FDA Alerts Industry and Consumers about the Use of Amanita Muscaria or its Constituents in Food
Constituent Update
December 18, 2024
Today, the U.S. Food and Drug Administration (FDA) issued a letter to food manufacturers that Amanita muscaria (A. muscaria), its extracts, and certain of its constituents (muscimol, ibotenic acid, and muscarine) are not authorized for use as ingredients in conventional food. 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 and its constituents, the FDA concluded that they do not meet the safety standard for use in food and that their use as food ingredients may be harmful. We also recommend that people avoid eating foods with these ingredients. The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety and public health.
The FDA determined that the use of this ingredient and its constituents do not meet the Generally Recognized As Safe (or 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. The agency updates this inventory periodically and we encourage food manufacturers to use it as a resource. The FDA reminds industry to engage the agency through the GRAS Notification Program, in which FDA experts evaluate the notifier’s GRAS conclusion which includes the notifier’s analysis of publicly available safety data.
The FDA is aware of these ingredients in foods intended to have hallucinogenic effects that look like their conventional counterparts, like candy bars. Because of the FDA’s safety concerns with these ingredients, the agency reminds manufacturers considering using them in foods of their responsibility to produce and market safe foods. This includes ensuring the safety and regulatory status of the ingredients they use in foods before they are available to consumers.
We chose to assess the use of this ingredient 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 this ingredient. This is not the first time we have shared our concerns about A. muscaria. The FDA’s “Bad Bug” book, released in 2012, identifies A. muscaria and its constituents as toxic agents that cause poisoning following ingestion.
As part of a broader assessment of these ingredients in the food supply, the FDA is also evaluating the use of these ingredients in dietary supplements. The FDA reminds manufacturers that are exploring the use of A. muscaria or its constituents in dietary supplements of their responsibility to ensure their ingredients meet the relevant safety standard and encourages them to engage the Office of Dietary Supplement Programs with questions.