. /. WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/907 
14 May 2004 
 (04-2158) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
 
NOTIFICATION  
 
1. Member to Agreement notifying:   UNITED STATES 
If applicable, name of local government involved: 
2. Agency responsible:   US Food and Drug Administration (FDA) 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Food (including dietary supplements) fo r human consumption in the United 
States, except for meat, poultry and egg products  that are exclusively regulated by the US 
Department of Agriculture 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  US 
trading partners  
5. Title, language and number of pages of the notified document:   Food labelling:  Nutrient 
content claims, general principles; health claims, general requirements and other specific 
requirements for individual health claims; re opening of the comment period (available in 
English, 7 pages). 
6. Description of content:   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 Requirements and 
Other Specific Requirements for Individual H ealth Claims" that was published in the 
Federal Register of 21 December 1995 (60 FR 66206) (the 1995 proposal).  In that document, FDA proposed a number of amendments  to its existing nutrient content claims 
and health claims regulations to provide additional flexibility in the use of these claims on food products.  Since the publication of the 1995 proposal, FDA established a Task Force for the Consumer Health Information for Better Nutrition Initiative, which recommended 
that FDA seek public comment on several topi cs related to qualified health claims and 
unqualified health claims (i.e., health claims  that are supported by significant scientific 
agreement (SSA) and authorized by FDA by regulation).  Some of these topics on unqualified health claims were specifically a ddressed in the 1995 proposal and, therefore, 
FDA is reopening the comment period on the 1995 proposal to seek comment on: the 
proposed amendments to permit unqualified hea lth 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 disqualifying nutrient levels related to unqualified health claims; and the proposed 
amendments to retain the word "may" or "mi ght" in unqualified health claims.  In addition, 
FDA is seeking comment on the proposed use 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 informa tion demonstrating that unlisted synonyms that 
are anchored to defined terms in nutrient content claims are reasonably understood by 
consumers to be synonyms of the defined term s.  For abbreviated health claims, FDA seeks 
comments and requests data or other informa tion regarding whether abbreviated health 
claims would mislead consumers. G/SPS/N/USA/907 
Page 2  
 
 7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[  ] protect humans from animal/plant pest or disease,  [   ]  protect territory from other 
damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  
9. Relevant documents and language(s ) in which these are available:  Federal Register  
69 FR 24541, 4 May 2004 http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10126.htm ; 
(available in English). 
The proposed rule is available in the Fede ral Register, 60 FR 66206, 21 December 1995, 
http://frwebgate5.access.gpo.gov/cgi-
bin/waisgate.cgi?WAISdocID= 209433399494+23+0+0&WAIS action=retrieve  (available in 
English.). 
10. Proposed date of adoption:   N/A 
11. Proposed date of entry into force:   N/A 
12. Final date for comments:  6 July 2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
You may submit comments, identified by Docket Nos. 1994P-0390 and 1995P-0241, by 
any of the following methods: 
 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 La ne, rm. 1061, Rockville, MD 20852. 
Federal Rulemaking Portal:  http://www.regulations.gov/   
 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 La ne, rm. 1061, Rockville, MD 20852.  
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:   U.S. Enquiry 
Point, U.S. Department of Agriculture, Stop 1027, Washington, DC  20250.  Tel:  (202) 720-677, fstsd@usda.gov .   
Document can be found online at: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10126.htm