. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1490 
16 January 2007 
 (07-0212) 
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 
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):   Not applicable.  
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:  Notice:  Food Labeling: 
Health Claims; Calcium and Osteoporosis and Calcium, Vitamin D, and Osteoporosis; 
Proposed rule (Available in English;  23 pages). 
6. Description of content:  The US Food and Drug Administration is proposing to amend the 
calcium and osteoporosis health claim regulation (21 CFR 101.72) to:  (1)  Include 
vitamin D so that, claims can be made for calcium and vitamin D and osteoporosis; 
(2) eliminate the requirement that the claim list sex, race, and age as specific risk factors for 
the development of osteoporosis;  (3) eliminat e the requirement that the claim does not state 
or imply that the risk of osteoporosis is e qually applicable to the general United States 
population, and that the claim identify the populations at particular risk for the development of osteoporosis;  (4) eliminate the requirem ent that the claim id entify the mechanism by 
which calcium reduces the risk of osteopor osis and instead make it optional;  and 
(5) eliminate the conditional requirement that th e claim include a statement that reflects the 
limit of the benefits derived from dietary calcium intake.  This proposal responds to a health 
claim petition submitted by the Beverage Institu te for Health and Wellness, the Coca-Cola 
Company. 
7. Objective and rationale: [   ] food safety,  [   ] animal health,  [   ] plant protection, 
[   ] protect humans from animal/plant pest or disease, [   ] protect territory from 
other damage from pests.  Provide consumers with more information on which to base 
healthy food choices for reduci ng the risk of osteoporosis.  
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/1490 
Page 2  
 
  9. Relevant documents and language(s) in which these are available:  US Code of Federal 
Regulations, title 21, part 101, section 72.  This document is available in the Federal Register, volume 72, number 3, pages 497–519,  published on Friday 5  January 2007, 
available in English, 23 pages.  http://www.fda.gov/OHRMS/DOCKETS  [Docket 
No. 2004P-0464]. The pdf file of the document is available at 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-22573.pdf  
10. Proposed date of adoption:  Not determined. 
11. Proposed date of entry into force:  Not applicable.  
12. Final date for comments:  21 March 2007. 
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 or electronic comments identified by [Docket Number 2004P-0464.], by any 
of the following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov   Follow the instructions 
for submitting comments. 
• Agency Web site:  http://www.fda.gov/dockets/ecomments   Follow the instructions 
for submitting comments on the agency Web site. 
 
Submit written submissions in the following ways: 
• Fax:  301-827-6870 
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Instructions:  All submissions received must include the agency name and docket number 
for this rulemaking. All objections recei ved will be posted w ithout change to 
http://www.fda.gov/ohrms/dockets/default.htm . 
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail add ress (if available) of other body:  US Enquiry 
Point, US Department of Agriculture, Stop 1027, Washington, DC 20250.  Tel:  202-720-9124; Fax: 202-690-0677; Email: fstsd@ fas.usda.gov, Fax: (202) 720-4051, 
fstsd@usda.gov.  Complete text can be  also be found on the Internet at 
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  and insert Docket No. [2004P-
0464].  For access to the docket to read bac kground documents or comments received, go to 
http://www.fda.gov/ohrms/dockets/default.htm  and insert the Docket No. [2004P-0464] into 
the "Search" box and follow the prompts.