[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Notices]
[Pages 64542-64543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0490]


Guidance for Industry: Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling and Consumer Protection 
Act of 2004 (Edition 4); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance document entitled ``Guidance for 
Industry: Questions and Answers Regarding Food Allergens, including the 
Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 
4).'' The guidance explains, using a question and answer format, FDA's 
current thinking on a number of issues related to the regulation of 
food allergens, including implementation of the Food Allergen Labeling 
and Consumer Protection Act of 2004 (FALCPA).

DATES:  Submit written or electronic comments on the agency guidance at 
any time.

ADDRESSES: Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Rhonda R. Kane, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371, or by e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The FALCPA (Public Law 108-282) amends the Federal Food, Drug, and 
Cosmetic Act (the act) and requires that the label of a food product 
that is, or that contains, an ingredient that bears or contains a 
``major food allergen'' declare the presence of the allergen as 
specified by FALCPA. FALCPA defines a ``major food allergen'' as one of 
eight foods or food groups or a food ingredient that contains protein 
derived from one of those foods or food groups. A food ingredient may 
be exempt from FALCPA's labeling requirements if it does not cause an 
allergic response that poses a risk to human health or if it does not 
contain allergenic protein. FALPCA's labeling requirements apply to 
products labeled on or after January 1, 2006.

II. Discussion

    FDA has received numerous questions about the application of 
FALCPA's requirements to food products. To explain FALCPA's 
requirements as well as FDA's current thinking on several issues 
relating to the regulation of food allergens, on October 5, 2005, FDA 
posted on the agency's Web site the first edition of a guidance 
entitled ``Guidance for Industry: Questions and Answers Regarding Food 
Allergens, including the Food Allergen Labeling and Consumer Protection 
Act of 2004'' (http://www.cfsan.fda.gov/~dms/alrguid.html). This 
guidance was subsequently updated in December 2005 (Edition 2) and 
April 2006 (Edition 3). The guidance that is the subject of this 
document ``Guidance for Industry: Questions and Answers Regarding Food 
Allergens, including the Food Allergen Labeling and Consumer Protection 
Act of 2004 (Edition 4),'' responds to additional questions about 
FALCPA and food allergens. The revised guidance is intended to share 
FDA's current thinking on the additional questions presented in the 
guidance.
    Given the nature of the revisions to the guidance, FDA is issuing 
the guidance as a level 1 guidance. Consistent with FDA's good guidance 
practices regulation (Sec.  10.115 (21 CFR 10.115)), the agency will 
accept comments, but it is implementing the guidance document 
immediately, in accordance with Sec.  10.115(g)(2), because the agency 
has determined that prior public participation is not feasible or 
appropriate. As noted, FALPCA's labeling requirements apply to products 
labeled on or after January 1, 2006. Clarifying FDA's current thinking 
on the additional issues presented by FALCPA's implementation will help 
facilitate the food industry's compliance with FALCPA's requirements.
    FDA expects to continue to receive questions regarding the 
implementation of FALCPA and the regulation of food allergens 
generally. The agency intends to respond to these inquires under

[[Page 64543]]

Sec.  10.115 as promptly as possible, using a question-and-answer 
format. The agency believes that, at the present time, it is reasonable 
to maintain all responses to questions concerning food allergens and 
FALCPA in a single document that is periodically updated as the agency 
receives and responds to additional questions. The following four 
indicators will be employed to help users of the guidance identify 
revisions: (1) The guidance will be identified as a revision of a 
previously issued document, (2) the revision date of the guidance will 
appear on its cover, (3) the edition number of the guidance will be 
included in its title, and (4) questions and answers that have been 
added to the original guidance will be identified as such in the body 
of the guidance.
    This guidance represents the agency's current thinking on issues 
related to FALCPA and food allergens generally that are presented in 
the guidance. The guidance does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance 
at any time. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments and the 
guidance may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.cfsan.fda.gov/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18443 Filed 11-1-06; 8:45 am]
BILLING CODE 4160-01-S