Consumer Responses to Modified Risk Tobacco Product Claims

消费者对降低风险烟草产品声明的反应

基本信息

批准号：
9610834
负责人：
Andrew Brian Seidenberg
金额：
$ 3.64万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-31 至 2020-07-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9610834
关键词：
Attitude Behavior Belief Cessation of life Chemicals Cigarette Cigarette Smoker Complement Country Data Data Set Disease Electronic cigarette Ethics Exposure to Family Smoking Prevention and Tobacco Control Act Goals Grant Harm Reduction Health Health Information National Trends Survey Individual Insurance Claim Review Japan Knowledge Laws Literature Malignant Neoplasms Marketing Measures Methods Modification Outcome Measure Participant Pattern Population Prevalence Process Public Health Publishing Randomized Regulation Research Research Personnel Research Proposals Review Literature Risk Sales Smoker Smoking Specificity Structure Subgroup Surveys Tobacco Tobacco use Training authority cancer prevention cigarette smoking experimental study health communication heart disease risk interest never smoker non-smoker population health preventable death recruit response systematic review tobacco advertising tobacco control

项目摘要

Project Summary/Abstract Cigarette smoking is the leading cause of preventable death and disease in the US, and is responsible for nearly one-third of all cancer deaths. To help reduce these harms, the Family Smoking Prevention and Tobacco Control Act granted FDA broad regulatory authority over tobacco products, and included a structured process for the marketing of reduced-risk tobacco products, called modified risk tobacco products (MRTPs). FDA can authorize MRTP marketing if evidence demonstrates that doing so will reduce harm and risk of tobacco-related disease to individual users and benefit population health. Two types of MRTP claims can be authorized by FDA: 1) risk modification (reduced risk of tobacco-related diseases), 2) exposure modification (reduced exposure to harmful chemicals). Further, MRTP claims can be classified by specificity. For instance, claims can be general (e.g., reduced-risk of tobacco-related diseases) or specific (e.g., reduced-risk of heart disease). To date, no MRTP claims have been authorized by FDA, and the public health impact of MRTP marketing remains unknown. The harm reduction potential of MRTP claims will depend on patterns of MRTP use. For instance, cigarette smokers could potentially benefit by switching completely to an MRTP. However, harm may increase if MRTP claims cause non-smokers to initiate MRTP use. Further, cessation from cigarettes could be undermined if smokers initiate MRTP use and continue smoking (i.e., dual product use). Therefore, knowledge of how consumers respond to MRTP claims is essential to FDA regulatory actions. The proposed research utilizes a multi-method approach to advance understanding of consumer responses to MRTP claims. The specific aims of the proposal are: 1) Conduct a systematic review of published research on consumer responses to MRTP claims;; 2) Analyze nationally-representative survey data (i.e., 2017 HINTS- FDA) to estimate the prevalence and predictors (e.g., sociodemographic, tobacco use behaviors) of interest in using MRTPs;; 3) Conduct an online experiment to determine whether the relationships between exposure to MRTP claims and MRTP use intentions and cigarette quit intentions vary by MRTP claim type (i.e., exposure vs. risk) and MRTP claim specificity (i.e., general vs. specific). The research proposal will support the applicant’s continued training in tobacco control, health communication, and ethical conduct of research, and will help the applicant achieve his goal of becoming an independent cancer prevention researcher. More importantly, the proposed study will help inform FDA regulation of MRTP claims, and directly responds to immediate research needs identified by FDA’s Center for Tobacco Products. The data collected from the proposed study could help FDA maximize potential benefits and minimize unintended consequences associated with MRTP claims.

项目概要/摘要吸烟是美国可预防的死亡和疾病的主要原因，并导致近三分之一的癌症死亡是为了帮助减少这些危害，家庭吸烟预防和《烟草控制法》授予 FDA 对烟草产品广泛的监管权力，并包括结构化的降低风险烟草产品的营销流程，称为改良风险烟草产品 (MRTP)。如果有证据表明这样做可以减少伤害和风险，FDA 可以授权 MRTP 营销 MRTP 声明可以分为两种类型： FDA 授权：1) 风险修改（降低烟草相关疾病的风险），2) 暴露修改（减少接触有害化学物质）此外，MRTP 声明可以按特异性进行分类。声称可以是一般性的（例如，降低烟草相关疾病的风险）或具体的（例如，降低心脏病的风险）迄今为止，任何 MRTP 声明均未获得 FDA 的授权，MRTP 的公共健康影响也尚未得到 FDA 的授权。 MRTP 声称的减害潜力仍未知，这将取决于 MRTP 的模式。例如，吸烟者可能会因完全改用 MRTP 而受益。如果 MRTP 声称导致非吸烟者开始使用 MRTP，危害可能会增加。如果吸烟者开始使用 MRTP 并继续吸烟（即双重产品使用），香烟可能会受到损害。因此，了解消费者如何应对 MRTP 声明对于 FDA 的监管行动至关重要。拟议的研究利用多种方法来加深对消费者反应的理解 MRTP 主张的具体目标是： 1) 对已发表的研究进行系统审查。消费者对 MRTP 声明的回应；；2) 分析全国代表性调查数据（即 2017 年提示） FDA）来估计感兴趣的患病率和预测因素（例如，社会人口统计学、烟草使用行为）使用 MRTP；；3) 进行在线实验以确定暴露之间是否存在关系 MRTP 声明、MRTP 使用意图和戒烟意图因 MRTP 声明类型（即暴露）而异与风险）和 MRTP 声明特异性（即一般与具体）。申请人在烟草控制、健康传播和研究道德行为方面的持续培训，以及将帮助申请人实现成为独立癌症预防研究员的目标。重要的是，拟议的研究将有助于告知 FDA 对 MRTP 声明的监管，并直接回应 FDA 烟草产品中心确定的即时研究需求从 FDA 收集的数据。拟议的研究可以帮助 FDA 最大限度地提高潜在效益并最大限度地减少意外后果与 MRTP 索赔相关。