In recent years, the number of GRAS notices submitted to the U.S. FDA has been on a steady upward trend. Since 2026, the U.S. FDA has been continuously updating its inventory of GRAS notices. CIRS Group has conducted a detailed statistical analysis and summary of FDA GRAS notices from January 2026 to March 2026, which is provided here for companies’ reference.
There are more than 200 types of HMOs, each with specific structures and functions, enabling applications across different fields. As a result, regulatory submissions for HMOs are rapidly increasing worldwide, with commercialization first initiated in Europe and the United States. In 2015, the U.S. Food and Drug Administration (FDA) recognized the first HMO—chemically synthesized 2’-fucosyllactose (2’-FL) submitted by Glycom A/S—as Generally Recognized as Safe (GRAS). Since then, multiple HMOs have successively obtained GRAS status in the United States.
The U.S. FDA recently approved a color additive petition (CAP 4C0326) submitted by Phytolon, allowing beetroot red to be used as a color additive exempt from batch certification in human food. The FDA accepted the petition on March 12, 2024, and issued a final rule in the Federal Register on February 6, 2026. A new regulation, 21 CFR § 73.39 Beetroot red (under 21 CFR Part 73), was established. The rule will take effect 45 days after publication, i.e., on March 23, 2026.
Earlier in September 2025, Shandong Runhan Biotechnology Co., Ltd. (“Runhan”) achieved a milestone in its international compliance journey for its core product, GlcNac. With comprehensive professional support from CIRS Group and its U.S. subsidiary, the company’s GlcNac has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
Recently, VDK’s synthetically produced β-carotene, manufactured using synthetic biology technology, obtained self-GRAS notification. This milestone signifies the product’s approval as a safe food ingredient for sale and use in the American market, providing crucial support for VDK’s global expansion strategy. This notification was fully supported by CIRS Group.
In 2025, GRAS notice remained highly active. To provide a comprehensive overview of the annual trends, CIRS Group conducted a systematic review and analysis of GRAS notice in 2025, offering insights and references for enterprises.
Nicotinamide Mononucleotide (NMN) is currently undergoing regulatory authorization processes in multiple major global markets. To help companies clearly understand the international compliance status of NMN, CIRS has summarized recent regulatory developments in the United States, Australia, and the European Union for reference.
On December 8, 2025, Tianjin Hesheng Biotechnology Co., Ltd. (HS SynBio) (Tianjin) received “FDA has no questions” letter. This marks the official recognition of its HMO 2'-Fucosyllactose (2'-FL) as GRAS.
In recent years, the enthusiasm for GRAS Notices to the U.S. FDA has remained strong. From July 2025 to the present, the FDA has released a large-scale update to the GRAS inventory. CIRS Group has conducted a detailed analysis and summary of GRAS submissions from July to September 2025, to help enterprises stay informed and make strategic reference. It is important to note that updates on the FDA website are often delayed – many substances may have already completed the GRAS review and received “no questions” letters, but their public status remains unchanged. CIRS Group closely monitors FDA updates, and this report summarizes the information newly released in Q3 2025.
On September 29, 2025, the Natural Products Association (NPA) announced that the U.S. Food and Drug Administration (FDA) reversed course and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements — ending nearly three years of regulatory uncertainty. This marks a historic breakthrough in NMN’s regulatory landscape.
