FDA Warns Amanita Muscaria Brand: Calm, Calmer and Santa Adulterated

On October 20, 2026, FDA posted a warning letter dated September 29, 2026, stating that Calm, Calmer and Santa, three Amanita muscaria products sold by Psyched Wellness Ltd., are adulterated dietary supplements. FDA says there is inadequate information to provide reasonable assurance that Amanita muscaria does not present a significant or unreasonable risk of illness or injury. The firm was asked to respond in writing within 15 working days of receiving the letter.

Key takeaways

• FDA determined Calm, Calmer and Santa are adulterated under section 402(f)(1)(B) of the FD&C Act.
• FDA treats Amanita muscaria, its extract, ibotenic acid, muscarine and muscimol as new dietary ingredients under section 413(d).
• Failure to respond adequately may lead to legal action, including seizure and injunction, according to FDA.

What happened

FDA's Human Foods Program issued Warning Letter CMS #730137 to Psyched Wellness Ltd., whose CEO is listed as Jeffrey Stevens and whose address is 36 Toronto Street, Ste 701, Toronto, ON, Canada. It is signed by Maria Knirk, J.D., M.B.A., Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program. FDA's warning-letter index lists it as posted October 20, 2026, under the subject 'Dietary Supplement/Adulterated.' The full letter is available on FDA's warning-letter page.

FDA reviewed www.psyched-wellness.com in May 2026. According to the letter, FDA determined that the firm takes orders on that website for products it represents as containing Amanita muscaria. On that basis, FDA concluded that Calm, Calmer and Santa are adulterated under section 402(f)(1)(B) of the FD&C Act, 21 U.S.C. 342(f)(1)(B).

What changed

The letter is a formal enforcement notice. It states that introducing adulterated supplements into interstate commerce is prohibited under section 301(a) of the FD&C Act. FDA's review found the labeling declares Amanita muscaria extract as a dietary ingredient.

FDA also states that Amanita muscaria, A. muscaria extract, ibotenic acid, muscarine and muscimol are new dietary ingredients under section 413(d). According to the letter, to the best of FDA's knowledge there is no information that Amanita muscaria was marketed as a dietary ingredient in the United States before October 15, 1994.

In its safety conclusion, FDA wrote: 'Based on our evaluation of the relevant safety evidence, there is inadequate information to provide reasonable assurance that Amanita muscaria does not present a significant or unreasonable risk of illness or injury.' The agency also wrote that 'available information on the use of Amanita muscaria in products raises serious safety concerns.'

FDA's list of submitted 75-day premarket notifications for new dietary ingredients includes NDI notification #1417, 'Amanita muscaria mushroom extract (AME-1),' from Psyched Wellness, submitted 7/8/2025, with FDA's response dated 9/18/25. The content of that response is not disclosed in the letter or the list, so this article cannot say what FDA concluded about the notification beyond those dates.

Who is affected

The letter names three products. Calm is listed on the company's Calm page as a 60 ml tincture with 30 servings, priced at $64.99. Its listed ingredients are Amanita muscaria extract made from mushroom caps, natural flavors and purified water. The page describes a 'patent-pending proprietary AME-1 Amanita Muscaria extract,' identifies muscimol as its active ingredient, and says a 'natural decarboxylation process' reduces muscarine and ibotenic acid to trace levels. These are the company's statements, not FDA findings.

Calmer is listed on its product page as a 60 ml tincture priced at $84.99, described as having 'double the amount of actives than Calm.' Santa, on its product page, is described as a 'spicy-sweet tonic powered by our Amanita Muscaria extract' that 'Contains Caffeine.' It is sold as 2 bottles (4 servings) for $14.99, with 6- and 12-bottle packs also offered.

The company's directions set daily limits. The Calm page says 'Do not exceed 10ml per day' and lists serving tiers of 2, 3-6 and 7-10 full droppers. The Calmer page says 'Do not exceed 5ml per day.' The Calm page also states 'Must be 18 or older to purchase. Available in all states in the USA, except the state of Louisiana. Not available in Canada.'

Which retail stores carry these products has not been disclosed.

What it means for shoppers

An adulterated designation is FDA's legal conclusion about a product under federal law. It is not, by itself, a finding that a specific person was harmed. The letter cites no specific adverse event reports tied to Calm, Calmer or Santa. Whether the company has responded to the letter, or plans to stop U.S. sales, has not been disclosed.

A few label details are worth checking on any mushroom-extract product, including ones not named in this letter:

• Look for 'Amanita muscaria,' 'A. muscaria extract,' or the constituents muscimol, ibotenic acid and muscarine in the ingredient list or product copy.
• Compare the directions with the serving size. The Calm page sets a 10 ml daily limit, while the Calmer page sets 5 ml.
• Note any stimulant ingredients. The Santa page says it contains caffeine.
• Check the seller's stated state and country restrictions before purchasing.
• Treat claims such as 'trace levels' as manufacturer statements unless a regulator or independent lab has verified them.

Is amanita muscaria legal in the US?

No, not in conventional food. FDA's December 18, 2024 letter to food manufacturers states that Amanita muscaria, its extracts, and the constituents muscimol, ibotenic acid and muscarine are not authorized for use as ingredients in conventional food. For dietary supplements, FDA treats these substances as new dietary ingredients under section 413(d), which requires premarket notification. The FDA food alert on Amanita muscaria sets out that position.

The September 29, 2026 letter applies that position to Calm, Calmer and Santa and concludes that these three products are adulterated. This article documents federal action only. It does not establish the rules in any individual state, so readers should check their own state's current requirements before buying.

What is muscimol?

Muscimol is the active compound the Calm product page names as its active ingredient, and FDA treats it as a new dietary ingredient. FDA lists muscimol among the constituents of Amanita muscaria that it classifies as new dietary ingredients, as described in the FDA food alert. FDA's 2012 'Bad Bug Book' identifies A. muscaria and its constituents as toxic agents that cause poisoning after ingestion. The amount of muscimol or ibotenic acid per serving of any of these products has not been disclosed.

Is Calm Amanita muscaria tincture safe?

FDA determined that Calm is adulterated under section 402(f)(1)(B) and that there is inadequate information to provide reasonable assurance that Amanita muscaria does not present a significant or unreasonable risk of illness or injury. The letter does not establish how any individual would respond to the product. Because amounts per serving are not disclosed, this article cannot establish a safe dose for Calm or any other Amanita muscaria product.

The background

The current letter builds on earlier FDA action. On December 18, 2024, FDA issued a letter to food manufacturers stating that Amanita muscaria, its extracts, and the constituents muscimol, ibotenic acid and muscarine are not authorized for use as ingredients in conventional food. FDA concluded that these ingredients do not meet the GRAS standard and are unapproved food additives, and it recommended that people avoid eating foods with them. FDA noted that these ingredients had been used in products marketed as 'psychedelic edibles,' 'legal psychedelics' or 'mushroom edibles.' At that time, FDA said it was also evaluating these ingredients in dietary supplements.

On September 11, 2025, FDA sent a warning letter to Blue Forest Farms LLC finding its Amanita Muscaria Microdose Capsules and Magic Potion Tincture adulterated under the same section 402(f)(1)(B), and its Amanita Muscaria Magic Chocolate adulterated as a food. That letter is listed on FDA's warning-letter page.

Published research on Amanita muscaria is limited. A 2022 report titled 'Two Cases of Severe Amanita Muscaria Poisoning Including a Fatality' is available at Wilderness and Environmental Medicine. A later case report, 'Emerging Risks of Amanita Muscaria: Case Reports on Increasing Consumption and Health Risks,' is available at NCBI PubMed Central. A review on Amanita muscaria in the novel psychoactive substances landscape appears at PubMed Central. Case reports can show that harm has occurred, but they cannot establish how often it happens or what dose is responsible. For another recent FDA enforcement example in a different food category, see FDA Warns Venezuelan Cheese Maker Over Roaches and No Safety Plan.

What to watch next

The letter asked Psyched Wellness to respond in writing within 15 working days of receipt. The date of receipt is not disclosed in the letter, so this article cannot calculate the exact deadline. FDA said that failure to address the matter may result in legal action, including, without limitation, seizure and injunction.

Readers should watch for several things: whether the company responds publicly, whether it changes or withdraws the products, whether any recall is initiated (none has been disclosed), and whether FDA publishes the content of its response to NDI notification #1417. Enforcement in another food area is also tracked in FDA Warns Ocean Pride Seafood Over Raw Tuna, Smoked Salmon.

The limits of current evidence are significant. The available evidence cannot establish how individuals will respond to these products, what dose is safe for any group, how common harm is, or how these products affect children, pregnant people or people taking medications, because those populations are not addressed in the letter or in the sources cited here.

If you want to see how an ingredient list reads one item at a time, scan the product yourself with the Aurascan app and read the cited explanation for each ingredient.