FDA issues warning letter to Chaga Mountain

The FDA has issued a warning letter to Chaga Mountain for serious violations of the Federal Food, Drug and Cosmetic Act.

The letter states these determinations were made based on findings from the FDA’s inspection of the company’s Dennistown, Maine, facility in September 2014 and a review of the Chaga’s website, though which the company takes orders for the products Chaga Mushroom Tincture/Extract – Alcohol Free, Chaga Mushroom Tea Bags, Chaga Mushroom Powdered Loose Teas, Chaga Skin Cream and Lip Balm with natural ingredients including natural essential oils.

Claims made by the company on its website establish “that the products are intended for use in the cure, mitigation, treatment or prevention of disease and/or articles intended to affect the structure or any function of the human body,” which classifies the products as drugs under section 201(g)(1)(B) and/or section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(B) and/or § 321(g)(1)(C)]. As such, the company’s introduction or delivery of the products through interstate commerce violates the Act, according to the FDA’s letter.

Aside from the company’s claims that its products have antiviral, anti-inflammatory and anti-cancer benefits, among others, the FDA stated that Chaga’s dietary supplement products are considered contaminated as per section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the Current Good Manufacturing Practice requirements for dietary supplements.

Additional violations included a failure to identity specifications for each component used in the manufacture of a dietary supplement, as well as failure to conduct at least one appropriate test or examination to verify the identity of any component considered a dietary ingredient prior to its use.

The FDA has given Chaga 15 days to reply with the specific steps the company will take to correct the violations and prevent their future occurrence.

Reference: www.fda.gov