Assessing the impacts of the four 2019/2020 US federal-level tobacco control actions: flavors, youth marketing, youth access, and Tobacco 21

项目摘要/摘要 美国在2019年12月/2020年1月采取了四项关键的联邦一级烟草控制行动，以减少 电子尼古丁输送系统(结束)/烟草使用的吸引力和可及性，特别是在年轻人中。 这4项行动是：(1)结束香精/设备指南，其中FDA优先执行 “任何调味的、基于药筒的终端产品(烟草或薄荷口味的终端产品除外)，”(2) 结束营销指导，在该指导中，FDA将强制执行的优先顺序放在了“任何目标终端产品”上 对未成年人或其营销可能会促进未成年人使用Ends的，“(3)Ends Access指南，#年 美国食品和药物管理局将执法的重点放在“制造商未能对其实施的所有其他终端产品”上 采取(或没有采取)足够的措施，防止未成年人接触，“和(4)联邦T21，其中 联邦最低烟草产品销售年龄从18岁提高到21岁。差不多在同一时间， 然而，发生了两起全国性的公共卫生事件，这可能也导致了#年人口水平的变化 END/烟草使用行为：CDC在8月份发现了END相关肺损伤的暴发 2019年(EVALI)，一种新型冠状病毒的传播于年在美国被宣布为公共卫生紧急状态 2020年1月(COVID19)。这些行动和事件的共同历史时机需要创新的方法 以应对评估每一项联邦行动的具体影响的挑战。我们将在理论上使用 扎根的中介模型，通过中间人将整体影响分解为特定于行动的影响 根据IARC，上诉和获得机会的措施预计将根据每一项联邦行动而改变 手册：评价烟草控制政策的方法。 我们将利用两个互补的、具有国家代表性的数据源进行二级数据分析， 每一项评估吸引力和可及性的关键中间措施，加起来包括61,000多项 参与者，为了调查Ends风味/设备指南、Ends营销指南、 结束访问指南，以及关于美国结束/烟草使用行为的联邦T21，同时还考虑 EVALI和COVID19的同时影响。我们将使用烟草纵向种群评估 和健康(PATH)研究青年和成人调查(2017-2021年)和国际烟草公司的美国分支 控制(国贸中心)项目青年和成人调查(2018-2021年)，利用完全不间断的数据收集 及早将国贸中心独有的COVID19项以及国家标识数据(PATH和国贸中心)提交至账户 对于在联邦T21之前生效的州级烟草21政策。我们将使用调解分析来统计 将行动的总效应分解为假设的中介效应。审查所有4项联邦行动 使用理论驱动的概念模型将全面了解 对数百万美国人的终端/烟草使用行为采取行动，以告知FDA监管评估。

PROJECT SUMMARY/ABSTRACT Four key federal-level tobacco control actions were taken in the US in December 2019/January 2020 to reduce Electronic Nicotine Delivery System (ENDS)/tobacco use appeal and access, particularly among young people. These 4 actions were: (1) ENDS Flavors/Device Guidance, in which FDA prioritized enforcement against “any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product),” (2) ENDS Marketing Guidance, in which FDA prioritized enforcement against “any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors,” (3) ENDS Access Guidance, in which FDA prioritized enforcement against “all other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access,” and (4) Federal T21, in which the federal minimum age of sale of tobacco products was raised from 18 to 21 years. Around the same time, though, two national public health events occurred that likely also contributed to population-level changes in ENDS/tobacco use behaviors: an outbreak of ENDS-associated lung injuries was identified by CDC in August 2019 (EVALI), and the spread of a novel coronavirus was declared a public health emergency in the US in January 2020 (COVID19). The shared historical timing of these actions and events require innovative methods to address the challenge of assessing the specific impacts of each federal action. We will use a theoretically grounded mediational model to disentangle overall impacts into action-specific impacts via intermediate measures of appeal and access expected to change in response to each federal action, based on the IARC Handbook: Methods for Evaluating Tobacco Control Policies. We will conduct secondary data analyses using two complementary nationally-representative data sources, which each assess key intermediate measures of appeal and access, and together include over 61,000 participants, to investigate the impacts of ENDS Flavors/Device Guidance, ENDS Marketing Guidance, ENDS Access Guidance, and Federal T21 on ENDS/tobacco use behaviors in the US, while also considering simultaneous impacts of EVALI and COVID19. We will use the longitudinal Population Assessment of Tobacco and Health (PATH) Study youth and adult surveys (2017-2021) and the US arm of the International Tobacco Control (ITC) Project youth and adult surveys (2018-2021), leveraging the fully uninterrupted data collection and early fielding of COVID19 items unique to ITC, as well as state identifier data (PATH and ITC) to account for state-level Tobacco 21 policies in effect prior to Federal T21. We will use mediation analyses to statistically decompose the total effects of actions into the hypothesized mediator effects. Examining all 4 federal actions using a theory-driven conceptual model will provide a comprehensive understanding of the impacts of each action on the ENDS/tobacco use behaviors of millions of Americans to inform FDA regulatory assessments.