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: 10211578
• 负责人: Kimberly G. Wagoner
• 金额: $ 56.33万
• 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/10211578
• 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.

项目概要 大麻二酚 (CBD) 产品迅速普及，超过 4600 万美国成年人报告使用该产品， 主要是为了治疗疾病。不断增长的 CBD 市场涵盖了美国食品公司的产品范围 药品管理局 (FDA) 监管的产品包括药品、膳食补充剂、食品/饮料和化妆品。 CBD 不能以具有治疗功效的方式进行营销，不能向消费者提供虚假或误导性信息，也不能传达以下信息： 产品已获得 FDA 批准或认可。此外，CBD不能作为食品添加剂或 膳食补充剂，因为它是已批准药物 Epidiolex 的活性成分。尽管如此，CBD 产品 已在网上向消费者非法宣传这些声明，包括未经证实的健康声明 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，增加对利益的看法，并 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 功效和产品质量的不确定性，消费者面临意想不到的后果的风险，包括 如果他们被误导了解 CBD 的风险，则会产生肝脏毒性以及与现有药物的不良药物相互作用 非法健康声明带来的好处。该项目的重点是为 CBD 的监管行动提供信息，旨在 记录实体 CBD 零售商提出的健康声明类型，评估消费者 对它们的看法，并评估它们对消费者购买 CBD 的影响。首先，我们将记录健康状况 来自三个州的 CBD 零售商的大量样本中显示的声明与大麻政策形成鲜明对比。我们的 大麻、公共卫生监管和健康传播方面的团队和专家将进行内容分析 健康声明，以确定潜在的 FDA 禁止声明。接下来，我们将评估消费者的看法 通过对具有全国代表性的样本进行网络调查，得出真实世界的 CBD 健康声明 3,000 名成人 CBD 用户和非用户。参与者将评估声明是否表明 FDA 禁止的类别， 分享他们对每个主张的解释含义，以及尝试 CBD 的兴趣。最后，在目标 3 中，我们将检查 使用模拟零售环境研究 CBD 健康声明对消费者购买行为的影响。我们将 在模拟 CBD 中进行双臂（CBD 主张，无主张对照）随机对照试验 (RCT) 拥有 400 名成年 CBD 用户和易受影响的非用户的零售商评估 CBD 健康声明对 购买 CBD 产品（主要）、尝试意愿、感知收益、产品安全性和结果 期望。拟议的研究涉及多个学科，包括烟草监管科学和 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 对这些主张的看法，并在现实世界的随机对照试验中测试这些主张对消费者行为的影响。这 研究将直接为监管行动提供信息，协助 FDA 确定消费者对哪些声明进行解读 法律禁止的方式，并确保消费者在 CBD 方面不被误导。