Mercola.com, LLC – FDA Warning Letter, Feb 8, 2021
On February 18, 2021, the FDA issued a Warning Letter to Mercola.com and MercolaMarket.com after reviewing their websites and social media on February 8, 2021. The FDA found that "Liposomal Vitamin C," "Liposomal Vitamin D3," and "Quercetin and Pterostilbene Advanced" were offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.
These products are deemed unapproved new drugs under Section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under Section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by Sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).
The letter cites examples of claims from articles on Mercola's websites, such as "Vitamin C and D Finally Adopted as Coronavirus Treatment" and "Quercetin and Vitamin C: Synergistic Therapy for COVID-19," which establish the products' intended use for COVID-19.
The FDA requires immediate action to cease the sale of these unapproved and unauthorized products. Within 48 hours, Mercola must email COVID
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