[Federal Register Volume 73, Number 139 (Friday, July 18, 2008)]
[Notices]
[Pages 41363-41364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16448]


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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