Patented Liquid Fermentation Technology Delivers Stable Erinacine A Content with Full International Certifications – Positioning for Strong Entry into the North American Neurohealth Market
New Bellus Enterprises Co., Ltd. (www.newbellus.com) proudly announces that its Hericium erinaceus mycelia raw material has officially successfully completed the U.S. Food and Drug Administration (FDA) New Dietary Ingredient (NDI) notification process. The FDA has acknowledged receipt and filed the submission under NDI No. 1422 without raising any safety objections, fully complying with U.S. regulatory requirements for market entry.
This milestone makes New Bellus the world’s first company to obtain FDA NDI acknowledgment for Hericium erinaceus mycelia, representing international recognition of its technological strength and marking the official launch of its strategic expansion into the North American market.
Hericium erinaceus (Lion’s Mane mushroom) has long been regarded in Asia as a precious tonic mushroom. In recent years, scientific research has demonstrated its potential in neuroprotection, cognitive function improvement, and delaying neurodegeneration, rapidly gaining attention in the European and North American dietary supplement industries. Previously, the lack of sufficient safety data in the U.S. market restricted commercial development. The successful completion of the FDA NDI process confirms the safety profile of this ingredient, allowing legal sales in the United States and laying a solid foundation for future product development across North America and Europe.
New Bellus’ R&D team emphasizes that the company has focused over 30 years on microbial fermentation technology. By employing its patented deep-tank liquid fermentation technology, the company achieves stable production of the key bioactive compound Erinacine A as well as polysaccharides. This advanced method enables scalable, sustainable mass production while overcoming the quality and yield limitations of traditional solid-state cultivation. The product has already earned multiple international quality certifications, including FSSC 22000, HACCP, NSF GMP, ISO 17025, and HALAL, ensuring safety, consistency, and global market acceptance.
Erinacine A, the signature bioactive compound found exclusively in liquid-fermented Hericium erinaceus mycelia (not present in wild or solid-cultivated fruiting bodies), has been shown in numerous peer-reviewed international studies to promote the expression of nerve growth factor (NGF). It supports neurological health, learning and memory function, and helps modulate neuroinflammatory responses, providing strong scientific evidence for its role in delaying neurodegeneration and promoting healthy aging.
Looking ahead, New Bellus remains committed to advancing functional fermentation technology. The company will continue to strengthen R&D capabilities and drive innovative applications of probiotics powder, mushroom mycelium powder, and other natural medicinal fermented powder, with a particular focus on cognitive health and nutritional support for middle-aged and elderly populations. In response to the global aging trend, New Bellus will uphold evidence-based science, sustainable manufacturing processes, and international partnerships as core principles to deliver safer, higher-value natural health solutions that enhance quality of life and human well-being worldwide.
About New Bellus Enterprises Co., Ltd. With over three decades of expertise in microbial fermentation services, New Bellus specializes patented liquid fermentation technology to develop high-potency, science-backed functional ingredients for the global nutraceutical and dietary supplement industries.