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.

项目摘要/摘要 一类新型的口服尼古丁袋中含有尼古丁粉，而不是烟叶 出现并属于FDA的权限，但实际上没有研究来告知这些法规 产品。这些新颖的小袋正在迅速增长。例如，在2020年，美国的美元销售额 便利店的“ Zyn”增长了470％，这是这些小袋的领先品牌。我们的初步研究表明 这些产品通常会以广告策略的形式向消费者销售 修改风险（即“无烟草”的描述符）。这些小袋含有非烟熏口味（例如，水果） 已知的年轻人。烟草行业研究表明，这些小袋的水平相似或更高 用户对使用传统无烟烟草产品的尼古丁，这表明他们可以生产 依赖。因为FDA在反思烟草产品时采用公共卫生标准，风险和 必须考虑新颖的口服尼古丁小袋的好处 从切换到新颖的尼古丁小袋）和非纽约汀使用者，尤其是年轻人（这是一个人口 尼古丁袋的使用将带来负面的公共卫生后果）。使用人类实验室研究，营销 监视和基于网络的实验，该创新项目将阐明产品功能和营销 可能会推动吸烟者和非纽约胺的新型口服尼古丁小袋的启动和继续使用的策略 包括青年在内的用户解决FDA CTP在成瘾/虐待责任，行为，行为，行为，行为， 和营销影响。在AIM 1中，吸烟者将使用不同口味（烟草；薄荷；水果）和 尼古丁剂量（低；高）及其自己的品牌香烟，超过7个实验室会议和药代动力学（PK）和 将评估药物动力学（PD）效应（例如，主观滥用责任和烟草戒断）。目标 2，我们将在5年内调查新颖尼古丁小袋的广告，以识别/监控营销策略 通过基于Web的实验进行检查，共同策略如何影响产品感知（即感知到的 危害，添加性和吸引力）并在吸烟者和青年非纽约汀使用者中使用意图。 AIM 3，我们将向吸烟者和成人非纽约定蛋白使用者进行第二次实验室研究，以确定一个共同点 营销策略（例如“无烟草”描述符）会影响这些小袋的行为和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影响 吸烟者和非新神经使用者（包括青年）启动，继续使用并可能沉迷于新颖 口服尼古丁小袋。此信息将允许FDA就哪些功能做出明智的决定 在新颖的尼古丁小袋中允许使用，应该如何获得以及应该是什么营销策略 允许。最终，这项研究可以通过告知政策来减轻使用这些研究来保护公共卫生 没有尼古丁青年的小袋以及可能有助于吸烟者产品转换的政策。