Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has created a global setting of clinical crisis and human anxiety. Without available safe and effective vaccines and cures, an unscrupulous marketplace has emerged selling COVID-19 quackery (fraudulent misrepresentation of preventions and treatments). METHODS: US Food and Drug Administration (FDA) Warning Letters issued from March 2020 to July 2020 were analyzed for themes pertaining to unapproved, adulterated, and misbranded COVID-19 products. RESULTS: During this period, the FDA issued 3,139 Warning Letters of which 98 (3.14%) of these were focused on COVID-19-related drugs, devices, biologics, and dietary supplements (products and ingredients). Specifically, these Warning Letters revealed regulatory nonconformities involving 40 identified herbs, 22 minerals/compounds, 6 devices and biologicals, and 3 vitamins. Products included hand sanitizers; COVID-19 antibody test kits; herbal teas and tinctures; nasal gel; toothpaste; and 1 vaccine. Nine Warning Letters were issued for products being sold via the Amazon online shopping platform. CONCLUSION: A small percentage of FDA Warning Letters recently have been focused on COVID-19. These Letters expose the blatant and potentially harmful quackery of vendors across the world who prioritize financial gain over clinical beneficence. Patient history-taking should include queries about non-traditional and unapproved products to identify, document, and report potentially harmful quackery. FDA Warning Letters are a component of meaningful corrective action; however, greater effort in spreading awareness of such misrepresented, unapproved, and adulterated products is needed to deter purchases of such products.