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Judges seem behind ephedra ban

DENVER - A federal appeals panel appeared to support the FDA's basis for banning ephedra and to reject a Utah court opinion that the prohibition runs afoul of dietary supplements law.

At a Monday hearing in Denver, judges for the 10th Circuit Court of Appeals questioned two key conclusions of the Utah court: that the FDA lacked the scientific evidence to show the amphetamine-like substance is dangerous at any dose, and that the agency was wrong to weigh the risks and benefits before deciding ephedra supplements pose an unreasonable risk of injury or illness, look http://wecanwait4u.com/neurostin-reviews.html.

Those arguments were reiterated Monday by Jonathan Emord, an attorney for Park City-based Nutraceutical Corp., the company that in April 2004 convinced U.S. District Judge Tena Campbell the ban was flawed.

The appeals court, however, wasn't so agreeable.

"How can you determine unreasonable risk without that balancing act?" asked Justice Paul J. Kelly Jr.

When Emord insisted federal law does not require supplement makers to show any benefit before selling their products, Kelly pounced.

"Are you suggesting that just because it's a supplement, they can put out stuff that poisons people?"

Emord countered that there is no evidence ephedra-based supplements, when taken in doses of 10 milligrams a day or less, is harmful, much less poisonous. He noted that the ban specifically excludes tea and other foods that contain ephedra. And he emphasized that salt and water are toxic at some level.

"But we can't just willy-nilly ban those things," Emord said.

Even FDA attorney Christine Kohl acknowledged there are no clinical studies showing low doses of ephedra pose an unreasonable risk of illness or injury. But she argued that is because current law does not require supplements be proved safe before they can be marketed.

With no such research to rely on, the FDA did the next best thing, Kohl said. The agency hired an expert to examine studies on epinephrine, a drug in the same pharmacological class as ephedra. The FDA also relied on some 19,000 reports of "adverse incidents" involving ephedra supplements, such as heart failure, high blood pressure and death.

Emord argued the report submitted by the FDA's expert did not meet the standard necessary to ban a dietary supplement. But Kelly seemed uncomfortable with Emord's suggestion that, when it comes to whether science supports an all-out ban on ephedra, the court - not the FDA - should judge the quality of the research.

After the hearing, Emord shrugged off suggestions that the panel was unsympathetic to his arguments, saying he has learned not to read too much into the judges' questions.

But he warned that, should Campbell's ruling be overturned, the FDA would be free to ban everything from peanut butter to Vitamin C.

"The principle in this case is vital," he said. "If the government wins, we will all be at the mercy of the FDA."