by function. Most abundant ingredients comprised sweeteners, aroma substances, humectants, fillers, and acidity regulators. 186 substances were identified. For some substances, acceptable daily intake limits set by European Food Safety Agency (EFSA) and Joint FAO/WHO Expert Committee on Food Additives are likely exceeded by moderate pouch consumption. Eight hazardous substances are classified according to the European CLP regulation. Thirteen substances were not authorized as food flavorings by EFSA, among them impurities such as myosmine and ledol. Three substances were classified by International Agency for Research on Cancer as possibly carcinogenic to humans. The two nicotine-free pouches contain pharmacologically active ingredients such as ashwagandha extract and caffeine. The presence of potentially harmful substances may point to the need for regulation of additives in nicotine-containing and nicotine-free pouches that could be based on provisions for food additives. For sure, additives may not pretend positive health effects in case the product is used.

An Analysis of Nicotine Pouch Use by Middle School and High School Students Surveyed by the National Youth Tobacco Survey in 2021 and a Review of the Literature.

OBJECTIVES: The use of alternative nicotine products by middle and high school students is a growing concern due to industry marketing techniques, availability, and popularity of new products, and ambiguous nicotine concentrations. The 2021 National Youth Tobacco Survey (NYTS) provides information about the frequency, and characteristics of middle, and high school students who have used nicotine pouches. METHODS: The National Youth Tobacco Surveys provide important information about the frequency of use of tobacco and alternative nicotine products by a representative sample of students in schools in the United States. The 2021 survey included questions about the use of nicotine pouches/dissolvable tobacco products. The results from the survey were analysis using descriptive statistics, and logistic regression to model the association between the use of these alternative nicotine products, and the use of electronic cigarettes or the use of conventional cigarettes. RESULTS: A total of 20 413 students participated in the survey year 2021; 17 842 were included in the final data analysis. Their ages ranged from 9 to 18+. Identified risk factors for the use of alternative nicotine products included race, and age. The adjusted odds ratio (OR) was lower in non-Hispanic Black and Hispanic students, as compared to non-Hispanic White students. Older students had a substantially higher risk of using nicotine/dissolvable tobacco products, specifically, compared to students less than or equal to 13 years old. The OR increased 174% (OR: 2.74; 1.70-4.41) in 17-year-old students. The perception of harm associated with electronic cigarettes increased the likelihood of using alternative nicotine products. Students who did not smoke cigarettes (OR: 0.39; 0.27-0.56) or did not smoke electronic cigarettes (OR: 0.20; 0.18-0.40) had significantly lower OR for using alternative nicotine products. CONCLUSIONS: The 2021 National Youth Tobacco Survey indicates that a relatively small percentage of middle school and high school student have used nicotine pouches. However, with the increase in new, alternative tobacco products, understanding adolescent use in comparison to other tobacco products is an important trend to monitor.

Effects of "Tobacco Free" Language in Warning Labels on Perceptions of Electronic Cigarettes and Nicotine Pouches among Young Adult Men: A Randomized Trial.

Background: Manufacturers of Puff Bar electronic cigarettes (e-cigarettes) and Fre nicotine pouches claim that their products contain synthetic nicotine. The packages for Puff Bar and Fre have modified versions of the warning labels required by the Food and Drug Administration (FDA) for tobacco products, which specify that Puff Bar and Fre products contain "tobacco free" or "non-tobacco" nicotine, respectively. We evaluated whether exposure to these "tobacco free" warning labels was associated with differing perceptions about the products. Method: N = 239 young adult men who were enrolled in a cohort study completed a short online experiment. Participants were randomly assigned to view either packages of Puff Bar and Fre nicotine pouches with the standard FDA warning or packages with the standard FDA warning + the tobacco free descriptor. We compared harm and addictiveness perceptions and products' perceived substitutability for cigarettes and smokeless tobacco (SLT) by exposure to a "tobacco free" warning. Results: Viewing a Puff Bar package with a "tobacco free" warning label was associated with increased perceived substitutability of the product for cigarettes and smokeless tobacco (p's<.05). Viewing a Fre package with a "non-tobacco" warning label was associated with thinking the product was less harmful than SLT (p<.01). Conclusions: "Tobacco free" descriptors in warning labels for e-cigarettes and nicotine pouches affect young adults' perceptions of the products. To date, it is unclear whether the FDA will continue to permit "tobacco free" descriptors in warning labels. As e-cigarettes and nicotine pouches are increasingly marketed with "tobacco free" language, urgent action is needed.

Assessing the Effectiveness of Tobacco 21 Laws to Reduce Underage Access to Tobacco: Protocol for a Repeated Multi-Site Study.

Prior to the federal law passed in December 2019, many states passed an increased age of sale law prohibiting youth under age 21 (or Tobacco 21) from purchasing tobacco products, including e-cigarettes. Although previous research has documented tobacco retail sale violations, fewer studies have examined age verification and illegal tobacco sales in the context of Tobacco 21 or repeated purchase attempts in various settings. In this study conducted between 2019 and 2022, buyers aged 18 to 20 years made repeated unsupervised purchase attempts of cigarettes, cigars, e-cigarettes, tobacco-free nicotine pouches, and smokeless tobacco at over 180 tobacco or e-cigarette retailers in New Jersey, New York City, and Pitt County (North Carolina). Buyers documented whether they were asked for identification and whether they were able to successfully purchase a tobacco or nicotine product at each visit. The primary outcome will be the percent of retailers that checked the buyers' identification at store visits and the percent of visits that resulted in a successful underage tobacco product purchase. We will compare the results across time periods, study sites, products, and buyer characteristics (i.e., gender, minoritized racial/ethnic identity) while controlling for repeated visits. These results will inform improvements to current compliance check inspection programs as well as interventions that reduce youth access to tobacco.

Use of Emerging and Conventional Oral Tobacco Among Adolescent and Young Adult E-Cigarette Users.

Background: National surveillance assessing use of novel oral tobacco products (OTPs; nicotine pouches, lozenges, and gums not approved for tobacco cessation) among adolescents and young adults is limited. Objectives: To assess OTP behaviors in a sample of adolescent and young adult e-cigarette users, including use prevalence, dual/poly use with other products, and associated demographics. Methods: A national (United States) cross-sectional survey was conducted from March to April 2021 among 2253 participants (ages 14-20; 65% female) who ever used e-cigarettes ≥3 times. Demographics, lifetime use, and past 30-day use of 10 tobacco and cannabis products, including novel and conventional (chew, moist snuff, or snus) OTPs was assessed. Analysis was descriptive, examining use prevalence (lifetime and past 30-day) of each product, including by demographics and other product use. Results: Nearly 44% reported ever using any OTP, with nicotine pouches being the most commonly ever used (29%) and used in the past month (11%). Novel OTP use was more common among older participants (18-20 years), male participants, and past 30-day users of e-cigarettes, combustible tobacco, and conventional oral tobacco. However, female participants and combustible tobacco non-users were over twice and 4-times as likely, respectively, to use novel OTPs than conventional OTPs. Nearly 73% of past 30-day conventional OTP users were past 30-day novel OTP users. Conclusion: Novel OTP use was prevalent among adolescent and young adult e-cigarette users. Compared to conventional OTPs, novel OTPs likely have greater appeal to females and combustible tobacco non-users. Action to restrict access and reduce interest in OTPs is needed to prevent use among this population.

Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers.

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.