. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1506 
12 February 2007 
 (07-0590) 
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 number(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:  Health 
Claims, Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (Available 
in English, 29 pages) 
6. Description of content:  The Food and Drug Administration (FDA) is proposing to amend 
the regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary hear t disease (CHD) (21 CFR 101.81).  The amendment 
proposes to exempt certain foods from the nutrient content requirement of “low fat.”  The 
exemption would apply if the food exceeds the "low fat" requirement due to fat content 
derived solely from eligible whole oat sources.   This proposal responds to a health claim 
petition submitted by the Quaker Oats Company. 
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/1506 
Page 2  
 
  9. Relevant documents and language(s) in which these are available:   
Federal Register, 6 February  2007, 72 FR Page 5367-5374 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1849.htm  
US Code of Federal Regulations, title 21, part 101, section 81 (21 CFR 101.81) 
This document will appear in the Federal Register when adopted. 
10. Proposed date of adoption:  Not determined. 
11. Proposed date of entry into force:  Not applicable 
12. Final date for comments:  23 April 2007 
Agency or authority designated to handle comments:  [ X ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
Submit written comments on the document to Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fi shers Lane, rm. 1061, Rockville, MD 20852, 
U.S.A.  It is possible to FAX comments to 301-827-6870, or submit electronic comments 
to:   http://www.fda.gov/dockets/ecomments.  Submit comments by indicating Docket No. 
2006P-0069 and title of document: Food Labelin g: Health Claims, Soluble Fiber from 
Certain Foods and Risk of Coronary Heart Disease; Proposed rule.  
13. Texts available from:  [ X ] National notifi cation authority, [   ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:   
United States SPS National Notification Author ity, USDA Foreign Agricultural Service, 
International Regulations and Standards Di vision (IRSD), Stop 1027, Washington D.C. 
20250. Tel:  202-720-1301; Fax:   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 
No. 2006P-0069. 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. 
2006P-0069 into the "Search" box and follow the prompts.