. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/855 
18 February 2004 
 (04-0696) 
Committee on Sanitary a nd 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 U.S. 
Department of Agriculture 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners who import food into the United States 
5. Title, language and number of pages of the notified document:   Food Labelling:  Health 
Claims;  Dietary Guidance (8 pages, available in English). 
6. Description of content:  The US Food and Drug Administration (FDA) issued an advance 
notice of proposed rulemaking (ANPRM) to reque st comments on alternatives for regulating 
qualified health cl aims in the labelling of conventional human foods and diet ary supplements.  
FDA solicited comments on various other issu es related to health claims and on the 
appropriateness and nature of di etary guidance statements on f ood labels.  Comments on the 
regulatory alternatives and the additional to pics informed FDA's rulemaking to establish 
regulations for qualified health  claims, as well as any policy initiatives(s) that FDA may 
undertake to give consumers information to help them make wise food choices.   
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[   ] protect humans from animal/plant pest or  disease, [   ] protec t 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, [ X ] 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:   
Notice in the Federal Register  (FR), 68 FR No. 227, pages 66040-66048, 
http://www.fda.gov/OHRMS/ DOCKETS/98fr/03-29448.pdf  (available in English) G/SPS/N/USA/855 
Page 2  
 
 10. Proposed date of adoption:   FDA intends, within one year, to initiate notice-and-comment 
rulemaking to establish scientif ic review criteria and proce dures for qualified health claim 
petitions.  FDA intends to complete its notice- and-comment rulemaking process in the Fall of 
2005. 
11. Proposed date of entry into force:   Fall of 2005 
12. Final date for comments:  26 January  2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   Submit written comments to the Division of Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, U.S.A.  Submit electronic comments to: http://www.fda.gov/dockets/ecomments
 by indicating Docket No. 2003N-0496. 
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. Department of Agriculture, Stop 1027, W ashington, DC  20250.  Tel (202) 720-4051,  
(202) 720-0677, fstsd@usda.gov .  Complete text can also be found on the Internet 
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under the date of 
publication in the Federal Regi ster, which is 25 November 2003.