. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/84/Add.5
10 March 2003
(03-1357)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 7 March 2003, has been received from the
United States.
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Comment Period For A Proposed Rule Entitled "Dietary  Supplements Containing Ephedrine Alkaloids"
Dietary Supplements Containing Ephedrine Alkaloids, Reopening the Comment Period.
Federal Register Vol. 68, No. 43, pages 10417-10420 (4 pages;  available in English)
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5072.pdf
The US Food and Drug Administration (FDA) ha s reopened for 30 days 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 diet ary 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 e phedrine alkaloids.  FDA also intends to consider, to the extent
possible, whether in light of current informa tion FDA should determine that dietary supplements
containing ephedrine alkaloids present a "significant or unreasonable risk of illness or injury underconditions of use recommended or suggested in labe ling, or if no conditions of use are suggested or
recommended in the labeling, under ordinary conditions of use."
Final date for comments:  Submit written or electronic comments by 4 April 2003.
Submit written comments on the document to the:
Dockets ManagementBranch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852, USA.
It is possible to submit electronic comments to:
http://www.fda.gov/dockets/ecommentsG/SPS/N/USA/84/Add.5
Page 2
Submit comments by indicating DOCKET Number  95N-0304 and Title of document "Dietary
Supplements Containing Ephedrine Alkaloids."
Mr. William Janis
US Department of AgricultureStop 1027
Washington, DC 20250
Tel (202) 720-9047, (202) 720-0677
fstsd@usda.gov
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. 95N-0304
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