The 9 Major Food Allergens US Law Requires on Food Labels

Federal law currently defines nine “major food allergens” that must be disclosed on US food labels: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. Sesame is the newest addition, made effective by the FASTER Act of 2021 for food introduced into interstate commerce on or after January 1, 2023. The law gives manufacturers two ways to disclose a major allergen on the label: a “Contains” statement after the ingredient list, or naming the food source in parentheses within the ingredient list itself.

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Key points

Federal law (21 U.S.C. 321(qq)(1)) names nine major food allergens: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame.
Sesame became the ninth major allergen under the FASTER Act of 2021, applying to food introduced into interstate commerce on or after January 1, 2023.
Manufacturers may disclose a major allergen with a “Contains” statement placed after the ingredient list, or by naming the food source in parentheses within the ingredient list.
This article does not address advisory “may contain” statements, cross-contact risk, or individual allergy-management guidance.

Major-allergen definition

The United States Code lists the nine foods that qualify as major food allergens:

“Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.” (21 U.S.C. 321(qq)(1))

This list appears in the “United States Code, 2024 Edition” (source), the current codified text of the statute.

Sesame addition

Sesame’s addition was a direct statutory amendment. The FASTER Act of 2021 changed the wording of the allergen definition itself:

“Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by striking ‘and soybeans’ and inserting ‘soybeans, and sesame’.” (FASTER Act of 2021)

The law also fixed the date the change would take effect:

“The amendment made by subsection (a) shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.” (FASTER Act of 2021)

Allergen declaration methods

Federal law (21 U.S.C. 343(w)) permits two label declaration formats. The first is a standalone “Contains” statement:

“the word ‘Contains’, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients” (21 U.S.C. 343(w))

The second is naming the food source directly inside the ingredient list:

“the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived” (21 U.S.C. 343(w))

A manufacturer can use either format to meet the disclosure requirement.

What this article does not answer

This article covers only what the statutes themselves settle: the current nine-item list of major food allergens, how and when sesame was added, and the two permitted label declaration formats. It does not address whether “may contain”-style advisory statements are required on a label — they are not mandated by this same provision, which in any case applies only to foods that are not a raw agricultural commodity. It also does not address whether highly refined oils are excluded from the major-allergen declaration requirement, cross-contact risk in food production, or any individual allergy-management guidance, such as which foods a person with a specific allergy should avoid. Readers with those questions should consult the FDA guidance and food-allergy resources listed below or a qualified professional.