FDA Drafts Industry Guidance on Food Allergen Labeling Exemptions

The U.S. Food and Drug Administration (FDA) has issued draft guidance intended to help the food industry prepare submissions for obtaining exemptions from the labeling requirements for major food allergens.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 apparently provides two processes through which manufacturers can obtain an exemption from this labeling requirement for a specific ingredient.

An ingredient may be exempted through submission and approval of either (i) a petition containing scientific evidence which demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health”; or (ii) a notification containing scientific evidence demonstrating that the ingredient “does not contain allergenic protein” or that a premarket approval process under section 409 of the Food, Drug, and Cosmetic Act (21 U.S.C. 348) has previously determined that the ingredient “does not cause an allergic response that poses a risk to human health.” FDA will accept comments about the guidance at any time, but suggests submitting them by September 5, 2014, to ensure consideration before the agency works on the final version. See Federal Register, May 8, 2014.

Issue 523