nothing about the compound they are actually buying. Tere is no regulatory standard for what a muscimol product’s COA must include. Two studies are particularly relevant here. Michelot and
Melendez-Howell (2003) documented the pharmacological activity of muscimol and ibotenic acid across human and animal subjects and noted that the differential toxicity between the two compounds creates different consumer risk profiles depending on processing quality. Aranko et al. (1985) established that ibotenic acid converts to muscimol reliably under acidic heat conditions but incompletely without sufficient time and temperature, parameters that vary by manufacturer. Te consumer has no practical way to verify these
parameters from a product label. Tis is a standard problem in the botanical supplement space, but it has particular force here because the pharmacological gap between a well- converted and poorly-converted product is larger than in most categories.
The FDA’s December 2024 action In December 2024, the Food and Drug Administration
issued a formal alert classifying muscimol as an unauthorized food additive, noting that it had not been granted Generally Recognized as Safe (GRAS) status and had not undergone food additive approval. Te alert referenced ibotenic acid in the same terms. What the FDA did not do is equally important. Te agency did not issue a recall. It did not classify muscimol as a controlled substance; muscimol is not scheduled by the Drug Enforcement Administration. It did not initiate enforcement actions against specific companies. Te December 2024 alert was regulatory positioning: a formal statement that the FDA considers these compounds to be operating outside the food additive framework, not a prohibition of sale. Tis distinction is one that much of the popular coverage
missed. Amanita muscaria mushrooms remain legal to buy, sell, and possess in 49 U.S. states. Louisiana banned A. muscaria in 2005, though the law has faced legal challenges (Louisiana Revised Statutes, 2005). Te mushroom itself is not a controlled substance. What the FDA action created is documented regulatory risk for manufacturers. It did not change the legal status of the product for consumers. For manufacturers, the alert means that products making
health claims or sold in ways that bring them under FDA food or supplement jurisdiction face formal regulatory exposure. For consumers, it means the category is operating in acknowledged regulatory gray space, which is relevant to purchasing decisions but is not a prohibition.
What the market looks like now
TeA. muscaria gummy market grew quickly between 2022 and 2025. Tird-party retail data suggests hundreds of brands entered the category, with products ranging from single-milligram “microdose” formats to high-dose products claiming 10 mg muscimol or more per unit. Te demographic overlap with the functional mushroom category is high: lion’s mane and reishi consumers, psilocybin-adjacent wellness buyers. Many approach A. muscaria products with a framework developed for adaptogens or dietary supplements, which does not apply.
Summer 2026 FUNGI Volume 19:2 23
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