Document ID: FDA-2014-D-0052-0002
Agency: fda
Document Type: Notice
Title: Food Allergen Labeling Exemption Petitions and Notifications; Guidance
for Industry; Availability
Posted Date: 2015-06-19T04:00Z

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Page 35372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15119]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0052]

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the availability of a draft guidance entitled ``Draft Guidance for 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.

    Dated: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15119 Filed 6-18-15; 8:45 am]
 BILLING CODE 4164-01-P