. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1019 
7 January 2005 
 (05-0081) 
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:   U.S. 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):  Dietary Supplements 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  U.S. 
trading partners  
5. Title, language and number of pages of the notified document:   Dietary Supplements; 
Premarket Notification for New Dietary Ingred ient Notifications;  Reopening of Comment 
Period (available in English;  2 pages). 
6. Description of content:  The FDA is reopening from 27 December 2004 to 1 February 
2005, the comment period for a notice th at appeared in the Federal Register  of 20 October 
2004 (69 FR 61680).  In the notice, FDA solicited comments on FDA's premarket notification program for new dietary ingredients (NDIs) and announced a public meeting 
on that topic.  The comment period closed on 3 December 2004.  FDA is reopening the 
comment period in response to a request from trade associations representing firms in the 
dietary supplement industry for additional time to submit comments. 
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, [ 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:  The meeting notice is 
published in the Federal Register at 69 FR 61680 (ava ilable in English;  5 pages).  This notice 
can be found at:  http://www.fda.gov/ohrms/dockets/98fr/04n-0454-nm00001-vol1.pdf .  
The notice reopening the comment is published in the Federal Register at 69 FR 77258 (available in English;  2 pages).  This notice can be found at: http://a257.g.akamaitech.net/7/257 /2422/06jun20041800/edocket.access.gpo.gov/2004/04-
28135.htm   or  http://www.fda.gov/OHRM S/DOCKETS/98fr/04-28135.pdf  
10. Proposed date of adoption:   Not applicable. G/SPS/N/USA/1019 
Page 2  
 
 11. Proposed date of entry into force:   Not applicable. 
12. Final date for comments:  Submit written or electronic comments by 1 February 2005. 
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:    
Submit written comments on the document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fisher s Lane, rm. 1061, Rockville, MD 20852, 
U.S.A.  It is possible to submit electronic comments to: 
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating DOCKET 
Number 2004N-0454 and Title of document Diet ary Supplements;  Premarket Notification 
for New Dietary Ingredient Notifications;  Public Meeting. 
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) 720-4051;  Fax:  (202) 690-0677;  Email:  fstsd@usda.gov .  Complete text can 
be also be found on the Internet http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/04-
28135.htm  or  http://www.fda.gov/OHRMS/DOCKETS/98fr/04-28135.pdf .  Complete text 
of the 24 October 2004 meeting notice can be found on the Internet at the following 
website: 
http://www.fda.gov/ohrms/dockets /98fr/04n-0454-nm00001-vol1.pdf . 
Comments to Dockets can be found at http://www.fda.gov/ohrms/docke ts/dockets/ 04n0454/04n0454.htm
.