Allergen Labeling
FDA requirements for disclosing the presence of major food allergens on product labels.
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.
Related Terms
FALCPA (Food Allergen Labeling and Consumer Protection Act)
The 2004 federal law requiring clear labeling of major food allergens on packaged foods.
Undeclared Allergen
A major food allergen present in a product but not listed on the label, the leading cause of food recalls in the U.S.
Cross-Contamination
The transfer of harmful bacteria, allergens, or other contaminants from one food, surface, or piece of equipment to another.
Misbranding
When a food product's label is false, misleading, or fails to include required information.
Frequently Asked Questions
What does Allergen Labeling mean?
FDA requirements for disclosing the presence of major food allergens on product labels.
Why is Allergen Labeling important for food safety?
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 eig...