Tran Allan, Sheikhan Natasha Y, Sheikhan Tania, Nowak Dominik A, Witek Theodore J
Institute of Health Policy, Management, and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, M5T 3M6, Canada.
Department of History of Art, University College London, London, UK.
J Cannabis Res. 2021 Dec 8;3(1):49. doi: 10.1186/s42238-021-00109-6.
The United States Food and Drug Administration (FDA) monitors, inspects, and enforces the promotion of products by companies that claim to mitigate, prevent, treat, diagnose, or cure COVID-19. The introduction of COVID-19-related diagnostics and therapeutics during the pandemic has highlighted the significance of rigorous clinical trials to ensure safety and efficacy of such interventions. The objective of this report is to provide a descriptive review of promotional violations of health products for COVID-19 infection.
Warning letters issued by the FDA's Center for Drug Evaluation and Research were retrieved over an 18 month period (March 6, 2020, to August 30, 2021) to identify promotional violations. FDA violation letters categorized as "Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)" were reviewed. A content analysis was performed for each letter to identify categories for product type, promotional venue, violation type, and country of origin. For cannabidiol-related violations, a content analysis was repeated within its own product category.
A total of 130 letters were reported. Across all letters, cannabidiol products were the most frequent subject of violation (15/130; 11.5%). Of the cannabidiol letters, all reported the promotion of unapproved products (15/15; 100%), misbranding (15/15; 100%), and/or had claims that lacked scientific substantiation (14/15; 93.3%). All promotional violations were linked to websites (15/15; 100%), along with other mainstream venues: Facebook, Instagram, YouTube, Twitter, LinkedIn, and email. Lastly, the cannabidiol products were described to provide therapeutic benefit to COVID-19, by acting as an anti-viral (5; 33.3%), pro-inflammatory (1; 6.7%), anti-inflammatory (7; 46.7%), immune-booster (5; 40%), immune-suppressor (2; 13.3%), and/or other (2; 13.3%).
Despite the urgent need for COVID-19 treatments, promotional material by companies must comply with standard regulatory requirements, namely substantiation of claims. As the pandemic persists, the FDA must continue their efforts to monitor, inspect, and enforce violative companies. Cannabidiol-related substances led the spectrum of products with unsubstantiated claims to treat COVID-19 infection. Improving awareness among the public, healthcare providers, and stakeholders highlights the value of drug approval process, while protecting public safety.
美国食品药品监督管理局（FDA）对声称可缓解、预防、治疗、诊断或治愈2019冠状病毒病（COVID-19）的公司所进行的产品推广活动进行监测、检查并实施监管。疫情期间COVID-19相关诊断方法和治疗手段的推出凸显了严格的临床试验对于确保此类干预措施的安全性和有效性的重要性。本报告的目的是对COVID-19感染相关健康产品的违规推广情况进行描述性综述。
检索FDA药品评价和研究中心在18个月期间（2020年3月6日至2021年8月30日）发出的警告信，以确定违规推广行为。对归类为“与2019冠状病毒病（COVID-19）相关的未经批准和标签错误的产品”的FDA违规信进行审查。对每封信进行内容分析，以确定产品类型、推广渠道、违规类型和原产国的类别。对于与大麻二酚相关的违规行为，在其自身产品类别内重复进行内容分析。
共报告了130封信。在所有信件中，大麻二酚产品是最常被违规的对象（15/130；11.5%）。在与大麻二酚相关的信件中，所有信件都报告了未经批准产品的推广（15/15；100%）、标签错误（15/15；100%）和/或存在缺乏科学依据的声称（14/15；93.3%）。所有违规推广都与网站有关（15/15；100%），以及其他主流渠道：脸书、照片墙、优兔、推特、领英和电子邮件。最后，大麻二酚产品被描述为通过作为抗病毒药物（5；33.3%）、促炎药物（1；6.7%）、抗炎药物（7；46.7%）、免疫增强剂（5；40%）、免疫抑制剂（2；13.3%）和/或其他药物（2；13.3%）为COVID-19提供治疗益处。
尽管迫切需要COVID-19治疗方法，但公司的推广材料必须符合标准监管要求，即声称要有依据。随着疫情持续，FDA必须继续努力监测、检查和监管违规公司。与大麻二酚相关的物质在声称可治疗COVID-19感染但缺乏依据的产品中占主导地位。提高公众、医疗服务提供者和利益相关者的认识凸显了药品审批过程的价值，同时保护公众安全。
