. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/825
11 November 2003
(03-6043)
Committee on Sanitary and 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 number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Iron-containing dietary s upplements and drug products in solid oral dosage
form
4. Regions or countries likely to be affected, to the extent relevant or practicable:  All US
trading partners
5. Title, language and number of pages of the notified document:   Iron-Containing
Supplements and Drugs:  Label Warning  Statements and Unit-Dose Packaging
Requirements;  Removal of Regulations for Unit-Dose Packaging Requirements for Dietary
Supplements and Drugs;  Final rule;  removal of regulatory provisions in response to court
order (available in English, 2 pages)
6. Description of content:  FDA is removing a part of a final rule that required unit-dose
packaging for iron-containing dietary s upplement and drug products that contain
30 milligrams or more of iron per dosage unit.  The action was taken in response to the
Court’s ruling in Nutritional Health Alliance v. FDA, in which the court concluded that the
Federal Food, Drug, and Cosmetic Act does not provide FDA the authority to require
unit-dose packaging for poison control purposes.  The final rule removes the requirement for
unit-dose packaging of dietary supplements a nd drug products from the agency's regulations
in Title 21 of the Code of Federal Regulations Part 111.50 and 310.518.
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, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection 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 final rule was
published in the 17 October 2003 Federal Register (68 FR 59714);  in English.
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-26188.pdf
10. Proposed date of adoption:   17 October 2003G/SPS/N/USA/825
Page 2
11. Proposed date of entry into force:   17 October 2003
12. Final date for comments:  There is no comment period
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 Fishers 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
Numbers 91P-0186 and 93P-0306.
13. Texts available from:  [   ] National notification 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)  720-1301, fstsd@usda.gov .  Complete text can be also be found on the Internet
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-26188.pdf  or
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under DOCKET
Nos. 91P-0186 and 93P-0306.