Recently, S-Adenosyl-L-Methionine Disulfate Tosylate (SAMe-DT), independently developed by Shandong Freda Biotechnology Co., Ltd., successfully passed the U.S. FDA New Dietary Ingredient (NDI) notification (NDIN No. 1473). This clearance enables the ingredient to be lawfully marketed in the U.S. dietary supplement market.

NDI notification represents a rigorous entry requirement for dietary ingredients in the U.S. The applicant must submit comprehensive data on manufacturing processes, quality control, and safety. Following the FDA’s statutory 75-day safety review period with no objection, the ingredient may be introduced into commerce. This notification serves as an authoritative recognition of the ingredient’s safety and the manufacturer’s standardized production capabilities.

S-Adenosyl-L-Methionine (SAMe) is an endogenous bioactive metabolite widely used in dietary products for mood and liver health support. However, it has historically faced challenges such as susceptibility to degradation and limited storage stability. The R&D team at Freda Biotech addressed these industry challenges by developing a proprietary SAMe-DT co-salt process, which significantly enhances the storage and thermal stability of the active ingredient. In parallel, the company has established a stringent quality control system across the entire production chain, enabling high-purity and stable large-scale manufacturing.

This NDI notification marks a key milestone in the company’s international ingredient strategy. It fully demonstrates Freda Biotech’s integrated R&D capabilities—from strain selection and process development to industrial-scale production and global regulatory filing. It also reflects the FDA’s acknowledgment of the company’s manufacturing processes, safety data, and quality management systems. With this clearance, the company has effectively opened access to the U.S. dietary ingredient market and strengthened its competitiveness overseas.

Looking ahead, Freda Biotech will continue to drive innovation in its ingredients portfolio, with a focus on the nutritional health raw materials sector. The company will further optimize its existing product offerings, leveraging its robust standardized production and quality control infrastructure to provide global customers with compliant, stable, and cost-effective specialty functional ingredients and associated technical services.