More than 160 foods can cause allergic reactions, and it is estimated that 5 million to 12 million Americans suffer from food allergies. This corresponds to 4% to 8% of children and 1% to 3% of adults. An allergic reaction to food occurs when a person’s immune system attacks a food substance, usually a protein. The U.S. Food and Drug Administration (FDA) estimates that 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths occur from food-related anaphylaxis annually.1 At present there is no cure for food allergies, so strict avoidance is the only way for a consumer to avoid an allergic reaction.
In order to help American consumers avoid the eight major allergens listed by the FDA, Congress passed the Food Allergen Labeling and Consumer Protection Act in 2004 (Public Law 108-282, Title II).2 This law, which mostly amends sections 403 and 201 of the Federal Food Drug and Cosmetic Act of 1938, became effective Jan. 1, 2006. The law requires labeling of the eight major allergens, which together cause 90% of allergic reactions to food in the U.S. The major allergens are crustacean shellfish, eggs, fish, milk, peanuts, soy, tree nuts, and wheat.
In the U.S., some of these allergens have been specifically defined. Milk in the U.S. is an ingredient derived from cows, as per the 21 Code of Federal Regulations (CFR), section 131.10. The Egg Products Inspection Act defines an egg as a shell egg of a domesticated chicken, turkey, duck, goose, or guinea fowl. The FDA defines crustacean shellfish as crabs, crayfish, lobsters, or shrimps. Tree nuts are defined by the FDA in a list that includes almond, beech nut, Brazil nut, butternut, cashew, chestnut, coconut, filbert (hazelnut), ginko nut, hickory nut, lichee nut, macadamia (bush nut), pecan, pine nut (piñon), pistachio, shea nut, and walnut. The FDA defines wheat as common wheat, durum wheat, club wheat, spelt, semolina, Einkorn, emmer, kamut, and triticale.
Outside the U.S.
In the U.S., ingredients like gluten, sulfites, and yellow No. 5 are not considered allergens but rather as sensitizing or intolerant ingredients and have their own specific labeling requirements. In other countries, different food items are recognized as allergens. In the European Union, the eight major allergens listed by the FDA are regarded as allergens, along with celery, mustard, sesame seeds, lupin, mollusks (e.g., clams and oysters), and sulfites.3
Some allergens, such as lentils—the fourth most common cause of allergic reactions in Spanish children and the fifth leading food allergen in India—can cause reactions that range from mild to severe.4 As more people from countries that use lentils in their diets settle in the U.S., this food allergy is seen more frequently. Rice, a common allergen in countries in which it is a staple food, is a less common allergen in the U.S., although the incidence of rice allergy is rising along with the increase in its consumption. Corn can trigger an allergic reaction, but the reactions are usually mild, though there have been cases of anaphylaxis related to corn and corn products.
The American Academy of Pediatrics (AAP) recently published a study that lists the frequency with which common allergens appear in children: 2% for peanut, 1.7% for milk, 1% for tree nuts, 0.8% for eggs, 0.5% for fin fish, 0.4% for strawberries, 0.4% for wheat, and 0.4% for soy.5 This research shows that, other than the inclusion of strawberries rather than crustaceans, the AAP’s list is in line with the FDA’s top eight allergens. Shellfish replace strawberries on the FDA list because 2% of adults are estimated to be allergic to shellfish.
U.S. law requires allergens to be listed on the packaging in one of two ways. The first method of labeling for allergens is a “contains” statement that immediately follows the ingredient list. The second method lists the allergen in parentheses immediately after the actual ingredient that contains the allergen, except when the name in the ingredient list specifies the allergen or when the allergen is already listed in the ingredient statement. For allergens from tree nuts, fish, and crustacean shellfish, the type or species of the allergen must be listed as part of the allergen declaration. Additionally, the law requires all ingredients that are derived from the allergen, including spices, flavorings, colorings, and incidental food additives, to comply with these regulations.