[Federal Register: November 2, 2006 (Volume 71, Number 212)]
[Notices]
[Page 64542-64543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no06-50]
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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: rhonda.kane@fda.hhs.gov.
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