June 8, 2000
Dear Colleague, Dietary Supplements Community:
I'm writing to you about an upcoming public meeting that will be convened by the United States Public Health Service (USPHS) concerning the safety of dietary supplements containing ephedrine alkaloids. In a Talk Paper released on March 31, 2000, the Food and Drug Administration (FDA) noted the availability of several Federal Register documents concerning dietary supplements containing ephedrine alkaloid products. One of the Federal Register documents announced a new public docket that makes available new adverse event reports and related information concerning dietary supplements containing ephedrine alkaloids. This document also announced FDA's intent to participate in a public forum to address this new information. As stated in the Talk Paper, this public meeting will be sponsored by the Public Health Service and designed to share information and seek opinion on the safety of dietary supplements containing ephedrine alkaloids.
The public meeting will be convened by the Department of Health and Human Services' Office on Women's Health (OWH), which is located in the USPHS. The meeting will begin on August 8, 2000, and will last for 2 or 3 days, depending upon the number of presenters. It will be held in the Washington, D.C., metropolitan area. The USPHS plans to issue an announcement later this month providing more details concerning the public meeting, e.g., location, name of a contact person, and registration. In addition, a Federal Register notice will be issued prior to the meeting providing more details about the public meeting, including the specific scientific issues to be addressed. This Federal Register notice will also notify interested persons that they will be afforded another opportunity - until September 30, 2000 -- to submit comments to FDA's public docket (Docket No. 00N-1200) after the public meeting.
The public meeting will focus on risk assessment regarding the safety of these products. Possible regulatory actions are not the topics for this meeting. These deliberations will occur after we have satisfied ourselves that the available scientific information has been fully discussed.
The announcement for the public meeting will appear on the OWH Internet site (The National Women's Health Information Center) www.4woman.gov on or about June 26, 2000.
FDA published a Federal Register notice on May 22, 2000 (65 FR 32113) extending the comment period until July 3, 2000 for the April 3, 2000 Federal Register document announcing a new public docket and making available new adverse event reports and related information concerning dietary supplements containing ephedrine alkaloids. This extension of the comment period provides interested persons with a total of 90 days to comment prior to the public meeting, in addition to the time after the public meeting referenced above.
I look forward to your participation in this public forum to discuss the available information about the safety of dietary supplements containing ephedrine alkaloids.
Joseph A. Levitt
Center for Food Safety and Applied Nutrition
March 31, 2000 Talk Paper: lrd/tpephedr.html FDA Announces the Availability of New Ephedrine and "Street Drug Alternative" Documents
May 22, 2000 Federal Register (65 FR 32113): Dietary Supplements Containing Ephedrine Alkaloids; Extension of Comment Period
April 3, 2000 Federal Register (65 FR 17474): Dietary Supplements Containing Ephedrine Alkaloids; Withdrawal in Part
April 3, 2000 Federal Register (65 FR 17510): Dietary Supplements Containing Ephedrine Alkaloids; Notice of Availability
April 3, 2000 Federal Register (65 FR 17509): Dietary Supplements Containing Ephedrine Alkaloids; Administrative Docket Update; Notice of Availability