Project 1

项目1：摘要/摘要 项目1(P1)：在美国青年中使用新型不可燃烟草产品(Leader，Lventhal) P1决定了不同新的不可燃产品的可用性如何影响美国的烟草产品使用 2024年至2028年的青年。为了实现这一目标，P1将：a)与监测未来(MTF)研究合作，以增加 一个新的调查模块专注于烟草监管科学(TRS)，并有自己独特的年度措施 对美国8年级、10年级和12年级学生的横断面调查(n=221,490人，历年汇总)；b)检验假设 可食用口腔尼古丁产品(ONPs；口香糖、含片/薄荷糖、口香糖)、袋装尼古丁的使用趋势 ONPs和电子烟；c)审查ONPs和电子烟的作用、产品特点和使用理由 在ONP和电子烟使用方面；以及d)估计种族/族裔、农村居住、精神健康和其他方面的关系 物质使用与ONPs、电子烟和可燃产品的使用和多用途。目标1是 确定在美国使用ONP和与电子烟、可燃或无烟烟草多次使用的流行病学 青年，2024-2028。我们假设：(A)在过去30天内，任何ONP、可食用ONPs或袋子的使用率 (B)抑郁症状、其他物质使用、农村和美国人 印度/阿拉斯加原住民身份将与ONP用途和ONP+其他产品多种用途相关联。目标2是 确定口味和尼古丁浓度在美国年轻人使用ONP和电子烟中的作用。我们假设 使用具有以下特征的ONPs或电子烟：(A)概念口味或明确销售的口味(薄荷、薄荷、水果、 甜点，冰块+水果混合，非薄荷醇冷却)口味与无味/烟草口味将与 较高的过去30天的使用频率(1-30天)和强度(每使用一天蒸发一次或一片/一袋)； (B)尼古丁浓度与使用频率和强度之间存在剂量-反应关系。目标3是 确定使用ONPs的感知原因与产品设计/特性之间的关联 在美国年轻人中使用ONP和多用途。我们假设在过去30天的ONP用户中：(A)以隐蔽性为由， 谨慎，方便，味道，尼古丁嗡嗡声，以及在其他烟草产品不允许的地方使用 使用ONP的原因将与ONP较高的使用频率和强度有关；(B)引用使用情况 不允许使用烟草产品将与更频繁地使用其他产品相关。含意 监管：如果美国年轻人使用ONPs和具有特定口味、尼古丁浓度或 设计特征(例如，易于隐藏的可食用ONPs)是常见的，并与频繁使用和多聚- 使用，FDA针对这类产品的营销否认或执行优先事项可能会减少年轻人的接受。 有证据表明，优先人群特别容易受到伤害，这将表明这种规定可能 减少非可燃烟草产品使用中的不平等。 FDA科学领域：行为与营销。

PROJECT 1: ABSTRACT/SUMMARY Project 1 (P1): Use of Novel Non-Combustible Tobacco Products among US Youth (Leader, Leventhal) P1 determines how availability of different new non-combustible products impacts tobacco product use in US youth from 2024-2028. To accomplish this, P1 will: a) partner with the Monitoring the Future (MTF) Study to add a new survey module focused on tobacco regulatory science (TRS) with its own unique measures to the annual cross-sectional survey of US 8th, 10th, and 12th graders (n=221,490, pooled across years); b) test hypotheses about 5-year trends in the use of edible oral nicotine products (ONPs; gums, lozenges/mints, gummies), pouch ONPs, and e-cigarettes; c) examine the role of ONP and e-cigarette product characteristics and reasons for use in ONP and e-cigarette use; and d) estimate relations of race/ethnicity, rural residence, mental health, and other substance use with use and poly-use of ONPs with e-cigarettes and with combustible products. Aim 1 is to determine the epidemiology of ONP use and poly-use with e-cigarette, combustible, or smokeless tobacco in US youth, 2024-2028. We hypothesize that: (a) past 30-day use prevalence of any ONP, edible ONPs, or pouch ONPs will increase across years, (b) depressive symptoms, other substance use, rural, and American Indian/Alaska Native status will be associated with ONP use and ONP+other product poly use. Aim 2 is to determine the role of flavors and nicotine concentration in ONP and e-cigarette use in US youth. We hypothesize that use of ONPs or e-cigarettes with: (a) concept flavors or explicitly-marketed flavors (menthol, mint, fruit, dessert, ice+fruit hybrid, non-menthol cooling) flavors vs. unflavored/tobacco flavors will be associated with higher past-30-day use frequency (1-30 days) and intensity (vaping episodes or pieces/pouches per use day); (b) nicotine concentration will have a dose-response association with use frequency and intensity. Aim 3 is to determine associations between perceived reasons for using ONPs related to product design/ characteristics and ONP use and poly-use in US youth. We hypothesize that in past-30-day ONP users: (a) citing concealability, discreetness, convenience, flavor, nicotine buzz, and use where other tobacco products are not allowed as reasons for ONP use will be associated with ONP higher use frequency and intensity; (b) citing use where tobacco products are not permitted will be associated with more frequent use of other products. Implications for Regulation: If U.S. youth use of ONPs and e-cigarettes with certain flavors, nicotine concentrations, or design features (e.g., easy to conceal edible ONPs) are common and associated with frequent use and poly- use, FDA targeting of such products in marketing denials or enforcement priorities might reduce youth uptake. Evidence that priority populations are disproportionately vulnerable would indicate that such regulations could reduce inequalities in non-combustible tobacco product use. FDA Scientific Areas: Behavior and Marketing.