We, the undersigned, respectfully urge U.S. Food and Drug Administration (FDA) to reconsider recent legislation regarding Amanita muscaria, also known as fly agaric, as an additive in food. Current prohibitive measures fail to provide standardized regulations, potentially driving consumers toward unregulated markets with varying potencies and unknown substances, increasing risks of poisoning and health complications. This approach not only jeopardizes public safety but also marginalizes indigenous traditions that hold this mushroom as sacred, undermining international agreements like the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP).

The lack of comprehensive, peer-reviewed research on Amanita muscaria's safety and potential therapeutic benefits highlights the need for a more evidence-based approach. Relying on data from entities with vested interests risks compromising the credibility of regulatory decisions. The FDA’s stance, which offers no clear pathway for controlled and safe use, stifles scientific research and innovation, leaving both manufacturers and consumers without guidance, and hindering the development of potentially beneficial products.

We call on the FDA to adopt a balanced and culturally sensitive approach by establishing clear regulatory guidelines for safe usage, consulting with indigenous communities to honor their traditions, and promoting rigorous scientific research into the mushroom’s risks and benefits. Such measures would ensure consumer safety, respect cultural practices, and foster a better understanding of Amanita muscaria’s potential. By addressing these issues now, the FDA can create a framework that supports innovation while safeguarding public health and cultural heritage.