FDA Issues Warnings on Amanita muscaria
What This Means for Consumers and Manufacturers
Breaking News: FDA Prohibits Use of Amanita muscaria in Food Products
In two significant updates, the U.S. Food and Drug Administration (FDA) has issued formal warnings to manufacturers and consumers regarding the use of Amanita muscaria mushrooms and their extracts, including constituents like muscimol, ibotenic acid, and muscarine, in food products. These substances have been deemed unapproved food additives, and food products containing them are now classified as adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
What Does the FDA Say?
Key Findings
The FDA’s investigation determined that Amanita muscaria and its extracts:
- Do not meet the "Generally Recognized as Safe" (GRAS) standard for use in food.
- Have insufficient safety evidence to support their consumption as food ingredients.
- Are linked to serious adverse health effects, including gastrointestinal distress, neurological symptoms, seizures, and, in severe cases, coma or death.
Adverse Event Reports
Reports from the FDA indicate hundreds of poison control calls and several hospitalizations in the past year due to products containing these substances. Symptoms reported include hallucinations, cardiovascular effects, respiratory depression, and central nervous system depression.
Scientific Evidence
The FDA’s conclusions were based on a review of over 600 scientific studies and adverse event reports. Despite attempts to detoxify Amanita muscaria through preparation techniques like boiling, the FDA states that these methods are not proven to completely eliminate toxicity.
What’s Prohibited?
Food Products Now Banned
Effective immediately, the use of Amanita muscaria or its extracts in conventional food products is prohibited. This includes:
- Gummies
- Chocolates
- Snacks or beverages
These products are now considered illegal to sell in the U.S. because they contain unapproved food additives. Manufacturers of such products are at risk of enforcement actions, including recalls and legal penalties.
Implications for Consumers
Steps to Stay Safe
- Avoid any food products that list Amanita muscaria, muscimol, ibotenic acid, or muscarine as ingredients.
- Be aware of the severe health risks associated with these substances, as outlined by the FDA.
- Report adverse events related to these products to the FDA through their Adverse Event Reporting System (CAERS).
Implications for Manufacturers
Compliance Obligations
- Any use of Amanita muscaria or its extracts in food products is illegal unless the substances are approved by the FDA or meet the GRAS standard.
- Manufacturers should review their product formulations immediately and remove any prohibited ingredients.
- Non-compliance could result in enforcement actions, including product seizures and legal repercussions.
What About Non-Food Products?
Other Potential Uses
The FDA’s letters specifically address conventional food products. Non-food uses of Amanita muscaria, such as in dietary supplements or other applications, may fall under different regulatory frameworks. However, such uses still require safety evidence and compliance with applicable laws.
What’s Next?
Ongoing Monitoring
The FDA will continue monitoring the marketplace and taking action against non-compliant products. Manufacturers and consumers alike should stay informed about these developments and ensure their activities align with FDA regulations.
Learn More
For More Information:
This FDA update underscores the importance of prioritizing consumer safety and compliance in the food industry. Both manufacturers and consumers should act promptly to address these warnings and avoid potential risks associated with Amanita muscaria.