Allergen Labeling

What It Means

Allergen labeling refers to the legal requirements for identifying the presence of major food allergens on food product labels in the United States. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires that food labels clearly identify if a product contains any of the eight original major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. In 2023, the FASTER Act added sesame as the ninth major food allergen requiring mandatory labeling. These allergens must be declared either in the ingredient list using their common names or in a separate "Contains" statement immediately following the ingredient list, for example, "Contains: milk, wheat, soy." Failure to properly label allergens is one of the most common reasons for food recalls in the United States, often resulting in Class I recalls because undeclared allergens can cause severe allergic reactions, including anaphylaxis, which can be fatal. Food manufacturers must have systems in place to ensure accurate allergen labeling, including reviewing ingredient formulations, monitoring supplier changes, verifying label accuracy, and preventing allergen cross-contamination during production. The FDA enforces allergen labeling requirements through inspections, label reviews, and recall actions when violations are identified.