. /.WORLD TRADE
ORGANIZATIONG/TBT/N/USA/36
25 March 2003
(03-1720)
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 (35)
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 Supplements
(ICS 71)
5. Title, number of pages and language(s) of the notified document:   Dietary Supplements
Containing Ephedrine Alkaloids;  Reopening of the Comment Period (4 pages, in English)
6. Description of content:   The Food and Drug Administ ration (FDA) is reopening the
comment period for a proposed rule entitled “Dietary Supplements Containing Ephedrine
Alkaloids” that published in the Federal Register of 4 June 1997 (62 FR 30678) (the
June 1997 proposal).  In that document, FDA proposed a number of requirements relating to
dietary supplements containing ephedrine alkaloids, including a requirement for a warning
statement on the product label.  Since publication of the June 1997 proposal, new scientific
evidence has come to light concerning health risks associated with the use of dietary
supplements containing ephedrine alkaloids.  FDA is reopening the comment period to
receive comment on this new evidence, as well as on the warning statement it is now
considering for dietary supplements containing ephedrine alkaloids.  FDA also intends to
consider, to the extent possible, whether in light of current information FDA shoulddetermine that dietary supplements containing ephedrine alkaloids present a “significant or
unreasonable risk of illness or injury under conditions of use recommended or suggested in
labeling, or if no conditions of use are suggested or recommended in the labeling, under
ordinary conditions of use.”
7. Objective and rationale, including the na ture of urgent problems where applicable:
Safety
8. Relevant documents:   68 Federal Register (FR) 10417, 5 March 2003; Title 21 Code of
Federal Regulations (CFR) Part 111and 4 June 1997 (62 FR 30678).  Will appear in the
Federal Register when adopted.G/TBT/N/USA/36
Page 2
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:   4 April 2003
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