NVE Takes First Shot At Ephedra Ban: FDA Violated DSHEA, Firm Says
This article was originally published in The Tan Sheet
NVE Pharmaceuticals is challenging FDA's ban of ephedra on the grounds the agency did not meet its burden of proving the ingredient unsafe under the Dietary Supplement Health & Education Act
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NVE Pharmaceuticals may not supplement FDA's administrative record as it proceeds with legal allegations against the agency's ephedra ban, a Third Circuit Court of Appeals judge rules Feb. 7. Thus, NVE may not provide expert affidavits or testimony and may not conduct discovery. The ruling affirms that of an August 2004 ruling by a district judge in Newark, N.J. federal court where the case was originally filed. The case is remanded to the district court for further proceedings in accordance with the opinion of the appellate court. NVE filed the complaint against FDA in March 2004 alleging that the agency could not ban supplements containing ephedrine alkaloids because it did not meet the burden of proof required by DSHEA (1"The Tan Sheet" March 15, 2004, p. 8). The agency also is appealing a Utah federal court ruling in a separate suit against its ephedra ban that was filed by Nutraceutical Corp (2"The Tan Sheet" Nov. 14, 2005, p. 4)...
FDA's use of a risk/benefit analysis to show that ephedra presented an "unreasonable risk of illness or injury" was an appropriate means of supporting the ban of the ingredient in 2004, according to the agency