By Dr. Kritika Mahadevan, MSc, PhD, Head of Regulatory Affairs, M2 Ingredients
At M2 Ingredients, food safety is not a checkbox—it’s our operating system. For our food and beverage partners, we invest in original, GLP (Good Laboratory Practice)-compliant, OECD toxicology studies, so brands can formulate with confidence and scale without surprises.
Our latest peer-reviewed toxicology study in Frontiers in Toxicology (Oct 27, 2025) evaluated two of our proprietary strains of organic whole-mushroom powders produced by M2:
- M2 Lion’s Mane 102™ (H. erinaceus, fruiting body and mycelial biomass cultivated on organic oats)
- M2 Turkey Tail 101™ (T. versicolor, primordia and mycelial biomass cultivated on organic oats)
Across acute, 90-day sub-chronic, and genotoxicity test batteries:
- No treatment-related adverse effects were observed at the highest dose tested (2,000 mg/kg bw/day) for both ingredients.
- Non-genotoxic in bacterial reverse mutation and in vivo micronucleus assays.
How this builds on our Reishi & Cordyceps safety platform
This work extends the same rigorous program we completed on two other industry leaders:
- M2 Reishi 102™ (G. lucidum, mycelial biomass + fruiting body on organic oats)
- M2 Cordyceps 116™ (C. militaris, mycelial biomass + fruiting body on organic oats)
Those comprehensive studies—conducted under GLP (Good Laboratory Practice) using OECD 425/408/471/474 protocols—reported no acute or subchronic oral toxicity up to the highest tested level of 2,000 mg/kg /day and no genotoxic potential.
Taken together, our portfolio of safety assessment covers four of the top-selling species in the functional mushroom category. Lion’s Mane, Reishi, Cordyceps, and Turkey Tail mushrooms have been recognized for centuries as valuable functional foods. Through the detailed safety assessments conducted by M2 Ingredients and verified by independent experts, our whole-powder preparations meet high standards of quality and safety.
WHY WE DO THIS
Functional mushrooms have deep culinary and traditional use histories, but today’s products are made with controlled indoor cultivation, defined strains, and standardized processes. That innovation deserves equally modern safety validation.
Our approach to safety validation:
- Full-spectrum, whole mushroom powders (mycelial biomass plus fruiting structures) grown on organic oats, DNA-verified.
- Independent, GLP laboratories following OECD guidelines for acute, subchronic, and genetic toxicology testing.
- Contextual interpretation focused on biological relevance—not just p-values—against normal physiological ranges and histopathology.
WHAT THIS MEANS FOR BRANDS
If you’re formulating food, beverage, or supplement products for the U.S. market, you now have end-to-end toxicology data supporting M2’s Lion’s Mane, Turkey Tail, Reishi, and Cordyceps powders.
This evidence base helps:
- De-risk commercialization and retailer/regulatory reviews
- Support specification and QA decisions
- Streamline claims substantiation frameworks alongside efficacy research
Bottom line: M2’s growing safety platform gives you scientifically grounded freedom to innovate—knowing the foundational toxicology is done, documented, and published.
References
- Mahadevan, K., Daoust, J., Brendler, T., et al. (2025). A toxicological assessment of Hericium erinaceus and Trametes versicolor mushroom powders. Frontiers in Toxicology, 7. https://doi.org/10.3389/ftox.2025.1651442
- Chrysostomou, P. P., Freeman, E., Murphy, M. M., Chaudhary, A., Siddiqui, N., and Daoust, J. (2024). A toxicological assessment of Ganoderma lucidum and Cordyceps militaris mushroom powders. Frontiers in Toxicology, 6, 1469348. doi:10.3389/ftox.2024.1469348
Regulatory note: These toxicology results inform safety assessments; brands remain responsible for compliance with all applicable food, beverage, and dietary supplement regulations in target markets.
