US FDA issues Draft Guidance on Food Allergen Labeling Exemption Petitions and Notifications


The US Food and Drug Administration (FDA) has issued draft guidance on May 7, Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications, that is intended to help industry prepare submissions that seek exemptions from the labeling requirements for ingredients derived from major food allergens.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans). Because an ingredient derived from a major food allergen may be modified to such an extent that it does not contain allergenic protein or does not cause an allergic response that poses a risk to human health, FALCPA provides for two processes through which a manufacturer can obtain an exemption from this labeling requirement for a specific ingredient.

The FDA release noted that the draft guidance is intended to help industry prepare comprehensive submissions to allow FDA to expeditiously evaluate whether the ingredients meet the exemption standards in FALCPA. Companies that have demonstrated to FDA that an ingredient qualifies for a labeling exemption are able to use that ingredient, derived from a major food allergen, in food products with no accompanying allergen declaration on the food label, and, as such, expand the variety of food products available to food-allergic consumers.

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