On May 7, 2014, FDA issued draft guidance, published in the May 8, 2014 edition of the Federal Register, entitled Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications. The guidance is intended to assist industry in preparing submissions that seek exemptions from the labeling requirements for ingredients derived from major food allergens. Federal law requires that food labels identify products containing major food allergens, such as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. However, because ingredients derived from major food allergens may be modified to the extent that they do not trigger an allergic response, the law allows for two pathways through which a manufacturer can obtain an exemption from allergen labeling. The guidance attempts to address the relevant issues for manufacturers seeking an exemption. Comments must be submitted by September 5, 2014, to ensure consideration by FDA before it begins to work on the final version of the guidance.
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