NEWARK, N.J.--On April 12--the day when the national ephedra ban was to go into effect--a judge denied an application for a restraining order that would have stalled the ban. NVE Pharmaceuticals, based in Andover, N.J., filed its lawsuit in early March requesting the court set aside the ban because it violated the Dietary Supplement Health and Education Act (DSHEA)--the Food and Drug Administration (FDA) did not satisfy the burden of establishing ephedra as posing an unreasonable risk. The Birmingham, Ala.-based manufacturer of Thermalean, The National Institute for Clinical Weight Loss, jointly filed with NVE.
“This lawsuit is about our day in court on the science,” NVE’s scientific counsel Terry Gaffney told INSIDER in March. “The RAND report, the government's own study, concluded that when ephedra is used as directed, it’s safe.” More on NVE’s suit can be found at www.naturalproductsinsider.com/hotnews/43h1015231.html.
U.S. District Judge Joel Pisano ruled he would not immediately stay the rule. The court ordered the parties to submit additional briefs so the court could decide whether to permanently stay the rule.
“The court's decision today makes clear that these dietary supplements may not be lawfully marketed while the matter remains under review by the court,” said Lester M. Crawford, Ph.D., FDA acting commissioner. The agency reported it plans to step up Internet surveillance to determine whether anyone, including the original 60-plus targeted firms selling ephedra-containing products, is continuing to actively promote and sell these products.
NVE Pharmaceuticals had not returned INSIDER’s calls for comment by press time.
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