Health Professionals
Approximately 1/3 of Americans need to lose weight.
Health professionals play a critical role in helping patients face
and conquer the challenge of being overweight and the implications
on your patients' overall health. This section can assist you in
obtaining critical information about Ephedra products. Below is
a report of a panel of medical and scientific experts that was presented
at a 2-day hearing held in August 2000 by the Office of Women's
Health at the Department of Health and Human Services. This report
is an analysis of the science to help answer questions about Ephedra
products. In addition to the report of the EEC expert panel, please
refer to the Scientific Studies and Reports
section for up to date information about other scientific studies
and data on dietary supplements containing Ephedra.
Expert Panel Report
This report reflects the conclusions of the most
comprehensive consensus panel review to date of the Ephedra safety
issue. The EEC Expert Panel, composed of seven medical and scientific
experts from a variety of relevant disciplines, was convened in
response to a request for information on Ephedra from the U.S. Department
of Health and Human Services. The Panel's review included comprehensive
reviews of the published literature and the FDA's adverse event
reports (AERs), as well as the only analysis of these reports relative
to the background incidence of the adverse events at issue. The
consensus findings of the Panel can be viewed by clicking here.
The EEC Expert Panel included the following medical and scientific
professionals:
Stephen E. Kimmel, M.D.
Steven B. Karch, M.D.
Norbert P. Page, M.S. , D.V.M.
Theodore Farber, Ph.D., DABT
John W. Olney, M.D.
Grover M. Hutchins, M.D
Edgar H. Adams, M.S., Sc.D.
In addition to the consensus statement, the EEC panel members issued
individual statements to the FDA on the safety of dietary supplements
containing ephedrine alkaloids and on the adverse event reports
(AERs). Click below to read the panel members' statements:
"Summary of Incidence of Seizures, Strokes, and
Myocardial Infarctions in the Population and Estimations of Risk
in the Population from Ephedra Products." Stephen E. Kimmel,
M.D
Statement of Steven B. Karch, M.D.
"Safety and Benefits of Ephedrine Alkaloid-Containing
Dietary Supplements." Norbert P. Page, M.S., D.V.M., and Theodore
Farber, Ph.D., DABT, Toxichemica, International.
Statement of John W. Olney, M.D.
Statement of Grover M. Hutchins, M.D. "Review and
Analysis of 276 Adverse Event Reports in FDA Docket."
Statement of Edgar H. Adams, M.S., Sc.D.
As a result of the EEC consensus and individual statements, a number
of documents were written to help further explain the panel's findings.
To view these items, click on the links below.
Table: Ephedra Consumption vs. Adverse
Event Reports
Ephedra and Weight Loss
Analysis of Background Risk of Seizures,
Strokes, and Myocardial Infarction Examination of FDA Literature
on Ephedra
Analysis of FDA's Concerns Regarding Adverse
Nervous System Effects
Analysis of Deaths Reported to FDA
as Possibly Linked to Dietary Supplements Containing Ephedrine Alkaloids
Examination of Adverse Event Reports
Released by FDA in April 2000
Examination of Dietary Supplements Containing
Ephedrine Alkaloids and Abuse or Dependence
Examination of FDA's Scientific
and Regulatory Decisions on Ephedra
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Ephedra Products Are Safe To
Use
Experts have reviewed all historical and clinical
data available and have concluded that Ephedra products are safe
when taken in accordance with the American Herbal Products Association's
recommended serving limits, warnings, and precautions (called Industry
recommendation).
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FDA's Regulatory Power Over Ephedra Is Strong
Under the Dietary Supplement Health and Education
Act (DSHEA), Congress gave the Food and Drug Administration (FDA)
the authority to assure that dietary supplements, including Ephedra,
are safe and are accurately and truthfully labeled. More details
about DSHEA and FDA's regulatory power can be located in the Public
Policy Center.
Unfortunately, FDA has failed to use its regulatory powers to get
illicit products off the market despite repeated requests by the
industry to require proper warning labels. Even without FDA's actions,
the industry has taken a proactive approach by adopting national
standards and supporting responsible regulations in several
states to address important health-related issues, such as warnings,
serving limits, etc.
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