Here’s the letter

Dear Manufacturer:

The U.S. Food and Drug Administration (FDA or we) is issuing this letter to ensure that you are aware that Amanita muscaria, its extracts, and certain constituents (muscimol, ibotenic acid, and muscarine), when used or intended for use in conventional food, are unapproved food additives. Food containing such ingredients is adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are subject to enforcement action. We remind manufacturers of their responsibility under the FD&C Act to ensure the food they market is safe and lawful. This includes ensuring each substance used in the manufacture of food complies with the food additive provisions in the FD&C Act under the manufacturer’s intended conditions of use.

The FDA’s assessment of these substances is detailed in a memorandum added to the agency’s public inventory. 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.

As part of FDA’s assessment, the FDA reviewed the publicly available scientific evidence relevant to the safety of the use of A. muscaria, A. muscaria extracts, muscimol, ibotenic acid, and muscarine in food, which included more than 600 unique publications. Our review revealed that there is not enough safety evidence to show the consumption of these substances as food ingredients would be safe. In fact, the information available indicates that their use as food ingredients may be harmful.

The toxic consequences of consumption of A. muscaria mushrooms are well known. For example, the FDA’s Bad Bug Book has long described A. muscaria mushrooms that cause poisoning following ingestion. The Bad Bug Book describes symptoms of A. muscaria ingestion as gastrointestinal symptoms, delirium, and sleepiness with a rapid onset and alternating periods of drowsiness and excitement for several hours after ingestion. With large exposures, for example when introduced into food as an extract or isolated constituents, severe neurological symptoms, such as convulsions and coma, have been reported. While the published literature discusses attempts to detoxify the mushroom, such as by boiling, the literature also reports that these preparation techniques may not completely detoxify the mushrooms. Extracts and isolated muscimol, ibotenic acid, and muscarine, are of even greater concern if used as food ingredients. Adverse event reports to CFSAN’s Adverse Event Reporting System in the last year have reported incidences of central nervous system depression, drowsiness, seizures, and hospitalizations associated with consumption of products containing A. muscaria, its extracts, or certain constituents (muscimol, ibotenic acid, and muscarine). A query of the National Poison Data System reported hundreds of calls in the last year associated with consumption of A. muscaria, its extracts, muscimol, ibotenic acid or muscarine, reporting similar symptoms as well as cardiovascular effects, hallucinations, respiratory depression, and even death.

Under the FD&C Act, any substance used or intended for use in food must be authorized by the FDA for use as a food additive unless that use is Generally Recognized As Safe or GRAS by qualified experts or meets a listed exception to the food additive definition in the FD&C Act. FDA’s regulations specify that GRAS status may be based only on the totality of the relevant, publicly available, and generally accepted safety evidence coupled with a consensus among the community of qualified experts that this evidence shows the intended uses would be safe. You can find more information on the GRAS standard on FDA’s website at https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras. The FDA’s safety standard for food ingredients is that there must be a reasonable certainty in the minds of competent scientists that no harm would result from the intended use of the substance.

The FDA will continue to monitor the food supply to help ensure the safety of ingredients in food. 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. We appreciate your attention to your responsibilities under the food additive provisions of the FD&C Act.

Sincerely,

/S/

Michael W. Roosevelt
Acting Director
Office of Post Market Assessment
Office of Food Chemical Safety, Dietary
Supplements, and Innovation
Human Foods Program

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