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FDA GRAS Rule Would Require Notice, Not Additive Approval
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Fusion42 · 12 September 2026 · Fusion42 review
The FDA has proposed a rule requiring companies to notify the agency before selling food additives they determine as "generally recognized as safe" (GRAS), without requiring FDA approval. The proposal mandates notification but leaves the safety determination with the company, and allows existing ingredients to remain on the market without submitting safety data. Comments on the rule are due by December 9.
This Wire brief sits within Fusion42's coverage of Foodtech.
◆ ◆ The Wire takeaway
You face a shift where you must notify the FDA about GRAS food additives but keep control of the safety claim. This opens a door to market with mandatory transparency but without waiting for agency approval, reshaping how you approach compliance and market entry.
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1 source · 12 Sep 2026
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