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Is Lion's Mane Considered a Drug | Australia

by Hamza Jamal |

Lion's mane is not a drug in raw, powder, or capsule form - it is an edible mushroom with a long history of use in Traditional Chinese Medicine (TCM).

Most of the confusion over whether lion's mane is a drug comes from the supplement version being available in a capsule.

Capsules are synonymous with drugs like paracetamol and Lemsip, but it's important to remember that multivitamins come in capsule form, too.

Some natural products, including lion's mane, also contain bioactive compounds that have drug-like effects on the body. Some pharmaceutical drugs are derived from natural sources, blurring the line between drugs and food.

These overlaps are mute when you know that lion's mane is a natural supplement supporting general health and well-being.

What's in Lion's Mane?

The bioactive terpenoid compounds in lion's mane - hericenones and erinacines - are preserved in most extracts alongside phenolic acids and ergosterol.

Lion's mane extracts are made using solvents to extract and concentrate the desired bioactive compounds from the mushroom, so the composition of the extracts differs between suppliers and supplement brands.

In a typical extract, you will find:

  •         Concentrated polysaccharides, responsible for many of the mushroom's immunomodulating and neuroprotective effects.
  •         Hericenones and erinacines, the focus of much research for their potential nerve growth factor-inducing and neuroprotective properties.
  •         Sterols, phenolic compounds, and isoindolinones, which may contribute to the mushroom's antioxidant, anti-inflammatory, and neuroprotective effects.

Compared to the raw mushroom, lion's mane extracts have lower levels of nutrients like proteins, minerals, and vitamins, as the extraction process focuses on the specific bioactive compounds rather than the full nutrient profile.

Fruiting Body Extract

Lion's Mane Mushroom Fruiting Body Extract 10:1 is the standardised extract most supplements, including vybey Lion's Mane, use – it's made exclusively from the mushroom's fruiting body instead of the mycelium (the underground part).

The 10:1 ratio tells us how concentrated the extract is; in this case, 10 parts of the raw mushroom fruiting body are used to create 1 part of the extract.

For example, processing 100 grams of raw lion's mane fruiting body creates 10 grams of the 10:1 extract. The concentration process used to create a 10:1 extract allows for higher levels of the mushroom's key bioactive compounds.

So, Definitely Not a Drug?

Nope, not a drug.

Drugs diagnose, treat, and prevent disease in humans or animals, while food supplements like lion's mane are dietary aids that support health.

What Do the Studies Tell Us?

The studies and clinical trials show that lion's mane has excellent potential for specific health applications as a dietary supplement and a potential therapeutic agent for immunity, sleep, and depression.

But a disclaimer—there's no consensus on whether lion's mane is effective for the treatment of any condition. More research is needed.


The bioactive compounds in Lion's Mane can modulate the key pathways involved in depression [1] in humans.

The study found that lion's mane stimulates nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) expression, which promotes neurogenesis, neuroplasticity, and neuronal health in the hippocampus and counteracts the reduced neurogenesis and hippocampal atrophy seen in depression.

A lion's mane extract also restored depleted levels of serotonin, norepinephrine, and dopamine in the hippocampus in animal models of depression – these neurotransmitters are often depleted in depressed people.

Inflammation is thought to play a role in the pathophysiology of depression, and lion's mane reduced pro-inflammatory cytokines responsible for low mood like TNF-α, IL-6 and IL-1β while increasing anti-inflammatory IL-10.


According to a study by Vigna et al. [2], lion's mane mushroom supplementation can help improve sleep disorders in overweight or obese patients.

The researchers assessed sleep disorders using the SCL-90 test before and after 8 weeks of H. erinaceus supplementation in overweight/obese patients.

Following 8 weeks of supplementation, sleep disorders measured by SCL-90 decreased by 34.4%. Remarkably, this improvement was maintained even after a 2-month washout period, with sleep disorders decreased by 39.1% compared to baseline.

Focusing on only patients who were positive for sleep disorders at baseline, the effect was even more pronounced. Interestingly, their mean sleep disorder score decreased by 44.25% after supplementation and remained 38.13% lower than baseline after washout.

While the mechanism is not known, the authors hypothesise it may be related to increasing neurotrophins like BDNF, which promote neurogenesis and plasticity.

It should be noted that while pro-BDNF increased after supplementation, mature BDNF levels did not change significantly in this study.


The protein HEP3 extracted from lion's mane mushroom exhibits immunomodulatory activities [3].

HEP3 decreased the production of pro-inflammatory cytokines TNF-α, IL-1β, and IL-6 in lipopolysaccharide in the study and suppressed LPS-induced nitric oxide production and inducible nitric oxide synthase expression.

In a mouse model of cyclophosphamide-induced immunosuppression, HEP3 restored the diversity and abundance of beneficial bacteria like Lactobacillus and Bifidobacterium while reducing pathogenic bacteria.

In an inflammatory bowel disease mouse model treated with antibiotics, HEP3 significantly increased the abundance of Bifidobacterium and alleviated gut tissue damage and inflammation, suggesting HEP3 may serve as a prebiotic.

HEP3 was also found to improve general immunity, possibly by regulating the proliferation and differentiation of T cells with the help of the gut microbiota.


Lion's mane is a food that can be eaten raw or as an extract in powder or capsule form – it isn't a drug, nor is it confirmed to treat any condition – but it can support your health as part of a healthy lifestyle.

vybey Lion's Mane is vegan friendly and contains no additives as a powder or capsule, although the capsule is HPMC, vegan cellulose.

You can mix the powder with food and drink, or alternatively, mix up a vybey Complete Meal Powder shake, which contains lion’s mane.

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