Q.01

Where can I find the FDA GRAS list?

FDA doesn't publish one complete "GRAS list." The closest thing is the GRAS Notice Inventory, FDA's searchable database of GRAS notices filed since 1998. You can open it at hfpappexternal.fda.gov/scripts/fdcc/?set=GRASNotices. The short link fda.gov/grasnoticeinventory redirects there, and the background is on FDA's GRAS Notice Inventory introduction page. The regulations also list GRAS substances in 21 CFR Parts 182, 184 and 186. Neither source is complete, because FDA states that "it is impracticable to list all substances that are generally recognized as safe" [1].

Where GRAS status is recorded

SourceWhat it covers
GRAS Notice Inventory (FDA online database)One entry per notice (GRN number): substance, intended use, basis (scientific procedures or common use in food), notifier, filing and closure dates, and FDA's response letter. GRN 1 is an example: soy isoflavone extract from Archer Daniels Midland, filed 02/10/1998, where FDA stopped its evaluation at the notifier's request [2]. FDA's page says it is updated about monthly, showed 1,360 records as of 10/21/2026, and that new notices have been posted on regulations.gov since July 2025 (FDA).
21 CFR Part 182Substances listed as GRAS, such as salt, pepper, vinegar, baking powder and MSG, for use under good manufacturing practice [1]. These were listed in 1958-1962 without a detailed scientific review [3].
21 CFR Part 184Ingredients added directly to human food that FDA has reviewed and "affirmed to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed" [4].
21 CFR Part 186Indirect food substances (food-contact uses) affirmed as GRAS [3].
SCOGS evaluationsHistorical reviews of GRAS substances by the Select Committee on GRAS Substances. For example, caffeine is covered in SCOGS Report No. 89 (1978), CAS 58-08-2 [5].

Things to keep in mind when using these sources

  • Not being listed doesn't mean not GRAS. Under 21 CFR 170.30(d), Parts 182, 184 and 186 "do not include all substances that are generally recognized as safe for their intended use in food" [3].
  • GRAS status only covers the conditions of use. If a listed ingredient has specific limitations, it "may be used in food only within such limitation(s)." Any other use requires a food additive regulation [3].
  • A notice is not an approval. The inventory records FDA's response to each notice, such as "no questions," evaluation stopped at the notifier's request, or pending. Read the letter for the specific GRN.

Approach: I searched the FDA GRAS Notice Inventory, the SCOGS GRAS evaluations and the current eCFR text of 21 CFR Parts 170-189, and opened FDA's GRAS Notices page for the current links.

If you give me a substance or GRN number, I can pull its notice, any FDA letter and any CFR GRAS listing.

Q.02

Does self-affirmed GRAS mean FDA approval?

No. A self-affirmed GRAS conclusion is the company's own determination, and FDA does not approve it. GRAS status is in fact the legal route that sits outside FDA premarket approval. Under 21 CFR Part 170, a company concludes that a substance is GRAS for its intended use. It "may" then notify FDA of its view that the substance "is not subject to the premarket approval requirements of section 409" of the FD&C Act [6].

What the regulations say about a self-affirmed (unnotified) GRAS conclusion

  • Notifying FDA is optional. Section 170.205 says any person "may" notify FDA; it does not say "shall" [6]. The regulations don't use the phrase "self-affirmed." They call it the company's "conclusion that the substance is GRAS under the conditions of its intended use" [7].
  • The company's own judgement is not enough. GRAS status requires "common knowledge throughout the scientific community" that there is "reasonable certainty that the substance is not harmful" under its intended use. It "may be based only on the views of experts qualified by scientific training and experience" [3].
  • The evidence bar is the same as for an approved food additive. GRAS based on scientific procedures "shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive." That evidence "ordinarily" has to be published, though unpublished data can corroborate it [3].
  • If the conclusion is wrong, the ingredient is an unapproved food additive. "A food ingredient that is not GRAS or subject to a prior sanction requires a food additive regulation promulgated under section 409 of the act before it may be directly or indirectly added to food" [3].
  • GRAS status can change. "New information may at any time require reconsideration of the GRAS status of a food ingredient" [3].

How it compares with the other GRAS routes

RouteFDA's role
Self-affirmed (not notified)None. The company holds the conclusion and its supporting record.
GRAS notice (Subpart E)FDA files the notice and, "within 180 days of filing," responds "by letter based on our evaluation of your notice." It can extend that by 90 days [8]. The notice must explain the basis for GRAS status and address any data that conflict with it [9]. FDA's letters are made public [10]. The regulation calls this an evaluation and response, not an approval.
Listed or affirmed by FDA in 21 CFR Parts 182, 184 and 186FDA has listed or affirmed GRAS status by regulation. Uses outside a listed limitation "shall require a food additive regulation" [3].
Food additive petition (section 409)This is the actual premarket approval route. It ends in a food additive regulation [3].

In practice, if a supplier says an ingredient is "GRAS," ask whether that is self-affirmed, notified (and if so, which GRN number and what FDA's letter said), or listed in 21 CFR Parts 182, 184 or 186. Each one tells you something different about how far FDA has looked at it.

Approach: I read the current eCFR text of 21 CFR Part 170: section 170.30 on GRAS eligibility, and Subpart E on GRAS notification (170.203, 170.205, 170.250, 170.265, 170.275). These cover the rules as currently codified; I did not look into any proposed changes to the self-affirmation pathway.

Q.03