. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/833
1 December 2003
(03-6348)
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 suppl ements and drug products in solid oral dosage
form
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:   Iron-Containing
Supplements and Drugs:  Label Warning Statement Requirements; Small Entity
Compliance Guide (Available in English; 1 page)
6. Description of content:  FDA announces availability of a small entity compliance guide to
revise and update an earlier guidance.  Guidan ce sets forth requirements for label warning
statements for iron-containing  dietary supplement and drug products in solid oral dosage
form.  It is issued to replace an existing guidance and incorporates the removal of arequirement for unit-dose packaging of high-pot ency iron-containing dietary supplement and
drug products in solid oral dosage form.
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection,
[  ] protect humans from animal/plant pest or di sease,  [   ]  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 notice was
published in the October 17, 2003 Federal Register (68 FR 59797); in English.  The guidance
can be found at http://www.cfsan.fda.gov/~dms/secgiro2.html  in English.
10. Proposed date of adoption:   17 October 2003
11. Proposed date of entry into force:   17 October 2003G/SPS/N/USA/833
Page 2
12. Final date for comments:  Comments will be accepted indefinitely.
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
Number 1997D-0443 and Title of document Iron-Containing S upplements and Drugs: Label
Warning Statement Requirements; Small Entity Compliance Guide; Availability
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point,
or address, fax number and E-mail address (if available) of other body:
Department of Agriculture, Stop 1027, Wash ington, DC  20250.  Tel (202)  720-4051; Fax
(202) 720-7772, fstsd@usda.gov .    Complete text can be also be found on the Internet
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-26189.pdf  or
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under DOCKET No.
1997D-0443.  The small entity compliance guide can be found at
http://www.cfsan.fda.gov/~dms/secgiro2.html