 
. /. WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/48/Add.3 
11 May 2004 
 
 (04-2097) 
Committee on Technical Barriers to Trade Original:   English 
  
 
 
NOTIFICATION 
 
Addendum 
 
 
 The following communication, dated 6 May 2004, is being circulated at the request of the 
Delegation of the United States.  
 
_____________  
 
 
 Food Labeling: Nutrient Content Claims, Ge neral Principles; Health Claims, General 
Requirements and Other Specific Requirements fo r Individual Health Claims; Reopening of the 
Comment Period. 
 The Food and Drug Administration (FDA or the agency) is reopening for 60 days the 
comment period for the proposed rule entitled "Food Labeling: Nutrient Content Claims, 
General Principles;  Health Claims, General Re quirements and Other Spec ific Requirements for 
Individual Health Claims'' (the 1995 proposal).  In that document, FDA proposed to amend its 
existing nutrient content claims and health claims re gulations to provide additional flexibility in the 
use of these claims on food products.  Since the publication of the 1995 propo sal, FDA established a 
task force for the Consumer Health Informati on for Better Nutrition Initiative, which recommended 
that FDA seek public comment on several topics re lated to qualified health  claims and unqualified 
health claims (i.e., health clai ms that are supported by significant scientific agreement (SSA) and 
authorized by FDA by regulation).  Some of these topics on unqualified health claims were specifically addressed in the 1995 proposal and, th erefore, FDA is reopening the comment period on 
the 1995 proposal to seek comment on the proposed amendments to permit unqualified health claims 
on certain foods that do not contain 10 percent or  more of one of certain required nutrients, the 
proposed amendments to provide criteria that FDA w ould consider in determining whether to grant an 
exemption from disqualifying nutrient levels related to unqualified hea lth claims of certain nutrients, 
and the proposed amendments to retain the word "may '' or "might" in unqualified health claims.  In 
addition, FDA is seeking comment on the proposed u se of unlisted synonyms and abbreviated health 
claims.  Specifically, for unlisted synonyms (i.e., terms not defined by regulation), FDA repeats its 
request for data or other information demonstrati ng that unlisted synonyms that are anchored to 
defined terms in nutrient content claims are reasona bly understood by consumers to be synonyms of 
the defined terms.  For abbreviated health clai ms, FDA seeks comments and requests data or other 
information regarding whether abbreviated health claims would mislead consumers. 
 
DATES:  Submit written or electronic comments by July 6, 2004. 
 
ADDRESSES:  You may submit comments, identifie d by Docket Nos. 1994 P-0390 and 1995P-0241, 
by any of the following methods: 
 G/TBT/N/USA/48/Add.3 
Page 2  
 
 - Federal eRulemaking Portal:  http://www.regulations.gov . Follow the instructions for 
submitting comments 
 - Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for 
submitting comments on the agency Web site. 
- E-mail: fdadockets@oc.fda.gov . Include Docket Nos. 1994P-0390 and 1995P-0241 in the 
subject line of your e-mail message. 
 
- FAX: 301-827-6870 
 
- Mail/Hand delivery/Courier [For paper, disk, or  CD-ROM submissions]; Division of Dockets 
Management, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 
  Instructions:  All submissions received must include the agency name and Docket No. or Regulatory Information Number (RIN) for this ru lemaking.  All comments received will be posted 
without change to http://www.fda.gov/dockets/ecomments , including any personal information 
provided.  For detailed instructions on subm itting comments and additional information on the 
rulemaking process, see the "How to Submit Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.  Docket: For access to the docke t to read background documents or comments received, go to 
http://www.fda.gov/dockets/ecomments  and/or the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. 
 FOR FURTHER INFORMATION CONTACT:  Julie Sc hrimpf, 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,  FAX 301-436-2636. 
 
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