NVE Pharmaceuticals Challenges Ephedra Ban

ANDOVER, N.J.--When announcing a ban on ephedra dietary supplements earlier this year, the Food and Drug Administration (FDA) left the door open for companies to challenge its decision in court--and the first company to do so is NVE Pharmaceuticals. The makers of ephedra-based Stacker 2® filed a lawsuit in U.S. District Court for the District of New Jersey to postpone FDA's ban to hear new evidence.

NVEs suit is asking the court set aside the ban because it violates the Dietary Supplement Health and Education Act (DSHEA), while setting a precedent for further damage claims to be filed against the government. In the suit, NVE claims that between 2000 and 2003, revenues grew from $29 million to $80 million, mainly due to ephedra sales.

This lawsuit is about our day in court on the science, said Terry Gaffney, scientific counsel for NVE and director of product defense at The Weinberg Group in Washington. The RAND report, the government's own study, concluded that when ephedra is used as directed, its safe.

He added that from a legal standpoint, DSHEA does not support FDAs actions. They have not have not met their burden to meet the unreasonable risk--the agency based its decision on misuse of ephedra rather than recommended use.

Ephedra-based products once counted for around 75 percent of sales at NVE; now, it is down to 5 percent. The company currently employs more than 200 people, and Gaffney said NVE owes it to them to fight this ban. If it's going to happen to us, let it be because of the science and not because of the career politicians and career bureaucrats.