FDA Sends Letters Warning That Products Containing Amanita Mushroom Violate Federal Law

The Food and Drug Administration (FDA) last week sent a letter to manufacturers using the amanita mushroom in its products warning that use of the fungus or its extracts violates the federal Food, Drug, and Cosmetics (FD&C) Act. The amanita mushroom is often used in products marketed as “psychedelic edibles,” “legal psychedelics” or “mushroom edibles” and sold in gas stations or smoke shops.    

“Specifically, FDA determined that Amanita muscaria, its extracts, and certain constituents (muscimol, ibotenic acid, and muscarine), do not meet the Generally Recognized as Safe (GRAS) standard and are unapproved food additives. We conducted this evaluation because we have received serious adverse event reports associated with multiple food products marketed as containing these substances and we reviewed published literature confirming reported human health risks.” — FDA “Letter to Industry on the Use of Amanita Muscaria or its Constituents in Food,” 12/18/24 

The agency contends that large exposure of the mushroom can lead to severe neurological symptoms, such as convulsions and that the National Poison Data System reported hundreds of calls in the last year associated with consumption of products containing the mushroom.  

The agency did not list the companies sent the letter but indicated that it “will continue to monitor the food supply to help ensure the safety of ingredients in food” and that “ultimately, it is the responsibility of manufacturers, processors, distributors, and other facility operators to ensure that their food products marketed in the U.S. market are safe and lawful.”