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April 2, 2004  
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Supplement Makers Sue FDA Over Ephedra Ban

By Editorial Staff

Two manufacturers of dietary supplements have filed suit against the federal government to stall the Food and Drug Administration's impending ban on ephedra. The suits, filed in New Jersey and Alabama, are asking that the courts place a halt on the ban, which is set to take effect April 12, and that new evidence be heard regarding ephedra's safety.

The first suit was filed March 9 by NVE Pharmaceuticals, a diet pill company headquartered in Andover, New Jersey and known for producing the "Stacker 2" line of dietary supplements.

NVE's suit, filed in the U.S. District Court for the District of New Jersey, asks that the court set aside the FDA's ban because it violates several provisions of the Dietary Supplement Health and Education Act of 1994. NVE's claim also appears to set a legal framework for damage claims against the government. According to the complaint, NVE's revenues grew from $29 million in 2000 to $80 million in 2003, nearly all of which came from sales of dietary supplements containing ephedra.

The FDA first considered limiting sales of ephedra in 1997, after concerns were raised by some scientists and consumer advocates. However, NVE claims that the government's ban is "unlawful," and that ephedra helps people lose weight and is safe when used as directed. The company has also announced plans to file multiple affidavits to counter the government's claims that ephedra can raise a person's blood pressure to dangerous levels.

Two weeks later, on March 23, the makers of the dietary supplement Thermalean filed suit in a federal court in Birmingham, Alabama. The suit, filed by the National Institute for Clinical Weight Loss, claims that the FDA's ban should be halted because the agency does not have sound proof that ephedra causes serious health problems.

"There's a tremendous amount of scientific evidence out there that it (ephedra) is safe when used properly" said Tim Fuller, a company attorney.

The Thermalean suit also argues that the FDA did not give ample notice of its intent to ban products containing ephedra. The ban was first announced on December 30, 2003 and finalized February 6, 2004.

Other companies that sold or manufactured supplements containing ephedra are considering whether or not to file similar lawsuits. A spokesperson for Metabolife International, one of the largest ephedra diet pill manufacturers before the ban was announced, said the company is still "weighing options" at this time.

"Metabolife believes that it's premature to say whether they will sue," said Jan Strode. "We are still weighing the options and going through the paperwork."

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