The short answer
U.S. law names 9 major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame became the ninth on January 1, 2023 under the FASTER Act. Every packaged food and dietary supplement sold in the U.S. must declare any of these it contains — either in the ingredient list or in a “Contains” statement. A missing allergen is a common reason for FDA detention (FDA charge “ALLERGEN”) and for recalls.
The 9 major food allergens
- Milk
- Eggs
- Fish
- Crustacean shellfish
- Tree nuts
- Peanuts
- Wheat
- Soybeans
- Sesame
Two ways to declare allergens
The Federal Food, Drug, and Cosmetic Act allows two methods. You can use either one, or both:
| Method | Example | Notes |
|---|---|---|
| In the ingredient list | Ingredients: wheat flour, sugar, butter (milk), lecithin (soy), tahini (sesame) | Put the allergen source in parentheses after an ingredient whose name does not already show it. |
| “Contains” statement | Contains: wheat, milk, soy, sesame. | Placed right after or next to the ingredient list. If you use one, it must list all the major allergens in the product. |
Name the type for tree nuts, fish and shellfish
For three allergen groups, the law requires the specific type:
- Tree nuts: the nut — for example almond, cashew, walnut, pecan, pistachio or hazelnut. “Contains: tree nuts” is not enough.
- Fish: the species — for example tuna, salmon, cod or anchovy.
- Crustacean shellfish: the species — for example shrimp, crab or lobster. Molluscs such as oysters, clams and squid are not major allergens under U.S. law (but must still be in the ingredient list).
What changed in FDA’s 2025 allergen guidance
On January 6, 2025, FDA finalized the fifth edition of its food allergen Q&A guidance. Three points matter for exporters:
- 1Coconut is no longer a “tree nut”FDA no longer treats coconut, kola nut, shea nut, chestnut, ginkgo, hickory, beechnut, butternut, chinquapin, palm nut or pili nut as tree nuts for allergen labeling. Coconut still goes in the ingredient list, but it should not appear in a “Contains” statement as a major allergen.
- 2Milk from goats and sheep is “milk”Milk from goats, sheep and other domesticated ruminants counts as the allergen milk. Name the animal: for example “whey (goat milk)” or “Contains: sheep milk”.
- 3Eggs from ducks, quail and other birds are “eggs”Name the bird: for example “Contains: duck egg”.
Example: a cheese from Greece
A feta made from sheep and goat milk must declare milk and name the animals, for example: “Ingredients: pasteurized sheep milk, goat milk, salt, cultures, rennet. Contains: sheep milk, goat milk.” A label that says only “sheep’s cheese” with no allergen declaration is misbranded.
“May contain” statements
Precautionary statements such as “may contain peanuts” or “made in a facility that also processes sesame” are voluntary and not required by U.S. law. FDA’s guidance says:
- Allergens present only through cross-contact do not have to be in the ingredient list or “Contains” statement.
- Do not put an allergen that is an intentional ingredient in a “may contain” statement — it must be declared properly.
- Do not use a “free from” claim and a “may contain” statement for the same allergen.
“May contain” is not a substitute for good allergen control at the factory. FDA’s preventive controls rules expect facilities to manage allergen cross-contact.
Common mistakes on imported labels
- Using an EU-style label where allergens are only bold in the ingredient list, with no parenthesis or “Contains” statement where needed
- Missing sesame — especially in breads, crackers, sauces, tahini, halva and spice blends
- Writing “nuts” instead of naming each tree nut
- Writing “fish sauce” or “shrimp paste” without the fish or shellfish species
- Leaving out allergens hidden in sub-ingredients — flavorings, seasonings, coatings, chocolate pieces or enzymes
- A “Contains” statement that lists only some of the allergens
Our Basic FDA label review checks your allergen declaration (including sesame), ingredient list and net quantity on your own artwork. $250 per product.
Frequently asked questions
What are the 9 major food allergens in the US?
Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added on January 1, 2023 under the FASTER Act.
Is coconut a tree nut for FDA labeling?
No, not since FDA’s final allergen guidance of January 6, 2025. Coconut must still be listed as an ingredient, but it is not declared as a tree nut allergen.
Do dietary supplements need allergen labeling?
Yes. Packaged foods and dietary supplements must declare the major food allergens they contain, including sesame.
Is “may contain” required?
No. Precautionary allergen statements are voluntary. They must be truthful and must not replace the required declaration of allergens that are intentional ingredients.
Sources
- FDA — FASTER Act: Sesame is the ninth major food allergen
- FDA — Allergic to sesame? Food labels now must list sesame as an allergen
- FDA — Questions and Answers Regarding Food Allergens, Edition 5 (final guidance, January 2025; copy hosted by FARRP)
- Covington — FDA finalizes two guidance documents related to food allergens (January 2025)
Dates and requirements checked against FDA sources on November 11, 2026. This article is general information, not legal advice.