[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Notices]
[Pages 25844-25845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0169]


Guidance for Industry: Guidance on the Labeling of Certain Uses 
of Lecithin Derived From Soy Under the Federal Food, Drug, and Cosmetic 
Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance on the Labeling 
of Certain Uses of Lecithin Derived From Soy Under the Federal Food, 
Drug, and Cosmetic Act'' (the act). The guidance explains FDA's current 
thinking on the labeling of certain uses of lecithin derived from soy 
under the act. This guidance is part of FDA's implementation of the 
Food Allergen Labeling and Consumer Protection Act (FALCPA).

DATES: This guidance is final upon the date of publication. Submit 
written or electronic comments on the guidance document at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Food Additive Safety (HFS-205), Center for Food Safety 
and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, 
301-436-1200, FAX: 301-436-2972. Send one self-addressed adhesive label 
to assist the office in processing your requests. 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. To ensure a timelier processing of comments, FDA is 
no longer accepting comments submitted to the agency by e-mail. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Paul M. Kuznesof, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1289, or e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled

[[Page 25845]]

``Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy 
Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act.'' 
This guidance is part of FDA's implementation of FALCPA (Public Law 
108-282). If a food is not a raw agricultural commodity and it is, or 
it contains an ingredient that bears or contains a major food allergen, 
the food must comply with section 403(w) of the act (21 U.S.C. 343(w)). 
Section 403(w)(1) requires that the food's label declare the name of 
the food source from which the major food allergen is derived in a 
manner specified by that section. This source declaration requirement 
is extended by section 403(w)(4) to any incidental additive that is, or 
that bears or contains, a major food allergen, notwithstanding the 
regulatory exemption for incidental additives in 21 CFR 101.100(a)(3). 
The requirements of section 403(w) of the act apply to foods labeled on 
or after January 1, 2006.

II. Discussion

    The purpose of the guidance document is to provide guidance to the 
industry on the labeling, under section 403(w) of the act, of certain 
uses of lecithin derived from soy in packaged foods. In particular, as 
discussed in the guidance, FDA intends to consider the exercise of 
enforcement discretion for a packaged food labeled on or after January 
1, 2006, in which lecithin derived from soy is used solely as a 
component of a release agent and the label for such food does not 
declare the presence of the lecithin consistent with the requirements 
of section 403(w). FDA intends to consider exercising such discretion 
when all of the factors discussed in the guidance are present.
    FDA is issuing this guidance as level 1 guidance consistent with 
FDA's good guidance practices regulation Sec.  10.115 (21 CFR 10.115). 
Consistent with FDA's good guidance practices regulation, the agency 
will accept comment, but 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, foods labeled on or after January 1, 2006, must 
comply with section 403(w) of the act's labeling requirements.
    This guidance represents the agency's current thinking on the 
labeling of certain uses of lecithin derived from soy under section 
403(w) of the act. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. You may use 
an alternative approach if such approach satisfies the requirements of 
the applicable statutes and regulations. If you want to discuss an 
alternative approach, contact the FDA staff responsible for 
implementing this guidance (see FOR FURTHER INFORMATION CONTACT).

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 ortwo 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. The guidance and received 
comments 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.

    Dated: April 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6551 Filed 5-1-06; 8:45 am]
BILLING CODE 4160-01-S