The U.S. Food and Drug Administration (FDA) issued a letter to food manufacturers earlier this week that Amanita muscaria and its extracts are not authorized for use as ingredients in conventional food.
The FDA letter noted that products containing Amanita muscaria are intended to have hallucinogenic effects, and are sometimes marketed as “psychedelic edibles,” “legal psychedelics” or “mushroom edibles.” More recently it has been used in products that look like conventional packaged goods, such as candy bars.
The FDA determined that the use of this ingredient and its constituents do not meet the Generally Recognized As Safe (GRAS) standard and that they are unapproved food additives. 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.
“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,” noted the FDA letter.
The FDA letter notes that “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.”