FDA Issues Warning Letter Regarding Amanita Mushrooms

By Lauren Mendelsohn

December 29, 2024

 

Earlier this month, the U.S. Food and Drug Administration (FDA) issued a warning letter stating that Amanita Mushrooms, its extracts, and certain constituents (muscimol, ibotenic acid, and muscarine) are unapproved food additives, and using them in food products violates the federal Food, Drug & Cosmetic (FD&C) Act. Such products are considered adulterated, illegal, and subject to enforcement action. 

The FDA determined that Amanita Mushrooms, as well as extracts and certain constituents of Amanita Mushrooms (muscimol, ibotenic acid, and muscarine), do not meet the standard to be considered Generally Recognized as Safe (GRAS).

The FDA’s recent determination and letter come in response to reports of individuals having serious negative reactions to products containing Amanita Mushrooms, which have become widely available at gas stations and convenience stores as well as online. According to the letter, reactions have included but not been limited to “cardiovascular effects, hallucinations, respiratory depression, and even death.” 

The toxic effects of Amanita Mushrooms are well documented. (See the “Bad Bug Book” – the chapter on Mushroom Toxins begins on page 218.) Producers of food products and other consumer goods should be careful to avoid violating the FD&C Act and putting the public at risk. 

This information is provided as a public educational service and is not intended, nor should be construed, as legal advice. For specific questions regarding the legal status of mushrooms and products containing mushroom extracts / constituents, contact the Law Offices of Omar Figueroa at 707-829-0215 or info@omarfigueroa.com to schedule a confidential consultation.