Red Moon Herbs – FDA Warning Letter, Nov 5, 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
ID · bf2cdaa1-297d-423b-976f-bee58690d09e
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.