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How Low Do You Go? Food Allergen Thresholds

Millions of Americans have allergic reactions to food every year. While most food allergies cause relatively mild and minor symptoms, some food allergies may provoke reactions that are life-threatening. There is no cure for food allergies, so strict avoidance of food allergens is an important measure to prevent serious health consequences. The Food and Drug Administration (FDA) is responsible for the safety of the food supply for Americans, including those consumers with food allergies.

An allergic reaction to food occurs when the body’s immune system mounts a strong, rapid response to a specific food protein to which the body has become sensitized. Consumption of the food protein may trigger the immune system’s sudden release of histamine and other immediate-release chemicals, resulting in an allergic reaction. The reaction may be mild, resulting in a rash, hives, itching, or swelling or; the reaction may be sudden and severe, causing troubled breathing, wheezing, loss of consciousness, and potentially, death. Scientists estimate that as many as 15 million Americans suffer from food allergies. Although some people have a diminished response to food allergies as they mature, there is currently no cure for food allergy; consumers that have allergic reactions to certain foods must use avoidance to prevent allergic reactions.

Eight foods account for 90 percent of all food-allergic reactions. They are milk, egg, peanut, tree nuts (e.g., almonds, pecans, walnuts), fish (e.g., bass, cod, flounder), Crustacean shellfish (e.g., crab, lobster, shrimp), soybeans and wheat. Some people may outgrow the allergic response to certain allergens, but others will remain allergic to certain foods for life.1 These eight foods have been defined as major food allergens in the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. FALCPA also stated that food regulated under the Food, Drug and Cosmetic Act are misbranded unless they declare the presence of major food allergens on the product label, using the common or usual name of the major food allergen, as allergic consumers must use avoidance to prevent allergic reactions. Excluded from the definition is any highly refined oil derived from a major allergic food (such as peanut or soy) and any ingredient derived from the highly refined oil.

FDA established a Federal Register docket in December of 20122 to obtain comments on the information necessary to conduct a risk assessment to establish regulatory thresholds for the major food allergens. The comment period for collecting information on developing allergen thresholds has been extended, with the agency accepting comments through May 13, 2013.3 There are two mechanisms outlined in FALCPA through which ingredients may be deemed to be exempt from the major food allergen labeling requirement. First, an individual may petition for exemption by providing scientific evidence that the ingredient “does not cause an allergic response that poses a risk to human health.”4 Alternatively, a notification may be submitted that either provides scientific evidence showing that an ingredient does not contain allergenic protein, or that, through the premarket approval process, a determination has been made that the ingr