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.

On July 15, 2025, the U.S. Food and Drug Administration (FDA) issued a public announcement stating that it had sent seven warning letters to multiple companies for illegally selling products containing 7-hydroxymitragynine (7-OH), one of the active constituents of kratom. This compound exhibits potent opioid effects.

The U.S. Food and Drug Administration (FDA) has recently announced the repeal or proposed repeal of 52 food Standards of Identity (SOIs). According to the FDA, many of these standards are outdated and no longer relevant. Their removal is intended to enhance regulatory efficiency, foster food innovation, and better meet evolving consumer needs.

On June 22, 2025, Texas Governor Greg Abbott signed Senate Bill 25 (SB 25) into law, significantly tightening food labeling regulations in the state. Effective January 1, 2027, all food and beverage products sold in Texas that contain one or more of the 44 substances listed in the bill will be required to display a warning label.

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.