As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Blue Forest Farms LLC
New York, NY
The U.S. Food and Drug Administration has issued a warning letter to Blue Forest Farms LLC, located at 400 Madison Ave., New York, NY, for significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letter, dated Sept. 11, 2025, follows a review of the company’s website, www.blueforestfarms.com, conducted in July. The FDA determined that Blue Forest Farms’ products — Amanita Muscaria Microdose Capsules, Amanita Muscaria Magic Potion Tincture, and Amanita Muscaria Magic Chocolate — are adulterated because of the inclusion of Amanita muscaria, a substance that poses significant safety risks.
Critical violations
The FDA’s review identified serious issues with Blue Forest Farms’ products, which are marketed as dietary supplements and conventional foods containing Amanita muscaria, a mushroom with known toxic properties.
Adulterated dietary supplements
The Amanita Muscaria Microdose Capsules and Amanita Muscaria Magic Potion Tincture are labeled as dietary supplements, with Amanita muscaria listed as a dietary ingredient (whole dry fruiting bodies in the capsules and an extract in the tincture). The FDA classifies Amanita muscaria, its extract, and its components (ibotenic acid, muscarine and muscimol) as new dietary ingredients, as there is no evidence they were marketed in the U.S. before Oct. 15, 1994.
Dietary supplements containing new dietary ingredients are adulterated if there is inadequate evidence to ensure they do not present a significant or unreasonable risk of illness or injury. The FDA’s evaluation found insufficient safety data for Amanita muscaria, citing serious concerns about potential adverse effects, including delirium, seizures, coma, respiratory depression, and death. Consequently, these products are adulterated, and their introduction into interstate commerce is in violation of FDA regulations.
Adulterated conventional food
The Amanita Muscaria Magic Chocolate is marketed as a conventional food, not a dietary supplement, due to its chocolate bar format, packaging, and ingredients (chocolate, sugar, cocoa butter, soy lecithin, natural vanilla flavor, and milk). The use of “Dietary Supplement” labeling and a “Supplement Facts” panel does not override its representation as a conventional food.
Amanita muscaria, when added to conventional food, is considered a food additive unless it is generally recognized as safe (GRAS) or meets another exception. The FDA found no evidence that Amanita muscaria is GRAS, has a prior sanction, or qualifies for any exemption. Published scientific literature and adverse event reports highlight significant safety risks, including central nervous system effects. As an unapproved food additive, Amanita muscaria renders the Magic Chocolate adulterated, and its introduction into interstate commerce is in violation of FDA regulations.
FDA’s concerns and next steps
The FDA emphasized that Blue Forest Farms’ use of Amanita muscaria in its products poses serious public health risks due to the lack of safety data and documented adverse effects. The agency warned that failure to address these violations could lead to enforcement actions, including seizure or injunction.
Blue Forest Farms has 15 working days from receipt of the warning letter to respond with specific corrective actions, including steps to prevent recurrence and supporting documentation. If corrective actions cannot be completed within this timeframe, the company must explain the delay and provide a timeline for compliance.
The full warning letter can be viewed here.
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