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Maker's request to disallow ban rejected

4/12/2004 - Baltimore Orioles

NEWARK, N.J. -- A federal judge allowed a nationwide ban on
dietary supplements containing ephedra to take effect Monday,
turning aside a plea from two manufacturers.

Ephedra, once hugely popular for weight loss and bodybuilding,
has been linked to 155 deaths, including that of Baltimore Orioles
pitcher Steve Bechler a year ago.

U.S. District Judge Joel Pisano refused to grant a temporary
restraining order that would have prevented the Food and Drug
Administration from banning the products.

After years of fighting manufacturers over the risks, the FDA
announced in December that it was banning the sale of the
amphetamine-like herb -- the first such ban of a dietary supplement.

"These products pose unacceptable health risks, and any
consumers who are still using them should stop immediately,"
Health and Human Services Secretary Tommy G. Thompson said.

NVE Pharmaceuticals of Newton, manufacturer of the diet
supplement Stacker 2, had hoped to head off the ban, arguing its
product is safe if used as directed. It was joined by a second
company, the National Institute for Clinical Weight Loss,
manufacturer of a product called Thermalean.

The judge said the manufacturers did not meet several legal
requirements, including proving that they are likely to win the
case and that they would suffer irreparable harm if the ban took
effect.

Pisano's ruling means the ban will be in effect at least until
NVE's lawsuit can be heard. No trial date has been set.

Ephedra sales already had plummeted because of publicity about
the risks, especially after Bechler's death a year ago. Three
states -- New York, Illinois and California -- prohibited the
stimulant on their own.

"Ephedra has killed more than 100 individuals and injured
thousands of others," said Bruce Silverglade, legal director of
the Washington-based Center for Science in the Public Interest.
"The only problem is, it took the FDA almost 10 years to ban the
substance."

Unlike medications, which must be proven safe and effective
before they ae allowed to be sold, federal law allows dietary
supplements to be marketed without any such proof. To curb a
supplement, the FDA must show it poses a significant health threat.

NVE maintains that the FDA failed to prove such a threat if the
supplement is taken correctly, and was swayed by the outcry over
ephedra deaths.

"The FDA chose to ignore valid science that showed that there
wasn't a problem," said Walter Timpone, a lawyer for NVE. "In
1999, [there were] 104 deaths as a result of aspirin ingestion. Are
we going to ban aspirin now?"

Andrew Clark, a Justice Department lawyer arguing the case for
the FDA, said the ban is based on sound science.

Research shows ephedra can speed heart rate and constrict blood
vessels even in seemingly healthy people, and is particularly risky
for those who have heart disease or high blood pressure or engage
in strenuous exercise.

"We think it's a rule that can save lives," Clark said.

The ban does not affect decongestants and other medicines
containing ephedrine, a synthetic version of ephedra. Drugs
containing ephedrine and a chemical cousin called pseudoephedrine
are regulated and approved by the FDA and are safe, said agency
spokesman Lawrence Bachorik.