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Regulation & Compliance

FALCPA (Food Allergen Labeling and Consumer Protection Act)

The 2004 federal law requiring clear labeling of major food allergens on packaged foods.

What It Means

The Food Allergen Labeling and Consumer Protection Act (FALCPA), enacted in 2004 and effective January 1, 2006, is the primary federal law governing food allergen labeling in the United States. FALCPA amended the Federal Food, Drug, and Cosmetic Act to require that food labels clearly identify the presence of any of the major food allergens. Originally, FALCPA covered eight allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 added sesame as the ninth major allergen, effective January 1, 2023. Under FALCPA, allergens must be declared in one of two ways: by using the common name of the allergen in the ingredient list (for example, "casein (milk)"), or by including a "Contains" statement immediately after or adjacent to the ingredient list. FALCPA applies to all packaged foods regulated by the FDA, which includes most food products except meat, poultry, and certain egg products (which are regulated by the USDA). FALCPA has significantly improved food safety for the estimated 32 million Americans with food allergies by making it easier to identify allergens in packaged foods. Violations of FALCPA requirements can result in product recalls, FDA warning letters, and legal action. Undeclared allergens remain the number-one cause of food recalls in the United States.

Related Terms

Frequently Asked Questions

What does FALCPA (Food Allergen Labeling and Consumer Protection Act) mean?

The 2004 federal law requiring clear labeling of major food allergens on packaged foods.

Why is FALCPA (Food Allergen Labeling and Consumer Protection Act) important for food safety?

The Food Allergen Labeling and Consumer Protection Act (FALCPA), enacted in 2004 and effective January 1, 2006, is the primary federal law governing food allergen labeling in the United States. FALCPA amended the Federal Food, Drug, and Cosmetic Act to require that food labels clearly identify the p...

this entity is one of the U.S. FDA food, drug, and device recalls concepts that recurs across this site. The definition above is the technical answer; the paragraphs below add the practical context for how the concept connects to the the FDA openFDA enforcement-report API data behind every per-entity page on the site.

In the the FDA openFDA enforcement-report API data, this concept shapes one or more of the fields that drive the per-entity grades and rankings on this site. The methodology page describes which fields feed into which output; this glossary entry documents the underlying term.

Source: FDA Recalls, Market Withdrawals and Safety Alerts, 2026.