Testing the Impact of Tobacco Product Graphic Warning Labels at Retail Point-of-Sale

 描述（由申请人提供）：《家庭吸烟预防和烟草控制法》要求食品和药物管理局（FDA）在香烟包装和香烟广告中包括警告声明和图形警告标签。2011年，FDA发布了一项最终规则，要求用彩色图形描述吸烟对健康的负面影响，并附带9条关于香烟危害的文字警告声明。这一规则在法庭上受到几家烟草公司的挑战，经过诉讼，2012年，美国哥伦比亚特区巡回上诉法院撤销了这一规则，称FDA没有提供任何“丝毫证据”证明图形警告图像将“减少美国吸烟人数”（RJ Reynolds Tobacco Co诉FDA，696 F3d，1205，1219，DC Cir 2012）。2013年3月，政府决定不寻求进一步审查法院的裁决，可能只会重新讨论图形警告问题 如果研究表明它们对公共卫生有积极影响，则应使用标签。因此，FDA迫切需要严格测试图形警告标签对个人吸烟倾向的影响。拟议研究的总体目标是在实验性销售零售点环境中，通过实验测试烟草动力墙中显示的图形警告标签的影响。具体来说，在国家癌症研究所（R 01 CA 175209）的资助下，我们创建了一个实验性的便利店（“StoreLab”），除了在便利店中常见的其他产品（例如，苏打水、水、糖果等）。成年吸烟者，响应广告的“便利店购买模式”的研究，将被随机分配到商店购买价值15美元的产品，其中烟草动力墙存放有（1）没有图形警告标签的香烟包装（GWL-缺失）;或（2）带有图形警告标签的香烟包装（GWL-存在）。相关度量将是行为的（例如，店内烟草购买量、“挑选”戒烟小册子、下次购买香烟的时间以及一周随访时自我报告的吸烟变化）。我们还将测试个体差异变量的调节作用，这些变量可能会改变GWL如何影响行为。StoreLab还将配备最先进的商用系统，用于记录和分析参与者的注意力和情绪反应（使用Eckman的面部编码动作系统编码），以图形警告标签，因为他们在我们的实验性但生态有效的销售点环境中遇到它们。本实验的结果将为FDA提供新的和所需的信息，说明在典型零售环境中购买的卷烟包装上添加图形警告标签的价值。

 DESCRIPTION (provided by applicant): The Family Smoking Prevention and Tobacco Control Act required the Food and Drug Administration (FDA) to include warning statements and graphic warning labels on cigarette packages and in cigarette advertisements. In 2011, FDA published a final rule on the matter requiring color graphics depicting the negative health consequences of smoking with nine accompanying textual warning statements about the dangers of cigarettes. This rule was challenged in court by several tobacco companies, and after litigation, in 2012, the United States Court of Appeals for the District of Columbia Circuit vacated the rule, stating that that FDA did not provide any "shred of evidence" that the graphic warning images would "reduce the number of Americans who smoke" (RJ Reynolds Tobacco Co v FDA, 696 F3d, 1205, 1219, DC Cir 2012). In March, 2013, the government decided not to seek further review of the Court's ruling and will likely only revisit the issue of graphic warning labels if and when research shows that they have a positive impact on public health. Consequently, the FDA urgently needs rigorous tests of the impact of graphic warning labels on individuals' propensity to smoke. The overall aim of the proposed research is to experimentally test the impact of graphic warning labels on display in a tobacco powerwall in an experimental point-of-sale retail environment. Specifically, with funds from the National Cancer Institute (R01CA175209), we have created an experimental convenience store (a "StoreLab") that "sells" tobacco products (via a tobacco powerwall, behind the store cashier) in addition to other products typically found in convenience stores (e.g., soda, water, candy, etc.). Adult smokers, responding to ads for a study of "convenience store purchase patterns", will be randomly assigned to shop for $15 worth of products in the Storelab with a tobacco powerwall stocked with either (1) cigarette packages without graphic warning labels (GWLs-absent); or (2) cigarette packages with graphic warning labels (GWLs-present). Dependent measures will be behavioral (e.g., in-store tobacco purchases, "picking up" cessation pamphlets, time to next cigarette purchase, and self-reported changes in smoking at one week follow-up). We will also test the moderating role of individual difference variables that may alter how GWLs impact behavior. The StoreLab will also be equipped with state-of-the-art, commercially available systems for recording and analyzing participant attention and emotional reactions (coded with Eckman's Facial Coding Action System) to graphic warning labels as they encounter them in our experimental yet ecologically valid point-of-sale environment. The results of this experiment will provide new and needed information to FDA about the value of adding graphic warning labels to cigarette packages available for purchase in typical retail environments.