Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Cannabis Cannabinoid Res. 2021 Dec;6(6):559-563. doi: 10.1089/can.2020.0166. Epub 2021 Jun 17.
Cannabidiol (CBD) products are increasingly available to consumers in the United States and are subject to regulation by the U.S. Food and Drug Administration (FDA). CBD products cannot be marketed as unapproved new drugs with claims of therapeutic benefit. In addition, because CBD is the active ingredient in a FDA-approved CBD product, Epidiolex, CBD cannot be marketed as, or in, food products or dietary supplements. The FDA has issued Warning Letters to promote voluntary regulatory compliance. These letters provide insights as to the types of violations for CBD products detected in the U.S. market. The goal of this retrospective study was to content analyze Warning Letters issued by the FDA to identify illicit marketing of CBD products. Warning Letters issued by the FDA between 2015 and 2019 were content analyzed using a deductive approach. We extracted year of issuance, issuing office, and claim types that are currently prohibited by the FDA, including (i) unapproved new drug, (ii) misbranded drug, (iii) false and/or misleading, (iv) FDA-approved/endorsed, (v) dietary supplement, and (vi) adulterated food product. In addition, we documented the disease or conditions the product claimed to affect, pharmacological effects, and location of violation. Of the 39 Warning Letters issued, 97% were for violations made on company websites and 56% were for social media accounts. Almost all letters (97%) cited violations of marketing CBD as an unapproved new drug. These illicit therapeutic claims were made for >125 unique health problems, including cancer (87.2%), diabetes (71.8%), inflammation (66.7%), pain (66.7%), and arthritis (66.7%). The majority of letters (79.5%) also cited illicit marketing of CBD as a dietary supplement or food product. CBD was promoted as having 16 unique pharmacological effects, including anti-inflammatory (53.8%), anticancer (43.6%), and antipsychotic (30.8%). CBD products have been unlawfully advertised online as unauthorized drugs with health claims that promote therapeutic benefits and as dietary supplements. Efforts are needed to regulate and monitor illicit advertising so consumers are not misled about the risks and benefits of CBD use.
大麻二酚（CBD）产品在美国越来越受到消费者的欢迎，并受到美国食品和药物管理局（FDA）的监管。CBD 产品不能作为未经批准的新药进行营销，并声称具有治疗效果。此外，由于 CBD 是 FDA 批准的 CBD 产品（Epidiolex）的有效成分，因此 CBD 不能作为食品或膳食补充剂进行营销。FDA 已发出警告信以促进自愿监管合规。这些信件提供了有关在美国市场上检测到的 CBD 产品违规类型的见解。本回顾性研究的目的是对 FDA 发出的警告信进行内容分析，以确定 CBD 产品的非法营销。对 FDA 于 2015 年至 2019 年期间发布的警告信进行了内容分析，采用了演绎法。我们提取了发布年份、发布办公室和目前被 FDA 禁止的声称类型，包括（i）未经批准的新药，（ii）未经批准的新药，（iii）虚假和/或误导性，（iv）FDA 批准/认可，（v）膳食补充剂和（vi）掺假食品。此外，我们记录了产品声称影响的疾病或状况、药理作用和违规地点。在发出的 39 封警告信中，97%是针对公司网站上的违规行为，56%是针对社交媒体账户的违规行为。几乎所有信件（97%）都引用了将 CBD 营销为未经批准的新药的违规行为。这些非法治疗性声称是针对 >125 种独特的健康问题提出的，包括癌症（87.2%）、糖尿病（71.8%）、炎症（66.7%）、疼痛（66.7%）和关节炎（66.7%）。大多数信件（79.5%）还引用了将 CBD 作为膳食补充剂或食品产品进行非法营销的情况。CBD 被宣传具有 16 种独特的药理作用，包括抗炎（53.8%）、抗癌（43.6%）和抗精神病（30.8%）。CBD 产品已在网上非法宣传为未经授权的药物，具有促进治疗益处的健康声称，并作为膳食补充剂。需要努力监管和监测非法广告，以免消费者对 CBD 使用的风险和益处产生误解。
