SCIENTIFIC
AND MEDICAL EXPERTS SUPPORT CURRENT NATIONAL STANDARDS FOR
EPHEDRA
Similar
to Over-the-Counter Products, There is No Association Between
Reported Adverse Events and Ephedra When Consumed as Directed
Washington,
DC (August 7, 2000)--- A seven-member panel of experts
completing the most comprehensive multidisciplinary review
of Ephedra concluded today that, as with over-the-counter
products that contain ephedrine or pseudoephedrine, there
is no association between serious adverse events and Ephedra
when consumed as directed. Additionally, based on studies
of Ephedra and caffeine, the panel viewed the current data
as supporting the usefulness of Ephedra in combating one of
the most serious public health problems in the U.S, weight
management.
"Available
information does not demonstrate an association between the
use of dietary supplements containing ephedrine alkaloids
and serious adverse events when used according to the American
Herbal Products Association (AHPA) trade recommendation for
Ephedra products," said Dr. Stephen E. Kimmel, panel chairman.
"This recommendation includes a serving limit of not more
than 25 mg of total ephedrine alkaloids, a limit on daily
consumption of not more than 100 mg of total ephedrine alkaloids,
and appropriate warnings consistent with other available over-the-counter
ephedrine alkaloid products."
Conservative
estimates show no greater risk than the risk in the general
population. The number of reported events are consistent with
what would occur in the general population without the consumption
of Ephedra.
In 1997,
the U.S. Food and Drug Administration (FDA) proposed an outright
ban on the marketing of Ephedra for use in weight management
and severe restrictions on serving amounts based primarily
on over 800 reports of alleged adverse events the agency had
received, but never reviewed over a four year period. As a
result of overwhelming criticism from consumers, industry,
Congress and a General Accounting Office report establishing
that FDA's proposal had no valid scientific basis, FDA withdrew
the most controversial portions of its proposal on April 3,
2000.
Recognizing
the confusion and questions that FDA's more recent release
of additional adverse events has caused, the expert panel
also recommended that NIH, HHS and industry work together
to consider additional research to establish a more comprehensive
database, and, as is usual practice, that an independent multidisciplinary
panel be formed to review all deaths reported to FDA, even
though no association between existing reports and Ephedra
was found.
The panel's
findings will be presented at an August 8 Public Health Service
meeting convened by the Department of Health and Human Services.
Members of the panel were selected because of their scientific
and medical experience and broad depth of knowledge in different
disciplines, including toxicology, neurology, pathology, and
epidemiology, and several members have worked as consultants
or as senior management for the FDA.
The members
of the scientific panel include:
