FDA to Require Food Manufacturers to List Food Allergens

Consumers with Allergies Will Benefit From Improved Food Labels

Effective January 1, 2006, the Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods. As a result of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say “contains” followed by name of the source of the food allergen after or adjacent to the list of ingredients.

“I applaud Congress for the passage of FALCPA,” said Andrew C. von Eschenbach, M.D., Acting FDA Commissioner. “Chairman Joe Barton and Ranking Member John D. Dingell in the House, Energy and Commerce Committee were instrumental in moving this bipartisan legislation forward. Representative Nita Lowey was the original sponsor of the legislation. FDA also applauds the dedication and leadership of the legislation’s sponsors in the Senate, which include Senators Judd Gregg and Edward Kennedy.”

This labeling will be especially helpful to children who must learn to recognize the presence of substances they must avoid. For example, if a product contains the milk-derived protein, casein, the product’s label will have to use the term “milk” in addition to the term “casein” so that those with milk allergies can clearly understand the presence of the allergen they need to avoid.

It is estimated that 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies. Approximately 30,000 consumers require emergency room treatment and 150 Americans die each year because of allergic reactions to food.

“The eight major food allergens account for 90 percent of all documented food allergic reactions, and some reactions may be severe or life-threatening,” said Robert E. Brackett, PhD, Director of FDA’s Center for Food Safety and Applied Nutrition. “Consumers will benefit from improved food labels for products that contain food allergens.”

FALCPA does not require food manufacturers or retailers to relabel or remove from grocery or supermarket shelves products that do not reflect the additional allergen labeling as long as the products were labeled before the effective date. As a result, FDA cautions consumers that there will be a transition period of undetermined length during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

Contact Information

Susan Cruzan

Food and Drug Administration (FDA)

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