The Generally Recognized as Safe (GRAS) notification pathway remains a critical route for food ingredient regulatory compliance and commercialization in the United States. Following our previous reviews for Q1 and H1 2026, CIRS Group compiled the latest GRAS notification updates published on the official U.S. Food and Drug Administration (FDA) website from July through October 15, 2026.

On October 7, with comprehensive support from CIRS Group, Inner Mongolia Kingdomway Pharmaceutical Limited (hereinafter referred to as “Kingdomway”) officially received a “FDA Has No Questions Letter” from the U.S. Food and Drug Administration (FDA) for its fermentation-derived brazzein (GRAS Notice No. 001305). This milestone marks the successful completion of the FDA’s review of the company’s GRAS notice for the product.

This successful FDA evaluation marks a major breakthrough in the product’s international compliance capabilities, providing a solid foundation for the company’s overseas business expansion and the implementation of its global strategy.

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 these circumstances, CIRS Group has prepared the White Paper Series on Global Novel Food and Feed Ingredient Submissions, with the aim of helping businesses navigate the evolving global regulations and accelerate global expansion.

On August 10, 2025, the U.S. Department of HHS officially issued a proposed rule on mandatory GRAS notifications. The FDA proposes to change the current voluntary GRAS notification process to a mandatory system, directly targeting the Self-GRAS pathway.

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.

Navigating the regulatory landscape for exporting food and feed ingredients to the United States requires a clear understanding of the FDA compliance pathways, safety assessments, and procedures. Backed by U.S.-based toxicologists and a 100% success rate, CIRS Group provides comprehensive global regulatory submissions for GRAS, NDI, and novel food ingredients.

In 2025, the U.S. Congress introduced three proposals related to food substances “Generally Recognized As Safe” (GRAS): S.2341, H.R.4958, and S.3122. These proposals all focus on improving the GRAS evaluation process, substance safety, and regulatory requirements for self-GRAS.

Recently, HHS/FDA updated the GRAS reform rule entry in the Federal Register’s “Uniform Agenda”, adjusting the proposed rule’s publication date to December of this year. More importantly, this update not only reflects a change in the timeline but also reveals the design philosophy behind the rule.

On July 6, Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd. (Hengyuan) received a "no questions" letter from the FDA regarding the GRAS (Generally Recognized as Safe) notice for its D-psicose. Produced via an enzymatic bioconversion process, the ingredient's safety has now been officially recognized by the FDA.