GRAS
"Generally Recognized As Safe" — an FDA designation for food substances that qualified experts consider safe under conditions of intended use based on established evidence.
Definition
GRAS (Generally Recognized As Safe) is an FDA designation established under the Federal Food, Drug, and Cosmetic Act for food additives and substances that qualified scientific experts determine to be safe for their intended use in food based on either (1) scientific procedures and evidence or (2) common use in food before 1958. GRAS substances are exempt from the pre-market food additive approval process. The GRAS designation is specific to food use contexts and does not constitute approval for pharmaceutical or research chemical applications. Common examples include amino acids, vitamins, and certain peptides used as food ingredients.
Research Context
The GRAS designation is relevant in the peptide research context because some amino acids and simple peptides have GRAS status for food use, which sometimes creates confusion about whether this status confers regulatory approval for other uses. GRAS status for a food ingredient does not imply safety or regulatory approval for use as a research compound, pharmaceutical drug, or in any context other than food additive use at the levels and purposes for which GRAS was determined. Researchers should not interpret GRAS status of any substance as relevant to its status as a research compound.
Relevant Compounds
This term applies to the following research compound hubs.
Frequently Asked Questions
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