Building evidence for effective and sustainable cigarette warning label policy

美国食品和药物管理局(FDA)现在对烟草拥有监管权，包括 香烟健康警示标签图文内容的选择与更改 包装。2012年9月，美国计划在网上实施9种不同的短信和图片 HWL将覆盖50%的香烟包装正面和背面。在第一轮图片式HWL之后 一旦实施，其影响将随着时间的推移而“逐渐消失”。FDA被指控在以下情况下更改HWL的内容 他们有证据表明，改变这些规则将“……促进公众更好地了解相关风险。 与烟草产品的使用有关。拟议的研究将解决以前在方法上的不足 为研究人员和美国监管机构提供关键药物影响的最先进科学证据的研究 吸烟者对吸烟相关风险认识的HWL政策特征 戒烟。这一结果将为实施美国当前政策带来的法律挑战提供信息，他们 将为美国和世界各地关于未来图片式HWL政策的决策提供依据。 我们建议对美国和三个类似国家的成年吸烟者进行研究，这三个国家都将 在2012年实施新的图片式HWL，但政策在重要方面有所不同： 1.美国将实施第一轮图片式HWL，使用简短而简单的风险信息； 2.墨西哥将以世界上最高的频率轮换新的HWL(即每三个月轮换两个新的HWL)； 2.加拿大将实施第二轮图片式HWL，其中包括全面的风险和退出信息； 4.澳大利亚将实施第二轮图片式HWL，同时还将实施 禁止在香烟包装上使用品牌颜色和标志，以提高HWL的效力。 这个项目将利用前所未有的机会，系统地检查现实世界的影响 随着时间的推移，美国监管机构应该在未来的政策制定中考虑不同的HWL政策。 拟议的项目将实现以下具体目标： 具体目标1：我们将使用四个国家的成年吸烟者小组的准实验设计 (加拿大、澳大利亚、墨西哥、美国)，以确定最有效的图形HWL特征 促进对吸烟相关风险的了解，增加戒烟行为。 具体目标2：我们将在#年对成年吸烟者进行一系列对照随机实验 同样的四个国家，系统地改变他们对新颖的图画HWL特征的暴露 相对于现有的HWL，以确定这些操作的认知和情感影响。 实现这些目标将产生美国监管机构所需的科学证据，以了解 不同的图片式HWL政策选项。研究结果将分发给研究人员和决策者， 包括FDA，它可以修改美国的HWL，以提高消费者对吸烟相关危害的理解。

The US Food and Drug Administration (FDA) now has regulatory authority over tobacco, including the selection and changing of pictorial and textual content for health warning labels (HWLs) on cigarette packaging. In September 2012, the US is scheduled to implement nine different text messages and images on HWLs that will cover 50% of the front and back of cigarette packs. After the first round of pictorial HWLs is implemented, its effects will "wear out" over time. The FDA is charged with changing the content of HWLs if they have evidence that changing them will "...promote greater public understanding of the risks associated with the use of tobacco products.'' The proposed study will address methodological shortfalls of previous studies to provide researchers and US regulators with state-of-the-art scientific evidence on the effects of key pictorial HWL policy characteristics on smokers' understanding of smoking-related risks and on smoking cessation. The results will inform legal challenges to implementation of current US policy, and they will provide the basis for decision-making about future pictorial HWL policy in the US and around the world. We propose to conduct studies of adult smokers in the US and in three comparable countries that will all implement new pictorial HWLs in 2012, but with policies that differ from one another in important ways: 1. the US will implement its 1st round of pictorial HWLs, using short and simple risk messages; 2. Mexico will rotate new HWLs at the highest frequency in the world (i.e., two new HWLs every three months); 2. Canada will implement its 2nd round of pictorial HWLs, which include comprehensive risk and quit messages; 4. Australia will implement its 2nd round of pictorial HWLs, while also implementing the innovative policy of prohibiting brand colors and logos from cigarette packages in order to enhance the efficacy of HWLs. This project will capitalize on the unprecedented opportunity to systematically examine the real world effects over time of different pictorial HWL policies that US regulators should consider for future policy development. The proposed project will pursue the following specific aims: Specific Aim 1: We will use a quasi-experimental design with panels of adult smokers in four countries (Canada, Australia, Mexico, United States) to determine which pictorial HWL characteristics most effectively promote understanding of smoking-related risks and increase cessation behavior. Specific Aim 2: We will conduct a series of controlled randomized experiments among adult smokers in the same four countries, systematically varying their exposure to pictorial HWL characteristics that are novel relative to existing HWLs, in order to determine the cognitive and affective impact of these manipulations. Meeting these aims will produce the scientific evidence that US regulators need on the real world impacts of different pictorial HWL policy options. Results will be disseminated to researchers and decision-makers, including the FDA, which can revise US HWLs to improve consumer understanding of smoking-related harms.