Food Allergens: Detection and the Importance of Validation in the Application of Analytical Methods

Eric A.E. Garber

Center for Food Safety and Applied Nutrition, U.S. FDA, College Park, MD 20740

Food allergies afflict millions of people with no known remedy other than the avoidance of foods that contain the particular allergen. Incident rates for food allergies have been estimated at 3 - 4% for adults and 6 - 8% for children younger than 3 years. The Food Allergen Labeling and Consumer Protection Act (FALCPA, Public Law 108-282) required foods labeled on or after January 1, 2006 to disclose the presence of the Big Eight Major Allergens (peanuts, egg, milk, wheat, soybeans, fish, crustacean shellfish, and tree nuts). Analytical methods that accurately and reliably detect the presence of allergenic foods / ingredients are needed to effectively meet the needs of the Food and Drug Administration in its mission to safeguard the food supply. Current efforts to evaluate commercial test kits for the detection of food allergens, facilitate the availability of validated methods for the detection of food allergens, and the scientific application of test kits will be discussed.