FDA warned food manufacturers that Amanita muscaria (A. muscaria) is not “authorized for use in conventional foods,” does not meet Generally Recognized as Safe (GRAS) standards and poses a health risk, as highlighted by CDC research.
A. muscaria is a mushroom characterized by a red cap and white spots with psychoactive properties. FDA said the mushroom has been found in products like gummies or candy bars, in addition to dietary supplements which will be further evaluated by the agency.
“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,’” the agency stated.
“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 report and inquiries from state and local regulatory about the regulatory status and safety of this ingredient,” FDA said.
The unapproved food additive is included in FDA’s Post-market Determinations that the Use of a Substance is Not GRAS inventory, a resource the agency encourages manufacturers to refer to regularly for ingredient safety updates.
The agency also shared its safety concerns of A. muscaria in its “Bad Bug” book, which was released in 2012. The book, which identifies the mushroom as a toxin, features current technical and scientific information about pathogens that cause foodborne illnesses.
Study finds A. muscaria present with other Schedule I mushrooms
A. muscaria has been found across five gummy brands in smoke shops and gas stations in Charlottesville, Va., according to a July 2024 report from Michienzi et al, published in US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly study.
The gummies, which were marketed as cognitive enhancements, contained A. muscaria and “other unnamed mushrooms,” while three brands contained psilocybin and psilocin, both Schedule I substances currently illegal in Virginia. The gummies caused users hallucinations, agitation, gastrointestinal upset and seizures, according to the report.
A. muscaria is not currently classified a controlled substance in the US, however, the mushroom can cause “undesired symptoms” such as gastrointestinal upset, agitation and seizures, the report stated. However, the use of non-GRAS Schedule I psilocybin and psilocin in these products in Virginia “represents a potential risk to the public,” CDC confirmed.
“Persons who purchase products advertised as psychedelic or nootropic mushroom gummies should be aware that package labels might not accurately represent the contents and that these products could contain substances that might produce unexpected and potentially toxic effects,” CDC stated.
However, some DTC nootropic gummy brands like Shrumfuzed and Dream Dose clarify that their products do not contain A. muscaria and psilocybin. For example, “magic mushroom” gummy brand, Dream Dose, prints a disclaimer on the back of packaging stating that the product “contains no psilocybin or amanita muscaria.”
