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

项目总结/摘要 2019年12月/2020年1月，美国采取了四项关键的联邦烟草控制行动，以减少 电子尼古丁输送系统（ENDS）/烟草使用的吸引力和获得，特别是在年轻人中。 这4项行动是：（1）ENDS风味/器械指南，其中FDA优先执行 “任何调味的、以烟草为基础的ENDS产品（烟草或薄荷味的ENDS产品除外），”（2） ENDS营销指南，其中FDA优先执行针对“任何有针对性的ENDS产品” 向未成年人或其营销可能促进未成年人使用ENDS，”（3）ENDS访问指南， FDA优先执行针对“制造商未能 采取（或未采取）适当措施防止未成年人接触”，以及（4）联邦T21，其中 联邦烟草制品销售的最低年龄从18岁提高到21岁。大约在同一时间， 不过，发生了两起全国性的公共卫生事件，这两起事件可能也导致了人口水平的变化， ENDS/烟草使用行为：疾病预防控制中心在8月发现了ENDS相关肺损伤的爆发 2019年（EVALI），一种新型冠状病毒的传播在美国被宣布为突发公共卫生事件。 2020年1月（COVID 19）。这些行动和事件的共同历史时间需要创新的方法 应对评估每项联邦行动具体影响的挑战。我们将使用理论上 一个接地的中介模型，通过中介将整体影响分解为具体行动的影响 根据国际癌症研究机构的数据，上诉和访问措施预计将根据每一项联邦行动而改变 手册：评估烟草控制政策的方法。 我们将使用两个互补的全国代表性数据源进行二级数据分析， 每一个评估上诉和访问的关键中间措施，共包括61，000多个 参与者，调查ENDS风味/器械指南、ENDS营销指南， ENDS访问指南和联邦T21关于美国ENDS/烟草使用行为，同时还考虑 EVALI和COVID的同时影响19。我们将使用纵向烟草人口评估 青年和成人调查（2017-2021年）和国际烟草协会美国分会 控制（ITC）项目青年和成人调查（2018-2021），利用完全不间断的数据收集 和早期部署ITC独有的COVID 19项目，以及州标识符数据（PATH和ITC），以考虑 在联邦T21之前实施的州一级烟草21政策。我们将使用中介分析来统计 将行为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提供对每种影响的全面理解 对数百万美国人的ENDS/烟草使用行为采取行动，为FDA的监管评估提供信息。

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.