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.

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 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