FDA’s Proposed GRAS Rule, and What Industry Should Do Now

The proposed notification requirement is straightforward, but its legal and commercial consequences are not.

On August 10, 2026, FDA proposed a rule that would generally make GRAS notification mandatory. Companies could still reach independent GRAS conclusions, but they would largely lose the option of keeping those conclusions private. For industry, the proposal raises important questions about FDA’s legal authority, the treatment of existing ingredients, and what greater scrutiny could mean for bringing products to market.

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