U.S. Food and Drug Administration (FDA) Finds Amanita Muscaria Unsafe in Food After Mushroom-Edible Illnesses (2024)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. How the Outbreak Investigation Unfolded
3. Reported Symptoms and Where the Products Were Sold
4. The Recall and Products Left on Shelves
5. What U.S. Food and Drug Administration Laboratory Testing Found
6. The December 2024 Determination on Amanita Muscaria
7. The Evidence the U.S. Food and Drug Administration Cited
8. What “Not Generally Recognized as Safe” and “Unapproved Food Additive” Mean
9. What the Actions Do Not Do
10. Dates and Status as of 11 October 2026
11. How the Actions Fit Other U.S. Food and Drug Administration Work
12. Primary Documents
13. Key Research Papers
14. Connections
15. Featured Videos

1. What the U.S. Food and Drug Administration Did

The 2024 record consists of two kinds of U.S. Food and Drug Administration document, neither of them a Federal Register rule:

• An outbreak investigation, 7 June to 15 November 2024. The U.S. Food and Drug Administration posted an outbreak-investigation page (an advisory the agency updates as an investigation proceeds) on 7 June 2024 and updated it more than a dozen times. The investigation was run with the U.S. Centers for Disease Control and Prevention, America’s Poison Centers and state and local partners. Its final update, dated 15 November 2024, gives the status as “Ended” and says the U.S. Food and Drug Administration’s response had moved to “post-incident actions and activities,” which may include additional surveillance, prevention and compliance work.
• A post-market determination, 18 December 2024. On that date the U.S. Food and Drug Administration issued a “Letter to Industry on the Use of Amanita Muscaria or its Constituents in Food,” addressed “Dear Manufacturer,” and a Human Foods Program constituent update, addressed to industry and consumers, announcing it. The letter states that A. muscaria, its extracts, muscimol, ibotenic acid and muscarine, “when used or intended for use in conventional food, are unapproved food additives,” and that food containing them “is adulterated” under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and subject to enforcement action.

The letter is signed by Michael W. Roosevelt, Acting Director of the Office of Post Market Assessment in the Human Foods Program’s Office of Food Chemical Safety, Dietary Supplements, and Innovation. The U.S. Food and Drug Administration’s detailed assessment is a memorandum the agency added to its public inventory titled “Post-market Determinations that the Use of a Substance is Not generally recognized as safe.”

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2. How the Outbreak Investigation Unfolded

The first U.S. Food and Drug Administration update, on 7 June 2024, concerned one brand’s “microdosing” chocolate bars: eight illnesses in four states, all eight people seeking medical care and six hospitalized, with no deaths. By 10 June people who became ill had also reported the same brand’s cones and gummies. The counts the U.S. Food and Drug Administration published as the summer went on were:

The final count rests on a case definition used by state health departments: illness with moderate or major clinical effects, or death, in a person who ate any of the recalled brand’s products or another chocolate product marketed as containing mushrooms, from 1 January 2024 onward. Of the 180 cases, 118 people reportedly ate the recalled brand, 36 ate a mushroom chocolate bar of an unspecified brand and 26 ate a mushroom chocolate bar of a different brand. The largest state counts on the final list were Georgia (21), Texas (19) and Arizona (13).

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3. Reported Symptoms and Where the Products Were Sold

According to the U.S. Food and Drug Administration advisory, people who became ill reported “a variety of severe symptoms,” including:

• seizures;
• central nervous system depression — loss of consciousness, confusion and sleepiness;
• agitation;
• abnormal heart rates;
• high or low blood pressure;
• nausea and vomiting.

Distribution was nationwide. The U.S. Food and Drug Administration said the products were sold online and in person at a variety of retail locations, “including smoke/vape shops, and at retailers that sell hemp-derived products such as cannabidiol (CBD) or delta-8 tetrahydrocannabinol (THC).” The advisory also noted that these products “may appeal to children and teenagers” and have a long shelf life.

The U.S. Food and Drug Administration’s advice to the public, as stated on its advisory, was that consumers not buy or eat any flavor of the recalled chocolate bars, cones or gummies, check their homes and discard them or return them for a refund; that anyone who became ill after eating them contact a healthcare provider or the Poison Help Line (1-800-222-1222); and that healthcare providers report such illnesses to their local health department or the Poison Help Line.

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4. The Recall and Products Left on Shelves

The U.S. Food and Drug Administration’s 18 and 25 June updates say the agency had been in contact with the firm about a possible voluntary recall, but that the firm had not yet started one. On 27 June 2024 the firm recalled all flavors of its chocolate bars, cones and gummies. According to the firm, the products contained muscimol, “a chemical found in some mushrooms,” which it said could be a potential cause of some of the symptoms seen; the U.S. Food and Drug Administration wrote that it was “evaluating this information.”

The recall did not empty the shelves. On 16 July the U.S. Food and Drug Administration reported that recalled products were still on sale at several smoke and vape shops and at hemp-product retailers, that it was monitoring the recall’s effectiveness, and that it was working with national trade associations for convenience stores and smoke shops to spread word of it. After “numerous reports of retailers continuing to sell the recalled products,” the U.S. Food and Drug Administration published a list of store names and locations on 30 July 2024 and updated it on 2 August, 20 August and 18 October 2024, inviting the public to report any retailer, online or in person, still selling the products.

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5. What U.S. Food and Drug Administration Laboratory Testing Found

By the final update the U.S. Food and Drug Administration had tested 22 chocolate bars, 10 infused cones, 22 gummies and one raw ingredient reportedly used to make some of the products. The results, current as of 4 November 2024, were:

• Muscimol in 9 of the 22 chocolate bars, 5 of the 10 cones and the raw ingredient. No gummy sample is listed as containing it.
• Acetylpsilocin (also called 4-acetoxy-N,N-dimethyltryptamine, 4-AcO-DMT, O-acetylpsilocin or psilacetin) in 9 chocolate bars, 5 cones and 14 gummies.
• Psilocin, which the U.S. Food and Drug Administration describes as a Schedule I-controlled substance, in 4 chocolate bars, 5 cones and 14 gummies.
• Pregabalin, a prescription drug, in 3 chocolate bars, 5 cones and 4 gummies.
• Kavalactones — desmethoxyyangonin, dihydrokavain and kavain, compounds found in the kava plant — all present together in 18 chocolate bars, all 10 cones and 11 gummies.
• Ibotenic acid and muscimol in the raw ingredient.

Six of the 22 gummies tested negative for every compound on the U.S. Food and Drug Administration’s list, and 10 products tested negative for cannabis-associated cannabinoids. The U.S. Food and Drug Administration’s table shows different compounds in different flavors and notes that even the same flavor could vary in what it contained.

The U.S. Food and Drug Administration drew two limits around these findings. First, muscimol “does not appear in all products and cannot explain all the symptoms reported by ill people.” Second, “although these compounds individually have known effects when ingested, there is less research on the interactions between these compounds when ingested together.” The outbreak documents do not tie the illnesses to any single compound.

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6. The December 2024 Determination on Amanita Muscaria

The 18 December 2024 constituent update says the U.S. Food and Drug Administration “issued a letter to food manufacturers that Amanita muscaria (A. muscaria), its extracts, and certain of its constituents (muscimol, ibotenic acid, and muscarine) are not authorized for use as ingredients in conventional food.” It states that these ingredients “have been used in foods intended to have hallucinogenic effects, sometimes marketed as ‘psychedelic edibles’, ‘legal psychedelics’ or ‘mushroom edibles’,” and that the U.S. Food and Drug Administration is aware of such foods that “look like their conventional counterparts, like candy bars.”

The agency’s conclusions, in its own words:

• the substances “do not meet the Generally Recognized As Safe (or generally recognized as safe) standard and … they are unapproved food additives”;
• “their use as food ingredients may be harmful”;
• food containing them is adulterated under the FD&C Act and subject to enforcement action.

The constituent update also states: “We also recommend that people avoid eating foods with these ingredients.” That is the U.S. Food and Drug Administration’s recommendation, reported here as such. Both documents remind manufacturers that it is their responsibility to make sure the ingredients they use are safe and lawful before the foods reach consumers, and the update points them to the U.S. Food and Drug Administration’s generally recognized as safe Notification Program, in which agency experts evaluate a company’s own generally recognized as safe conclusion.

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7. The Evidence the U.S. Food and Drug Administration Cited

The constituent update says the U.S. Food and Drug Administration chose to assess these ingredients “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.” The letter adds that the agency had “received serious adverse event reports associated with multiple food products marketed as containing these substances.” The evidence the two documents describe:

• The published literature. The U.S. Food and Drug Administration reviewed “more than 600 unique publications” and found “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.”
• The U.S. Food and Drug Administration’s own reference on foodborne hazards. The U.S. Food and Drug Administration’s “Bad Bug Book,” released in 2012, identifies A. muscaria and its constituents as toxic agents that cause poisoning after ingestion. As the letter summarizes it, the book describes gastrointestinal symptoms, delirium and sleepiness with a rapid onset, and alternating periods of drowsiness and excitement for several hours.
• Larger exposures. With large exposures, “for example when introduced into food as an extract or isolated constituents,” the letter says severe neurological symptoms such as convulsions and coma have been reported, and that extracts and the isolated compounds “are of even greater concern if used as food ingredients.”
• Preparation. The letter notes that the literature discusses attempts to detoxify the mushroom, for example by boiling, and that it also reports these techniques “may not completely detoxify the mushrooms.”
• Adverse event reports. Reports to the U.S. Food and Drug Administration food center’s Adverse Event Reporting System in the preceding year described central nervous system depression, drowsiness, seizures and hospitalizations linked to products containing A. muscaria, its extracts or the three constituents.
• Poison center calls. A query of the National Poison Data System found “hundreds of calls in the last year” associated with these substances, reporting similar symptoms as well as cardiovascular effects, hallucinations, respiratory depression, “and even death.”

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8. What “Not Generally Recognized as Safe” and “Unapproved Food Additive” Mean

The December letter sets out the legal framework behind its wording. Under the FD&C Act, any substance used or intended for use in food must be authorized by the U.S. Food and Drug Administration as a food additive, unless that use is “Generally Recognized As Safe,” or generally recognized as safe, by qualified experts, or falls under a listed exception to the food additive definition. In plain terms, outside the listed exceptions, an ingredient may be used in ordinary food either because the U.S. Food and Drug Administration has authorized it or because qualified experts generally recognize that use as safe.

The letter explains that U.S. Food and Drug Administration regulations allow generally recognized as safe status to rest only on “the totality of the relevant, publicly available, and generally accepted safety evidence coupled with a consensus among the community of qualified experts that this evidence shows the intended uses would be safe.” The safety standard for food ingredients, it says, is that “there must be a reasonable certainty in the minds of competent scientists that no harm would result from the intended use of the substance.”

An ingredient that is neither authorized nor generally recognized as safe is an “unapproved food additive,” and food containing it, the letter says, is “adulterated” under the FD&C Act and subject to enforcement action. The U.S. Food and Drug Administration’s determination does not create a new law; it records the agency’s conclusion that A. muscaria and its three constituents fail the existing standard, and places that conclusion in a public inventory that the constituent update says the agency “updates periodically” and encourages food manufacturers to use as a resource.

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9. What the Actions Do Not Do

• It is not a rule. The determination is a post-market finding added to the U.S. Food and Drug Administration’s “not generally recognized as safe” inventory, announced by letter and constituent update; no Federal Register rule was issued.
• It covers conventional food only. The constituent update says that, as part of a broader assessment, “the U.S. Food and Drug Administration is also evaluating the use of these ingredients in dietary supplements,” and reminds makers exploring them in supplements of their responsibility to meet the relevant safety standard. The December 2024 documents do not settle that question.
• It does not cover mushrooms in general. It names one species, Amanita muscaria, its extracts and three of its constituents. Culinary and other mushrooms are not part of it, and it does not concern psilocybin-containing mushrooms.
• It does not name a single cause for the outbreak. The U.S. Food and Drug Administration said muscimol was not present in all the products and could not explain all the symptoms, and the testing found several other compounds whose combined effects are less studied.
• It does not rely only on the outbreak. The letter rests on the literature review, the Bad Bug Book, adverse event reports and poison center data; it refers to “multiple food products” and does not mention the recalled brand.

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10. Dates and Status as of 11 October 2026

• 7 June 2024 — U.S. Food and Drug Administration outbreak investigation opens (8 illnesses, 4 states).
• 27 June 2024 — the firm recalls all flavors of its chocolate bars, cones and gummies.
• 30 July 2024 — first U.S. Food and Drug Administration list of stores known to sell the recalled products; updated 2 August, 20 August and 18 October.
• 31 October 2024 — final case count: 180 illnesses, 34 states, 73 hospitalizations, 3 potentially associated deaths.
• 4 November 2024 — testing complete.
• 15 November 2024 — final update; investigation status “Ended,” response moved to post-incident activities.
• 18 December 2024 — letter to industry and constituent update: A. muscaria, its extracts, muscimol, ibotenic acid and muscarine are not generally recognized as safe and are unapproved food additives in conventional food.

Status as of 11 October 2026: in effect. The not-GRAS determination stands as an entry in the U.S. Food and Drug Administration’s post-market inventory; it was never a Federal Register rule. A check of the Federal Register through 11 October 2026 for “Amanita,” “muscimol” and “ibotenic” found no later document on the subject. The documents read for this page record no later U.S. Food and Drug Administration decision on these ingredients in dietary supplements, which the agency said in December 2024 it was still evaluating.

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11. How the Actions Fit Other U.S. Food and Drug Administration Work

The constituent update describes the determination as part of the U.S. Food and Drug Administration’s assessment of chemicals in the food supply, and it places the memorandum in the same public inventory of post-market “not generally recognized as safe” determinations that the agency uses for other ingredients. The U.S. Food and Drug Administration’s later work on generally recognized as safe and post-market chemical review is reported on the site’s pages U.S. Food and Drug Administration Moves on Self-Affirmed generally recognized as safe and Chemical Reviews (2025) and U.S. Food and Drug Administration Proposal to Make generally recognized as safe Notices Mandatory (2026).

The constituent update also points out that this was “not the first time” the U.S. Food and Drug Administration had shared concerns about A. muscaria, citing the 2012 Bad Bug Book. The outbreak itself unfolded in the same retail channel — smoke and vape shops and hemp-product retailers — that figures in two other 2024 U.S. Food and Drug Administration actions in this section: the warning to retailers about tianeptine and the joint U.S. Food and Drug Administration–FTC warnings to sellers of copycat delta-8 tetrahydrocannabinol snacks.

The determination is a food-safety action and is a different subject from the U.S. Food and Drug Administration’s handling of psychedelic drugs as medicines under clinical investigation, which is reported on U.S. Food and Drug Administration Final Guidance on Psychedelic Drug Trials (2026). The history of muscarine and the fly agaric in nineteenth-century pharmacology is told on Muscarine, the Fly Agaric and the Plant Drugs of Buchheim and Schmiedeberg.

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12. Primary Documents

1. U.S. Food and Drug Administration (2024). Investigation of Illnesses: [recalled brand] Chocolate Bars, Cones, & Gummies (June 2024). U.S. Food and Drug Administration outbreak-investigation page, updates of 7 June – 15 November 2024, status “Ended” — fda.gov, Food → Outbreaks of Foodborne Illness → Investigations of Foodborne Illness Outbreaks (not linked here because its address carries the brand name)
2. U.S. Food and Drug Administration, Human Foods Program (2024). U.S. Food and Drug Administration Alerts Industry and Consumers about the Use of Amanita Muscaria or its Constituents in Food. HFP Constituent Update, 18 December 2024 — fda.gov constituent update
3. U.S. Food and Drug Administration, Human Foods Program, Office of Post Market Assessment (2024). Letter to Industry on the Use of Amanita Muscaria or its Constituents in Food. 18 December 2024 — fda.gov letter to industry
4. U.S. Food and Drug Administration (2024). Scientific Memorandum: Amanita Muscaria, dated 9 September 2024 in the U.S. Food and Drug Administration’s listing; entry in the inventory “Post-market Determinations that the Use of a Substance is Not generally recognized as safe” (not quoted on this page) — fda.gov memorandum (PDF)

No Federal Register document or docket was issued for either action.

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Key Research Papers

1. Rumph JT, Winquist A, Troeschel AN, Pulver S, Schnall AH, Ebersole J, et al. (2026). Severe Illness Associated with Eating Mushroom-Containing Chocolate Products — United States, January–October 2024. MMWR Morbidity and Mortality Weekly Report 75(13):179-184 — PubMed PMID: 41955162
2. Moss MJ, Hendrickson RG (2019). Toxicity of muscimol and ibotenic acid containing mushrooms reported to a regional poison control center from 2002-2016. Clinical Toxicology 57(2):99-103 — PubMed PMID: 30073844
3. Michelot D, Melendez-Howell LM (2003). Amanita muscaria: chemistry, biology, toxicology, and ethnomycology. Mycological Research 107(Pt 2):131-146 — PubMed PMID: 12747324
4. Vendramin A, Brvar M (2014). Amanita muscaria and Amanita pantherina poisoning: two syndromes. Toxicon 90:269-272 — PubMed PMID: 25173077
5. Meisel EM, Morgan B, Schwartz M, Kazzi Z, Cetin H, Sahin A (2022). Two Cases of Severe Amanita Muscaria Poisoning Including a Fatality. Wilderness & Environmental Medicine 33(4):412-416 — PubMed PMID: 36210279
6. Rivera-Illanes D, Recabarren-Gajardo G (2024). Classics in Chemical Neuroscience: Muscimol. ACS Chemical Neuroscience 15(18):3257-3269 — PubMed PMID: 39254100

PubMed Topic Searches

1. PubMed: Amanita muscaria poisoning
2. PubMed: muscimol and ibotenic acid toxicity
3. PubMed: illness after mushroom chocolate products

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Connections

• U.S. Food and Drug Administration Actions of 2024
• U.S. Food and Drug Administration and Regulation
• U.S. Food and Drug Administration and FTC Warn Sellers of Copycat Delta-8 Tetrahydrocannabinol Snacks (2024)
• U.S. Food and Drug Administration Urges Retailers to Stop Selling Tianeptine (2024)
• U.S. Food and Drug Administration Revokes Brominated Vegetable Oil (BVO) in Food (2024)
• U.S. Food and Drug Administration Moves on Self-Affirmed Generally Recognized as Safe and Chemical Reviews (2025)
• U.S. Food and Drug Administration Proposal to Make Generally Recognized as Safe Notices Mandatory (2026)
• U.S. Food and Drug Administration Final Guidance on Psychedelic Drug Trials (2026)
• Muscarine and the Fly Agaric
• Albert Hofmann: Psilocybin and Psilocin
• John Jacob Abel: Glands, Toads, Leeches and Mushrooms
• Medicinal Mushrooms
• Culinary Mushrooms
• Kava
• Dark Chocolate
• Dangerous Supplements
• Food Additives
• Epilepsy

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