Executive
Summary of the HHS Ephedra Meeting
On August
8-9, 2000, the Department of Health and Human Services (HHS)
Office on Women's Health (OWH) sponsored a public meeting
to discuss the safety of dietary supplements containing ephedrine
alkaloids. This meeting stemmed from the criticisms contained
in the July 1999 General Accounting Office (GAO) report titled
"Dietary Supplements: Uncertainties in Analyses Underlying
FDA's Proposed Rule on Ephedrine Alkaloids," and FDA's withdrawal
of the substantive portions of its June 1997 proposed rule
regarding dietary supplements containing ephedrine alkaloids.
At the
meeting, the Food and Drug Administration (FDA) presented
a panel of FDA personnel and outside consultants. FDA and
its consultants presented their individual views but expressed
the same opinion: that, based on the adverse event reports
(AERs) that FDA has received, based on the published literature,
and based on the lack of any benefit from the products, dietary
supplements containing ephedrine alkaloids are associated
with serious adverse health effects. However, independent
researchers and leading academic experts consulting with industry
showed that the AER database was not useful from a scientific
standpoint, that FDA had seriously mischaracterized the published
literature, and that FDA and its consultants had ignored data
on the benefits of these products.
Executive Summary Continued >>
