Regulation or Suppression? The FDA’s Problematic Crackdown on Legal Psychedelic Mushrooms

How the FDA’s Fear of Natural Medicine Stifles Research, Fuels Misinformation, and Protects Big Pharma

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A Fistful of Mushrooms: The FDA's Heavy-Handed Crackdown on Amanita muscaria

On December 18, 2024, the FDA issued a damning verdict on Amanita muscaria, the fabled red-and-white mushroom immortalized in fairy tales and folklore. The agency’s letter to food manufacturers made it abundantly clear: the psychoactive mushroom and its key compounds—muscimol, ibotenic acid, and muscarine—are neither GRAS (Generally Recognized As Safe) nor authorized for use in food.

The FDA’s reasoning? A combination of adverse event reports, regulatory inquiries, and the agency’s long-standing categorization of A. muscaria as a toxic substance. But the backdrop to this crackdown paints a more complicated picture—one where scientific uncertainty collides with regulatory inertia, leaving consumers and innovators stuck in the crossfire.

The FDA's GRAS Games

Let’s talk about GRAS, the FDA’s gold standard for food safety. To achieve GRAS status, a substance must be broadly acknowledged by scientific “experts” as safe for its intended use, often backed by extensive toxicological studies. The process is costly, requiring millions of dollars in research and navigating a labyrinth of bureaucratic hurdles.

Here’s the catch: many natural substances with long histories of safe use don’t have GRAS approval. Think of herbal teas like chamomile or mint, which are staples of American pantries but technically sit outside the FDA’s rubber-stamped list. Nutmeg, the innocent spice you grate over eggnog, contains a hallucinogenic compound (myristicin) in large doses and isn’t GRAS-approved either.

So why is A. muscaria singled out? The FDA argues that without safety data specific to its modern uses—like being infused into chocolate bars or gummies—it poses an undue risk. Fair enough. But this brings us to the agency’s real Achilles’ heel: its refusal to allow comprehensive research on psychoactive substances.

The Catch-22 of Research

Here’s the FDA’s playbook: demand safety data for a natural product but block or obstruct the very research needed to gather it. Psychedelics, including A. muscaria, are trapped in this regulatory paradox. While the agency stresses consumer safety, it systematically denies researchers access to the tools needed to determine whether these substances are genuinely harmful or potentially beneficial.

“We will not allow the use of toxic ingredients in the food supply,” the FDA wrote in its letter, pointing to reported illnesses linked to mushroom edibles. Yet, the absence of a clear regulatory path for studying A. muscaria only pushes these substances further underground, where misuse is far more likely.

It’s not just about mushrooms. The agency’s historically tepid support for psychedelic research has stalled progress on substances that have shown immense promise in treating depression, PTSD, and addiction. The FDA’s own rejection of a recent MDMA-based therapy for PTSD due to “insufficient data” underscores its unwillingness to meet modern science halfway.

Legal Gummies and Cautionary Tales

The FDA’s crackdown is a direct response to poisonings allegedly tied to A. muscaria-infused edibles, including at least two deaths. While tragic, these cases highlight an important nuance: poorly labeled or improperly dosed products are a symptom of unregulated markets, not the substance itself. Regulating and standardizing A. muscaria products could address these risks without resorting to a blanket prohibition.

Instead, the FDA’s letter lumps all uses of A. muscaria into the “toxic” bin. It fails to acknowledge the mushroom’s long history in traditional medicine and spiritual practices, from Siberian shamanism to its depiction in ancient art.

Ironically, this crackdown follows the FDA’s approval of more controversial food additives. Did you know artificial dyes like Red 40, linked to hyperactivity in kids, are GRAS-approved? So is titanium dioxide, a whitening agent banned in the EU. Meanwhile, the humble mushroom—a substance with a cultural and historical significants—is denied even a chance at legitimate scrutiny.

Who Benefits?

Unsurprisingly, the stakeholders lining up behind this ban reveal much about the system’s inherent biases. Public health advocates emphasize safety, a fair concern given the lack of standardized dosing for psychoactive edibles. But critics argue that the FDA’s decision ultimately benefits pharmaceutical giants, which face no competition from these natural alternatives as long as they remain unregulated.

“We need a safety framework, not fear-mongering,” says Jonathan Devereux, CEO of a company specializing in A. muscaria products. “The FDA’s approach ignores the potential for responsible regulation and consumer education.”

On the other side, public health officials like Dr. Lisa Nakamura point to the danger of poorly informed self-experimentation. “People think they’re buying magic mushrooms but don’t realize the dosage or risks. This isn’t candy—it’s a pharmacologically active substance.”

Both perspectives are valid. But the FDA’s sledgehammer approach does little to address either side’s concerns.

What This Means for the Future

As the federal administration transitions into 2025, the FDA’s stance on A. muscaria raises questions about the broader regulatory landscape for psychedelics. The next administration has a choice: continue the current prohibitionist policies or embrace a more progressive approach to natural and psychedelic medicines.

Globally, the U.S. risks falling behind. Countries like Australia and Canada are leading the charge in medicalizing psychedelics, creating regulated frameworks for MDMA and psilocybin. In contrast, the FDA’s actions stifle domestic innovation and isolate the U.S. from international research collaborations.

A Missed Opportunity

By banning A. muscaria outright, the FDA misses a golden opportunity to create a safer, more informed market. Instead of driving the mushroom into the shadows, the agency could work with manufacturers and researchers to establish dosing guidelines, proper labeling, and consumer education programs.

The FDA’s job is to protect public health. But protecting doesn’t mean infantilizing the public. It means providing clear, evidence-based pathways for safe use while allowing for the exploration of substances that challenge conventional norms.

Because if nutmeg can sit quietly in your spice rack with its hallucinogenic secrets, perhaps it’s time to give Amanita muscaria its day in court—complete with a proper defense.