FDA WARNING_LETTER - Riverstone LLC - December 02, 2020

On December 21, 2020, the FDA and FTC issued a Warning Letter to Doctors Choice regarding unapproved and misbranded products related to COVID-19. The FDA reviewed the company's website, doctorschoice.org, on September 22 and December 2, 2020, and found products "Flu Immune Drops," "L-Lysine," "Lysine Extra," and "Monolaurin" 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 the website, such as "Products that may Slow Viruses and Boost the Immune System" and specific claims for "Lysine Extra" and "Monolaurin" regarding antiviral and immune support properties for infections.

Doctors Choice is required to take immediate action to cease the sale of these unapproved products. Within 48 hours, the company