04/01/2025
The FDA has officially banned fly agaric from being used in products meant for human consumption in the USA. This includes amanita muscaria as well as its N. American counterparts and the extracted chemical compounds muscimol, ibotenic acid, and muscarine.
The ban is the direct result of psychedelic edibles companies poisoning a large number of people in the US earlier this year via chocolates and gummies. Fly agaric itself isn’t necessarily the safety issue that led to the ban, but the shady sellers using unsafe, undisclosed ingredients in unregulated and unregistered products definitely are.
As a mushroom educator for many years, the poisonings may also partly have been caused by fly agaric species being confused with toxic amanita species as well as incorrect processing —both due to ignorance (and placing profit over people’s safety). It is important that all mushrooms are processed correctly before being ingested. Even eating “safe” edible mushrooms raw or improperly prepared can lead to poisoning symptoms.
Please note the new FDA ban is directed at the sale food products, not personal use by individuals. The mushroom itself and its constituents remain unscheduled (aka not included in the Controlled Substance Act).
Medicinal products are regulated separately from food products. If you are a herbal business selling medicinal fly agaric products within or to the US, you need to follow the regulations for dietary supplements covered in the Dietary Supplement Health & Education Act. If you are an occult shop, selling a fly agaric product as “a curio only” is insufficient.
This info is for educational purposes only and is not legal advice.
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More info:
“Mushroom edibles are making people sick. Scientists still don’t know why.” NPR, August 21, 2024.
“Need for a Public Health Response to the Unregulated Sales of Amanita muscaria Mushrooms.” American Journal of Preventative Medicine, Sept 2024.
“FDA alerts industry and consumers about the use of Amanita muscaria or its constituents in food.” FDA, Dec 18, 2024.
“FDA restricts a psychoactive mushroom used in some edibles.” NPR, Dec 21, 2024.