It is a clear victory for EMAX Enterprises, the importer that sued the FDA over seizure of the dietary supplements. Yet the company isn't gloating. It isn't even talking. Nor is Jonathan Emord, the normally outspoken attorney who represents EMAX, which has offices in Denver and Hong Kong.
To get the FDA to relinquish the EMAX shipment, Emord had to promise not to use the deal "to draw any adverse inferences" against the federal agency. In other words, Emord can't use this case to contend the FDA is not certain low-dose ephedra is dangerous or is irresponsible in allowing companies to import and sell a substance it knows to be harmful.
The keep-quiet clause is no formality: The agreement was codified in court papers May 5 - three days before the FDA appeared before a Denver appeals court to defend its dangerous-no-matter-the-dose rationale in hopes of restoring a ban on ephedra. The lawyer on the other side of the table: Jonathan Emord.
Ephedra, also called Ma huang, is a stimulant that quells fatigue and aids weight loss, making it a popular product among dieters and athletes looking for an energy boost. It also raises the risk of heart attacks, stroke and death, especially in people who have high blood pressure, heart disease or engage in strenuous exercise.
Since 1997, the amphetamine-like herb 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.
Most evidence about risks associated with ephedra involve higher doses or the stimulant's use along with caffeine. But the FDA said it would be unethical to conduct human studies of lower doses to establish safety. In February 2004, it banned the stimulant at any dose, saying the risks outweighed any benefits. A year later, a Utah judge voided that rationale.
U.S. District Judge Tena Campbell ruled in April 2005 the FDA could not stop Park City-based Nutraceutical Corp. from selling low-dose ephedra products because the agency had not proven that daily doses of 10 milligrams or less pose an unreasonable risk of injury or illness.
Campbell also said the FDA's risk-benefit analysis is flawed because it puts the burden on supplement makers to prove some benefit before marketing their products. Under the Dietary Supplements and Health Education Act, manufacturers are not required to demonstrate their products are safe and effective before marketing.
Despite Campbell's ruling, the FDA continues to enforce the ban - except for low-dose products sold by Nutraceutical. In November, FDA spokeswoman Kimberly Rawlings told The Salt Lake Tribune the agency would pursue action against all companies selling high doses of ephedra, and would take a "case-by-case" approach to those marketing capsules containing 10 milligrams or less.
Since the ban was announced in November 2004, the federal government has stopped ephedra shipments in Texas, Pennsylvania, Georgia and Utah.
Christine Kohl, the Department of Justice attorney representing the FDA before the appeals court, said Campbell essentially ignored scientific information on ephedra's effects on the body. And she defended the risk-benefit analysis, saying it would have been "irresponsible" to commission a clinical study to prove harm after the FDA began receiving reports of adverse effects.
Asked if the decision to permit EMAX to import low-dose ephedra undermines the FDA's appeal, Kohl deferred to the FDA, which said it does not comment on continuing litigation.
Marc Ullman, a New York-based supplement attorney, said the FDA's powers are greatest at the border, where a product can be confiscated merely if it appears to violate food and drug laws.
The FDA may have concluded, after the seizure, that Campbell's ruling permits Utah companies to sell low-dose ephedra, and agreed to release the EMAX shipment. Ullman, for one, doesn't believe the move constitutes a confession.
"Jonathan Emord is a good attorney, and the FDA probably just wanted to make sure he wouldn't portray this as the FDA saying there is nothing wrong with this product," Ullman said.
