[Federal Register: July 12, 2000 (Volume 65, Number 134)]
[Notices]
[Page 43021-43023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy00-73]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
 
Office of Women's Health; Notice of Public Meeting on the Safety
of Dietary Supplements Containing Ephedrine Alkaloids
 
AGENCY: Office of Public Health and Science, Office of the Secretary,
DHHS.
 
ACTION: Notice of Public Meeting on the Safety of Dietary Supplements
Containing Ephedrine Alkaloids.
 
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[[Page 43022]]
 
SUMMARY: The Department of Health and Human Services' Office of Women's
Health (OWH), which is part of the United States Public Health Service
(USPHS), is announcing a public meeting to discuss available
information about the safety of dietary supplements containing
ephedrine alkaloids. These products are promoted for uses such as
weight loss, body building, and increased energy. This meeting will
afford all interested persons an opportunity to provide focused
information and comment in a manner that will assist the USPHS in
understanding the use of dietary supplements containing ephedrine
alkaloids. Possible regulatory actions are not the topics for this
meeting.
 
DATES: The meeting will begin on Tuesday, August 8, 2000 and will last
for 2 or 3 days, depending on the number of presenters, from 9:00 a.m.
to 6:00 p.m. Registration will open at 8:00 a.m. Registration and
written notices of participation should be submitted by close of
business, August 1, 2000. Late registrations will be accepted
contingent on space availability.
 
ADDRESSES: The public meeting will be held at the Department of Health
and Human Services, Wilbur J. Cohen Building, Wilbur J. Cohen
Auditorium, 330 Independence Avenue, SW., Washington, DC 20201. Meeting
participants should enter on the Independence Avenue entrance. The
Wilbur J. Cohen Building is one block east of the Metro station
(Orange/Blue Lines) Federal Center SW.
    Background information on this meeting is available on the OWH
Internet site (The National Women's Health Information Center)
www.4woman.gov/owh/public. The agenda will be available at the public
meeting.
    In the Federal Register of April 3, 2000 (65 FR 17510), the Food
and Drug Administration (FDA) announced the establishment of a new
public docket that made available new adverse event reports and related
information concerning dietary supplements containing ephedrine
alkaloids. Interested persons were given until May 18, 2000 to submit
written comments on the April 3, 2000 Federal Register notice to FDA's
docket (Docket No. 00N-1200). FDA later extended this comment period
until July 3, 2000 (65 FR 32113, May 22, 2000). FDA intends to reopen
the comment period until September 30, 2000 via publication of a
Federal Register notice the week of July 3, 2000. The transcript,
presentations and views expressed at the USPHS public meeting on the
safety of dietary supplements containing ephedrine alkaloids will be
submitted to the FDA docket. For more Information, refer to
www.fda.gov.
 
FOR FURTHER INFORMATION CONTACT: To register for the public meeting,
contact: www.4woman.gov/owh/public, or contact Ms. Darlene Gregory,
Conference Manager, Conference Technologies International, a division
of the MayaTech Corporation (MTC), 8737 Colesville Road, 7th Floor,
Silver Spring, MD 20910-3921, via fax at (301) 587-1686
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    The Department of Health and Human Services' Office on Women's
Health (OWH), which is part of the USPHS, will convene this public
meeting. As part of this meeting, the USPHS will describe the
historical and current use of ephedra-containing compounds and adverse
events. The USPHS invites representatives from consumer groups,
industry, and the clinical research communities to register for the
meeting and to make presentations on the use of dietary supplements
containing ephedrine alkaloids, the links between the use of these
supplements and adverse events, and how best to characterize those
links. The USPHS will assemble a panel of government public health
experts representing such disciplines as epidemiology, clinical
pharmacology, and cardiovascular medicine, whose rule will be to seek
clarification from presenters.
 
II. Scope of the Discussion
 
    The scope of this meeting will be limited to the issues discussed
in this document. Possible regulatory actions are not the topics for
this meeting. In reference to the following questions, discussion will
cover such areas as the traditional medical use of these products, the
use of these products as dietary supplements labeled for weight loss
and exercise enhancement, and the known physiologic and pharmacologic
actions of these alkaloids, including their use in combination with
other stimulants. The specific questions on which USPHS is seeking
comment follow.
    1. What positive and adverse physiologic actions would be expected
of ephedra based on its known constituents? Does the available
information show an association between the use of dietary supplements
containing ephedrine alkaloids and adverse events (i.e.,
cardiovascular, central nervous system, psychotropic, etc.) when used
as directed?
    2. Are there any circumstances for which there are well-established
indications for the use of dietary supplements containing ephedrine
alkaloids? What does and duration of use are needed for those
indications? What is the quality of any data to support such use?
    3. How would you characterize the seriousness and/or severity of
the risks of ephedrine alkaloids labeled for weight loss and exercise
enhancement, taking into account issues such as user demographics (age,
sex, race/ethnicity); amount consumed across the population; use with
other natural or synthetic stimulants (e.g., caffeine, synephrine,
yohimbine); the added stress of exercise; and individual sensitivity to
these types of products?
    4. Are the outcomes associated with use of these products affected
by
    <bullet> Dosage;
    <bullet> User characteristics (e.g., age, predisposing health
conditions) or behaviors (e.g., combining use with other stimulants or
other compounds);
    <bullet> Duration of exposure; or
    <bullet> Other means?
 
III. Registration and Requests for Oral Presentations and Abstracts
 
    If you would like to attend the meeting, we request that you
register in writing with Ms. Darlene Gregory, Conference Technologies
International, a Division of the Maya Tech Corporation (MTC), 8737
Colesville Road, 7th Floor, Silver Spring, MD 20910-3921, by August 1,
2000, by providing your name, title, business affiliation, address,
telephone, fax number, and e-mail address. To expedite processing, this
registration information may be sent to Ms. Gregory by fax at (301)
587-1686, or via the internet at www.4woman.gov/owh/public.
    If you need special accomodations due to a disability, please
inform Ms. Gregory when you register.
    Researches with basic science, clinical, or other data responsive
to the questions described above for dietary supplements containing
ephedrine alkaloids are invited to register and to submit an abstract
for an oral presentation. Abstracts must fit completely in a box
measuring 6.5 inches wide by 4 inches deep and must follow this
structured format: a brief title; names, credentials, affiliations, and
locations of all authors (standard abbreviations are acceptable);
identification of source(s) of support for the research and
presentation; and the Objective Design, Results, and Conclusion of the
research or presentation. Presenters should specify whether the
research has been peer
 
[[Page 43023]]
 
reviewed, and the format of the presentation (slide, overhead,
powerpoint [specify version], or other).
    Other individuals wishing to provide remarks at the meeting are
invited to submit a brief summary of those remarks, to fit completely
in a box measuring 6.5 inches wide by 4 inches deep.
    Presentations and summaries should be responsive to one or more of
the specific focus questions identified in this notice. Incomplete
abstracts or summaries and those nonresponsive to any of the questions
will be rejected. Submitters should indicate if special accommodations
are needed for the presentation. Abstracts should be received by close
of business August 1, 2000, by Ms. Darlene Gregory, Conference Manager,
Conference Technologies International, a Division of the MayaTech
Corporation (MTC), 8737 Colesville Road, 7th Floor, Silver Spring, MD
20910-3921, via fax at (301) 587 1686.
    Depending upon the number of people who register to make
presentations, we may have to limit the time allotted for each
presentation. Time will be allotted according to the number of requests
received, but will be at least 3 minutes followed by 2 minutes of
discussion. Presenters will be notified of their time.
 
V. Transcripts
 
    You may request a transcript of the meeting in writing from the
Freedom of Information Office [HFI-35], Food and Drug Administration,
rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, approximately 15
working days after the meeting, at a cost of 10 cents per page.
    You may also examine the transcript of the meeting after August 25,
2000, at the Dockets Management Branch between 9:00 a.m. and 4:00 p.m.,
Monday through Friday, as well as on the FDA website at http://
www.fda.gov
 
    Dated: July 5, 2000.
Wanda K. Jones,
Deputy Assistant Secretary for Health (Women's Health).
[FR Doc. 00-17526 Filed 7-11-00; 8:45 am]
BILLING CODE 4160-17-M
 

Transcripts of the meetings