[Federal Register Volume 67, Number 236 (Monday, December 9, 2002)]
[Notices]
[Page 72963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0462]


Food Labeling: Nutrient Content Claims; Implied Nutrient Content 
Claim in the Brand Name CARBOLITE; Availability of Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a petition submitted by Carbolite Foods, 
Inc. (the petitioner), for the use of an implied nutrient content claim 
in their brand name CARBOLITE.

DATES: Submit written or electronic comments on the petition by January 
8, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. The petition is available for review at the Dockets 
Management Branch or electronically on the agency's Web site at http://www.fda.gov/ohrms/dockets. You also may request a copy of the petition 
from the Dockets Management Branch.

FOR FURTHER INFORMATION CONTACT: Constance Henry, Office of Nutritional 
Products, Labeling and Dietary Supplements, Center for Food Safety and 
Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD, 20740-3835, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 403(r)(4)(A)(iii) of the Federal Food, Drug and Cosmetic 
Act (the act) (21 U.S.C. 343(r)(4)(A)(iii)), provides that any person 
may petition the Secretary of Health and Human Services (and by 
delegation FDA) for permission to use an implied claim characterizing 
the level of a nutrient (nutrient content claim) in a brand name. Under 
Sec.  101.69(o)(3) (21 CFR 101.69(o)(3)), FDA will publish a notice of 
the petition in the Federal Register announcing its availability to the 
public and seeking comment on the petition. Within 100 days of the date 
of receipt of a petition accepted for review, FDA will notify the 
petitioner by letter of its decision to: (1) Grant the petitioner 
permission to use the proposed brand name, if such use is not 
misleading, specifying any conditions or limitations on such use, or 
(2) deny the petition, stating the reasons for the denial.
    FDA must grant the petition if it finds that the petitioned claim 
is not misleading and is consistent with terms defined by regulation 
under section 403(r)(2)(A)(i) of the act. If FDA fails to notify the 
petitioner of its decision to grant or deny the petition within the 
100-day period, the petition shall be considered to be granted. We have 
determined this 100-day deadline to be January 15, 2003.

II. Nutrient Content Claim in a Brand Name Petition

    Carbolite Foods, Inc., submitted a petition to FDA on October 7, 
2002, under section 403(r)(4)(A)(iii) of the act (Sec.  101.69(o)) 
seeking permission to use its brand name CARBOLITE as an implied 
nutrient content claim in a brand name.
    In accordance with Sec.  101.69(o), Carbolite's petition for a 
nutrient content claim in a brand name must identify the implied 
nutrient content claim for CARBOLITE, the nutrient the claim is 
intended to characterize (sugar), the corresponding term for 
characterizing the level of such nutrient as defined by a regulation 
under section 403(r)(2)(A)(i) of the act (``zero sugar'' (also referred 
to as ``sugar free'' and defined in 21 CFR 101.60(c)(1)) and ``reduced 
sugar'' (defined in 21 CFR 101.60(c)(5))), and the brand name of which 
the implied claim is intended to be a part--CARBOLITE. The petition 
states that the petitioner seeks permission ``to use the company brand 
name `CARBOLITE' for its line of `zero sugar' and `reduced sugar' food 
products.''

III. Comments

    You may submit written or electronic comments to the Dockets 
Management Branch (see ADDRESSES). Groups or organizations must submit 
two copies of any mailed comments. Individuals may submit one copy of 
their comments. Submit only one copy of your comment if submitting an 
electronic comment. Identify your written or electronic comments with 
the docket number found in brackets in the heading of this document. 
The petition and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 3, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-31067 Filed 12-4-02; 3:17 pm]
BILLING CODE 4160-01-S