NVE Pharmaceuticals, an Andover, N.J., manufacturer of weight-loss supplements, filed suit March 9 in U.S. District Court, claiming that the Food and Drug Administration?s ban against ephedra violates the 1994 Dietary Supplement Health and Education Act.
NVE manufactures the Stacker 2 line of ephedra-based supplements, as well as other products marketed to promote energy and weight loss. Sales from ephedra products previously made up at least 75 percent of the company?s $80 million revenue, said Terry Gaffney, a spokesman for the company.
The FDA ban is the result of a ?political agenda,? which includes the repeal of DSHEA, he said, and is not based on science, which supports the safety of ephedra when taken as directed. ?The science is not only supportive, it is exemplary,? said Gaffney, who also is an attorney with The Weinberg Group, a scientific consulting group that claims NVE as a client.
NVE is requesting that the court delay the April 12 ban and hear new evidence. ?We are not going to allow the scientific debate to be swayed without the use of facts,? said Gaffney. ?If the court relies on the science, we think we have a very good chance [of winning the suit].?
Natural Foods Merchandiser volume XXV/number 4/p. 8