Federal judge allows ephedra ban to take effect

Dietary supplement's makers requested delay


NEWARK, N.J. - A federal judge cleared the way yesterday for a ban on the sale or manufacture of ephedra to start immediately.

The judge denied a request by two manufacturers of the dietary supplement to delay the ban pending the outcome of a lawsuit. The manufacturers have sued the Food and Drug Administration and the Department of Health and Human Services.

Judge Joel A. Pisano of U.S. District Court in Newark ruled that NVE Pharmaceuticals of Andover, N.J., manufacturer of Stacker 2, and the National Institute for Clinical Weight Loss of Birmingham, Ala., manufacturer of Thermalean, had not met the standards for a temporary restraining order.

In a briefing, the FDA said that the ban was in place and that it was investigating whether manufacturers or retail outlets were violating the law by continuing to sell ephedra. An assistant commissioner, Jeffrey Shuren, said the agency would be able to enforce the ban.

"Right now," Shuren said, "we think we have the people we need to get the job done. This is really going to be a test case."

A lawyer for NVE, Walter P. Timpone, said he was disappointed with yesterday's ruling.

Timothy M. Fulmer, a lawyer for the weight loss institute, said, "If this rule goes forward as of today, they will have no product."

Sen. Richard J. Durbin, an Illinois Democrat, had said the FDA was too understaffed to monitor a multibillion-dollar industry effectively.

For a restraining order, Pisano would have had to find that the manufacturers' case had a strong likelihood of prevailing, that they would suffer irreparable harm and that the public interest would be served. He ruled against the companies on all three points.

"Virtually every fact in this case is disputed," Pisano said.

He added that the number of documents submitted in the case - the FDA submitted 133,000 pages - made it impossible for him to decide which side was likely to prevail.

"The resolution of the findings in this case is going to require a full evidentiary hearing and a full review of the administrative record," Pisano said.

He noted that the agency had received 18,000 reports of harm associated with ephedra, including 164 deaths.

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