Wednesday August 4 12:10 AM ET

FDA CAN'T JUSTIFY EPHEDRINE LIMITS, REPORT SAYS

WASHINGTON (Reuters) - The Food and Drug Administration does not have
enough scientific evidence to support limits on ephedrine, a common
weight-loss substance that the FDA considers dangerous, a
congressional report to be released Wednesday said.

The FDA has warned consumers that dietary supplements containing
ephedrine, plant-derived compound that is often promoted as a natural
version of the once-popular diet drug combination ``fen-phen,'' can be
dangerous because of its potentially powerful stimulant effects.

The agency also has proposed limits on ephedrine levels in dietary
supplements coupled with warnings against consuming
ephedrine-containing products for more than seven days.

Some members of Congress asked the General Accounting Office, the
investigative arm of Congress, to investigate the FDA's ephedrine
proposal after the dietary supplements industry questioned the FDA's
conclusions.

The GAO concluded that the FDA needed to provide stronger evidence
about ephedrine's side effects to support its proposed restrictions,
according to a memo prepared by the House Science Committee staff.

``FDA needs to provide stronger evidence on the relationship between
the intake of dietary supplements containing ephedrine alkaloids and
the occurrence of adverse reactions,'' the GAO said.

Ephedrine, also known as Ma Huang, is used in dietary supplements
promoting weight loss and body building. ''Fen-phen'' was a popular
diet drug combination until manufacturers recalled its components in
1997 due to safety concerns.

The FDA proposed ephedrine restrictions after receiving more than 800
reports of harmful effects to people taking supplements containing the
substance. Reactions included heart problems that could put patients
at risk for heart attacks, strokes and death.

But the GAO said those reports by themselves are unreliable because
they do not prove that the substance caused the reaction and also
could include reactions as minor as headaches. In the case of
ephedrine, FDA relied heavily on the so-called Adverse Events Reports
without providing its usual follow-up investigation, the GAO said.