FDA WARNING_LETTER - Blue Forest Farms, LLC - July 31, 2025

The FDA issued a warning letter to Blue Forest Farms, located at 400 Madison Avenue, New York, following a review of their website in July 2025. The inspection identified significant violations concerning the company"s human food products containing Amanita muscaria. The FDA determined that the Amanita Muscaria Microdose Capsules and Amanita Muscaria Magic Potion Tincture are adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(f)(1)(B)) due to the inclusion of a new dietary ingredient without adequate safety information. Additionally, the Amanita Muscaria Magic Chocolate is considered adulterated under section 402(a)(2)(C)(i) (21 U.S.C. 342(a)(2)(C)(i)) as it contains an unapproved food additive.

The regulatory framework requires that dietary supplements containing new dietary ingredients must have sufficient safety data to ensure no significant risk of illness or injury. The FDA found no such assurance for Amanita muscaria, which is also not recognized as safe (GRAS) for use in conventional foods. Consequently, the introduction of these products into interstate commerce violates section 301(a) of the Act.

Blue Forest Farms must address these violations by ceasing the distribution of the adulterated products and ensuring compliance with FDA regulations. The company is responsible for investigating the causes of these violations and implementing measures to prevent future occurrences. The FDA emphasizes that this letter is not exhaustive of all potential violations, and the company must ensure comprehensive compliance with all applicable regulations.