A Regulatory Impact Analysis of the FDA Warning Statement on Youth Preferences for Electronic Nicotine Delivery Systems

FDA 关于青少年电子尼古丁输送系统偏好的警告声明的监管影响分析

• 批准号: 9440206
• 负责人: Scott R Weaver
• 金额: $ 11.36万
• 依托单位: GEORGIA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-21 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9440206
• 关键词: Address; Advertisements; Age; Attenuated; Chemicals; Cigarette; Communication; Economic Policy; Effectiveness; Electronic Nicotine Delivery Systems; Electronic cigarette; Food Analysis; Fruit; Future; Goals; Health; Health system; Individual Differences; Intention; Mediating; Medicine; Menthol; Nicotine; Outcomes Research; Perception; Policy Maker; Population; Public Health; Randomized; Regulation; Relative Risks; Research; Research Priority; Risk; Sampling; Smoking; Surveys; Tobacco; Tobacco use; United States Food and Drug Administration; Youth; behavioral economics; demographics; design; economic impact; experimental study; neurodevelopment; preference; response; risk perception; willingness; young adult

PROJECT SUMMARY There is much concern by many within public health and medicine, and among policy makers, regarding the increasing use of electronic nicotine delivery systems (ENDS) by youth given the known risks of nicotine on neurodevelopment and growing evidence of other potential health risks of ENDS use. Since the Food & Drug Administration (FDA) announced its final Deeming Rule, ENDS have been deemed a tobacco product and are now subject to several new regulations, among which include a new warning statement requirement for ENDS products and advertisements that will take effect in August 2018. However, the limited empirical evidence of the impact of the ENDS warning statement on perceptions and use of ENDS presents a critical barrier for the FDA in conducting an accurate Regulatory Impact Analysis (RIA) for its ENDS health warning statement requirement. Therefore, the goal of this project is to address this critical barrier by evaluating the effects of the required FDA Deeming warning statement on the likelihood to purchase ENDS among youth and young adults, and whether this effect depends on ENDS flavor. The objective is to conduct a behavioral economic experiment with U.S. youth and young adults to address three aims to examine: (1) the effects of the presence of ENDS warning statement on the willingness to purchase ENDS and intentions to use ENDS among youth and young adults; (2) if the effect of warning statement on willingness to purchase is mediated by risk perceptions of ENDS; and (3) whether product flavors and individual difference factors (e.g., demographics; tobacco use) modify the effect of ENDS warning statement on risk perceptions, intentions to use, and willingness to purchase. These aims will be accomplished by an online experiment in which 900 youth and young adults sampled to be representative of the US population of 16-25 years old are randomized into conditions varying according to the warning statement (no warning statement, FDA warning statement, and MarkTen warning statement) and ENDS flavor (tobacco, menthol, and fruit flavor), and are asked to complete a hypothetical purchase task. This proposed research addresses FDA Center for Tobacco Products (CTP) research priorities of understanding the impact of economics and policies on tobacco use and perceptions (how is youth tobacco use changing in response to FDA regulatory actions).

项目摘要 许多公共卫生和医学界人士以及决策者对日益严重的 考虑到尼古丁对神经发育的已知风险，青少年使用电子尼古丁输送系统（ENDS） 越来越多的证据表明，使用ENDS会带来其他潜在的健康风险。自美国食品和药物管理局（FDA） 宣布其最终认定规则，ENDS已被视为烟草产品，现在受到几个新的 法规，其中包括对ENDS产品和广告的新警告声明要求， 将于2018年8月生效。然而，ENDS警告声明影响的经验证据有限， 对ENDS的认知和使用是FDA进行准确监管影响的关键障碍 分析（RIA）的ENDS健康警告声明的要求。因此，本项目的目标是解决 通过评估所需FDA推定警告声明对以下可能性的影响， 购买ENDS在青年和年轻的成年人，以及是否这种影响取决于ENDS的味道。目标是 对美国青年和年轻人进行行为经济学实验，以解决三个目标：（1） ENDS警告声明的存在对购买ENDS的意愿和使用ENDS的意图的影响 （2）警告性陈述对购买意愿的影响是否受风险的中介作用 对ENDS的感知;以及（3）产品风味和个体差异因素（例如，人口统计学;烟草 使用）修改ENDS警告声明对风险认知、使用意图和购买意愿的影响。 这些目标将通过一项在线实验来实现，在这项实验中，900名青年和年轻人被抽样调查， 16-25岁的美国人群的代表被随机分配到不同的条件下， 警告声明（无警告声明、FDA警告声明和MarkTen警告声明）和ENDS风味 （烟草、薄荷醇和水果香料），并被要求完成假设的购买任务。这项拟议的研究 解决了FDA烟草制品中心（CTP）的研究重点，即了解经济学的影响， 烟草使用政策和观念（青年烟草使用如何随着FDA的监管行动而变化）。