The FDA is issuing a final order revoking the authorized use of Orange Bas a color additive in food and is proposing to revoke the authorized use of Citrus Red No.2 as a color additive in food.

In 2025, the U.S. Congress introduced three proposals related to food substances “Generally Recognized As Safe” (GRAS): S.2341, H.R.4958, and S.3122. These proposals all focus on improving the GRAS evaluation process, substance safety, and regulatory requirements for self-GRAS.

The U.S. New Dietary Ingredient (NDI) database was updated on July 13, 2026, with a total of 25 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 April 1, 2026. 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.

Recently, HHS/FDA updated the GRAS reform rule entry in the Federal Register’s “Uniform Agenda”, adjusting the proposed rule’s publication date to December of this year. More importantly, this update not only reflects a change in the timeline but also reveals the design philosophy behind the rule.

On July 6, Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd. (Hengyuan) received a "no questions" letter from the FDA regarding the GRAS (Generally Recognized as Safe) notice for its D-psicose. Produced via an enzymatic bioconversion process, the ingredient's safety has now been officially recognized by the FDA.

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.