Project 1

项目1：摘要/总结 项目1（P1）：美国青少年使用新型不可燃烟草产品（领导者，Leventhal） P1确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 2024-2028年的青年。为实现这一目标，P1将：a）与监测未来（MTF）研究合作， 新的调查模块侧重于烟草监管科学（TRS），其独特的措施， 美国8年级、10年级和12年级学生的横断面调查（n= 221，490，跨年度汇总）; B）检验假设 可食用口服尼古丁产品（ONP;口香糖、锭剂/薄荷糖、橡皮糖）使用的约5年趋势， ONP和电子烟; c）检查ONP和电子烟产品特性的作用和使用原因 在ONP和电子烟使用中;以及d）估计种族/民族、农村居民、心理健康等的关系 ONP与电子烟和可燃产品一起使用和聚合使用的物质。目标1： 确定美国ONP使用和与电子烟、可燃或无烟烟草混合使用的流行病学 青年，2024-2028年。我们假设：（a）过去30天使用任何ONP，可食用ONP或袋的患病率 ONP将逐年增加，（B）抑郁症状，其他物质使用，农村和美国 印第安人/阿拉斯加原住民身份将与ONP使用和ONP+其他产品聚乙烯使用相关。目标二是 确定香料和尼古丁浓度在美国青年使用ONP和电子烟中的作用。我们假设 ONP或电子烟与以下物质的使用：（a）概念香料或明确销售的香料（薄荷醇，薄荷，水果， 甜点、冰+水果混合物、非薄荷醇冷却）风味剂与未调味/烟草风味剂将与 过去30天的使用频率（1-30天）和强度（每个使用日的vaping事件或件/袋）更高; (b)尼古丁浓度将与使用频率和强度具有剂量反应关联。目标3是 确定与产品设计/特征相关的使用ONP的感知原因之间的关联 以及美国青少年中ONP的使用和多用途。我们假设，在过去30天的ONP用户：（a）引用隐蔽性， 谨慎，方便，风味，尼古丁嗡嗡声，并在其他烟草产品不允许的情况下使用， 使用ONP的原因将与ONP较高的使用频率和强度相关;（B）引用使用， 烟草制品不被允许将与更频繁地使用其他产品。影响 监管：如果美国青少年使用具有某些口味，尼古丁浓度或 设计特征（例如，容易隐藏的可食用ONP）是常见的，并与频繁使用和聚- 使用，FDA在营销拒绝或执法优先事项中针对此类产品可能会减少青少年的吸收。 有证据表明，重点人群的脆弱程度不成比例，这表明，这种规定可能 减少不燃烟草产品使用方面的不平等。 FDA科学领域：行为和营销。

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.