[Federal Register: December 9, 2002 (Volume 67, Number 236)]
[Notices]
[Page 72963]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de02-87]
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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