FDA WARNING_LETTER - Red Moon Herbs - November 05, 2020

On November 18, 2020, the FDA and FTC issued a Warning Letter to Red Moon Herbs regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's website (https://redmoonherbs.com/) and social media (Facebook, Instagram) on November 4-5, 2020.

The FDA observed that Red Moon Herbs offered numerous products, including American Ginseng Elixir, Ashwagandha, and Elderberry, for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These claims establish the products as 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 company's "COVID-19 Herbal Resource Hub" webpage and social media. The FDA requests immediate action to cease the sale of these unapproved and unauthorized products for COVID-19 related uses. The company must email COVID-19-Task-Force-CFSAN