. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1739 
30 November 2007  
 (07-5275) 
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:  Food and Drug Administration (FDA) (161) 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Food (ICS 67) 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  Trading 
partners 
5. Title, language and number of pages of the notified document:  Food Labeling:  Nutrient 
Content Claims; Alpha-Linolenic  Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid 
Omega-3 Fatty Acids (availab le in English, 45 pages) 
6. Description of content:  This proposal is in response to three notifications submitted for 
nutrient content claims based on an authoritative statement for certain omega-3 fatty acids.  One notification was submitted collectively by  Alaska General Seafoods, Ocean Beauty 
Seafoods, Inc., and Trans-Ocean Products, Inc.  (the seafood processors notification);  a 
second notification was submitted by Martek Bi osciences Corp.; and a third notification was 
submitted by Ocean Nutrition Canada, Ltd.  The Food and Drug Administration (FDA) is 
proposing to prohibit the nutrient content clai ms for DHA and EPA set forth in the three 
notifications because they are not based on an aut horitative statement that identifies a nutrient 
level to which the claims refer,  as required by the ac t.  FDA is also proposing to prohibit the 
nutrient content claims for ALA set forth in th e seafood processors notification because they 
are based on a daily value that was determined by a different method than daily values already 
established for other nutrients.  FDA is, however , proposing to take no regulatory action with 
respect to the nutrient content claims for ALA set forth in the Martek notification.  
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:    G/SPS/N/USA/1739 
Page 2  
 
  9. Relevant documents and language (s) in which these are available:   Document published 
in the Federal Register, 72 FR 66103, availa ble in English.  It can be found at 
http://www.fda.gov/OHRMS/DOC KETS/98fr/E7-22991.htm
   
10. Proposed date of adoption:  Not determined. 
11. Proposed date of entry into force:  Not applicable. 
12. Final date for comments:  11 February 2008 
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 Di vision of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane , rm. 1061, Rockville, MD 20852, U.S.A.  
It is possible to FAX comments to 301-827- 6870, or submit electr onic comments to:  
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating Docket Nos.  
2004N-0217, 2005P-0189, and 2006P-0137 and title of  document:  Food Labeling:  Nutrient 
Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid 
Omega-3 Fatty Acids; Proposed rule. 
13. Texts available from:  [   ] National notifica tion authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS National Notification Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Di vision (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720-1301;  Fax:  +(1 202) 690-0677;  E-mail:  fstsd@fas.usda.gov.  
Complete text can be also be found on the Internet  http://www.accessdata.fda.gov/ scripts/oc/ohrms/index.cfm
 by looking under Docket Nos. 
2004N-0217, 2005P-0189, and 2006P-0137 or 
http://www.fda.gov/OHRMS/DOC KETS/98fr/E7-22991.htm .  For access to the docket to 
read background documents or comments received, go to http://www.fda.gov/ohrms /dockets/default.htm
 and insert the Docket No. 2004N-0217, 
2005P-0189, and 2006P-0137 into the "Search" box and follow the prompts.