FALCPA and FASTER Act: Food Allergen Labeling Guide
Learn FALCPA allergen labeling rules, the nine major food allergens, FASTER Act sesame requirements, Contains statements, oils and common mistakes.
FALCPA requires packaged foods sold in the United States to declare the nine "major food allergens" whenever one is present as an ingredient. The requirement comes from the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which wrote allergen disclosure into section 403(w) of the Federal Food, Drug, and Cosmetic Act, and from the FASTER Act of 2021, which added sesame as the ninth allergen effective January 1, 2023. There are exactly two compliant ways to make the disclosure, a parenthetical inside the ingredient list or a separate "Contains" statement, and undeclared allergens remain the leading cause of US food recalls, year after year.
FALCPA allergen labeling covers nine major allergens
- Milk
- Eggs
- Fish, declared by species (e.g. cod, flounder, tuna)
- Crustacean shellfish, declared by species (e.g. shrimp, crab, lobster)
- Tree nuts: declared by the specific nut (almonds, walnuts, pecans), never just "tree nuts"
- Peanuts
- Wheat
- Soybeans
- Sesame (added by the FASTER Act, effective January 1, 2023)
Two details trip people up. First, the species rule: "fish" and "tree nuts" are category headings, and the label must name the specific fish or nut.
Second, the tree nut category itself has narrowed. FDA's updated allergen guidance, finalized in early 2025, trimmed the enforcement list of tree nuts, and coconut is no longer treated as a major-allergen tree nut.
Also note what is not on the US list: molluscan shellfish (oysters, clams, squid), celery, mustard, and lupin are major allergens in other jurisdictions but not under FALCPA.
The two compliant FALCPA disclosure methods
Option 1, parenthetical in the ingredient list
Name the food source in parentheses immediately after the ingredient, the first time it appears:
"Ingredients: enriched flour (wheat), cocoa powder, whey (milk), soy lecithin (soybean)."
If the ingredient name already states the allergen source in plain English ("buttermilk," "wheat flour"), no parenthetical is needed for that ingredient.
Option 2, a separate "Contains" statement
Print a "Contains:" line immediately after, or adjacent to, the ingredient list, in type no smaller than the ingredient list itself:
"Contains: wheat, milk, soy."
The critical rule: if you use a Contains statement at all, it must name every major allergen present in the product. A Contains line that lists wheat and milk but omits the soy lecithin is a misbranded label, even though soy appears in the ingredient list.
Most manufacturers pick Option 2 because it is easier for shoppers to scan, and it is the default in the NFL generator: tick each allergen on the Allergens tab and the statement builds itself.
Derivatives, oils, and FALCPA edge cases
FALCPA applies to any ingredient that contains protein derived from a major allergen, so whey, casein, and milk powder all require a milk declaration, and soy lecithin requires soy.
The one statutory exemption is highly refined oils and ingredients derived from them. Refined soybean oil or refined peanut oil does not trigger a declaration because the refining process removes the allergenic protein. Cold-pressed, expeller-pressed, or flavored oils do not qualify for the exemption.
There is also a petition and notification process under section 403(w) for demonstrating that a specific ingredient does not cause an allergic response, but successful exemptions are rare. For how allergen callouts interact with the rest of the statement, see our guide to writing ingredient statements.
"May contain" and facility statements
Advisory statements ("may contain peanuts," "processed in a facility that also handles tree nuts") are voluntary. FDA has never required them, and they are not a substitute for the cross-contact controls required under current good manufacturing practice.
If you use one, it must be truthful and reflect a genuine, unavoidable risk. FDA has said advisory labeling should not be used as a blanket liability shield. An advisory statement also never replaces the mandatory declaration when an allergen is an actual ingredient.
How US allergen labeling compares internationally
If you export, the allergen list changes at the border. A US-compliant label is not automatically compliant elsewhere:
| Jurisdiction | Mandatory allergens | Notable differences vs US |
|---|---|---|
| United States | 9 | Contains statement permitted |
| European Union | 14 | Adds celery, mustard, lupin, molluscs, sulphites; requires in-list emphasis, no Contains line |
| Canada | 11 priority allergens | Adds mustard and sulphites; bilingual declaration |
| Japan | 8 mandatory | Includes buckwheat and walnut; ~20 more recommended |
The EU approach is covered in depth in our EU 1169/2011 guide, and country-by-country allergen lists are built into all 152 label formats on the coverage page.
Common FALCPA and FASTER Act mistakes that trigger recalls
- Naming the category instead of the species, "tree nuts" instead of "almonds"
- Omitting sesame because the label template predates the FASTER Act
- A Contains statement that misses one allergen already in the ingredient list
- Losing an allergen during a supplier or reformulation change without updating artwork
- Assuming a "may contain" advisory covers an allergen that is actually an ingredient
For the declaration mechanics in more depth, including formatting and the sell-through rules that applied when sesame was added, see the companion piece on FALCPA and FASTER Act declarations, or browse the label FAQ.
FALCPA and allergen labeling frequently asked questions
Is a "may contain" statement ever legally required?
No. FDA has never mandated advisory cross-contact statements. They are voluntary, must be truthful, and cannot substitute for declaring an allergen that is actually present as an ingredient or for the cross-contact controls required by good manufacturing practice.
Do I have to declare an allergen twice if I use a Contains statement?
The allergen ingredient still appears in the ingredient list by its usual name; the Contains statement then names its food source. You do not need parentheticals as well, but if you use a Contains line, it must list every major allergen in the product.
Does gluten-free labeling follow the same rules?
No. "Gluten-free" is a separate voluntary claim regulated under 21 CFR 101.91, requiring less than 20 ppm gluten. Declaring wheat under FALCPA is mandatory when wheat is present; a gluten-free claim is an additional, optional statement with its own criteria.
Ready to build a compliant allergen declaration? Open the free label generator, tick the allergens on the Allergens tab, and the Contains statement writes itself for any of 152 label formats.
