ABSTRACT
BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSION: 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.