. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/907/Add.1 
26 November 2004 
 (04-5146) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum
 
  The following communication, dated 23 November 2004, is being circulated at the request of 
the United States. 
_______________  
 
  The Food and Drug Administration (FDA) is reopening for 60 days the comment period for 
the proposed rule entitled "Food Labeling:  Nutrient  Content Claims, General Principles;  Health 
Claims, General Requirements and Other Specific Re quirements for Individual Health Claims" (the 
1995 proposal, 60 FR 66206, 21 December 1995).  In the 1995 proposal, 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.  In the Federa l Register of 4 May 2004 (69 FR 24541), FDA 
reopened the comment period for the 1995 proposal to seek comment on the proposed amendments to 
permit unqualified health claims on certain foods that  do not contain 10 per cent or more of one of 
certain required nutrients, the proposed amendments to provide criteria that FDA would consider in 
determining whether to grant an exemption from di squalifying nutrient levels  related to unqualified 
health claims of certain nutrients, and the proposed amendments to retain the word "may" or "might" 
in unqualified health claims.  In addition, F DA sought comment on the proposed use of unlisted 
synonyms and abbreviated health claims.  The comment period for the 1995 proposal closed on 
6 July 2004.  FDA is reopening the comment period again in response to four requests for additional 
time to submit comments to FDA.  The reopening of  comments for the proposed rule was published in 
the 18 November 2004, Federal Regist er (69 FR 67513); in English:  
http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-25529.pdf
.  The 1995 proposed rule can be found at: 
http://frwebgate5.access.gpo.gov/cgi-
bin/waisgate.cgi?WAISdocID=8840713 64211+0+0+0&WAISaction=retrieve   
  Final Date for Comments is 18 January 2005.  Comments may be submitted, identified by 
Docket Nos. 1994P-0390 and 1995P-0241, by any of the following methods:    
• Federal eRulemaking Portal:  http://www.regul ations.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 Website.  
• 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, rm. 1061, Rockville, MD 20852. 
 
 For information contact:  Ritu Nalubola, Ce nter for Food Safety and Applied Nutrition (HFS-
820), Food and Drug Administration, 5100 Paint Bran ch Pkwy., College Park, MD  20740, 301-436-
2371  G/SPS/N/USA/907/Add.1 
Page 2  
 
  
 Ms. Julie Morin, United States SPS Enquiry  Point Officer, USDA Foreign Agricultural 
Service, Food Safety & Technical Services Division, Stop 1027, Washington D.C. 20250.  Tel:  202-720-4051;  Fax:  202-690-0677;  Email:  fstsd@usda.gov
 
 
 
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