Maker's request to disallow ban rejected

Updated: April 12, 2004, 10:44 PM ET
Associated Press

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.

Ephedra has killed more than 100 individuals and injured thousands of others. The only problem is, it took the FDA almost 10 years to ban the substance.
Bruce Silverglade, legal director of D.C.-based public interest group

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.


Copyright 2004 by The Associated Press