Quick answer
An allergen statement names any of the 9 major food allergens an ingredient comes from, either in a Contains line right after the ingredient list, such as Contains wheat, milk, and soy, or in parentheses in the list, as in whey (milk). US law applies this to dietary supplements as well as foods.1,2
Key facts
- The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.1
- Sesame became the ninth on January 1, 2023, under the FASTER Act; products already on shelves then did not have to be relabeled.1
- The label must name the specific tree nut, such as almonds, and the species of fish or shellfish, such as cod or shrimp.1
- A Contains statement must be in type no smaller than the ingredient list.2
- Highly refined oils made from these foods are excluded from the definition of a major food allergen.3
The two ways to declare an allergen
| Format | Example | Where it goes |
|---|---|---|
| Contains statement | Contains wheat, milk, and soy. | Immediately after or next to the ingredient list |
| In the ingredient list | lecithin (soy), flour (wheat), whey (milk) | In parentheses after the ingredient's name |
Nothing more is needed when an ingredient's own name already names the food source, as with buttermilk.1
Flavorings, colorings and incidental additives that contain a major food allergen must be labeled too, even though such ingredients can otherwise be declared by class.2,3
May contain and similar phrases
Phrases such as may contain or produced in a facility that also uses are advisory statements, and no law requires them. FDA says they may be used only for cross-contact that cannot be avoided, must be truthful and not misleading, and are no substitute for good manufacturing practice.1
FDA has not set a threshold for any allergen, that is, a level below which a reaction in an allergic person is unlikely.1
Supplements are covered
FDA enforces these rules for most packaged foods, and its list names dietary supplements. The law applies to foods labeled on or after January 1, 2006.1,3
In a supplement, an allergen can come from a dietary ingredient, such as whey from milk, or from one of the other ingredients, such as lecithin from soy.1,4
If you have a food allergy
FDA advises people with food allergies to read labels and avoid the foods they are allergic to. If you are unsure whether a product contains an allergen, such as sesame on stock labeled before 2023, check with the company named on the label.1
A severe reaction, called anaphylaxis, can involve swelling of the throat and difficulty breathing. Seek medical help at once if that happens.1
Questions people ask
Do supplements have to list allergens?
Yes. The Food Allergen Labeling and Consumer Protection Act covers dietary supplements, so a supplement made with a major food allergen must name the source food.1
Is gluten one of the major allergens?
Wheat is on the list of nine; gluten as such is not. Gluten free claims follow a separate FDA rule.1
What if a label has no may contain statement?
That tells you little, because advisory statements are voluntary. If a product has none of the nine major allergens as ingredients, no Contains line is required either.1
See what we make
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Sources
- U.S. Food and Drug Administration. Food Allergies. Content current as of March 11, 2026. Opened 2026-10-07.
- United States Code, Title 21, Section 343: Misbranded food (paragraphs r(6), s and w). Legal Information Institute, Cornell Law School. Opened 2026-10-07.
- U.S. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), Public Law 108-282, Title II. Content current as of November 29, 2022. Opened 2026-10-07.
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Content current as of August 27, 2026. Opened 2026-10-07.
This page is information, not medical advice. Talk to your doctor or pharmacist about your own situation.