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The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?

ABSTRACT: Nicotine pouches to be put under the upper lip are a new category of products that are being rapidly developed and marketed as consumer goods with little research or regulatory oversight. We have identified research gaps in assessing their harm and benefit potential, and possible regulatory science approaches to inform the policies that can allow a maximization of the category's public health potential while minimizing unintended consequences. Implications: This commentary presents a potential blueprint for a comprehensive assessment of the nicotine pouches category. Data from the proposed research areas can better inform the regulatory policy decisions around the category, with the aim to maximize the category's tobacco harm reduction potential while minimizing unintended harms.

SUBMITTER: Patwardhan S

PROVIDER: S-EPMC8887571 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?

Patwardhan Sudhanshu S Fagerström Karl K

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20220301 4

Nicotine pouches to be put under the upper lip are a new category of products that are being rapidly developed and marketed as consumer goods with little research or regulatory oversight. We have identified research gaps in assessing their harm and benefit potential, and possible regulatory science approaches to inform the policies that can allow a maximization of the category's public health potential while minimizing unintended consequences. Implications: This commentary presents a potential b ...[more]

PMID: 34606613

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Project description:BackgroundIntroduction of new tobacco products in the United States, including those that may be lower on the risk continuum than traditional combustible cigarettes, requires premarket authorization by the US Food and Drug Administration and information on the potential impact of the products on consumer behaviors. Efficient recruitment and data capture processes are needed to collect relevant information in a near-to-real-world environment.ObjectiveThe aim of this pilot study was to develop and test a protocol for an actual use study of a new tobacco product. The product included in this study was a commercially available oral nicotine pouch. Through the process of study design and execution, learnings were garnered to inform the design, execution, analysis, and report writing of future full-scale actual use studies with tobacco products.MethodsA small sample (n=100) of healthy adult daily smokers of 7 or more cigarettes per day were recruited to participate in an 8-week prospective observational study conducted at 4 geographically dispersed sites in the United States. A smartphone-based customized electronic diary (eDiary) was employed to capture daily tobacco product use, including 1 week of baseline smoking and 6 weeks during which participants were provided with oral nicotine pouches for use as desired.ResultsOnline screening procedures with follow-up telephone interviews and on-site enrollment were successfully implemented. Of 100 participants, 97 completed the study, with more than half (59/99, 60%) identifying as dual- or poly-users of cigarettes and other types of tobacco products at baseline. There was more than 90% (91-93/99, 92%-94%) compliance with daily eDiary reporting, and the majority (92/99, 93%) of participants expressed satisfaction with the study processes. Product use data from the eDiary indicated that after an initial period of trial use, pouches per day increased among those continuing to use the products, while per day average cigarette consumption decreased for 82% (79/97) of all study participants. At the end of the week 6, 16% (15/97) of participants had reduced their cigarette consumption by more than half.ConclusionsThe design of this study, including recruiting, enrollment, eDiary use, and oversight, was successfully implemented through the application of a detailed protocol, a user-friendly eDiary, electronically administered questionnaires, and remote monitoring procedures. High-resolution information was obtained on prospective changes in tobacco product use patterns in the context of availability of a new tobacco product. Future, larger actual use studies will provide important evidence supporting the role that alternatives to combustible cigarettes may play in smoking reduction and/or cessation and lowering the population health burden of tobacco and nicotine-containing products.

Project description:IntroductionThis manuscript examines prevalence of awareness and use of nicotine pouches among U.S. middle and high school students by sociodemographic characteristics and other tobacco product use and characterizes nicotine pouch and other tobacco product use behaviors among current nicotine pouch users.Aims and methodsData are from the 2021 National Tobacco Youth Survey, a cross-sectional, school-based survey of middle and high school students (N = 20 413; overall response rate: 44.6%), which included questions on nicotine pouches in 2021 for the first time. Prevalence estimates, 95% confidence intervals, and estimated population counts were assessed for nicotine pouch awareness, ever use, and current (past 30 days) use, and for use behaviors related to nicotine pouches (frequency of use, flavor(s) used) and other tobacco products (ever, current, frequency of use) among current nicotine pouch users.ResultsOver one-third of students (35.5%) had ever heard of nicotine pouches. An estimated 1.9% (490 000) reported ever using them, while 0.8% (200 000) reported current use. Among current nicotine pouch users, 61.6% reported flavored nicotine pouch use, 64.2% reported current e-cigarette use, and 52.6% used multiple (≥2) tobacco products. Current use of nicotine pouches was common among current smokeless tobacco users (41.3%).ConclusionsOverall, in 2021, while relatively few students had ever tried nicotine pouches or currently used them, more than one-third had heard of them. Current nicotine pouch users tended to use other tobacco products, particularly e-cigarettes and smokeless tobacco. Given previous rapid increases in youth uptake of e-cigarettes, it is important to continue monitoring nicotine pouch use among young people.ImplicationsThis study's findings provide an important baseline for future monitoring of nicotine pouch awareness and use among middle and high school students. Emerging tobacco products, particularly those that are flavored, widely available, discreet, and inexpensive have the potential to attract youth. Given the potential of these products to appeal to young people, ongoing monitoring of nicotine pouch use behaviors is important to inform public health and regulatory efforts.

Project description:According to the Centers for Disease Control and Prevention, about 45 million Americans continue to smoke, even after one of the most intense public health campaigns in history, now over 40 years old. Each year some 438,000 smokers die from smoking-related diseases, including lung and other cancers, cardiovascular disorders and pulmonary diseases. Many smokers are unable--or at least unwilling--to achieve cessation through complete nicotine and tobacco abstinence; they continue smoking despite the very real and obvious adverse health consequences. Conventional smoking cessation policies and programs generally present smokers with two unpleasant alternatives: quit, or die. A third approach to smoking cessation, tobacco harm reduction, involves the use of alternative sources of nicotine, including modern smokeless tobacco products. A substantial body of research, much of it produced over the past decade, establishes the scientific and medical foundation for tobacco harm reduction using smokeless tobacco products. This report provides a description of traditional and modern smokeless tobacco products, and of the prevalence of their use in the United States and Sweden. It reviews the epidemiologic evidence for low health risks associated with smokeless use, both in absolute terms and in comparison to the much higher risks of smoking. The report also describes evidence that smokeless tobacco has served as an effective substitute for cigarettes among Swedish men, who consequently have among the lowest smoking-related mortality rates in the developed world. The report documents the fact that extensive misinformation about ST products is widely available from ostensibly reputable sources, including governmental health agencies and major health organizations. The American Council on Science and Health believes that strong support of tobacco harm reduction is fully consistent with its mission to promote sound science in regulation and in public policy, and to assist consumers in distinguishing real health threats from spurious health claims. As this report documents, there is a strong scientific and medical foundation for tobacco harm reduction, and it shows great potential as a public health strategy to help millions of smokers.

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The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?

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The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?

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