SAFE
USE OF EPHEDRA DIETARY SUPPLEMENTS ESTABLISHED
Washington,
DC (December 20, 2000) -- Scientific and medical experts
announced today that the popular dietary supplement Ephedra
is safe at a total daily dosage of 90mg, divided into smaller
doses of up to 30mg. This finding is based on the conclusions
of a comprehensive science based risk analysis performed by
Cantox Health Sciences International, a world-renowned, independent
scientific consulting firm. Cantox assessed all available scientific
information -- focusing on 19 clinical trials, including the
critical data from a recent Harvard and Columbia trial that
found Ephedra both safe and beneficial for weight loss at the
90mg per day dosage, as well as other key data including adverse
event reports (AERs) collected by the Food and Drug Administration
(FDA).
"The
information reported here today is a win for consumers, a win
for regulators and a win for industry. Consumers can continue
to use Ephedra supplements for weight management; FDA has a
credible scientific basis for implementing sound regulatory
policy on Ephedra; and the industry is committed to continuing
self-regulatory initiatives that benefit consumers," said
John Cordaro, President and Chief Executive Officer of the Council
for Responsible Nutrition. CRN had commissioned Cantox to perform
the risk assessment analysis.
John
Hathcock, Ph.D., Vice President of Nutritional and Regulatory
Science for CRN, explained the three conditions for safe Ephedra
supplement use identified in the Cantox Report: dosage limits,
effective labeling and post-market monitoring. "A dosage
of 90mg of Ephedra per day, taken in divided doses of 30mg,
caused no observed adverse effects�the No Observed Adverse Effect
Level (NOAEL). The report also identified a 150mg total daily
dosage as the lowest level at which moderate adverse effects
were first observed�the Lowest Observed Adverse Effect Level
(LOAEL)," explained Hathcock.
In
reviewing data on both Ephedra and ephedrine, Cantox analyzed
in detail clinical trials, AERs from FDA, case reports and published
articles, including data on both human and animal studies. Its
exhaustive study revealed no serious concerns dealing with toxicity
or other potentially harmful effects. This comprehensive database
was analyzed in the context of the U.S. National Academies�
Food and Nutrition Board Upper Limit methodology, which is well
established and broadly accepted.
"The
Cantox dietary supplement assessment report is invaluable to
establishing regulatory policy. CRN urges FDA to objectively
analyze the conclusions and findings and to work with industry
on appropriate implementation," Cordaro added.
In
addition to introducing the Cantox findings, CRN�s Cordaro,
Hathcock and John Cardellina, Ph.D. were joined by Carol Boozer,
D.S.C., Patricia Daly, M.D., the principal investigators of
the Columbia/Harvard clinical study. George Bray, M.D. addressed
Ephedra�s benefits in weight management.
Founded
in 1973, The Council for Responsible Nutrition (CRN) represents
105 companies in the dietary supplement industry, including
ingredient suppliers and manufacturers. CRN members adhere to
a strong Code of Ethics, comply with dosage limits and manufacture
dietary supplements to high quality standards under good manufacturing
practices.
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