How to Write an Allergen Statement (FDA Big 9)

If your product contains a major food allergen, federal law requires you to say so on the label — and it prescribes exactly how. Getting this wrong is the single most common reason for food recalls in the US.

The nine major allergens

Federal law (21 U.S.C. 321(qq), as amended by the FASTER Act) defines nine major food allergens:

1. Milk
2. Eggs
3. Fish (e.g., bass, flounder, cod)
4. Crustacean shellfish (e.g., crab, lobster, shrimp)
5. Tree nuts (e.g., almonds, pecans, walnuts)
6. Wheat
7. Peanuts
8. Soybeans
9. Sesame

Sesame is the newest addition: it applies to food introduced into interstate commerce on or after January 1, 2023 (FASTER Act, signed April 23, 2021).

Two legal ways to declare them

Under 21 U.S.C. 343(w)(1) you can declare allergens either way:

Option A — a "Contains" statement. The word "Contains" followed by the allergen source names, printed immediately after or adjacent to the ingredient list, in type no smaller than the ingredient list itself. Example: Contains: Wheat, Milk, Eggs.

Option B — inside the ingredient list. The ingredient's common name followed by the allergen source in parentheses — e.g., "flour (wheat)", "whey (milk)". The parenthetical isn't needed when the ingredient name already contains the source name ("wheat flour") or the source appears elsewhere in the list.

Be specific with nuts, fish, and shellfish

For tree nuts, fish, and crustacean shellfish, the law requires the specific type or species — "almonds", not "tree nuts"; "cod", not "fish" (21 U.S.C. 343(w)(2)). A trail mix with three kinds of nuts must name all three.

Don't forget cross-contact

The mandatory declaration covers allergens that are ingredients — including flavorings, colorings, and incidental additives (21 U.S.C. 343(w)(4)). Advisory statements like "made in a facility that also processes peanuts" are voluntary, but many small producers add them honestly. If you share a kitchen with allergens, consider it.

Practical checklist

• List every allergen present in any ingredient, including sub-ingredients.
• Pick ONE style (Contains statement is easier to audit) and use it consistently.
• Name specific nuts, fish species, and shellfish species.
• Re-check the statement every time the recipe changes.