A hericenone molecule does not know what country it is in.
The Lion's Mane extract Prima Materia makes in Amsterdam contains the same compounds as the Lion's Mane a Chinese doctor has been prescribing for decades. Same mushroom. Same molecules. Same published studies.
What differs is the paperwork.
In some countries, the state has said: this is medicine. We approve it. We prescribe it. We pay for it through national health insurance.
In others: this is food. You can sell it, but don't tell anyone what it does.
That gap is wider than most people think, and older. And — here is what matters — it is not a scientific gap. It is an institutional one.
Tier 1 — where the state has said yes
These are the jurisdictions where medicinal mushroom compounds have been reviewed by a pharmaceutical regulator, entered into a pharmacopoeia, and in several cases covered by national health insurance.
Not folk tradition. Not herbalist practice. Formal state approval of a mushroom as medicine.
🇷🇺 Russia — since 1955. The Soviet Ministry of Health approved Befungin, a Chaga extract, as a pharmaceutical in 1955. It has been continuously prescribed in Russian and Polish pharmacies ever since. Seventy-one years of uninterrupted regulatory approval — the oldest mushroom medicine in modern pharmacology. [¹]
🇯🇵 Japan — since 1976. PSK (Krestin), a protein-bound polysaccharide from Turkey Tail, was approved for the treatment of gastric, lung, and breast cancer. It has been used as an adjunctive cancer treatment in thousands of patients since the mid-1970s, backed by a meta-analysis covering 8,009 patients.
Lentinan, a beta-glucan from Shiitake, has been licensed as a drug for gastric cancer since the mid-1980s, with randomised trials published as early as 1986.
Both are prescription drugs covered by Japan's national health insurance. [²][³][⁴][⁵]
This is not a fringe list. These are G7 members, permanent UN Security Council members. Their pharmacists, oncologists, and regulators have reviewed the same literature available on PubMed — and they said yes.
🇨🇳 China — Ganoderma in the State Pharmacopoeia. The State Pharmacopoeia of the People's Republic of China lists G. lucidum with formal indications. Seven distinct patent medicines containing Lion's Mane as the active ingredient have been approved under China's drug regulatory system. [⁶][⁷][⁸]
🇨🇭 Switzerland runs a simplified authorisation pathway for herbal medicinal products under its Ordinance on Complementary and Herbal Medicinal Products. [⁹]
Tier 2 — where the state has said "it's food. Don't make claims."
These are the jurisdictions where medicinal mushrooms exist in a legal half-light. You are allowed to sell them. You are not allowed to say what they do. The science is tolerated; the sentence is not.
🇪🇺 European Union. Under EU Regulation 2015/2283, the fruiting body of Lion's Mane and its aqueous extracts are classified as not novel — consumed in the EU before 15 May 1997, freely marketable as food across all 27 member states. Only dehydrated mycelium powder requires pre-market authorisation.
The form Prima Materia produces is legal food throughout the EU — but the same regulation forbids any medicinal claim about it. You can sell it. You cannot say why it works. [¹⁰]
🇺🇸 United States. Under DSHEA (1994), all medicinal mushrooms are dietary supplements. No FDA drug approval exists for any mushroom compound — despite the National Cancer Institute publishing a Medicinal Mushrooms PDQ for clinicians that summarises the same evidence Japanese regulators acted on fifty years ago. [³]
🇦🇺 Australia. In 2024, FSANZ removed Lion's Mane gummies from retail sale on the grounds that they are unapproved novel foods.
A mushroom that has been food in Tokyo for centuries and medicine in Beijing for decades is, in Australia, either contraband or a prescription. [¹¹]
🇳🇱 Netherlands, and the rest of Europe. Fruiting body extracts are legal food; medicinal claims are forbidden; the framework assumes the consumer must be protected from knowing what the research says.
The hypocrisy
Between Tier 1 and Tier 2, the underlying science is identical.
The molecules are the same. The studies are the same — peer-reviewed, indexed in PubMed, readable in any university library in the world.
The Japanese PSK approval file from 1976 has been public for fifty years. The Chinese State Pharmacopoeia entry for Ganoderma has been translated and published in Western academic textbooks since at least 2011.
No regulator in Tier 2 is missing information. They all have it. They have had it for decades.
And yet the public communication in Tier 2 goes: "There isn't enough evidence yet. We need more studies. We are being cautious."
That is not a scientific statement. It is a procedural one.
What it actually means is: "We don't have enough evidence generated inside our own regulatory framework, by companies who could afford our approval process, under study designs our committees pre-approved."
The public hears science. It's bureaucracy.
The cost of that lands on people.
In Osaka, a patient with gastric cancer can receive PSK as part of their standard of care — studied in their own country for fifty years, supported by meta-analyses covering thousands of patients.
In Amsterdam, a person with the same diagnosis cannot.
Their oncologist has read the same papers. They are legally not allowed to recommend them. The person can buy the extract at a shop, pay out of pocket, and be told — by every official voice they encounter — that what they are buying is not medicine.
Same molecule. Same disease. Same evidence. And one answer is four decades old, still being called "emerging."
That is not caution. That is a regulatory system protecting itself from having to update.
What the map actually says
The disagreement between Tier 1 and Tier 2 is frequently described as a "cultural difference" or an "evidence gap." It is neither.
The real gap is willingness to update.
Tier 1 countries updated their pharmacopoeias when the evidence became persuasive — as early as 1955, as recently as 2000. They treated the science as what it was: the work of scientists publishing in peer-reviewed journals, to be evaluated on its merits.
Tier 2 countries inherited regulatory frameworks that classify fungal compounds by default as supplements or food, and require those compounds to be re-proven through a drug-approval process so expensive that only pharmaceutical companies can afford it.
No pharmaceutical company is going to spend hundreds of millions of euros proving a mushroom works when the mushroom itself cannot be patented.
So the studies get done anyway, in Japan and China at universities and hospitals — and the Tier 2 regulators read them, nod, and file them under "traditional use, not yet authorised."
The studies never become unauthorised. They just never become authorised either.
Fifty years of PSK data sits in exactly that drawer.
Where we stand
We're not asking you to pick a side. Just to see the map.
Both cannot be right. Only one side is treating patients with it.
The science on medicinal mushrooms is more advanced than your local regulator wants to admit. It has been more advanced for seventy years — ever since a Soviet pharmacist wrote "Befunginum" into the Soviet Pharmacopoeia in 1955.
We're just a little less willing to wait.
Sources
1. Géry, A., et al. (2018). Chaga (Inonotus obliquus), a Future Potential Medicinal Fungus in Oncology? Integrative Cancer Therapies, 17(4), 1062-1071. Read [↑]
2. Maehara, Y., et al. (2012). Biological mechanism and clinical effect of protein-bound polysaccharide K (KRESTIN): review of development and future perspectives. Surgery Today, 42, 8-28. Read [↑]
3. National Cancer Institute. Medicinal Mushrooms (PDQ) — Health Professional Version. Read [↑]
4. Ina, K., Kataoka, T., & Ando, T. (2013). The Use of Lentinan for Treating Gastric Cancer. Anti-Cancer Agents in Medicinal Chemistry, 13(5), 681-688. Read [↑]
5. Wakui, A., et al. (1986). Randomized study of lentinan on patients with advanced gastric and colorectal cancer. Gan To Kagaku Ryoho, 13(4), 1050-1059. PubMed [↑]
6. Wachtel-Galor, S., et al. (2011). Ganoderma lucidum (Lingzhi or Reishi): A Medicinal Mushroom. In: Herbal Medicine: Biomolecular and Clinical Aspects, 2nd ed. Read [↑]
7. Wu, P., et al. (2024). Bioactivities and industrial standardization status of Ganoderma lucidum: A comprehensive review. Heliyon, 10(18), e36987. Read [↑]
8. Friedman, M. (2015). Chemistry, Nutrition, and Health-Promoting Properties of Hericium erinaceus (Lion's Mane) Mushroom Fruiting Bodies and Mycelia and Their Bioactive Compounds. Journal of Agricultural and Food Chemistry, 63(32), 7108-7123. DOI: 10.1021/acs.jafc.5b02914. Read [↑]
9. Swissmedic. Complementary & Herbal Medicines. Ordinance SR 812.212.24. Read [↑]
10. EU Novel Food Catalogue — Hericium erinaceus status. European Commission. Regulatory analysis: Hooley Brown. Primary catalogue: EU Commission. [↑]
11. Gilmore, T. (2024). Not quite medicine, not quite food. The Conversation. Read [↑]
Written by Claude · Prompted by Stef Spijkermans · Prima Materia · Amsterdam