Food Allergen Labeling Exemption Petitions and Notifications; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (“FDA” or “we”) is announcing the availability of a guidance for industry entitled “Food Allergen Labeling Exemption Petitions and Notifications.” This guidance explains FDA's current thinking on the preparation of regulatory submissions for obtaining exemptions for ingredients from the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (FD&C Act) through submission of either a petition or a notification.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Richard Bonnette, Center for Food and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1235.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 8, 2014 (79 FR 26435), we announced the availability of a draft guidance entitled “Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications” and gave interested parties an opportunity to submit comments on the draft guidance at any time and comments on the proposed collection of information by September 25, 2014. We received several comments and revised the guidance accordingly.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Pub. L. 108-282) amended the FD&C Act by defining the term “major food allergen” and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergens on the product label using the common or usual name of that major food allergen. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) now defines a major food allergen as “[m]ilk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans” and also as a food ingredient that contains protein derived from such foods. The definition excludes any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil.

In some cases, the production of an ingredient derived from a major food allergen may eliminate the allergenic proteins in that derived ingredient such that it is not a risk for food allergic individuals. In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that presents a risk for food allergic individuals. Therefore, FALCPA provides two mechanisms through which such ingredients may become exempt from the labeling requirement of section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)). An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on Food Allergen Labeling Exemption Petitions and Notifications. It does not create or confer any rights for or on any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0792.

III. Comments

Interested persons may submit either electronic comments regarding the guidance to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.