CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification

Recently, S-adenosyl-L-methionine disulfate tosylate (SAMe-DT), independently developed by Shandong Freda Biotechnology Co., Ltd. (hereinafter refered to as Shandong Freda), has successfully completed FDA New Dietary Ingredient (NDI) notification, with the NDIN number being 1473, marking the ingredient’s compliance for entry into the U.S. dietary supplement market. CIRS Group provided full support throughout the notification process.

NDI Notification is a mandatory premarket safety notification requirement for new dietary ingredients in the United States. Under Section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the manufacturer or distributor of an NDI, or of a dietary supplement containing the NDI, must submit to FDA, at least 75 days before the product is introduced or delivered for introduction into interstate commerce, a notification containing the history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.

S-Adenosylmethionine (SAMe) is an endogenous active metabolite in the human body and is widely used in dietary products for mood support and liver health. It is, however, prone to degradation and has poor storage stability. The R&D team at Shandong Freda has overcome these industry challenges by independently developing the SAMe-DT compound salt process, which significantly enhances the storage and thermal stability of the active ingredient. The company has also established a rigorous end-to-end quality control system to achieve high-purity, stable mass production.

The successful notification marks a major breakthrough in the company’s international raw material strategy. It fully demonstrates the company’s integrated research and development capabilities—spanning from strain selection and process development to large-scale production and global regulatory compliance—and confirms that its product processes, safety data, and quality control standards successfully met the stringent requirements for FDA's acceptance of the NDI notification. This achievement has fully opened up channels to the U.S. dietary ingredient market and strengthened the company’s core competitiveness in overseas markets.

About Shandong Freda

Shandong Freda takes synthetic biology fermentation raw materials as its industrialization direction, and its products are applied in multiple fields such as cosmetics, food, health products, and medicines. In terms of food raw materials, it mainly involves the research and development, production and sales of food additives such as natamycin, Nisin, ε -polylysine and its hydrochloride, compound food additives and functional food raw materials such as γ -aminobutyric acid, medicinal and edible extracts, and solid condiments. In terms of cosmetic raw materials, the cosmetic raw materials business covers multiple fields, mainly including ectoin, polysodium glutamate, Hdroxypropyl tetrahydropyrantriol and fermentation filtrate produced by synthetic biology fermentation technology. Special raw materials such as Centella asiatica and Mingyan Butterfly extract are extracted using the “intelligent manufacturing of Traditional Chinese medicine” process; In addition, it also focuses on the innovative research and development of recombinant collagen in the “collagen core” era. And functional active ingredients such as VC ethyl ether and tranexamic acid, etc. The company adheres to product quality as its core and has currently passed certifications such as ISO9001, ISO22000, FDA, BRC, KOSHER, HALAL, and COSMOS.

About CIRS 

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.