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Allergen labeling and the 9 major allergens

U.S. law requires packaged food to clearly declare nine major allergens. Here is the full list — including sesame, the newest addition — how the law (FALCPA and the FASTER Act) works, and exactly how allergens must appear on a label.

Updated June 19, 2026 · 4 min read · Sourced from FDA guidance

The 9 major food allergens

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified eight major food allergens. The FASTER Act of 2021 added sesame as the ninth, effective January 1, 2023. Together, the nine major allergens are:

  • Milk
  • Eggs
  • Fish (e.g., bass, flounder, cod) — the specific species must be named
  • Crustacean shellfish (e.g., crab, lobster, shrimp) — the specific type must be named
  • Tree nuts (e.g., almonds, walnuts, pecans) — the specific nut must be named
  • Peanuts
  • Wheat
  • Soybeans
  • Sesame — the newest, added by the FASTER Act
Note

When FALCPA passed, these allergens accounted for about 90% of food allergies and serious allergic reactions in the U.S. Note that crustacean shellfish is covered, but mollusks such as clams, mussels, and oysters are not among the major allergens.

How allergens must be declared

The name of the food source of each major allergen must appear in at least one of two ways:

  1. In parentheses after the ingredient in the ingredient list — for example, 'lecithin (soy),' 'flour (wheat),' or 'whey (milk),' or
  2. In a separate 'Contains' statement placed immediately after or next to the ingredient list — for example, 'Contains wheat, milk, and soy.'

If a 'Contains' statement is used, it must list every major allergen in the product. And because fish, crustacean shellfish, and tree nuts each cover many species, the specific type has to be identified — 'tree nuts (almonds),' not just 'tree nuts.'

Important

Allergen labeling sits outside the small-business Nutrition Facts exemption. Even a business that is exempt from the Nutrition Facts panel must still declare major allergens. See the small-business labeling guide.

What about 'may contain' and cross-contact?

Advisory statements like 'may contain traces of peanuts' or 'made in a facility that also processes tree nuts' refer to cross-contact — the unintentional presence of an allergen. These statements are voluntary, are not a substitute for the required allergen declaration, and should not stand in for good manufacturing practices that prevent cross-contact. Treat them as an extra caution, not a regulated guarantee.

Sesame: the newest allergen

Sesame became the ninth major allergen on January 1, 2023 under the FASTER Act. Foods packaged on or after that date must declare sesame like any other major allergen. Products already on shelves before that date did not have to be relabeled, so for a transition period some older stock may not show a sesame declaration — when in doubt, the FDA advises checking with the manufacturer.

Gluten-free is a separate claim

'Gluten-free' is not part of allergen labeling — it is a voluntary claim with its own FDA rule (a food bearing it must contain less than 20 ppm gluten); see the gluten-free labeling guide. Declaring wheat as an allergen and labeling a product gluten-free are different things governed by different rules.

Frequently asked questions

What are the 9 major food allergens in the U.S.?
Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. The first eight come from FALCPA (2004); sesame was added by the FASTER Act, effective January 1, 2023.
How must allergens be listed on a food label?
In at least one of two ways: in parentheses after the ingredient (e.g., 'flour (wheat)'), or in a separate 'Contains' statement next to the ingredient list (e.g., 'Contains wheat, milk, soy'). For fish, crustacean shellfish, and tree nuts, the specific type must be named.
Does 'may contain' mean the product has the allergen?
Not necessarily. 'May contain' and similar advisories refer to possible cross-contact — unintentional presence — and are voluntary. They are not a substitute for the required allergen declaration, so people with serious allergies should treat them cautiously.
Is sesame really required on labels now?
Yes. As of January 1, 2023, sesame is the ninth major allergen and must be declared on foods packaged on or after that date. Products made before then were not required to be relabeled, so some may not show it.
Are small businesses exempt from allergen labeling?
No. The small-business exemption applies only to the Nutrition Facts panel. Major-allergen declarations are required regardless of business size.

Sources

Related tools & guides

This guide is general educational information, not legal advice, and labeling rules can change. Your obligations depend on your specific products, claims, sales, and state. Verify your situation against the current FDA guidance and eCFR linked above, or consult a qualified food-labeling professional, before printing a label.