Informing ENDS policies: Studying the impact of e-cigarette warnings on behavior

摘要 美国现在要求电子烟的包装和广告必须有一个关于尼古丁成瘾的警告。 FDA有权要求额外的电子烟警告，并指出，一个电子烟 警告可能会“随着时间的推移而变得陈旧”。目前还没有数据表明，目前的电子烟或其他电子烟 警告影响vaping或破坏戒烟可燃香烟的动机。而且小 关于电子烟警示如何以及对谁有效，包括在弱势群体中有效，已有数据。 理想情况下，电子烟警告将阻止非用户中的vaping启动，减少电子烟中的vaping， 仅限烟草使用者，并支持双重使用者最终戒烟。我们建议 研究目前电子烟警告的影响，并告知适当的新发展 警告.在目标1中，我们将使用3项大型调查的数据开发新的电子烟警告。我们的目标是 创建电子烟用户认可的有效警告，并且不会导致意外 青少年、年轻人和成年人，尤其是双重使用者的后果。评估将包括 目前美国电子烟关于尼古丁成瘾的警告声明。目标1的主要产品将是 选择Aim 2 RCT中使用的警告。在目标2中，我们将评估电子烟的影响 在RCT中警告vaping。青少年和成年电子烟使用者将收到4个新的警告贴在 他们的电子烟设备和笔芯在为期4周的研究，以随机顺序分配。我们将评估 电子烟警告是否增加电子烟戒烟尝试，并检查警告是否影响 不同的双重用户，弱势群体（年轻人;低收入;和男同性恋，女同性恋和双性恋[GLB] e- 吸烟者）。我们亦会研究有关警告是否会增加烟草商的烟草销售模式（TWM） 在电子烟的背景下戒烟的先决条件。目标2的主要产品将是 电子烟警告对vaping的影响，以及了解TWM对行为的影响 解释影响。最后，在目标3中，我们将研究电子烟警告是否推动电子烟 使用者吸烟。我们将研究电子烟警告对不吸烟动机的影响 （定义为双重使用者的戒烟意愿，以及仅电子烟的吸烟易感性 吸烟行为和不准确的风险认知。我们将研究警告的影响是否因 弱势群体和预警规模。目标3的最后产品将是对警告的影响的估计， 意想不到的后果，包括推动人们吸烟。在这三个目标中，我们将开发 关于如何在不推动双重用户的情况下最大限度地发挥电子烟警告的影响的可推广原则 吸烟的倾向我们的研究结果将创建一个证据基础，可以为有效电子烟的开发提供信息。 美国和全球的警告、警告和广告政策，以及其他尼古丁成瘾和癌症 预防宣传和反营销运动。

ABSTRACT The US now requires e-cigarette packaging and advertising to have a single warning about nicotine addiction. FDA has the authority to require additional e-cigarette warnings and has stated that a single e-cigarette warning could “grow stale over time.” No data are available on whether the current or other e-cigarette warnings affect vaping or undermine the motivation to quit smoking combustible cigarettes. Furthermore, little data are available on how and for whom e-cigarette warnings work, including among vulnerable populations. Ideally, e-cigarette warnings would discourage vaping initiation among non-users, reduce vaping among e- cigarette-only users, and support dual-users eventually quitting use of tobacco products. We propose to study the impact of the current e-cigarette warning and inform development of appropriate new warnings. In Aim 1, we will develop new e-cigarette warnings using data from 3 large surveys. We aim to create warnings that e-cigarette users endorse as being effective and that do not cause unintended consequences among adolescents, young adults, and adults, especially dual users. This evaluation will include the current US e-cigarette warning statement about nicotine addiction. The main product of Aim 1 will be the selection of warnings for use in the Aim 2 RCT. In Aim 2, we will evaluate the impact of e-cigarette warnings on vaping in an RCT. Young adult and adult e-cigarette users will receive 4 new warnings affixed to their e-cigarette devices and refills during the 4-week study, allocated in a random order. We will assess whether the e-cigarette warnings increase e-cigarette quit attempts and examine whether the warnings impact varies for dual users, vulnerable populations (young adult; low-income; and gay, lesbian, and bisexual [GLB] e- cigarette users). We will also examine whether the warnings increase Tobacco Warnings Model (TWM) antecedents to quitting in the context of e-cigarettes. The main product of Aim 2 will be an estimate of the impact of e-cigarette warnings on vaping, and an understanding of which TWM antecedents to behavior explain the impact. Finally, in Aim 3, we will examine whether e-cigarette warnings push e-cigarette users toward smoking. We will examine the impact of e-cigarette warnings on motivation to not smoke (defined as cigarette quit intentions among dual users, and susceptibility to smoke among e-cigarette only users), smoking behavior and inaccurate risk perceptions. We will examine if warnings' impact varies for vulnerable groups and warning size. The final product of Aim 3 will be an estimate of the impact of warnings on unintended consequences, including pushing people toward smoking. Across the three aims, we will develop generalizable principles on how to maximize the impact of e-cigarette warnings without pushing dual users toward smoking. Our findings will create an evidence base that can inform development of effective e-cigarette warnings, warnings and advertising policy in the US and globally, and other nicotine addiction and cancer prevention communication and countermarketing campaigns.