Fascination with the legendary Amanita muscaria is rising alongside a global mushroom movement spanning psychedelic to medicinal products. But a pressing question looms: Can brands rise to the challenge of creating legal A. muscaria mushroom extracts that meet both quality and compliance standards?

The answer lies in deeply understanding this unique mushroom species, safely extracting its active ingredients, and adhering to best practices when producing and marketing A. muscaria mushrooms to consumers.

Understanding Amanita Muscaria

A. muscaria, or “Fly Agaric” or “Toadstool,” is a captivating psychoactive mushroom with a distinct red or orange cap adorned with white dots and a tall white stalk.

Revered by ancient tribal peoples from Siberia to Eastern Europe, A. muscaria holds a rich history of use for purposes ranging from mind-altering and spiritual to medicinal and nutritional. It’s important to note that there are hundreds of Amanita species, and muscaria is just one of those.

A. muscaria’s active ingredients include muscimol, ibotenic acid, and muscarine, making its psychoactive effects wholly distinct from classic psychedelic (psilocybe) also known as magic mushrooms. A. muscaria is not considered a psychedelic, but rather a deliriant.

Magic mushrooms, rich in psilocybin and many other active compounds, can elicit hallucinations and ego-dissolving experiences. A. muscaria’s chemical composition, on the other hand, can be relaxing and sedative or downright euphoric and “dreamlike.” It can also be highly toxic, necessitating caution and proper preparation.

Legality 

A. muscaria enjoys a privileged legal standing compared to magic mushrooms throughout much of the world. In the United States, its active compounds are not on the DEA’s Controlled Substances Act (CSA) list. As a result, brands sell extracts in various forms, from oils to edibles, nationwide. Still, its legal status is not so simple. 

States can criminalize A. muscaria at any time, similar to the recent bans on hemp-derived Delta-8 THC in 17 states and counting. Louisiana law already explicitly outlaws A. muscaria sales and many states could follow.

A. muscaria’s legal status becomes even more complicated when brands start marketing their products, specifically ingestible extracts. That’s where FDA oversight comes into play. 

The FDA approves food, drugs, cosmetics, and medical devices for sale in the U.S. It also regulates their safety, efficacy, and labeling according to the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA does not consider A. muscaria a drug but rather a food. As such, the organization can take legal action against any brand making unapproved health claims or violating the FD&C’s food safety and labeling standards. 

Action against CBD companies since 2017 offers a clear case study for this risk. Over the past six years, the FDA forced countless CBD brands to either cease selling, re-brand, or reformulate products for infractions such as:

• Publishing blogs about CBD and COVID-19 research.

• Claiming products “ease muscle discomfort.”

• Creating products that appeal to children, like infused hard candies and cookies.

• Formulating ingestible products for food-producing animals.

• Selling formulas with “unsafe food additives,” like Delta-8, which are not generally recognized as safe (GRAS) by the FDA.

Considering that A. muscaria possesses mind-altering properties, it’s reasonable to anticipate that the FDA and state agencies could step in as more Amanita brands enter the market. 

Safety

A. muscaria’s safety profile is another risk for brands selling extracts to a broad consumer base. The irony is that A. muscaria mushrooms can be highly beneficial.

The species contain muscimol, a  psychotropic compound researchers have studied for epilepsy and Parkinson’s disease due to its sedative, muscle-relaxant effects. Yet this vibrant species can also be hazardous, causing adverse outcomes ranging from vomiting and confusion to coma and toxicity in rare cases, depending on how it’s prepared and ingested.

Research indicates that raw A. muscaria’s adverse effects occur primarily from its ibotenic acid content. Ibotenic acid is an excitatory neurotoxin that can cause nausea, restlessness, and agitated delirium at high doses. 

Dehydrating A. muscaria decarboxylates ibotenic acid, reducing its ratio to muscimol, but the conversion rate is low so the remaining substance may still contain ibotenic acid levels. To produce safe ingestible products, A. muscaria brands must carefully extract, convert, and filter the final product through a multi-step process.

The resulting extract should meet purity and potency requirements, with specific limits for contaminants and pesticides and minimal ibotenic acid. ACS Laboratory, for example, tests
A. muscaria to ensure it’s free from pesticides, heavy metals, mycotoxins, and bacteria, as well as ensure that the A. muscaria does not contain any psilocybin or psilocin. Only a DEA-registered third-party laboratory can confirm these essential legality, safety, and quality standards, minimizing liability risks.  

Blunders & Best Practices for Production, Marketing & Testing

The A. muscaria market is in its very early stages. Still, pioneer brand blunders and achievements provide valuable insights for others looking to capitalize on the growing A. muscaria trend.

Blunders

Late last year, Chillum, a hemp dispensary in Tampa, faced regulatory action from the Florida Department of Agriculture and Consumer Services after selling edibles containing A. muscaria mushroom extracts. The Department ordered the shop to stop selling the products, considering the mushroom a dangerous ingredient that is not approved for use in food. Additionally, lab testing indicated a hemp joint containing
A. muscaria powder had high levels of toxic heavy metals. 

Chillum complied with the order. It threw out the joints and returned the edibles to its supplier, Psilo Mart, but dispensary owner Carlos Jose Angel Hermida didn’t give up. Chillum later resumed selling the edibles with labels warning against human consumption. According to the new label, these products are for “education” or “spiritual purposes” only. Since February, Florida has cited five additional businesses across the state for similar infractions.

One takeaway here is that brands selling A. muscaria extracts should carefully consider how they label products containing unapproved food additives. But the bigger takeaway is ensuring products are safe to consume.

Best Practices

On the other side of the spectrum, Toronto-based company Psyched Wellness conducted preclinical studies on its “Calm” A. muscaria extract. The organization spent millions of dollars formulating, testing, and gaining GRAS certification for the proprietary extract known as AME-1. As a result, Psyched Wellness is the first and only company in the U.S. that can legally sell a psychedelic food supplement without a prescription. 

Another critical distinction between Calm and many emerging A. muscaria brands is dosage, labeling, and marketing. Psyched Wellness understands that regulators get uncomfortable with overtly psychoactive products.

So, they designed a formula to be consumed as a microdose for stress reduction, muscle tension, and restorative sleep rather than tripping out. Psyched Wellness goes even further by lab-testing its extract for stability and toxicity, although it does not publish a Certificate of Analysis (COA) on its website. 

Transparent brands that want to avoid regulatory and consumer suspicion should test products for potency and purity. Tests should analyze muscimol and ibotenic acid levels and rule out potential contaminants like heavy metals, pesticides, and chemical solvents.

Potency tests must also include psilocybin and psilocin to rule out these federally scheduled compounds. Further, brands must consider publishing the COA with the results on their website to prove their product is safe and compliant. 

The Bottom Line

A. muscaria products are unregulated in the U.S. and many countries, signifying an enormous opportunity for brands to expand their portfolio.

However, organizations that rush to market without properly manufacturing, testing, and labeling their products will likely be penalized and potentially harm innocent consumers.

Bad actors can also damage the entire industry’s reputation and cause statewide Amanita bans, preventing consumers from accessing this incredible compound. The future of the United States A. muscaria industry lies in the choices brands make today.

This article first appeared in Volume 5 Issue 2 of Cannabis & Tech Today. Read the full issue here.