GRAS
Generally Recognized As Safe · Generally Recognized As Safe · self-GRAS · notified GRAS · GRAS notification · GRN
US regulatory status under 21 CFR 170.30 exempting a food ingredient from food-additive approval when qualified experts conclude — from publicly available data — that the intended use is safe.
GRAS — Generally Recognized As Safe — is the US pathway under section 201(s) of the FD&C Act and 21 CFR 170.30 that exempts food ingredients from premarket food additive approval when a panel of qualified experts concludes, based on publicly available scientific data of the same quantity and quality that would support a food additive petition, that the ingredient is safe under the intended conditions of use. The safety standard is identical to that for food additive approval ('reasonable certainty of no harm'); the difference is the evidentiary route — GRAS conclusions must rest on publicly available, generally accepted data, not confidential proprietary studies.
Two operational variants exist. Self-determined GRAS — the dossier and Expert Panel Statement are prepared and held in the company's files, and the ingredient may be marketed immediately. FDA-notified GRAS — the same dossier is submitted to the FDA's GRAS Notification Program, the FDA reviews within a 180-day target window, and on acceptance issues a 'no questions' letter with a GRN number visible on the FDA website. The 2016 final rule at 21 CFR 170 Subpart E codifies the notification framework and reinforces the expectation that GRAS conclusions be reached by a qualified expert panel (not a single individual) with disclosed conflicts and independence from the sponsor.
A defensible GRAS dossier covers ingredient identity, manufacturing process and specifications, intended conditions of use (food categories, levels, target population, daily intake), self-limiting use levels where applicable, safety narrative drawing on toxicology, ADME and human exposure data, comparable regulatory status in other jurisdictions, and the signed Expert Panel Statement with panellist credentials and conflict disclosures. For dietary supplements, GRAS for food use does not automatically authorise use as a dietary ingredient — supplement use of a non-grandfathered ingredient generally requires a separate New Dietary Ingredient (NDI) notification under DSHEA, and FDA has issued enforcement letters where a notified-GRAS food ingredient was marketed as a supplement ingredient without an NDI notification.
- 21 CFR 170.30
- 21 CFR 170 Subpart E
- FD&C Act §201(s)
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