Ephedra Ban Challenged

Ephedra Ban Challenged

ANDOVER, N.J.When announcinga ban on ephedra dietary supplements earlier this year, the Food and DrugAdministration (FDA) left the door open for companies and organizations tochallenge its decision in courtwhich NVE Pharmaceuticals and the AmericanHerbal Products Association (AHPA) have done.

The makers of ephedra-based Stacker 2 filed a lawsuit inU.S. District Court for the District of New Jersey to postpone FDAs ban tohear new evidence. NVEs suit is asking the court set aside the ban because itviolates the Dietary Supplement Health and Education Act (DSHEA), while settinga precedent for further damage claims to be filed against the government. In thesuit, 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 defenseat The Weinberg Group in Washington. The RAND report, the governments ownstudy, concluded that when ephedra is used as directed, its safe.

He told INSIDER that from a legal standpoint, DSHEAdoes not support FDAs actions. They have not met their burden to meet theunreasonable riskthe agency based its decision on misuse of ephedra ratherthan recommended use.

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

In a related move, on March 13 AHPAs Chinese HerbalProducts Committee filed a petition for stay and reconsideration of FDAsephedra ban as it pertains to traditional herbal formulas. The Acupuncture andOriental Medicine Alliance also joined the petition, which requests FDArecognize dietary supplements that contain ephedrine alkaloids do not present anunreasonable risk of illness or injury under conditions of use that includetraditional Asian and Ayurvedic herbal formulas dispensed by licensed healthcare practitioners.

Even though FDA made numerous comments in the preamble to thefinal rule that the ban would not apply to traditional Asian medicinescontaining ephedrine alkaloids, the petition is asking FDA to clarify itsintentions in the rule itself. A copy of the petition is posted at www.ahpa.org/04March12PetitionReconsiderationAndStayCHP.pdf.