Mushroom‑Based Medicine: Regulatory Frameworks Around the World
With the rise of functional medicine and holistic nutrition, functional mushrooms have garnered significant interest among the public. Mushrooms are described as an ancient medicine with varying therapeutic potential, including antiviral, analgesic, antifungal, antipyretic, anticancer, and antioxidant properties.
Mushrooms are fungi with plant-like forms and have been used in ancient times to treat various age-related diseases. Certain types of psychedelic mushrooms are known as magic mushrooms, giving hallucinogenic effects. The regulatory framework for using mushrooms as novel foods or medicine is uncertain. Continue reading the article to get insights into the regulatory framework of mushroom-based medicine.
Medicinal Mushrooms: From Functional Food to Dietary Supplement
The medicinal mushroom market is evolving from the functional use to dietary supplements and mushroom-based medicine. Mushrooms have been used for a long time due to their culinary and nutritional value. Now, they are recognized for their medicinal properties, so they are not only used as functional mushrooms but also as nutraceuticals, dietary supplements, and mycotherapy.
The use of mushrooms in medicine dates back to ancient times in Asian regions; however, the use of medicinal mushrooms (MM)in the West is relatively recent. Medicinal mushrooms offer various health benefits and perform antiallergic, antibacterial, antifungal, anti-inflammatory, antiviral, immunomodulating, antidepressant, cytotoxic, antidiabetic, hepatoprotective, digestive, neuroprotective, and hypotensive functions.
Novel Food Status of Mushrooms
The global market size of functional mushrooms in 2024 was $35.74 billion and is expected to grow from $38.88 billion in 2025 to $76.35 billion by 2033, at a CAGR of 8.8%. The rising trend of vegetarian or vegan diets is one of the contributors to draw consumers’ attention towards functional mushrooms. Many researchers look for the adaptogenic and nootropic properties of mushrooms to support brain health, mood stability, and stress resilience.
A ‘novel food’ is a food or ingredient that has not been used to a significant level in the European Union before May 15, 1997. Mushrooms have been in use for a long time; their root-like structure (mycelium) and concentrated extracts can be categorized as novel foods. The novel food status is labeled in accordance with the EU's Novel Food Regulation (2015/2283), drawing a clear line between traditional culinary mushrooms and new varieties.
Global Regulatory Landscape of Medicinal Mushrooms
The regulatory landscape of medicinal mushrooms is complex due to the overlap of food and medicine laws. In some countries, such as the U.S., Canada, and the EU, mushrooms are treated as foods or dietary supplements. In some countries, including China and Japan, mushrooms are recognized as traditional medicines.
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North America
Scientific research and evidence highlighted the health benefits of mushrooms. In 2000, a regulatory approval was received by Johns Hopkins to continue the research on psychedelics using private funding. In 2021, the National Institute of Health (NIH) awarded the first grant to research psilocybin for the treatment of tobacco addiction. Recent research evidence shows the therapeutic potential of mushrooms, supported by data from animal model studies, brain imaging, and biochemical studies.
In the United States, the Food and Drug Administration usually regulates medicinal mushrooms as dietary supplements. The Dietary Supplement Health and Education Act of 1994 (DSHEA) regulates the manufacture, distribution, and sale of dietary supplements. Psilocybin was federally prohibited, and a movement started to decriminalize psilocybin in 2019 in various cities of the U.S. In 2020, the Oregon Psilocybin Service Act was established by passing the ballot measure in Oregon.
This not only decriminalizes psilocybin but also allows its use under supervised medical settings. In 2023, many centres and facilitators were licensed and provided facilitator-assisted therapies to people for depression, addiction, trauma, and anxiety. On April 02, 2025, the first licensed healing centre opened in Colorado.
In Canada, the possession and use of psilocybin is prohibited under the Controlled Substances Act (CSA), except for palliative care. In some countries, laws and regulations are specific to psychedelics and allow the possession and sale of extracts derived from them. There is a legal ambiguity due to the absence of psilobyn and psilocin in the Psilocybe mushroom spores, allowing the sale of fungal spores to be legal where magic mushrooms are prohibited.
In Health Canada, medicinal mushrooms are regulated as Natural Health Products (NHP). The product must be assessed for quality, efficacy, and safety by Health Canada and obtain a product license with an 8-digit Natural Product Number (NPN).
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Asia
In Asia, mushrooms have a long history of use as medicinal products and have been incorporated into traditional healing systems, such as Traditional Chinese Medicine (TCM). The regulatory landscape of mushroom-based medicine is complex as you move across asian markets, including Japan, China, and Korea.
In Japan, traditional Kampo medicine uses ginseng and reishi mushrooms as ingredients. In Korea, ginseng and green tea are widely known and used for their numerous health benefits in the wellness industry. In China, there is a significant demand for exotic ingredients, like cordyceps and goji berries.
In Japan, the Consumer Affairs Agency (CAA) and the Ministry of Health, Labor, and Welfare are the two primary regulatory authorities responsible for regulating mushrooms. Dietary supplements, which are non-traditional, require comprehensive approval through safety studies and scientific evidence. Health claims and all documentation must comply with the Food Sanitation Act and Health Promotion Act.
In China, the regulatory authority is the State Administration for Market Regulation (SAMR). The regulatory system is further fragmented into AQSIQ and the National Health Commission for supervision of product approvals. Supplements using exotic ingredients need strict scrutiny. Companies must submit all the documentation from ingredient sourcing to the manufacturing process and health claims. Businesses must stay informed on new policies due to the evolving regulatory framework of mushrooms.
According to the Korea Health Functional Foods Act, all dietary supplements require pre-market approval. The main focus of the regulatory body, the Ministry of Food and Drug Safety (MFDS), is to ensure that the ingredients are safe, effective, and well-documented.
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Europe
In Europe, the regulatory framework for mushrooms is complex and governed by the "Novel Food" Regulation (EU) n°2015/2283, which means the food was not widely used before 1997. The novel food status requires strict safety assessment, making it difficult for businesses to introduce new products. Shiitake and Cordyceps sinensis mycelia are the two mushrooms that are approved for use.
Health claims on products help consumers make informed choices, but getting approval is a complicated and costly process. The European Food Safety Authority (EFSA) assesses these claims for scientific evidence and accuracy. Out of thousands of health claims, only a few hundred have been approved, mainly related to vitamins and minerals. Mushroom supplements face challenges due to the limited number of human studies and high cost, making it difficult for companies to label products with health claims, such as ‘supports natural defense’. Despite these hurdles, continuous efforts are being made to obtain approval for health claims related to mushrooms. Reishi, Cordyceps, and Maitake mushrooms are seeking authorization from EFSA for allegations related to immune support and other benefits.
Regulatory Challenges & Future Outlook
The regulations governing mushrooms vary significantly depending on their use as food, dietary supplements, or medicine. Different countries highlight the legal uncertainties and challenges to balance traditional knowledge with scientific evidence. The future of Mushroom-based medicine or supplements is challenging due to the high cost and risk associated with regulatory approval. The future isn’t hopeless at all, as companies continue to invest in research to create more concrete scientific evidence supporting health claims.
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