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Judge Rules Against FDA Ban on Ephedra

Product More Food Than Drug, She Says

By Mark Thiessen
Associated Press
Friday, April 15, 2005; Page E05

SALT LAKE CITY, April 14 -- A federal judge Thursday struck down the FDA ban on supplements containing ephedra, the once-popular weight-loss aid that was yanked from the market one year ago after it was linked to dozens of deaths.

The judge ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. Nutraceutical International Corp. claimed that ephedra has been safely consumed for hundreds of years.

A U.S. district judge struck down the federal ban on ephedra, the weight-loss aid that was removed from the market last year after it was linked to 155 deaths. Nutraceutical, a Utah company that challenged the ban, said in its lawsuit that ephedra "has been safely consumed" for hundreds of years and is a food, not a drug. (Steven Senne -- AP)

Industry groups said supplements that included ephedra were once used by 12 million people. Last year's ban of ephedra was the first such outlawing of a dietary supplement.

Research shows that ephedra -- an amphetamine-like herb -- can speed heart rate and constrict blood vessels even in seemingly healthy people but that it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Among the deaths linked to the substance was that of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago.

The judge's decision was seen by some anti-ephedra advocates as falling short of an outright reversal of the ban, though a Nutraceutical lawyer declared flatly, "The ban is gone." The company said it is too soon to say whether it will put the product back on shelves.

The FDA was evaluating the ruling, but Health and Human Services Department spokesman William Pierce said the agency "made the right decision from the standpoint of science and our statutory authority." He added, "This is exactly when the dietary supplement law should apply."

Health officials and Justice Department lawyers are examining the ruling to determine the next step, Pierce said.

U.S. District Judge Tena Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not a food. She said a 1994 federal dietary supplement law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs.

The judge said the law requires the FDA to prove that a dietary supplement is harmful, rather than requiring the manufacturer to prove it is safe, as is required with drugs.

"The [FDA's] statement that a safe level cannot be determined is simply not sufficient to meet the government's burden," Campbell wrote.

Her order prevents the FDA from stopping Nutraceutical from selling its product and sends the case back to the FDA for a determination of what are safe and dangerous levels of ephedrine, ephedra's active ingredient.

Nutraceutical President Bruce R. Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it.

"This is a great affirmation for the system, that the court goes back and says, 'This is Congress's intent,' " he said.

Ephedra opponents said the language in the order applies to only a specific, lower-dosage segment of the market. The ruling's final page prohibits the FDA from enforcing the ban on Nutraceutical's supplements containing 10 milligrams or less of ephedra.

Ten milligrams per day was the dosage of Nutraceutical's products.

"No one -- not the FDA, the supplement industry, nor the public -- has been satisfied by how ephedra has been regulated," said Sen. Orrin G. Hatch (R-Utah), who helped write the 1994 law that also deregulated the supplement industry. "Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems," he said.

Sen. Richard J. Durbin (D-Ill.), a frequent ephedra critic who worked for the ban, said the ruling underlined the need for "a mandatory and uniform system of reporting adverse health events that result from use of certain dietary supplements."

© 2005 The Washington Post Company


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