We are proud to announce that our Hericium erinaceus Mycelium (Heri-Mycelium HE12) ingredient has successfully completed the U.S. FDA’s New Dietary Ingredient (NDI) notification process (NDI No. 1422), with no safety objections raised. This recognition makes it the world’s first Hericium erinaceus mycelium ingredient approved under the FDA’s NDI process, marking a major milestone for Taiwan’s functional mushroom research and New Bellus’ expansion into the North American nutraceutical market.
What Is NDI and Why It Matters for Formulators
The NDI process is the FDA’s pre-market pathway that evaluates a new dietary ingredient’s safety profile and intended conditions of use. Acceptance signals that safety information has been reviewed without objection—reducing regulatory uncertainty, accelerating route-to-market, and facilitating channel acceptance for brand owners. For consumers and partners alike, it elevates confidence in product development founded on documented safety.
What Is Lion’s Mane—and Why the Surge in Interest?
Lion’s Mane (Hericium erinaceus) has long been valued in Asian food therapy and traditional applications. Recent research has highlighted its neuro-support and cognitive wellness potential, fueling rapid growth in categories tied to healthy aging and mental performance. With the FDA’s acceptance of New Bellus’ NDI submission, the U.S. market now has a clear regulatory basis for lawful commercialization and evidence-driven formulation.
Why Focus on Mycelium?
Among Lion’s Mane actives, Erinacine A is often cited as a key compound. Scientific literature suggests it may support nerve growth factor (NGF) expression, helping maintain neurological health and cognitive function, with emerging preclinical data pointing to roles in neuroinflammation modulation and systemic wellness. Critically, Erinacine A is found in liquid-fermented mycelium—not in wild or solid-state cultivated fruiting bodies—making mycelium via liquid fermentation fundamentally different in composition and applicability.
Patented Submerged Fermentation × Erinacine A: Built for Cognitive Formulations
New Bellus produces Hericium erinaceus mycelium through Patented Submerged Fermentation, enabling consistent, scalable output of Erinacine A alongside polysaccharides. This manufacturing route delivers:
- Batch-to-batch consistency for long-term product performance;
- Formulation flexibility across capsules, tablets, stick packs, and functional beverages;
- Supply scalability to meet global expansion needs.
Quality & Traceability: Certifications for Global Confidence
The ingredient is supported by a robust quality system and multiple third-party standards, including FSSC 22000, HACCP, NSF GMP, ISO 17025, and HALAL. These certifications back safety, traceability, and consistency, helping brands de-risk launches across North America and global markets while advancing sustainability-minded manufacturing.
Small Things Creating Big Value: Our Brand Promise
With three decades in microbial fermentation, New Bellus is committed to turning small biological advantages into real-world value:
- Evidence-based development as the shared language between R&D and brands;
- Precise, stable, and scalable processes to preserve key actives;
- Sustainability-driven manufacturing to improve sourcing and process footprints.
The FDA’s acceptance of U.S. FDA NDI No. 1422 is a verifiable outcome of that philosophy at the regulatory level.
About New Bellus
New Bellus advances innovation in probiotics, mushroom mycelium, and fermented ingredients—with a focus on brain health, cognitive performance, immune balance, and healthy aging. Guided by evidence and sustainability, we deliver safe, effective, and natural health solutions that improve quality of life worldwide.
Disclaimer
This article is based on recent academic research and intended solely for internal use by B2B customers in R&D, procurement, and product planning. Reported health effects are drawn from scientific studies and are not specific product claims. End-product marketing claims must comply with local regulations and gain regulatory approval.