The FDA has sent a warning letter to Mercola.com about their products being marketed as diagnostic tools, treatment options, and cures for COVID-19. The letter, dated February 18, 2021, addresses “Unapproved and Misbranded Products Related to Coronavirus Disease 2019.” The company’s websites and social media accounts promote these products which are considered unapproved new drugs sold in violation of the FDA’s Food, Drug and Cosmetic Act.
The FDA is taking urgent measures to protect consumers that, without approval or authorization by that agency, claim to “mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” The government states that Mercola must take immediate action to cease the sale of these unapproved and unauthorized products.
Some of the claims on the company’s websites include, “Vitamins C and D are finally being adopted in the conventional treatment of novel coronavirus, SARS-CoV2. This fortunate turn of events is likely to save thousands of lives.” and “Vitamins C and D are finally being adopted in the conventional treatment of novel coronavirus, SARS-CoV-2.” The company also claims that “Vitamin C at extremely high doses acts as an antiviral drug, actually killing viruses.” and “Based on the available scientific evidence, there’s no reason to ignore vitamins C and D for the prevention and treatment of COVID-19 and other respiratory infections.”
Articles written by Joseph Mercola state, “Vitamin C and quercetin have synergistic effects that make them useful in the prevention and early at-home treatment of COVID-19.” and “There is evidence that vitamin C and quercetin co-administration exerts a synergistic antiviral action due to overlapping antiviral and immunomodulatory properties and the capacity of ascorbate to recycle quercetin, increasing its efficacy.”
All of these statements, according to the FDA, establish the intended use of the products and “misleadingly represent them as safe and/or effective for the treatment of prevention of COVID-19.”
Further, the FDA warns Mercola that the company must take immediate action to address these violations. It is their responsibility to make sure that the products they sell are in compliance with federal regulations.
The FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment and prevention of COVID-19. A list of companies that have promoted fraudulent COVID-19 products is at the FDA web site.
