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.

Recently, CIRS Group successfully assisted Penglai Marine in obtaining Self-GRAS Notice for its anhydrous magnesium citrate. It signifies that Penglai Marine’s anhydrous magnesium citrate may now be legally marketed and utilized as a safe food ingredient within the U.S. market, marking a significant step forward in Penglai Marine’s internationalization efforts.

Understanding the US FDA’s regulations and policies is vital for companies that intend to export their food materials to the US market. However, in recent years several companies have ceased their submitted GRAS Notice, and it's important to understand the reasons why.