. /.WORLD TRADE
ORGANIZATIONG/TBT/N/USA/38
1 April 2003
(03-1839)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Food and Drug Administration (38)          
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Dietary Ingredients and
Dietary Supplements (HS Section IV)  (ICS 71)
5. Title, number of pages and language(s) of the notified document:   Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and
Dietary Supplements (106 pages, in English)
6. Description of content:   The Administration is proposing current good manufacturing
practice (CGMP) regulations for dietary ingredients and dietary supplements.  The proposed
rule would establish the minimum CGMPs necessary to ensure that, if you engage inactivities related to manufacturing, packaging, or holding dietary ingredients or dietary
supplements, you do so in a manner that will not adulterate and misbrand such dietary
ingredients or dietary supplements.  The provis ions would require manufacturers to evaluate
the identity, purity, quality, strength, and composition of their dietary ingredients and
dietary supplements.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To promote and protect the public health
8. Relevant documents:   68 Federal Register (FR) 12158, 13 March 2003; Title 21 Code of
Federal Regulations (CFR) Parts 111 and 112.  Will appear in the Federal Register whenadopted
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:   11 June 2003G/TBT/N/USA/38
Page 2
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
http://www.access.gpo.gov/nara/index.html
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. 96N-0417