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

项目概要/摘要 最近，一种新型的含有尼古丁粉末而不是烟草叶的口服尼古丁袋已经在美国上市。 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 产品.这些新颖的邮袋迅速增长的普及。例如，于二零二零年，美国的美元销售额为100，000，000港元。 便利店增长了470%的'Zyn'，一个领先的品牌，这些袋。我们的初步研究表明 这些产品被大量地推销给消费者，通常使用广告策略， 修改的风险（即，“无烟草”的描述符）。这些小袋含有非烟草香料（例如，水果）， 对年轻人的吸引力。烟草行业的研究表明，这些邮袋提供类似的，或更高的水平， 尼古丁的使用者比传统的无烟口服烟草产品，这表明他们可以产生 依赖由于FDA在管理烟草产品时适用公共卫生标准， 必须考虑新的口服尼古丁袋对当前吸烟者的益处（可能受益的人群 从转换到新型尼古丁袋）和非尼古丁使用者，特别是青年（对他们来说， 使用尼古丁袋会对公众健康产生负面影响）。利用人体实验室研究， 监测和基于网络的实验，这个创新项目将阐明产品的特点和营销 可能促使吸烟者开始和继续使用新型口服尼古丁袋的策略， 用户，包括青少年，解决FDA CTP在成瘾/滥用责任，行为， 营销影响力。在目标1中，吸烟者将使用不同口味的小袋（烟草;薄荷;水果）， 尼古丁剂量（低;高）和他们自己品牌的香烟，超过7个实验室会话和药代动力学（PK）， 药效学（PD）效应（例如，主观滥用倾向和烟草戒断）进行评估。在Aim中 2.我们将在5年内监测新型尼古丁袋的广告，以确定/监测营销策略 并通过基于网络的实验，研究常见策略如何影响产品感知（即，感知 危害性、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。在 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 营销策略（例如，“无烟草”描述符）影响这些小袋的使用行为和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、继续使用并可能对新的尼古丁成瘾。 口服尼古丁袋。这些信息将使FDA能够做出明智的决定， 允许在新的尼古丁袋，如何访问他们应该是，什么营销策略应该是 允许的。最终，这项研究可以通过告知政策来减少这些药物的使用，从而保护公众健康。 尼古丁幼稚的年轻人以及可能促进吸烟者转换产品的政策。

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.