October 21, 2026 By: Asa Waldstein

Amanita Safety Concerns Lead to Another Warning Letter

Takeaway -

Submitting an NDI notification does not replace adequate safety support

Amanita mushrooms are great to look at in nature, but do they have a place in dietary supplements? Let’s see what we can learn.

FDA recently issued a warning letter to a company selling Amanita muscaria “supplements.” This is at least the second Amanita-related warning letter and should be a sign to companies selling this ingredient that FDA’s safety concerns need to be addressed.

I also ran Apex Compliance® on the company’s website and found some claims related to pain and anxiety.

From the warning letter: “Amanita muscaria, A. muscaria extract, ibotenic acid, muscarine, and muscimol are new dietary ingredients… because, to the best of FDA’s knowledge, there is no information demonstrating that Amanita muscaria was marketed as a dietary ingredient in the United States before October 15, 1994.”

Asa comments: Here is an interesting detail: the company had already submitted an NDI notification for its Amanita muscaria extract, and FDA raised safety concerns about the supporting information. If there is a path forward, it would need to address those concerns with solid safety evidence.

For all my regulatory detectives out there, here are some helpful links.

NDI submission

FDA’s response

Here’s a recent WLW post with some parallels. Both companies submitted NDI notifications and FDA raised safety objections, but they marketed products anyway. Those unresolved safety concerns gave FDA a good reason to issue the warning letters.

From the warning letter: “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. Therefore, your dietary supplements containing Amanita muscaria are adulterated…”

Asa comments: This further reinforces FDA’s position that there are serious safety concerns with taking this ingredient.

The key takeaway is that submitting an NDI notification does not establish safety, and companies selling Amanita muscaria supplements without adequate safety support risk FDA warning letters.

Read the warning letter.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Technology & AI Innovation Committee.
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