[Federal Register Volume 65, Number 134 (Wednesday, July 12, 2000)]
[Notices]
[Pages 43021-43023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17526]


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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
     Dosage;
     User characteristics (e.g., age, predisposing health 
conditions) or behaviors (e.g., combining use with other stimulants or 
other compounds);
     Duration of exposure; or
     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