FDA Released Proposed Rule on Mandatory GRAS Notification— 120-Day Comment Period Opens

On August 10, 2026, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) officially released the proposed GRAS rule, which is scheduled for publication in the Federal Register on August 11. Either electronic or written comments on the proposed rule must be submitted by December 9, 2026. The core of the proposed rule is to eliminate the Self-GRAS pathway and require companies to submit GRAS notices to FDA.

CIRS has set up a branch office in Virginia, USA. Our U.S. team covers full-time food regulatory and toxicology experts, including 2 US certified toxicologists (DABT), 1 European registered toxicologist (ERT) and 24 Chinese certified toxicologists (DCST).  We support clinets with US food compliance services, including FDA GRAS, NDI, CAP, Animal Food GRAS, FDA Animal Food Ingredient Consultation, AAFCO SRIS, etc. 

With more than 15 years of experience in food regulatory compliance, CIRS Group has successfully supported numerous FDA GRAS projects, including human milk oligosaccharides (2’-FL, LNnT, LNT, etc.), steviol glycosides, inositol, brazzein, lycopene, enzymatically modified steviol glycoside RebM2, D-allulose, zeaxanthin, PQQ, etc.

During this critical public comment period, CIRS Group can help your company:

• Perform thorough gap analyses on GRAS notification dossiers.
• Connect with scientific experts to review the strength and validity of your safety data.
• Evaluate whether voluntarily submitting a GRAS notification now offers a competitive advantage.
• Continuously track regulatory developments and related congressional legislation.

Driven by a global wave of food innovation, regulatory compliance and market access for novel food ingredients and additives have become critical hurdles for companies expanding internationally. Under this circumstance, CIRS Group has prepared the White Paper Series on Global Novel Food and Feed Ingredient Submissions, with the aim to help businesses navigate the evolving global regulations and accelerate global expansion.

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CIRS Group

11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China

Email: service@cirs-group.com.

Tel: +86 571 87206538

Further Reading

How to Legally Export New Food Ingredients to the U.S.: Frequently Asked Questions on GRAS Notice