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

项目摘要/摘要 最近，一种新型的含有尼古丁粉末而不是烟叶的口服尼古丁胶囊 出现并落在FDA的职权范围内，但实际上没有任何研究来告知这些监管 产品。这些新奇的袋子正迅速流行起来。例如，2020年，美元在美国的销售额。 便利店增长了470%，‘Zyn’，这些袋子的领先品牌。我们的初步研究表明 这些产品正大量地向消费者推销，通常使用的广告策略可能会传达 修改风险(即“无烟”的描述符)。这些袋子含有非烟草口味(例如，水果) 已知的对年轻人的吸引力。烟草行业的研究表明，这些袋子提供的水平与之相似，甚至更高 与传统的无烟口服烟草产品相比，尼古丁对使用者的影响更大，这表明它们可以产生 依赖。由于FDA在监管烟草产品时采用公共卫生标准，因此风险和 必须考虑对当前吸烟者(可能受益的人群)使用新型口服尼古丁胶囊的益处 从改用新型尼古丁袋子)和非尼古丁使用者，特别是年轻人(对他们来说 使用尼古丁袋子会对公共健康造成负面影响)。利用人体实验室研究，市场营销 监控和基于网络的实验，这个创新的项目将阐明产品功能和营销 可推动吸烟者和非尼古丁患者开始和继续使用新型口服尼古丁胶囊的策略 用户，包括青少年，解决FDA CTP在成瘾/滥用责任、行为、 和市场营销的影响。在目标1中，吸烟者将使用不同口味的袋子(烟草、薄荷、水果)和 尼古丁剂量(低；高)，以及他们自己的香烟品牌，超过7次实验室会议和药代动力学(PK)和 将评估药效学(PD)效应(例如，主观滥用责任和戒烟)。在AIM 2、我们将在5年内监控新型尼古丁袋子的广告，以确定/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感知(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向。在……里面 目标3，我们将对吸烟者和成年非尼古丁使用者进行第二次实验室研究，以确定普通尼古丁 营销策略(如“无烟”描述符)影响这些袋子的使用行为和PK/PD效应。 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 吸烟者和非尼古丁使用者(包括青少年)开始、继续吸食，并可能对小说上瘾 口服尼古丁药包。这些信息将使FDA能够做出明智的决定，决定哪些功能应该 允许放在新的尼古丁袋子里，它们应该有多容易获得，以及应该采取什么营销策略 被允许的。最终，这项研究可以通过告知警方减少使用这些药物来保护公众健康 尼古丁天真青年的烟袋，以及可能为吸烟者提供产品转换便利的政策。

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.