Novel "Tobacco-Free" Oral Nicotine Pouches: The impact of Product Features and Marketing Influences on Abuse Liability, Perceptions, and Use Behavior in Smokers and Non-Nicotine Users

新型“无烟草”口服尼古丁袋：产品特性和营销对吸烟者和非尼古丁使用者的滥用倾向、认知和使用行为的影响

• 批准号: 10597702
• 负责人: Meghan Bridgid Moran
• 金额: $ 80.02万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10597702
• 关键词: 20 year old; Address; Adult; Advertisements; Advertising; Affect; Area; Authorization documentation; Behavior; Benefits and Risks; Cigarette; Cigarette Smoker; Data; Dependence; Descriptor; Dose; Electronic cigarette; European Economic Community; Flavoring; Fruit; Genus Mentha; Health Benefit; Human; Influentials; Interdisciplinary Study; Marketing; Monitor; Nicotine; Nicotine Withdrawal; Online Systems; Oral; Oral Tobacco; Participant; Perception; Plasma; Police; Policies; Population; Powder dose form; Predisposition; Public Health; Recording of previous events; Regulation; Research; Risk; Sales; Sampling; Smokeless; Smoker; Surveillance Methods; Testing; Time; Tobacco; Tobacco Industry; Withdrawal; Withdrawal Symptom; Youth; abuse liability; addiction; authority; combustible cigarette; experience; experimental study; innovation; interest; non-cigarette tobacco product; novel; pharmacokinetics and pharmacodynamics; smoking abstinence; snus; tobacco advertising; tobacco flavor; tobacco products; tobacco regulation; tobacco-free; virtual

PROJECT SUMMARY/ABSTRACT A novel class of oral nicotine pouches that contain a nicotine powder instead of tobacco leaves have recently emerged and fall under FDA’s purview, but there is virtually no research to inform the regulation of these products. These novel pouches are rapidly growing in popularity. For example, in 2020, dollar sales in U.S. convenience stores grew by 470% for ‘Zyn’, a leading brand of these pouches. Our preliminary research indicates that these products are being marketed heavily to consumers, often with advertising tactics that may convey modified risk (i.e., descriptors of “tobacco-free”). These pouches contain non-tobacco flavors (e.g., fruit) with known appeal to youth. Tobacco industry research shows that these pouches deliver similar, or greater, levels of nicotine to users than traditional smokeless oral tobacco products, suggesting that they can produce dependence. Because FDA applies a public health standard when regulating tobacco products, the risks and benefits of novel oral nicotine pouches must be considered for current smokers (a population that may benefit from switching to novel nicotine pouches) and non-nicotine users, especially youth (a population for whom nicotine pouch use would have negative public health consequences). Using human lab studies, marketing surveillance, and web-based experiments, this innovative project will elucidate product features and marketing tactics that may drive initiation and continued use of novel oral nicotine pouches for smokers and non-nicotine users, including youth, addressing FDA CTP’s areas of scientific interest in Addiction/Abuse Liability, Behavior, and Marketing Influences. In Aim 1, smokers will use pouches of different flavors (tobacco; mint; fruit) and nicotine doses (low; high), and their own brand of cigarettes, over 7 lab sessions and pharmacokinetic (PK) and pharmacodynamic (PD) effects (e.g., subjective abuse liability and tobacco withdrawal) will be assessed. In Aim 2, we will surveil advertisements for novel nicotine pouches over 5 years to identify/monitor marketing tactics and examine, via web-based experiments, how common tactics influence product perceptions (i.e., perceived harm, addictiveness, and appeal) and use intentions among cigarette smokers and youth non-nicotine users. In Aim 3, we will conduct a second lab study with smokers and adult non-nicotine users to determine how a common marketing tactic (e.g., “tobacco-free” descriptors) impacts use behaviors and PK/PD effects of these pouches. This project will provide vital new data on product features and marketing tactics that may influence whether smokers and non-nicotine users (including youth) initiate, continue using, and possibly become addicted to novel oral nicotine pouches. This information will allow FDA to make informed decisions about what features should be allowable in novel nicotine pouches, how accessible they should be, and what marketing tactics should be permissible. Ultimately, this research can protect public health by informing polices to mitigate use of these pouches by nicotine-naïve youth as well as policies that may facilitate product switching for smokers.

项目概要/摘要 最近出现了一种新型口服尼古丁袋，其中含有尼古丁粉而不是烟叶 出现并属于 FDA 的职权范围，但实际上没有研究来告知这些监管 例如，这些新颖的袋子在 2020 年在美国的销售额迅速增长。 我们的初步研究表明，此类小袋的领先品牌“Zyn”的便利店增长了 470%。 这些产品正在大量向消费者推销，通常采用的广告策略可能传达 修改后的风险（即“无烟草”的描述）。这些袋含有非烟草香料（例如水果）。 烟草行业研究表明，这些烟袋具有相似或更高的水平。 与传统的无烟口腔烟草产品相比，使用者的尼古丁含量更高，这表明它们可以生产 由于 FDA 在监管烟草产品时采用公共卫生标准，因此存在风险和依赖性。 必须考虑新型口服尼古丁袋对当前吸烟者（可能受益的人群）的好处 从改用新型尼古丁袋）和非尼古丁使用者，尤其是年轻人（对于这些人群来说 使用尼古丁袋会对公共健康产生负面影响）。 监控和基于网络的实验，这个创新项目将阐明产品功能和营销 可能推动吸烟者和非尼古丁患者开始并继续使用新型口服尼古丁袋的策略 包括青少年在内的用户，解决 FDA CTP 在成瘾/滥用责任、行为、 在目标 1 中，吸烟者将使用不同口味的烟袋（烟草、薄荷、水果）和 尼古丁剂量（低；高），以及他们自己品牌的香烟，超过 7 个实验室课程和药代动力学 (PK) 以及 将评估药效 (PD) 效应（例如主观滥用倾向和烟草戒断）。 2、我们将在五年内对新型尼古丁袋的广告进行监测，以识别/监控营销策略 并通过基于网络的实验检查常见策略如何影响产品认知（即感知 危害、成瘾性和吸引力）以及吸烟者和青少年非尼古丁使用者的使用意图。 目标 3，我们将针对吸烟者和成年非尼古丁使用者进行第二项实验室研究，以确定常见的 营销策略（例如“无烟”描述符）会影响这些袋的使用行为和 PK/PD 效果。 该项目将提供有关产品功能和营销策略的重要新数据，这些数据可能会影响是否 吸烟者和非尼古丁使用者（包括青少年）开始、继续使用小说，并可能对小说上瘾 这些信息将使 FDA 能够就应具备哪些功能做出明智的决定。 新型尼古丁袋是否允许使用，它们的可及性如何，以及营销策略应该是什么 最终，这项研究可以通过告知政策减少使用这些药物来保护公众健康。 不接触尼古丁的年轻人使用的烟袋以及可能促进吸烟者转换产品的政策。