Strengthening Cigar Warnings to Prevent Adolescent Use

摘要 目前有超过140万青少年抽雪茄，最近的数据来自全国青少年烟草调查（2019年） 雪茄是年轻人中第二大最常用的烟草产品。汽车使用暴露 青少年在关键的发育时期对尼古丁的成瘾作用，并增加他们的风险， 多种癌症和过早死亡雪茄的三种主要类型-大雪茄，小雪茄， 小雪茄和小雪茄（LCC）是美国最常用的，特别是在 年轻人LCC的使用也有助于烟草健康的差异，因为黑人/非洲裔美国青年使用 比其他年轻人更常抽雪茄。2016年，美国食品和药物管理局（FDA）要求六个 在LCC包装上循环使用纯文本警告声明。很少有研究考察 FDA授权的LCC警告降低了青少年使用LCC的意愿。研究从研究 香烟建议，有效的警告应该是大的，包括图像，说明了负面的 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，因为：1）没有证据表明FDA的有效性- 强制性的纯文本LCC警告青少年的行为意图或结果; 2）法院裁定， 一种烟草产品上的有效烟草警告（即，香烟）不能被用来证明警告 在其他类型的烟草上（即，LCC），以及3）LCC用户具有不同的人口统计和消费概况 吸烟者。此外，美国DC巡回上诉法院最近裁定，FDA 不能要求雪茄的警告标签，声称FDA没有提供雪茄影响的证据 关于吸烟率的警告，包括开始和停止。 我们的目标是进行研究，推进科学的LCC警告，是有效的， 15 - 20岁的青少年，目前使用，曾经使用，或容易使用LCC，特别是 黑人/非裔美国青年。我们将在三年的赠款中实现三个目标。目标1将确定 最有效的图像，以配合FDA授权的LCC纯文本警告声明使用青年咨询 委员会和定量在线调查提供了500名青年。目标2将通过实验研究LCC是否 警告的大小（30% vs 50%）和类型（纯文本vs.文本+图像）会影响 LCC警告在一个单独的在线样本500青年。在目标3中，我们将进行随机 一项有900名年轻人参加的对照试验，旨在测试Aim 2中最有效的LCC警告是否会降低 针对FDA规定的30%尺寸的纯文本LCC警告和控制条件使用LCC。我们的目标3 将通过短信中嵌入的在线调查链接向青年提供试用版。我们的研究将 提供FDA和政策制定者需要实施的数据和可操作的证据， LCC警告旨在减少青少年中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.