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Magic Health’s flagship ingredient, PERFQUQ™ (Pyrroloquinoline Quinone Disodium Salt), has officially earned Self-GRAS (Generally Recognized as Safe) status in the United States following unanimous approval from an independent expert panel. This key regulatory milestone confirms the ingredient's safety for use in U.S. foods and beverages, marking a significant step forward in Magic Health’s international expansion. CIRS Group provided end-to-end support throughout the GRAS assessment.
The U.S. FDA proposes making the voluntary Generally Recognized as Safe (GRAS) notification mandatory while preserving "Self-GRAS" statutory status. If finalized, companies face mandatory filing timelines: a one-year window to submit abbreviated notices for existing unnotified ingredients, exemptions for current "no questions" letters, and required pre-market FDA submissions for new ingredients.
On October 19, 2026, the FDA simultaneously issued two NDI guidance documents to further refine the requirements for submitting New Dietary Ingredients (NDI) for dietary supplements. CIRS Group provides an in-depth analysis of the key changes in the guidance to assist companies in conducting NDI compliance assessments and filing submissions for the U.S. market.
The FDA is modernizing its 30-year-old GRAS system by replacing voluntary notifications with a mandatory regime to close safety blind spots. Companies using human or animal food ingredients under GRAS provisions must notify the agency, though existing marketed ingredients benefit from a one-year simplified submission window and an 18-month overall compliance grace period.
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.
To help industry players navigate these compliance hurdles, CIRS Group has compiled the Guide to U.S. Animal Food Ingredient Regulatory Submissions: Animal Food GRAS Notices, Food Additive Petitions, FDA Animal Food Ingredient Consultation (AFIC), and AAFCO Scientific Review of Ingredient Submissions (SRIS).
On August 19, 2026, the U.S. Federal Register Vol. 91, No. 159 published notices announcing the acceptance of three food color additive petitions. At the same time, the WTO issued SPS notifications G/SPS/N/USA/3592, G/SPS/N/USA/3594, and G/SPS/N/USA/3595. The three petitions concern safflower extract, gardenia (genipin) blue, and acetone as a processing solvent for carrot oil, respectively. All three applications are currently under technical review.
On August 3, 2026, the U.S. Environmental Protection Agency (EPA) issued Notice No. 2026-15761, revising the maximum residue limits (MRLs) for isofetamid in certain foods. The notice was officially published in the Federal Register on August 4, 2026, and took effect on the date of publication.