Question 1

What are the FDA Big 9 allergens?

Accepted Answer

Milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame is the ninth and newest: the FASTER Act added it as a major food allergen with effect from 1 January 2023. Molluscan shellfish such as clams, oysters and scallops are not on the US list, though they are covered in the EU and several other markets, so a product exported from the US may need a longer declaration than its domestic label carries.

Question 2

Does a "Contains" statement have to appear on the label?

Accepted Answer

One of two forms is required, not both. Either each major allergen is named in parentheses inside the ingredient list, or a separate "Contains" statement appears immediately after or adjacent to it. If you use the "Contains" statement it must list every Big 9 allergen present in the food, including those already obvious from an ingredient name. The statement sits alongside the ingredient list, never in place of it.

Question 3

Do I have to declare the specific type of tree nut or fish?

Accepted Answer

Yes. The specific species is required: "almond" rather than "tree nut", "cod" rather than "fish". The same applies to Crustacean shellfish. Grouping them under the category name is one of the more common reasons a US label is found non-compliant, and it is also the detail an importer in another market is most likely to query.

Question 4

Are "may contain" statements regulated?

Accepted Answer

No. Precautionary allergen labelling is voluntary in the United States, and FDA has not defined the wording or set a threshold that triggers it. It therefore cannot substitute for allergen controls in the plant, and it cannot be used to cover an allergen that is genuinely an ingredient. Several other markets are moving toward defining these statements, so check the destination market rather than assuming the US position travels.

Question 5

Does this tool replace an allergen review?

Accepted Answer

No. It reads the ingredient statement you paste and flags the Big 9 terms it recognises, including many derivative names. It cannot know your processing aids, your rework, your shared equipment or a supplier change you have not told it about. Treat the output as a first pass over the wording and keep the plant-level allergen assessment where it belongs.

Allergen Detection

Ingredient list

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The FDA Big 9 allergens

The rules this tool implements

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