FDA takes action against Amanita muscaria in edibles : Shots

Federal regulators are taking aim at a popular category of psychoactive edibles that contain an iconic red-capped mushroom in the wake of a rash of illnesses and even a few suspected deaths.

This week, the Food and Drug Administration warned food manufacturers that Amanita muscaria and the compounds in that mushroom are not authorized for use in food, citing a review of the scientific evidence that found these ingredients do not meet “safety standards.”

There’s considerable folklore surrounding the white-spotted fungus, also known as “fly agaric,” which still permeates popular culture, even appearing in the Mario video game franchise and as emojis.

Unlike psilocybin, the active ingredient in magic mushrooms, Amanita muscaria isn’t listed as a controlled substance.

It’s advertised as an ingredient in some edibles, which are touted as having cognitive-enhancing “nootropic” or “microdosing” blends. Many are sold in trippy-looking packaging at convenience stores, smoke and vape shops, and online.

In its warning letter to food manufacturers, the FDA notes these are sometimes marketed as “psychedelic edibles” or “legal psychedelics,” and that “adverse event reports” prompted the agency to assess the mushroom’s safety profile.

“I feel it’s the right call,” says Eric Leas, an epidemiologist at the University of California, San Diego who has documented public health concerns around the mushroom. “It could potentially have very large implications for this market.”

Christian Rasmussen, who runs an online retailer of Amanita muscaria, said his lawyers are still figuring out the implications, but called it a “huge obstacle” for his business, the industry and individuals who’ve been using the mushroom.

“A lot of this seems to be brought on by the actual adulterated products that have hit the market in recent years, containing various synthetic drugs and being marketed as Amanita,” Rasmussen, who runs MN Nice Botanicals, said in an email.

NPR contacted several other major companies that sell these mushroom edibles and did not receive a response.

Hospitalizations led to edible recall

These products drew considerable attention earlier this year as poison centers across the country received reports of people being hospitalized after consuming chocolates and gummies marketed under the brand name Diamond Shruumz, which were made by a California-based company known as Prophet Premium Blends. The company recalled the products.

Subsequent testing revealed some of those edibles contained “muscimol,” one of the active ingredients in Amanita muscaria. However, there was also a mixture of other substances, including a synthetic version of psilocybin, the prescription anticonvulsant drug pregabalin and the supplement kava. Others who’ve tested mushroom edible products have also documented a variety of undisclosed substances, as NPR reported earlier this year.

The FDA investigation concluded that muscimol “couldn’t explain all the symptoms reported by ill people who consumed the Diamond Shruumz-brand products.”

The agency is now prohibiting the use of three compounds in the mushroom — muscimol, ibotenic acid and muscarine — given safety concerns identified in its review of the evidence. Exactly how the FDA will decide to enforce its decision remains to be seen.

The market for these psychoactive edibles has grown substantially in just the last few years.

“There are hundreds of brands sold online,” says UCSD’s Leas, “This threatens the legal status of manufacturers so it could put a stop to that trend.”

And Dr. Mason Marks, a law professor and senior fellow with the Project on Psychedelics Law and Regulation at Harvard Law School’s Petrie-Flom Center, says inaccurately labeling food products is “quite concerning” and against federal regulations, regardless of whether or not they contain Amanita muscaria. 

“The problem with these products is we just don’t know what’s in them,” says Marks. “It’s a little bit difficult to predict what comes next.”

It’s unclear how the FDA will enforce mushroom prohibition

The FDA has a variety of options at its disposal — it can work with companies to initiate a recall, as it already did with Diamond Shruumz, seize products on store shelves, get a court order or an injunction to prevent sales.

In theory, the agency could even push the Drug Enforcement Administration to designate the mushroom or its active ingredients a controlled substance, although that would depend on how the incoming Trump administration wants to handle the matter, says Marks.

“The FDA issues a lot of these warning letters,” he says. “There’s a possibility that nothing will happen.”

The situation has parallels to what’s happening with certain hemp-derived products like Delta-9 THC and CBD, or cannabidiol.

Those populate stores even though they’re “not considered legal ingredients by the FDA,” says Shawn Hauser, a partner at the Colorado-based law firm Vicente, which focuses on psychedelics, cannabis and novel natural ingredients like mushrooms.

“There have been warning letters around that, but they generally haven’t been enforced unless there’s unlawful drug claims, marketing to children or other public safety issues,” she says.

A spokesperson for the National Association of Convenience Stores said they were alerting their members so that they “can take appropriate action” in response to the warning letter.

Marks says the FDA ruling doesn’t prohibit people from growing or picking this kind of mushroom, which has a relatively small following compared to other psychedelics.

Amanita muscaria targets GABA receptors (unlike psilocybin that primarily acts on serotonin receptors) and can lead to a dissociative state that some describe as quite unpleasant and even disturbing in high doses.

“There are people that are interested in having heavy psychedelic experiences, and this really isn’t the mushroom to go to for that,” says Kevin Feeney, a lawyer and a cultural anthropologist at Central Washington University who has edited a compendium on Amanita muscaria.

People often seek it out for microdosing out of the belief that it helps anxiety, sleep and even more serious problems like addiction to benzodiazepines and alcohol, though there’s little evidence from clinical research on its possible therapeutic properties in humans.

“[FDA] is clearly addressing this mushroom,” Feeney says. “But to what degree are they addressing the other additives that are in these products?”

Feeney is also an adviser to Psyched Wellness, a company that sells Amanita muscaria products and is affected by the FDA decision. He says his comments do not reflect the company’s views.

While the mushroom is poisonous, there are not many documented reports of overdose and death.

In its scientific review, FDA staff noted there were no “toxicity studies sufficient to establish the safe use” of the mushroom or its extracts, and that the available information “underscores their potential for serious harm and adverse effects on the central nervous system,” including hallucinations, drowsiness, delirium and seizure.

Online retailer Rasmussen and others in the industry have said the mushroom can be prepared in ways that reduce undesirable effects. The FDA said there are no internationally recognized food standards to support safe processing and consumption.

Hauser, the Colorado-based lawyer, sees this as a cautionary tale of the “hands-off” approach that the FDA has taken with some natural substances that have a history of being used for medicinal, beneficial or spiritual purposes.

“This is one of the places where consumer demand is moving faster than the law, and businesses are going to try and meet that demand,” she says. “When these products are unregulated and when there isn’t consumer education, that’s where you have real public safety issues.”