Functional mushroom safety, efficacy and quality: An insider’s guide to fungal products

“First do no harm” (Primum non Nocere) is a maxim worth applying to many facets of life, but it becomes paramount when health is involved. Mushrooms are safe and nutritious foods, but, either fresh or dried, must be cooked prior to consumption as a food or a medicine. It is the mushroom itself, or “fruiting body” that humans have traditionally consumed and prepared as treatments and what is used as the starting reference material for international pharmacopeia such as the American Herbal Pharmacopoeia’s Reishi Mushroom Fruiting Body Monograph.

Safety

For commercial food products, safety must be demonstrated. In the United States, that would mean having GRAS (generally recognized as safe) or self-affirmed GRAS status to be used in foods, beverages, dietary supplements, and coffee and tea products.

Adherence to regulations and internal due diligence are essential given the incentive for adulteration in a robust economic market. Safety, efficacy and quality are embedded into many manufacturing streams within the natural category. When they are not, it can be disastrous: The U.S. Food and Drug Administration issued a statement in March 2024, warning of six commercial cinnamon products with elevated levels of lead.

Efforts to stem the tide of adulteration continue, such as through the American Botanical Council at the Botanical Adulterants Prevention Program (BAPP). BAPP is the largest international nonprofit consortium focused on reducing adulteration in botanical ingredients and finished products sold as dietary and food supplements, conventional foods, cosmetics, OTC (over-the-counter) drugs, herbal medicines, and other natural health products. Safety is a concern across the board with conventional food and supplements and it’s up to each company to institute sound practices and adhere to the guidelines that are in place. Safety is only as good as the validity of a firm’s quality system, compliance with national and international regulations and documentation for any dietary ingredient.

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Efficacy

Mushrooms are pharmacologically complex. One of the most researched examples is reishi mushroom (Ganoderma lingzhi), containing over 120 different triterpenes as well as beta-glucans, proteins and other bioactive compounds. Our knowledge is increasing but the possibilities seem infinite. A vast amount of data is available on the 150,000 species of fungi currently discovered and identified. This is a fraction of what is calculated by mycologists to exist, as the kingdom is thought to include between 2 million and 13 million species. We’ve barely scratched the surface. In the U.S. dietary supplement market, the dollars and attention are spent primarily on five species: lion’s mane, reishi, cordyceps, chaga and turkey tail.

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There are certainly more in vitro/petri dish studies being conducted than human clinical trials but there are some peer-reviewed randomized controlled trials (RCTs) for lion’s mane mushroom, the most popular of species at this moment. These studies lasted anywhere from three to six months, though some studies showed positive results for mild cognitive impairment in as little as 16 weeks.

An interesting study done in 2009 employed cookies as a delivery and the dose was four cookies a day containing 500 milligrams each for a 2-gram dose per day. They measured the clinical effects of H. erinaceus on menopause, depression, sleep quality and indefinite complaints and showed improvements in all areas versus the placebo cookie. Most studies’ dosages range between 2-5 grams daily of the mushroom or its extracted equivalent.

Much of the focus on lion’s mane research is driven by some studies on special preparations of pure mycelium (the vegetative body of a fungal organism). These are cited many times but this type of product with standardized amounts of Erinacine A (a compound unique to the pure mycelium) on the label is rare in the marketplace. Most U.S. mycelium products contain the grain substrate and do not list any active constituents on their label. If the grain is not disclosed, quantified or accounted for on the label, it should be considered an adulterant. Many products will refer to this as fermented mushroom, yet it’s the grain that is being fermented by the mycelium, which is designed to consume its substrate until the conditions allow for the production of a mushroom.

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Let’s look at the numbers. How much myceliated grain do you need to get an equivalent product to the substance used in the study quoted above? Published analytical data showed that mycelium contains 0.105 mg/g of Erinacine A1. It would require 48 grams of pure mycelium to produce 5 milligrams of Erinacine A. Considering a healthy conversion of sterilized grain substrate to mycelium, the dry weight of the mycelium would be less than 10% of the total biomass. So, 48 grams of mycelium is equivalent to approximately 494 grams of myceliated grain. This type of equivalency requires 989 x 500 mg caps or a little over a pound of dry myceliated biomass material. You could more easily duplicate clinical efficacy doses with a mushroom extract given 2-10 grams of dried mushrooms were administered in most of the studies conducted on dried mushroom/“fruiting bodies.”

It is clear that some of the immediate and dose-responsive effects of natural products are exaggerated via advertising that promises instant focus, energy, beauty and health, but the most compelling statistics involve daily incorporation as a food along with other positive lifestyle adjustments.

This longitudinal study published in 2021 by NHANES (the National Health and Examination Survey) had the following background to report on U.S. consumption of mushrooms: “Whether mushroom consumption, which is rich in several bioactive compounds, including the crucial antioxidants ergothioneine and glutathione, is inversely associated with low all-cause and cause-specific mortality remains uncertain. This study aimed to prospectively investigate the association between mushroom consumption and all-cause and cause-specific mortality risk.” The conclusions were that “mushroom consumption was associated with a lower risk of total mortality in this nationally representative sample of U.S. adults.”

Quality

The dietary supplement provisions in the code of federal regulations (21 CFR part 111) say: “Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition, and limits on contaminants, and has been manufactured, packaged, labeled and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3) and (a)(4) of the act.”

Compliance with good manufacturing practices and regular audits by third parties are foundational to an effective quality system. Nammex has chosen a third-party analytical lab specializing in food authenticity with fit-for-purpose analytical tools. For mushroom authentication, the lab uses nuclear magnetic resonance. We are also engaging in a customer-facing product certification program with our partner lab, and we encourage our clients to validate our certificates of analysis (CoA) for identity, purity and potency with reputable third-party labs.

A tried-and-true method of quality assurance for natural products is incomplete without having on-site appraisal and audits of farms and facilities in the country of origin conducted by third-party agencies in person. Many suppliers regularly inspect the farms where their raw materials are grown and processed, as they should. Skye Chilton (Nammex CEO), Adam Chilton (Nammex director of brands) and I traveled to China in July to visit three farms in Inner Mongolia and Heilongjiang Province in the far northeastern forests of China.

The specialty or functional mushroom side of the world-leading country of cultivation for this superfood is highly incentivized by the Chinese government. It is being used to lift rural economies out of poverty and provide sustainable income streams for the farmers. Our close connection to processing and the farms for the last 30 years has taken our relationship beyond transactions to true partnership as mutually invested stakeholders. This is not a metric that appears on a CoA but at the end of the day is central to our operations at Nammex.

As the mushroom category continues to expand, focus on safety, quality and efficacy must be front and center in order to earn and keep consumer trust and support growth.