Health Product Promotional Violations During the COVID-19 Pandemic: Return of Snake Oil Medicine

Background: Since March 6, 2020, the FDA has continued to monitor, inspect and enforce the promotion of products by companies that claim to mitigate, prevent, treat, diagnose; or cure COVID-19. Herein, we provide a descriptive review of the violative companies and their products in question. Methods: We examined the warning and notice of violation letters to companies posted on the FDA webpage over a 6-month period from March 6-August 31. Of all letters, we identified the product in violation, the venue of promotion, violation type, and country of the violating firm. Findings: A total of 93 letters were reported. Across all letters, USA-based companies had the leading number of warning and violation letters. The most common product category was CBD-containing products, followed by essential oils, and approved drug products for off-label use. While all letters reported the promotion of unapproved product(s) (93/93; 100%), the majority of letters reported misbranding (90/93; 97%), and/or had claims that lacked scientific substantiation (83/93; 89%). Finally, all promotional violations were linked to websites, along with other mainstream venue(s): Facebook, Instagram, YouTube, Twitter, LinkedIn, and/or email. Interpretation: Despite the desperate need of COVID-19 treatments, it remains mandatory for the promotion of products by companies to comply to standard regulatory requirements. As the pandemic persists, the FDA must continue their efforts to monitor, inspect, and enforce violative companies. Improving awareness among the public, healthcare providers, and stakeholders could increase the value of the drug approval process and protect patients and consumers from risks posed by these products. Funding Statement: No funding was received for this study. Declaration of Interests: We declare we have no conflicts of interest. Dr. Witek declares being a member of the Board of Directors of Trudell Medical International and Molecular Sciences Corporation. Dr. Nowak declares receiving consulting fees from TELUS Corporation, Akira by TELUS Health, and the Dalla Lana School of Public Health. Honoraria from the Ontario Medical Association, Ontario College of Family Physicians, Centre for Effective Practice, Canada Health Infoway, University of Toronto, and McMaster University.