Nutrition Diva Touching GRAS: What ‘generally recognized as safe’ really means
Nov 5, 2025
Dive into the controversial world of food safety as manufacturers exploit regulatory loopholes with GRAS status. Discover what 'generally recognized as safe' truly means and how substances gain this status. Explore the differences between U.S. and EU approval processes for food additives. Uncover the implications of self-affirmed GRAS status and the transparency (or lack thereof) of these determinations. Learn why food safety remains crucial for manufacturers and how historical usage aids in safety assessments.
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What GRAS Really Means
- GRAS means a substance can bypass formal pre-market approval if experts agree it's safe for a specific use.
- Companies must compile toxicology, metabolism data and expert consensus to claim GRAS status.
Submit Dossiers For FDA Review
- Submit your GRAS dossier to FDA to get a 'no questions' response and an official record.
- If FDA raises concerns, amend and resubmit to avoid legal and financial risks.
Self-Affirmed GRAS Still Requires Proof
- Self-affirmed GRAS is optional but carries the same burden of evidence as FDA-submitted dossiers.
- Companies must produce their dossier on demand or face serious consequences.