FDA announced the agency and the Federal Trade Commission (FTC) have sent three warning letters to companies marketing unapproved products claiming to treat or prevent COVID-19. According to the agency, there are no FDA-approved products currently available to treat or prevent COVID-19, and FDA is exercising its authority to protect consumers.
The first letter, dated April 10, 2020, was sent to Herbs of Kedem, who’s website sells herbal products “intended to mitigate, prevent, treat, diagnose, or cure COVID-19.” FDA considers these products unapproved and in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) and “introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).”