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.
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.
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.
GRAS (Generally Recognized As Safe) means that a substance is generally recognized as safe. If a substance is recognized as safe under its intended use, it is classified as GRAS and can be exempted from pre-market approval procedures required by U.S. law. As a key basis for recognizing new food ingredients in the United States, FDA GRAS notifications remain active. After nearly three months without updates, the FDA recently made a significant update to the FDA GRAS list, with the most recent update as of June 10, 2025.
In 2024, the restructuring of the U.S. Food and Drug Administration (FDA) was approved and officially took effect on October 1, 2024. A key change in this restructuring is the creation of Human Foods Program(HFP) and the adoption of new models for on-site operations, along with other significant modernization efforts. As a result, changes have also occurred in the management of GRAS substances and NDI.
The FDA regulates GRAS ingredients in animal food through the GRAS Notification Program. Food companies and manufacturers may either submit a GRAS Notice (GRN) to the FDA to get a “No Questions” letter, or independently draw the GRAS conclusion based on the opinions of the panel group.
GRAS stands for Generally Recognized As Safe. It is the FDA primary framework for managing the safety of food ingredients. To obtain GRAS status, a company must compile a complete English‑language GRAS dossier and have it reviewed independently by a qualified panel of experts, who must reach a consensus on the ingredient’s safety. The dossier is a technical compilation that systematically explains the substance’s characteristics and its safety for consumption. Under 21 CFR Part 170 Subpart E, a GRAS notice must contain seven statutory parts.
