New Bellus Enterprises’ Lion’s Mane Mycelium Receives FDA NDI Recognition, Marking a Major Milestone in Neurohealth Innovation

Patented Liquid-State Fermentation Ensures Stable Erinacine A Production and Global-Standard Certifications as the Company Enters the North American Market

New Bellus Enterprises Co., Ltd. (www.newbellus.com) announced that its Lion’s Mane mushroom mycelium ingredient has officially passed the U.S. Food and Drug Administration (FDA) New Dietary Ingredient (NDI) process. The FDA has received and filed the submission (NDI No. 1422) without raising any safety objections, confirming compliance with U.S. regulatory requirements for market entry.

This achievement makes New Bellus Enterprises the first developer worldwide to obtain FDA NDI acknowledgment for Lion’s Mane mushroom mycelium, demonstrating its technological leadership and signaling the company’s full-scale expansion into the North American health supplement market.

Lion’s Mane mushroom has long been valued in Asia as a tonic food with nourishing benefits. In recent years, scientific studies have highlighted its potential in neuroprotection, cognitive support, and healthy aging, driving rapid interest in the European and U.S. nutraceutical industries. However, the U.S. market previously lacked sufficient safety data, limiting its widespread adoption.

With FDA’s NDI acceptance, the ingredient’s safety profile is now officially recognized, enabling lawful commercial use in the United States and laying a solid foundation for future product development across Western markets.

The R&D team at New Bellus Enterprises emphasized that the company has specialized in microbial fermentation services for over three decades. Its patented deep liquid-state fermentation technology enables consistent production of the key bioactive compound Erinacine A alongside valuable polysaccharides. This method allows scalable, sustainable manufacturing while overcoming the quality and yield limitations of traditional solid-state cultivation.

The company’s Lion’s Mane mycelium ingredient has obtained a full suite of global quality certifications, including FSSC 22000, HACCP, NSF GMP, ISO 17025, and HALAL, ensuring product safety, consistency, and international compliance.

Erinacine A is one of the most important active compounds in Lion’s Mane mycelium, known for promoting the expression of nerve growth factor (NGF). Numerous peer-reviewed studies have demonstrated its potential to support neurological health, enhance learning and memory, and modulate neuroinflammatory responses—making it a promising ingredient for neuroprotection and healthy aging applications.

Notably, Erinacine A is present exclusively in liquid-fermented mycelium and is absent in wild-grown or solid-state cultivated fruiting bodies, further highlighting the advantages of New Bellus’s fermentation technology.

New Bellus Enterprises stated that the company will continue advancing its functional fermentation capabilities while expanding R&D initiatives in probiotics, mushroom mycelium ingredients, and other naturally derived fermented raw materials. Its future product strategy will place emphasis on cognitive health and nutritional support for middle-aged and older populations.

In response to accelerating global population aging, New Bellus Enterprises aims to deliver safer, higher-value natural health solutions built upon scientific validation, sustainable manufacturing, and international collaboration—continuing its mission to enhance human wellness and quality of life.

Source: 工商時報，理財周刊，Yahoo News，