[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]
[Page 41363-41364]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy08-97]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1995-N-0400 (formerly Docket No. 1995N-0245), FDA-1995-
N-0029 (formerly Docket No. 1995N-0282), FDA-1995-N-0224 (formerly
Docket No. 1995N-0347)]
Small Entity Compliance Guide: Food Labeling; Nutrient Content
Claims: Definition for ``High Potency'' and Definition of
``Antioxidant'' for Use in Nutrient Content Claims for Dietary
Supplements and Conventional Foods; 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 small entity compliance guide (SECG) for a final rule
published in the Federal Register of September 23, 1997, entitled
``Food Labeling; Nutrient Content Claims; Definition for ``High
Potency'' and Definition of ``Antioxidant'' for Use in Nutrient Content
Claims for Dietary Supplements and Conventional Foods.'' This SECG is
intended to set forth in plain language the requirements of the
regulation and to help small businesses understand the regulation.
DATES: Submit written or electronic comments on the SECG at any time.
ADDRESSES: Submit written comments on the SECG to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
on the SECG to http://www.regulations.gov. Submit written requests for
single copies of the SECG to the Division of Dietary Supplement
Programs, Office of Nutrition, Labeling, and Dietary Supplements (HFS-
810), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to 301-436-2639. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2375.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 23, 1997 (62 FR 49868), FDA
issued a final rule amending its regulations to: Define the term ``high
potency'' as a nutrient content claim; define nutrient content claims
using the term ``antioxidant'' (e.g., ``good source of antioxidants,''
``high in antioxidants,'' ``more antioxidants'') and to correct an
omission pertaining to the use of ``sugar free'' claims on dietary
supplements. This final rule became effective March 23, 1999.\1\
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\1\ FDA published a correction to the final rule in the Federal
Register of October 24, 1997 (62 FR 55331). The correction was to
correct a RIN number that appeared in the September 23, 1997, final
rule.
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FDA examined the economic implementation of the final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and
determined that the final rule might have a significant economic impact
on a substantial number of small entities. In compliance with section
212 of the Small Business Regulatory Enforcement Fairness Act (Public
Law 104-121), FDA is making available this SECG stating in plain
language the requirements of the regulation.
FDA is issuing this SECG as level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
represents the agency's current thinking on this subject. It 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.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this SECG.
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. The SECG and received
[[Page 41364]]
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov/guidance.html.
Dated: July 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16448 Filed 7-17-08; 8:45 am]
BILLING CODE 4160-01-S