FDA Allergen Labeling: The Nine Major Allergens and What the FASTER Act Changed

Allergen labeling is one of the most common reasons food shipments are refused entry at US ports, and it is one of the most frequent triggers for FDA Warning Letters and mandatory recalls. The United States requires declaration of nine major food allergens on the labels of all packaged foods regulated by the FDA. Foreign manufacturers who export to the US must understand that allergen labeling rules in the United States differ significantly from those in the EU, Japan, Australia, and other major markets — and that a label compliant in another jurisdiction is almost never sufficient for the US market without modification.

The nine major allergens under US law

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) established the original eight major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act (Food Allergy Safety, Treatment, Education, and Research Act), signed into law on April 23, 2021, added sesame as the ninth major allergen effective January 1, 2023. Any packaged food regulated by FDA that contains a major allergen as an ingredient — whether as a primary component or as a sub-ingredient of a compound ingredient — must declare that allergen on the label. The declaration must use the specific common name of the allergen source (for example, 'milk' rather than 'casein,' or 'wheat' rather than 'semolina').

Tree nuts must be identified by their specific type — almond, cashew, walnut, pecan, pistachio, macadamia, Brazil nut, hazelnut, chestnut, and so on. Fish must be identified by species (such as 'bass,' 'cod,' or 'tilapia'). Crustacean shellfish must be identified by species (such as 'shrimp,' 'crab,' or 'lobster'). This specificity requirement is stricter than allergen labeling rules in many other countries, where broader category declarations may be acceptable.

How allergens must be declared on the label

FALCPA provides two acceptable methods for declaring major allergens. The first method is to include the allergen source name in parentheses immediately after the ingredient in the ingredient list — for example, 'sodium caseinate (milk)' or 'lecithin (soy).' The second method is to place a separate 'Contains' statement immediately after or adjacent to the ingredient list — for example, 'Contains: milk, wheat, soy.' If a manufacturer chooses to use a 'Contains' statement, it must list all major allergens present in the product, not just those that are not already clearly identified in the ingredient list. Manufacturers may use both methods simultaneously, but the 'Contains' statement must be complete if used.

The allergen declaration must appear on the same label panel as the ingredient list (typically the information panel), and it must be in a type size no smaller than the type size used for the ingredient list. The declaration must be in English, and if the label includes text in another language, the allergen declaration must appear in both English and the other language. Allergen declarations that are incomplete, that use scientific rather than common names, or that are placed in locations where consumers cannot easily find them are all grounds for the product to be considered misbranded under Section 403(w) of the FD&C Act.

What the FASTER Act changed about sesame

Before the FASTER Act, sesame was not classified as a major allergen in the United States, even though it was already recognized as a major allergen in the EU, Canada, Australia, and many other jurisdictions. The FASTER Act changed this by amending Section 201(qq) of the FD&C Act to add sesame to the list of major food allergens. The effective date of January 1, 2023 meant that all food labels printed after that date must include sesame in the allergen declaration if sesame is present in the product. Products with labels printed before that date were given a reasonable period to transition, but as of 2026, there is no tolerance for non-compliant labels.

The sesame addition created significant challenges for food manufacturers because sesame can appear in products under many names — tahini, halvah, sesame oil, sesame seeds, sesame flour — and it is a common ingredient in seasonings, bread products, hummus, and Asian sauces. Some manufacturers had historically listed sesame under its botanical name (Sesamum indicum) or under less common names that consumers might not recognize as sesame. Under the FASTER Act, the declaration must use the word 'sesame' in plain English, regardless of what form the sesame ingredient takes.

Precautionary allergen labeling — may contain statements

Advisory statements such as 'may contain traces of peanuts' or 'manufactured in a facility that also processes tree nuts' are voluntary and are not regulated by FALCPA or the FASTER Act. The FDA does not require precautionary allergen labeling, but it does expect that any advisory statements used are truthful and not misleading. The FDA has issued guidance indicating that advisory labeling should not be used as a substitute for good manufacturing practices — if a manufacturer can prevent cross-contact through proper cleaning, segregation, and scheduling, an advisory statement should not be used in place of those controls. Advisory labeling should reflect a genuine, unavoidable risk of cross-contact that cannot be eliminated through reasonable manufacturing controls.

How FDABridge helps with allergen label compliance

FDABridge offers food label review services that include comprehensive allergen declaration review against current FALCPA and FASTER Act requirements. Our team evaluates your ingredient lists, verifies that all major allergens are properly declared using FDA-required common names, and identifies cross-contact risks that may need advisory labeling. Visit fdabridge.com/food to learn more about our food labeling services or fdabridge.com/contact to request a label compliance review.