The nine major food allergens
FDA identifies nine major food allergens for U.S. labeling: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame became the ninth major allergen under the FASTER Act, effective January 1, 2023. These rules apply to many FDA-regulated packaged foods and dietary supplements.
The label needs to disclose the food source of a major allergen when that allergen is present as an ingredient or as part of an ingredient. The disclosure can be made in the ingredient list using parentheses, in a Contains statement, or through the common or usual name when it already identifies the allergen clearly.
- Milk
- Eggs
- Fish
- Crustacean shellfish
- Tree nuts
- Peanuts
- Wheat
- Soybeans
- Sesame
Basic Contains format
A typical Contains statement begins with Contains followed by the allergen food source names, such as Contains: Milk, Egg, Wheat, Soy. It should appear immediately after or adjacent to the ingredient list and use a type size no smaller than the ingredient list. Keep the punctuation and capitalization simple and consistent.
Do not list only brand names, technical ingredients or supplier shorthand. Whey should connect to milk, albumin should connect to egg, and tahini should connect to sesame if the allergen source is not otherwise clear. For tree nuts, fish and Crustacean shellfish, the specific type can matter, so review the FDA guidance and ingredient identity.
Parenthetical option
Instead of a Contains statement, a label can identify the allergen source in parentheses after the ingredient name, such as whey (milk), flour (wheat) or lecithin (soy). This works best when every allergen source is handled clearly and the ingredient list stays readable.
Many small brands prefer to use both clear parentheticals where needed and a final Contains statement as a check for customers. If you do both, they must agree. A Contains statement that omits an allergen shown in the ingredient list creates confusion and risk.
- Ingredient list: Whey (milk)
- Contains statement: Contains: Milk
- Do not let the two methods conflict.
May contain is different
A Contains statement declares allergens that are ingredients. A may contain or manufactured in a facility statement is precautionary allergen labeling for possible cross-contact. It is not a substitute for declaring a major allergen that is actually an ingredient.
Precautionary statements should be truthful and not misleading. Do not use a blanket may contain every allergen statement to avoid sanitation or label controls. Allergen cross-contact prevention, supplier control and label verification are part of the operational system behind the label.
Common ingredient traps
Compound ingredients are a frequent source of mistakes. Chocolate chips may contain milk or soy lecithin. Bread crumbs may contain wheat, milk or sesame. Sauces may contain fish, shellfish, soy or wheat. Spice blends and flavors may have carrier ingredients that need review. Do not rely on the front name of a purchased ingredient.
Another trap is supplier substitution. If your co-packer replaces one chocolate chip with another, the allergen statement may change. If your bakery changes from a plain bun to a sesame bun, sesame must be declared. Keep supplier specifications and final labels tied together.
Label review checklist
Before printing, compare the formula, supplier specs, ingredient list and Contains statement line by line. Confirm spelling, allergen source names, tree nut or fish species details where needed, and placement. Check that the Contains statement is not separated from the ingredient list by marketing copy or a barcode.
Finally, check online listings and sell sheets. FDA allergen labeling focuses on labels and labeling, and undeclared allergens are a major cause of recalls. A clean printed label helps, but your process should also prevent old images, wrong descriptions and stale spec sheets from staying in circulation.
Frequently asked questions
What should a Contains statement look like?
A common format is Contains: Milk, Egg, Wheat, Soy. It should be adjacent to the ingredient list and match the allergens in the formula.
Is sesame a major allergen in the U.S.?
Yes. Sesame became the ninth major U.S. food allergen effective January 1, 2023.
Can I use may contain instead of Contains?
No. May contain is precautionary cross-contact wording. It does not replace required declaration of allergens that are ingredients.
Do I need to name the tree nut?
Tree nut declarations can require the specific type, such as almond or walnut. Check the ingredient and FDA guidance.
Can a dietary supplement need allergen labeling?
Yes. Dietary supplements can be subject to food allergen labeling requirements.