Judge Lifts FDA Ban on Ephedra

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 claimed that ephedra had been safely consumed for hundreds of years.

Judge Tena Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not as a food. She said a 1994 federal dietary supplement law placed more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs. The judge said the law required the FDA to prove that a dietary supplement was harmful, rather than having the manufacturer prove it was safe, as was 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 sent the case back to the FDA for a determination of what were safe and dangerous levels.

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

Research shows ephedra -- an amphetamine-like herb -- can speed heart rate and constrict blood vessels even in seemingly healthy people, but 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 antiephedra 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 was too soon to say whether it will put the product back on shelves.

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

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

Ephedra opponents said the language in the order applied only to a very 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.