Allergen Labeling for Packaged Food

U.S. law requires food labels to identify the major food allergens. These rules come from the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the FASTER Act of 2021, codified at 21 U.S.C. 321(qq) and 343(w). They are separate from the Nutrition Facts label, and the small-business nutrition labeling exemptions don't remove them.

The 9 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, walnuts, pecans)
6. Peanuts
7. Wheat
8. Soybeans
9. Sesame

A major food allergen also includes any food ingredient that contains protein derived from one of these foods (21 U.S.C. 321(qq)). Sesame became the ninth major allergen under the FASTER Act, effective January 1, 2023 (FDA, Food Allergies).

Molluscan shellfish are not major food allergens under the law. That covers oysters, clams, mussels and scallops (FDA Edition 5 guidance, Q&A B.9). They still go in the ingredient list.

How to declare them

You have two options (21 U.S.C. 343(w)(1)):

• A "Contains" statement, immediately after or next to the ingredient list. It must be in type no smaller than the ingredient list, e.g. "Contains: wheat, milk, egg, soy."
• In the ingredient list, with the allergen source in parentheses, e.g. "whey (milk)" or "lecithin (soy)". This isn't needed when the ingredient's name already identifies the source ("milk," "wheat flour"), or the source already appears elsewhere in the list.

You can use both. If you use a "Contains" statement, it must list every major food allergen in the product.

Be specific for tree nuts, fish and shellfish

The law requires the specific type of tree nut (e.g., "almond," "pecan") and the species of fish or Crustacean shellfish (e.g., "cod," "shrimp") (21 U.S.C. 343(w)(2)). A label can't just say "tree nuts" or "fish."

For fish and shellfish names, FDA points to the acceptable market names in its Seafood List. In a "Contains" statement a generic name such as "salmon" may be used (FDA Edition 5 guidance, Q&A C.6).

Highly refined oils are excluded

Highly refined oils made from a major food allergen are not major food allergens. Neither are ingredients derived from such oils (21 U.S.C. 321(qq)(2)(A)). A typical example is highly refined soybean oil. The oil still has to be named in the ingredient list.

What changed in January 2025 (Edition 5)

In January 2025 FDA issued Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the FD&C Act (Edition 5). It is guidance, and it changes how FDA reads the law in three ways:

1. Milk and eggs from other animals

• Milk now means milk from domesticated cows, goats, sheep or other ruminants.
• Eggs now means eggs from domesticated chickens, ducks, geese, quail and other fowl.

For animals other than cows and chickens, FDA recommends naming the animal: "goat milk," "whey (goat milk)," "Contains goat milk"; "duck egg," "Contains duck egg" (Edition 5, Q&A C.1–C.4).

2. A shorter tree nut list

Only the tree nuts in Table 1 of Edition 5 are considered major food allergens:

No longer on the list: coconut, beech nut, butternut, chestnut, chinquapin, cola/kola nut, ginkgo nut, hickory nut, palm nut, pili nut, shea nut and lichee nut (FDA allergen FAQ).

• These should not appear in a "Contains" statement, which is reserved for major food allergens.
• They must still be listed in the ingredient list by their common or usual name (Edition 5, Q&A C.8; 21 CFR 101.4).

3. When to update your labels

• Labels that list coconut (or another removed nut) in "Contains": FDA says these can be corrected the next time they are printed, or covered with a sticker (FDA allergen FAQ).
• Goat milk or duck egg left out of "Contains": FDA says to add them, and recommends making the change as soon as practicable (FDA allergen FAQ).
• January 1, 2028 uniform compliance date: this does not apply to the allergen requirements (FDA allergen FAQ).

"May contain" and "free-from" statements

• Advisory statements such as "may contain" or "made in a facility that also processes" are not required by the allergen law (FD&C Act 403(w)). If you use one, it must be truthful and not misleading, and it is not a substitute for good manufacturing practices or allergen controls (Edition 5, Q&A D.12).
• Don't combine "Contains milk" with "may contain milk." FDA calls an advisory statement for an allergen that is already an ingredient potentially misleading (Q&A D.14).
• "Free-from" claims such as "milk-free" must be truthful. FDA expects no milk allergen at all, including from cross-contact. A product with such a claim shouldn't also carry an advisory statement for the same allergen (Q&A D.13).

Using the allergen checklist in FactsReady

The label tool has a checklist for the nine allergens, with pickers for the tree nut type (the Table 1 names above) and for fish and shellfish species. It writes a draft "Contains" statement and reminds you about the type size rule.

For example, an ingredient list with whey (milk), almond flour, coconut oil, sesame seeds, highly refined soybean oil and goat milk produces "Contains: milk, goat milk, almond, sesame." Coconut is left out (Edition 5), and soy is left out because highly refined oils are excluded.

You are responsible for checking the statement against your actual formula and suppliers' documents.

Sources

• 21 U.S.C. 321(qq), 343(w): FD&C Act sections 201(qq) and 403(w)
• FDA, Edition 5 guidance (Jan 2025): https://www.fda.gov/media/117410/download
• FDA, Allergen labeling FAQ: https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/frequently-asked-questions-food-allergen-labeling-guidance-industry
• FDA, Food Allergies: https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/food-allergies

Checked October 22, 2026. FDA guidance is nonbinding. Not legal advice.