GRAS: What Generally Recognized as Safe Means | Dose Track
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GRAS

Also called generally recognized as safe, GRAS notice · Reviewed

Definition: GRAS stands for generally recognized as safe. FDA explains that any substance intentionally added to food is a food additive that needs FDA review and approval, unless qualified experts generally recognize it as adequately shown to be safe under its intended conditions of use. That exception is GRAS.

The two routes to GRAS

Under 21 CFR 170.30, a use can be GRAS in one of two ways:

  • Scientific procedures: FDA says this needs the same quantity and quality of evidence as approval of a food additive, based on generally available data that are ordinarily published.
  • Common use in food: only for substances used in food before 1958, and it needs a substantial history of consumption by a significant number of people.

FDA keeps a public inventory of GRAS notices it has received. On August 10, 2026, FDA proposed a rule to increase oversight of substances claimed to be GRAS.

GRAS is for a use, not a substance in general

The status covers the intended conditions of use, such as the food and amount. It does not mean a substance is safe at any dose, by any route, or as an injection. GRAS is a food rule; new dietary ingredient notices are the separate route for supplement ingredients.

Why it matters for your log

Product pages sometimes cite GRAS as a safety badge. Check what use it covers. If you take a powder or capsule in larger amounts than food would contain, the GRAS basis may not apply, so log the amount you actually take.

Read more on Dose Track: Collagen vs whey protein · Psyllium vs inulin · Side-by-side comparisons

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
Dietary supplementA dietary supplement , under US law (21 U.S.C. 321(ff)), is a product intended for ingestion to supplement… New dietary ingredientA new dietary ingredient (NDI) is a dietary ingredient that was not marketed in the United States before… Structure/function claimA structure/function claim is a statement on a dietary supplement label about how an ingredient affects… Excipient (inactive ingredient)An excipient is any ingredient in a drug other than the active drug. FDA rules call it an inactive…

Frequently asked questions

Does GRAS mean FDA approved?+
No. GRAS is an exception to food additive approval, based on general recognition of safety among qualified experts for a specific intended use.
Can something be GRAS from history alone?+
Only for a substance used in food before 1958, and it needs a substantial history of consumption by a significant number of people, according to FDA.

Sources

  1. FDA: Generally Recognized as Safe (GRAS)

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