FDA WARNING_LETTER - Prairie Dawn Herbs - October 01, 2020

On October 7, 2020, the FDA and FTC issued a Warning Letter to Prairie Dawn Herbs regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites (prairiedawnherbs.com and facebook.com/prairiedawnherbs/) on September 24 and October 1, 2020.

The FDA found that Prairie Dawn Herbs offered herbal products, including Echinacea Tincture, Thieves Oil, and Chest Tea, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These claims, such as "herbal formulas to help protect the immune system and combat symptoms of . . . covid," render the products 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 FTC stated that advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence, including well-controlled human clinical studies, violates the FTC Act (15 U.S.