Ephedra Ban Lifted by U.S. District Judge
FDA says it's evaluating the ruling before deciding whether to appeal
THURSDAY, April 14, 2005 (HealthDay News) -- Saying that the U.S. Food and Drug Administration had not met the burden of proof that any specific dosage of the controversial weight-loss drug ephedra was dangerous, a U.S. District Court judge in Salt Lake City has lifted the year-old FDA ban and sent the matter back to the agency for further evaluation.
A lawsuit against the ban, which the FDA initiated in February 2004, was brought by Nutraceutical Corp. and Solray Inc. of Park City, Utah, a nutritional supplement manufacturer. On Thursday, Judge Tena Campbell ruled that the FDA had not proved that its arbitrarily-set dosages of 10 milligrams (mg) or less of ephedrine-alkaloid dietary supplements (EDS) were dangerous.
In fact, Campbell said in her ruling that the FDA had rested its entire case on research offered by the agency and its advisory committee that could not determine what a safe level of an EDS would be.
"A negative inference is different from the affirmative proof required..." Campbell wrote in her opinion. "There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low dose EDS."
Late Thursday afternoon, FDA officials were evaluating whether the minimum 10 mg dose was sufficient to appeal Campbell's decision or whether more research was necessary.
"The FDA is evaluating the question of appeal," spokeswoman Kimberly Rawlings said. Rawlings said she expected a decision by early Friday.
The Associated Press quoted Nutraceutical president Bruce Hough as saying the decision is about "protecting the public's access to safe and effective dietary supplements."
The government's decision to ban ephedra came late in 2003. At a news conference, then-Health and Human Services Secretary Tommy Thompson said the government had enough evidence to confirm that ephedra caused heart attacks.
Thompson announced a "consumer alert" on the safety of products containing ephedra and said the agency had notified manufacturers of its intent to publish a final rule banning the sale of supplements containing the compound. The ban came after the government reviewed more than 16,000 reports of adverse events, Thompson said. The actual ban was issued in February 2004.
Ephedrine, the active ingredient, increases metabolic rate, heat production, and the risk of heatstroke. A group of San Francisco researchers had claimed that ephedra was the most dangerous herbal product on the market, based on data collected from poison control centers. Because ephedra is an herb, it was not subject to regulations governing pharmaceutical drugs and could be sold over-the-counter.
More than 155 deaths have been linked to ephedra, according to Public Citizen's Health Research Group in Washington, D.C., including the 2003 death of 23-year-old Baltimore Orioles pitcher Steve Bechler. Bechler's death resulted in a slew of negative publicity that, in turn, contributed to declining sales of ephedra products.
Metabolife International Inc., one of ephedra's largest manufacturers, said at the time it "respectfully" disagreed with the FDA's decision. And the company added that the FDA lacked data and information that would enable it to meet the burden of proving that ephedra products -- when taken in accordance with their label directions for use -- present a significant or unreasonable risk of illness or injury."
The American Heart Association, however, applauded the move, calling it "a victory" for the health of Americans.
"It sends a clear message to consumers either using or considering the use of these products, who may be unaware of the potential risks," then-AHA president Dr. Augustus O. Grant said in a prepared statement. "While they may believe they are doing something good for their health, in truth they could be putting themselves at serious risk."
The National Center for Complementary and Alternative Medicine has more on ephedra.