Information
About Ephedra Diet Pills
Experts Review Most Recent FDA Reports
on Ephedra Diet Pills
June 2001
Experts who reviewed the most recent Food
and Drug Administration (FDA) reports on Ephedra diet pills confirmed
their conclusion, based on the totality of evidence, that these reports
do not demonstrate an association between Ephedra consumption and serious
adverse events (AERs). This conclusion is consistent with recent clinical
data showing that Ephedra is safe and beneficial for weight loss, and
with the previous findings of Cantox Health Sciences International's quantitative
risk analysis, and of a multidisciplinary expert panel sponsored by the
Ephedra Education Council (EEC).
As part of an ongoing effort to work with
the FDA and other federal and state agencies to establish responsible
standards for dietary supplements and diet pills containing Ephedra, the
dietary supplement industry has obtained from the FDA the most recent
AERs for Ephedra products. AERs cannot be viewed as scientific "data,"
and it is not possible to use AERs to establish whether an event is attributable
to Ephedra or whether Ephedra increases the risk of adverse events. Nonetheless,
the industry has agreed to review all new AERs that the FDA receives for
Ephedra products in an effort to help monitor whether the current national
standard for these products is working, and in order to foster a more
cooperative approach with the FDA concerning the regulation of these products.
"The review of the most recent AERs
is consistent with the written comments of the Expert Panel of the Ephedra
Education Council submitted to FDA in October 2000, which stated that
'available information does not demonstrate an association between the
use of dietary supplements containing ephedrine alkaloids and serious
adverse events' when consumed according to the national standard,"
said Dr. Stephen Kimmel, Chairman of the EEC's Expert Panel.
"These conclusions are also consistent
with a quantitative risk study submitted to FDA in December 2000 by Cantox
Health Sciences International, and with data from clinical studies on
ephedrine and Ephedra diet pill products, including the recently published
abstract of the Harvard and Columbia study," Dr. Kimmel added.
Researchers at the prestigious Harvard
and Columbia Universities, who recently published data in abstract form
in the FASEB Journal and Obesity Research, found that herbal Ephedra,
when combined with caffeine, lowered body weight, fat and body mass index.
There were no significant adverse events in this 6-month study, and rigorous
testing of cardiac function showed little or no effect on heart rate or
blood pressure. In addition, data published last month in The International
Journal of Obesity also showed that the combination of Ephedra and Guarana
in healthy, overweight subjects produced significant weight and fat loss.
As with past reports, the most recent
batch of AERs shows why frequent media reporting of the raw number of
AERs is meaningless and only confuses consumers. The new AERs include
many that bear no relationship to Ephedra
consumption. This includes reports on products that did not contain Ephedra,
reports where no adverse event is listed, and cases where the event occurred
well prior to any Ephedra diet pills consumption. Also included were cases
medically unrelated to Ephedra, such as gallstones, small bowel obstruction
and fat feet, as well as ludicrous reports such as that of a married woman
who had an affair with a student, for which she has been criminally prosecuted.
The only experts who have reviewed the entire FDA collection of AERs have
consistently found that the AERs, when considered in the context of scientific
data from clinical studies, do not represent a public health concern when
Ephedra products are consumed according to current standards - a total
dose of 100mg per day at 25mg four times a day.
Most important, the enormous potential
benefits of Ephedra diet pills for millions of consumers must be considered.
According to the Centers for Disease Control, more than 60% of Americans
are obese or overweight, and obesity results in 300,000 preventable deaths
each year in the United States. Because of the clinical data showing safety
and efficacy, leading experts in obesity have urged FDA to permit continued
access to Ephedra products, one of the few useful tools that consumers
have to help them lose weight.
The Ephedra Education Council (EEC) is
supported primarily by members of the Ephedra Committee of the American
Herbal Products Association, a recognized leader in promoting the safe
and responsible marketing of dietary supplements. The Council provides
factual information to the media and public about diet pills and dietary
supplements containing Ephedra. For more information, logon to www.EphedraFacts.com
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