Strengthening Cigar Warnings to Prevent Adolescent Use

摘要 超过140万的年轻人目前抽雪茄，以及全国青年烟草调查(2019)的最新数据。 数据显示，雪茄是青少年中第二大最常用的烟草产品。雪茄的使用暴露了 青少年在发育的关键时期对尼古丁的成瘾作用，并增加他们患 多种癌症和过早死亡。三种主要的雪茄--大雪茄、小雪茄和 雪茄-小雪茄和雪茄(LCC)是美国最常用的雪茄，尤其是在 年轻人。LCC的使用也导致了烟草健康差异，因为黑人/非裔美国青年使用LCC 比其他年轻人更频繁地抽雪茄。2016年，美国食品和药物管理局(FDA)强制要求 将纯文本警告语句旋转到LCC包装上。很少有研究检验这种方法的有效性。 FDA授权的LCC警告中的一项，以降低年轻人使用LCC的意愿。研究来自……的研究 香烟建议，有效的警告应该是大的，并包括说明负面影响的图像 与使用相关的健康影响。然而，香烟警告的证据不能充分说明 实施改进的LCC警告是因为：1)没有证据表明FDA的有效性- 关于年轻人的行为意图或结果的强制文本LCC警告；2)法院裁定 一种烟草产品(即香烟)上的有效烟草警告不能用来证明警告是合理的。 关于其他类型的烟草(即LCC)，以及3)LCC使用者具有不同的人口统计和消费特征 而不是吸烟者。此外，美国华盛顿特区巡回上诉法院最近裁定，FDA 不能要求雪茄贴上警告标签，声称FDA没有提供雪茄影响的证据 关于吸烟率的警告，包括开始和戒烟。 我们的目标是进行研究，推动生命周期控制警告的科学进步，这些警告对 15-20岁的年轻人，目前正在使用、曾经使用过或容易使用LCC，特别是 黑人/非裔美国青年。在为期三年的拨款中，我们会达到三个目标。目标1将确定 使用青年建议将最有效的图像与FDA授权的LCC纯文本警告声明配对 并对500名青年进行了一项量化的在线调查。目标2将在实验上检查LCC 警告大小(30%对50%)和类型(纯文本与文本+图像)会影响以下内容的感知消息有效性 LCC警告在另一个500名年轻人的在线样本中。在目标3中，我们将进行一项随机的 对900名年轻人进行对照试验，以测试来自Aim 2的最有效的LCC警告是否会降低意愿 针对FDA规定的30%文本大小的LCC警告和控制条件使用LCC。我们的目标3 将通过嵌入短信的在线调查链接向青年提供试用。我们的研究将 提供数据和可操作的证据，表明FDA和政策制定者需要实施加强 LCC警告旨在减少年轻人中LCC的使用，并减少与烟草有关的差异。

ABSTRACT Over 1.4 million youth currently smoke cigars and recent data from the National Youth Tobacco Survey (2019) indicate that cigars are the second most commonly used tobacco product among youth. Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases their risks for multiple cancers and premature death. Of the three major types of cigars—large cigars, little cigars, and cigarillos—little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black/African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) mandated six rotating text-only warning statements to be on LCC packaging. Little research has examined the effectiveness of the FDA-mandated LCC warnings in reducing youth willingness to use LCCs. Research from studies of cigarettes suggests that effective warnings should be large and include images that illustrate the negative health effects associated with use. However, evidence for cigarette warnings cannot adequately inform implementation of improved LCC warnings because: 1) there is no evidence on the effectiveness of the FDA- mandated text-only LCC warnings on behavioral intentions or outcomes among youth; 2) courts have ruled that effective tobacco warnings on one type of tobacco product (i.e., cigarettes) cannot be used to justify warnings on other types of tobacco (i.e., LCCs), and 3) LCC users have different demographic and consumption profiles than cigarette users. Furthermore, the US Court of Appeals for the DC Circuit recently ruled that the FDA cannot require warning labels for cigars, claiming that the FDA did not provide evidence on the impact of cigar warnings on smoking rates, including initiation and cessation. Our goal is to conduct research that advances the science on LCC warnings that are effective for youth ages 15 – 20 who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. We will achieve three aims over the three-year grant. Aim 1 will identify the most effective images to pair with FDA-mandated LCC text-only warning statements using a youth advisory board and a quantitative online survey delivered to 500 youth. Aim 2 will experimentally examine whether LCC warning size (30% vs 50%) and type (text-only vs. text + image) affect perceived message effectiveness of LCC warnings among a separate online sample of 500 youth. In Aim 3, we will conduct a randomized controlled trial with 900 youth to test whether the most effective LCC warnings from Aim 2 reduce willingness to use LCCs against the text-only 30% size FDA-mandated LCC warnings and a control condition. Our Aim 3 trial will be delivered to youth through an online survey link embedded in text messages. Our study will provide data and actionable evidence that FDA and policy makers need to implement strengthened LCC warnings aimed to reduce LCC use among youth and decrease tobacco-related disparities.