FDA GRAS Notice
Issued by FDA Center for Food Safety and Applied Nutrition (CFSAN)
RegistrationAudit Scope
GRAS (Generally Recognized As Safe) notice published in FDA's GRAS Notice Inventory. Voluntary submission by ingredient sponsor; FDA review + 'no questions' or 'cease to evaluate' letter. Substance-specific (not facility-wide).
What It Proves
Substance has a published GRAS Notice in FDA's public inventory (GRN number assigned). FDA reviewed the sponsor's safety dossier and issued a 'no questions' letter for the intended use described in the notice.
What It Does Not Prove
Does NOT mean FDA endorses or approves the ingredient. Does NOT cover uses beyond those described in the notice. Does NOT extend to other forms / dosages / populations. 'Self-affirmed GRAS' (where the sponsor concluded GRAS internally without notifying FDA) is DISTINCT and does NOT appear in the GRAS Notice Inventory. Per Mericon Industries 2025 FDA enforcement action: self-affirmed GRAS without published notice is regulatory exposure.
How Vendors Report It
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