The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior

销售点大麻二酚 (CBD) 健康声明对消费者认知和行为的影响

• 批准号: 10447709
• 负责人: Kimberly G. Wagoner
• 金额: $ 61.08万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10447709
• 关键词: Address; Adult; Advertising; Age; Agriculture; Alzheimer' s Disease; Behavior; Benefits and Risks; Beverages; Cannabidiol; Cannabis; Cannabis Abuse; Cannabis sativa plant; Categories; Chemicals; Classification; Confusion; Cosmetics; Coupled; Development; Discipline; Drug Interactions; Drug Prescriptions; Drug abuse; Ensure; Environment; Epidiolex; Epilepsy; Expectancy; Explosion; Food; Food Additives; Future; Health; Hemp; Hepatotoxicity; Imaging technology; Industry; Laws; Letters; Mainstreaming; Malignant Neoplasms; Marijuana; Marketing; Medical; Methods; Nutritional; Online Systems; Participant; Perception; Pharmaceutical Preparations; Policies; Policy Research; Prevalence; Psychotropic Drugs; Public Health; Randomized Controlled Trials; Regulation; Report (document); Reporting; Research; Research Personnel; Research Priority; Risk; Safety; Sales; Sampling; Schedule; Science; Structure; Supervision; Surveys; Syndrome; Testing; Tetrahydrocannabinol; Therapeutic; Tobacco; Uncertainty; United States Food and Drug Administration; arm; authority; chronic pain; chronic pain relief; consumer behavior; dietary supplements; health communication; high risk; innovation; interest; marijuana use; medical specialties; prevent; safety outcomes; tobacco regulatory science; vaping; willingness

Project Summary Cannabidiol (CBD) products have rapidly gained popularity, with more than 46 million US adults reporting use, primarily to treat medical ailments. The growing CBD market spans the range of products that the US Food and Drug Administration (FDA) regulates including drugs, dietary supplements, food/beverages and cosmetics. CBD cannot be marketed as having therapeutic benefits, be false or misleading to consumers, or convey the products are approved or endorsed by the FDA. In addition, CBD cannot be marketed as a food additive or dietary supplement since it is an active ingredient in an approved drug, Epidiolex. Despite this, CBD products have been unlawfully advertised online to consumers with these claims including unsubstantiated health claims that promote benefits including curing cancer, preventing Alzheimer’s disease and providing chronic pain relief. This a public health concern as these claims may reduce perceptions of harm, increase perceived benefits and influence consumers to delay medical treatment. Coupled with lacking scientific evidence on CBD’s safety and efficacy and uncertainty about product quality, consumers are at risk for unintended consequences including liver toxicity and adverse drug interactions with existing medications if they are misled about CBD’s risks and benefits by illicit health claims. This project, focused on informing regulatory actions for CBD, aims to document the types of health claims being made by brick and mortar CBD retailers, evaluate consumer perceptions of them, and assess their impact on consumer purchase of CBD. First, we will document health claims displayed in a large sample of CBD retailers from three states with contrasting cannabis policies. Our team and experts in cannabis, public health regulation and health communication will content analyze the health claims to identify potential FDA-prohibited claims. Next, we will assess consumer perceptions of the real-world CBD health claims by conducting a web-based survey with a nationally representative sample of 3,000 adult CBD users and non-users. Participants will assess if the claims indicate a FDA-prohibited category, share their interpreted meaning of each claim, and interest in trying CBD. Finally, in Aim 3, we will examine the impact of CBD health claims on consumer purchase behavior using a simulated retail environment. We will conduct a two-arm (CBD claims, no claim control) randomized controlled trial (RCT) in a simulated CBD retailer with 400 adult CBD users and susceptible non-users to evaluate the impact of CBD health claims on the purchase of CBD products (primary), willingness to try, perceived benefits, product safety, and outcome expectancies. The proposed study, informed by multiple disciplines including tobacco regulatory science and food and nutritional claims, will be the first to document health claims made by CBD retailers, assess consumer perceptions of those claims, and test the impact of claims on consumer behavior in a real-world RCT. This study will directly inform regulatory actions, assisting FDA in determining which claims consumers interpret in ways prohibited by law and ensuring consumers are not misled about CBD.

项目摘要 大麻二酚（CBD）产品迅速流行，超过4600万美国成年人报告使用， 主要用于治疗疾病。不断增长的CBD市场涵盖了美国食品和药物管理局 美国食品和药物管理局（FDA）对包括药物、膳食补充剂、食品/饮料和化妆品在内的所有产品进行监管。 CBD不能以具有治疗益处的方式进行营销，不能对消费者进行虚假或误导，也不能传达 产品已获得FDA批准或认可。此外，CBD不能作为食品添加剂销售， 膳食补充剂，因为它是批准的药物Epidiolex中的活性成分。尽管如此，CBD产品 在网上向消费者非法宣传这些声称，包括未经证实的健康声称 这些药物可以促进治疗癌症、预防阿尔茨海默病和缓解慢性疼痛等益处。 这是一个公共卫生问题，因为这些声明可能会减少对伤害的看法，增加对益处的看法， 影响消费者延误就医。再加上缺乏关于CBD安全性的科学证据， 产品质量的有效性和不确定性，消费者面临意外后果的风险，包括 肝脏毒性和与现有药物的不良药物相互作用，如果他们被误导CBD的风险， 非法健康声明的好处。该项目的重点是为《生物多样性公约》的监管行动提供信息， 记录CBD实体零售商提出的健康声明类型，评估消费者 他们的看法，并评估其对消费者购买CBD的影响。首先，我们将记录健康 来自三个州的CBD零售商的大样本中显示的索赔与对比大麻政策。我们 大麻，公共卫生法规和健康传播方面的团队和专家将对 健康声明，以确定潜在的FDA禁止的索赔。接下来，我们将评估消费者对 通过对全国代表性样本进行基于网络的调查， 3，000名成人CBD用户和非用户。参与者将评估索赔是否表明FDA禁止的类别， 分享他们对每一个索赔的解释意义，以及尝试CBD的兴趣。最后，在目标3中，我们将检查 CBD健康声明对消费者购买行为的影响使用模拟零售环境。我们将 在模拟CBD中进行一项两组（CBD声明，无声明对照）随机对照试验（RCT） 零售商与400名成年CBD用户和易感非用户评估CBD健康索赔的影响， CBD产品的购买（主要），尝试的意愿，感知的好处，产品安全性和结果 期望这项拟议的研究得到了包括烟草监管科学在内的多个学科的启发， 食品和营养声明，将是第一个记录CBD零售商提出的健康声明，评估消费者 这些索赔的看法，并在现实世界的随机对照试验中测试索赔对消费者行为的影响。这 这项研究将直接为监管行动提供信息，协助FDA确定消费者在 法律禁止的方式，并确保消费者不会被CBD误导。