Psyched Wellness: Amanita muscaria for the masses

Psyched Wellness CEO Jeff Stevens speaks to Psychedelic Health about how the company has launched the first legal Amanita muscaria extract available for sale in the United States.

The Amanita muscaria mushroom – also known as the fly agaric – is famous the world over for its striking looks. Often present in folklore and fairy tales, the iconic red and white mushroom has been consumed for centuries in traditional settings.

Amanita muscaria is mainly known for the psychoactive compounds ibotenic acid and muscimol. Deaths from Amanita muscaria are extremely rare, but it can make people very ill if not prepared properly. There is currently very little research into the mushroom, meaning the current scientific understanding of Amanita mascaria’s therapeutic benefits is limited. 

Psyched Wellness is now working with the mushroom to investigate its properties on the likes of sleep, anxiety and inflammation. 

The company is one of the first to commercialise a legal Amanita muscaria extract – ‘Calm’. Primarily composed of muscimol, Psyched says the product aims to promote feelings of relaxation and calmness, without producing any psychedelic effects.

Psyched Wellness’ CEO Jeff Stevens told Psychedelic Health that the company identified Amanita muscaria as its mushroom of choice as muscimol has never been scheduled as a drug. This enables the company to work with the compound as a food supplement by obtaining a Generally Recognized As Safe (GRAS) approval from the US Food and Drug Administration (FDA).

“We have done two years of scientific studies in our preclinical trials, which included toxicology, safety studies, and a whole host of other studies, to compile all of that data to submit it to get a GRAS approval,” said Stevens.

“We compiled a dossier that was peer-reviewed and approved. So, the path we chose rather than going to clinical trials to develop a drug, was to find a way to bring some of these really exciting and special compounds to market.

“The mushroom itself is legal. But to convert that into a product for human use, and human consumption is illegal unless you do the work that we’ve done. We spent time getting the scientific data, to present that data and get approvals.

“We’re so excited about Calm coming to market. It’s our flagship product. It’s a tincture in a 30 mil bottle, and we recommend one to two milliliters per dosage that fall within our GRAS approval range. There’s room to go higher if you just so if you so desire, but it it’s designed to be microdose, so we use it to promote relaxation and restfulness.”

Human clinical trials have not yet been carried out on Calm, but Stevens says preclinical data suggests that muscimol could potentially help with the likes of pain, anxiety and sleep. 

“We recognise that globally, there’s a sleep issue whether you’re aged 15, 95 or in between. We wanted to do something that we felt could help the most amount of people,” said Stevens. 

“When you look at people struggling with the stresses of the world – coming out of Covid-19 and inflation and all of the things that are happening now – having something that can help you relax that you can take 30 minutes before you go to bed is beneficial.”

The wellness opportunities of psychedelics

Highlighting the changing attitudes of mainstream media towards psychedelics, Stevens says that as the psychedelic industry matures, there needs to be a recognition of the health and wellness opportunities as well as the medical opportunities that these compounds can provide. 

“People – such as Prince Harry – are talking about how they’ve used psychedelics and how it’s benefited them from an anecdotal standpoint, and that’s being backed up now scientifically with results that are coming through from clinical studies,” said Stevens.

“Psyched Wellness is in a unique situation because we’re not working with a scheduled drug. We’re a food supplement.

“I really think that as we progress as an industry, we should start talking about the fact that these are actually health and wellness opportunities.”

Calm is Psyched Wellness’ flagship product and the company’s research and development team is now working to bring other methods of delivery to market. The tincture is currently sold in 40 different states through the company’s online channels, but Stevens says it intends to open brick-and-mortar stores in the future.

Psyched Wellness is also carrying out studies with the National Research Council of Canada on the anti-inflammatory qualities of AME-1 – the company’s proprietary extract of Amanita muscaria from which Calm is derived.