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A FEMA GRAS number on a flavor spec is not an FDA approval. FDA receives the data but does not formally review the decision.
“FEMA GRAS No. 2286” is a typical line. 2286 is cinnamaldehyde, the molecule behind cinnamon, and it happens to be an easy case: FDA also lists it by name in its own regulation (21 CFR 182.60). Plenty of the lines next to it on the same sheet carry only the FEMA number.
GRAS means generally recognized as safe. It is a legal status, and US law lets qualified experts reach it without FDA signing off. For flavors, those experts are the FEMA Expert Panel, independent scientists who have reviewed flavor ingredients since 1959.
Four lines that look alike on a US spec sheet carry four levels of FDA involvement. A 21 CFR 182.60 listing means FDA itself lists the substance as GRAS. A 21 CFR 172.515 listing means FDA approved it as a synthetic flavoring food additive. A GRN number means a company notified FDA and received a “no questions” letter. A FEMA GRAS number means an expert panel decided, and FDA did not formally review it.
The safety record backs the panel. FEMA reports that FDA has never disagreed with a panel decision, and the two have worked together to remove a few ingredients. Even so, the panel made the call on its own.
FDA’s proposed rule of August 11, 2026 would add a step: GRAS notification would become mandatory, and FEMA GRAS status alone would not exempt a substance. Ingredients already on the market would get a one year window for a shorter filing. Comments close December 9, 2026.
Pull one current flavor spec and mark which of the four lines each ingredient carries, then ask your flavor supplier how they plan to handle the filing.
Explore our flavor catalogue: https://aromatech-portfolio.vercel.app/index.html
