But that's not all Emax wants. The company, which has offices in Denver and Hong Kong, has asked Utah's federal court to do what U.S. Secretary of Health and Human Services Mike Leavitt will not: suspend the federal ban on ephedra, a popular ingredient in supplements used to quell fatigue and aid weight loss. It also wants to punish the U.S. Food and Drug Administration for enforcing it. The April 21 lawsuit, which names former Utah Gov. Leavitt, as well as the FDA and U.S. Customs directors, is notable because:
l It was filed with the same court that, in April 2005, ruled that the FDA erred in banning ephedra.
l Denver's 10th Circuit Court of Appeals is a week away from hearing the government's challenge to the year-old ruling.
l The attorney for Emax is Jonathan Emord, the same Washington, D.C., lawyer who defeated the FDA during the first go-around.
"This is very much about Emax and the denial of its shipment," Emord says. "But it's also a sad story of a government agency refusing to follow the law."
The FDA insists last year's ruling, issued by U.S. District Judge Tena Campbell, frees up only Nutraceutical Corp., the Park City-based supplement company that filed the initial challenge, to make and sell low-dose ephedra products. And so far, few supplement makers, including Nutraceutical, have been willing to challenge that rationale and ramp up production.
One reason is that the FDA continues to confiscate ephedra, whether in herb form or in processed supplements. But it's also because the amphetaminelike alkaloids raise the risk of heart attacks, stroke and death, especially in people who have high blood pressure or heart disease and those who engage in strenuous exercise.
The herb, also known as Ma Huang, has been linked to 19,000 "adverse events" and dozens of deaths, including that of 23-year-old Baltimore Orioles pitcher Steve Bechler, who collapsed during a spring-training workout in February 2003.
The high-profile case caused a number of lawmakers, including supplement-industry champion Sen. Orrin Hatch of Utah, to call for a "prompt federal review" of ephedra.
Most ephedra-related problems involved higher doses than the 10-milligram-per-day products Nutraceutical and Emax want to sell.
But in February 2004, the FDA banned ephedra at any dose, arguing it would be unethical to conduct human studies to determine at what dose ephedra is dangerous. Six months later, the agency issued a notice prohibiting the importation of any herb containing ephedra or ephedrine alkaloids whether in supplements or bulk form.
According to the FDA, the risks of taking ephedra at any dose outweigh any benefits, although the ban does not apply to ephedra tea often known as "Brigham's Tea" or "Mormon Tea" for its popularity among Mormon pioneers. Even before the ban, most supplement companies had switched to ephedra-free weight-loss and energy-boosting products.
Nutraceutical, however, challenged the FDA in Campbell's court and won. Campbell ruled that the FDA had not proved that ephedra in daily doses of 10 milligrams or less posed an unreasonable risk of illness or injury, and the agency's risk-benefit rationale ran afoul of the Dietary Supplements and Health Education Act, or DSHEA, which does not require that supplements prove their products are safe before marketing them.
One interpretation is that the ruling was a huge victory for supplement makers. Others, such as California Rep. Henry Waxman, said the ruling, if allowed to stand, would prompt Congress to re-write DSHEA to give the FDA more authority to ban harmful supplements.
Rather than ask Campbell to stay her ruling while the case was on appeal, the FDA simply ignored it, attorney Emord says.
"What's the meaning of a judicial decision if it's entirely academic?" Emord asks. "Why did my client spend all that money to get a judgment only to have FDA refuse to abide by it?"
Even more surprising, Emord says, is the FDA's audacity to seize a shipment of ephedrine supplements in the very jurisdiction of Campbell's court.
"We were falling over," Emord says. "We couldn't believe the government had the temerity to do that."
The appeals court will hear arguments in the Campbell case May 8 in Denver, but a final ruling could take months. Meanwhile, the FDA continues to confiscate supplements containing ephedra - six seizures since February 2004, when the ban took effect - citing authority under the import alert and the final ephedra rule that Campbell concluded was flawed.
Steven Shapiro, a well-known supplement-industry attorney from New York City, agrees with the FDA's position that it is free to enforce the ban against all supplement makers except Nutraceutical.
And he is skeptical that the Emax case will get far while the Campbell ruling is still in limbo.
"It is difficult for me to imagine another judge in Utah, with a case pending before the 10th Circuit, would issue a ruling in a different but related case."

