# FDA WARNING_LETTER - Red Moon Herbs - November 05, 2020

Source: https://www.keypedia.com/records/warning_letter/red-moon-herbs/bf2cdaa1-297d-423b-976f-bee58690d09e

> FDA WARNING_LETTER for Red Moon Herbs on November 05, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Red Moon Herbs
- Inspection Date: 2020-11-05
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

## Related Officers

- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/red-moon-herbs/bc9af018-2503-49d4-a49d-04f63022133e

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2