FDA Reminds Industry That Psychoactive Amanita muscaria Mushroom is Not Approved for Food Use
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After 180 people were sickened and three people died from eating mushroom-based chocolates and candy edibles sold at retail locations across the country earlier in 2024, the U.S. Food and Drug Administration (FDA) has informed industry that the mushroom Amanita muscaria is not authorized for use as an ingredient in conventional food.
A. muscaria, commonly known as the fly agaric or fly amanita, is a mushroom that has psychotropic effects, but can also cause poisoning. A. muscaria and its constituents have been used in foods intended to have hallucinogenic effects, sometimes marketed as “psychedelic edibles,” “legal psychedelics,” or “mushroom edibles.” After reviewing the available information about A. muscaria, its extracts, and its constituents (muscimol, ibotenic acid, and muscarine), FDA concluded that they do not meet the safety standard for use in food and that their use as food ingredients may be harmful.
FDA determined that the use of this ingredient and its constituents do not meet the “Generally Recognized as Safe” (GRAS) standard, and that they are unapproved food additives. The agency included its assessment in a memorandum added to the "Post-Market Determinations That the Use of a Substance is Not GRAS" inventory.
FDA chose to assess the use of A. muscaria and its constituents in food because of new information about its safety profile, including adverse event reports, news reports, and inquiries from state and local regulators about the regulatory status and safety of the ingredient.
In June 2024, FDA and the U.S. Centers for disease Control and Prevention (CDC) announced a food poisoning outbreak linked to Diamond Shruumz-brand chocolate and candies involving seizures and other severe symptoms. By the time the investigation of the outbreak closed in October, a total of 180 illnesses had been reported in 34 states, resulting in 73 hospitalizations and three potentially associated deaths. FDA testing of Diamond Shruumz products revealed the presence of multiple substances, including muscimol and ibotenic acid. Muscimol was found in nine chocolate bar samples and four infused cone samples, but was not listed as an ingredient in all products. Ibotenic acid and muscimol were detected in a raw ingredient used in the manufacturing of some Diamond Shruumz products.
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