With the first half of 2026 concluded, Chinese ingredient companies are demonstrating strong momentum in GRAS notices; the number of approvals secured in this period alone (16) rivals the total for the entire year of 2025 (19). Drawing on publicly available FDA GRAS notice data, CIRS Group has compiled updates from January to June. By systematically reviewing metrics such as total volume, ingredient categories, outcomes, and the origins of applicants, CIRS provides valuable insights for food ingredient companies looking to enter the U.S. market.

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.

Recently, Enhe Aiju (Hangzhou) Science and Technology Co., Ltd. (Enhe Aiju) has completed the FDA GRAS notice for its self-developed zeaxanthin, produced via fermentation using production strain Yarrowia lipolytica CGMCC 39021 (GRN No. 1300). This is the world’s first high-concentration crystalline zeaxanthin product manufactured at commercial scale using cell factory technology to receive GRAS, fully under the support of CIRS Group.

California AB 660 takes effect July 1, 2026, requiring all packaged food products sold in California to use standardized quality date and safety date labels. “Sell by” dates will be prohibited on consumer-facing packaging, with a narrow exception for coded dates used solely for inventory management purposes. Companies that manufacture, distribute, or sell packaged food products in California should act now to avoid potential penalties and litigation risk. CIRS has summarized the two key changes to California’s food date labeling rules.

In the US, products similar to health foods are referred to as dietary supplements. Compared to health foods in China, there are significant differences in the naming, marketing requirements in America. To help companies better understand the compliance requirements for dietary supplements in the US, CIRS Group has summarized the relevant regulations for reference.

The U.S. New Dietary Ingredient (NDI) database was updated on May 8, with a total of 27 substances having their status updated. CIRS has organized the updated data for you. It should be noted that there is a lag in the NDI database updates. The latest FDA response times in this update report are all earlier than December 18, 2025. Currently, the actual number of completed NDI notifications is actually greater than the data currently published on the official website. CIRS Group will continue to pay close attention to subsequent updates on the FDA official website.

To help companies clearly understand the international compliance status of NMN, CIRS Group will summarize the application approval status of NMN in the EU, the US, and Australia for reference.

The New York State Assembly passed the Food Safety and Chemical Disclosure Act (Bill No. S1239F/A1556G) on April 21, which has now been sent to Governor for signature. If the governor officially signs it, this will be the first state law in the United States requiring businesses to publicly disclose safety evidence for self-GRAS substances to the state government.

To sell dietary supplements containing new dietary ingredients (NDI) in the U.S. market, you must submit an NDI notification (NDIN) to the FDA at least 75 days in advance. However, the FDA’s response to an NDIN does not have a clear conclusion like a GRAS notice, such as “FDA has no questions”. As a result, many companies often find it difficult to determine whether their notification has been “notified” when faced with a response filled with regulatory clauses and template terminology. CIRS Group combines FDA official guidelines and real cases to break down the types of NDIN responses and interpret the notification results for your reference.

Recently, Shandong Weiyan Biotechnology Co., Ltd. (“Shandong Weiyan”) achieved a milestone in its international compliance journey for its product, astaxanthin. With comprehensive professional support from CIRS Group, the company’s astaxanthin has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).