Let science rule on ephedra

According to a federal court ruling in Utah late last week, the Food and Drug Administration wrongly treated ephedra supplements as drugs when it leveled a ban on sales of the adrenaline-like substance linked to a number of deaths and hundreds of adverse reactions. U.S. District Judge Tena Campbell ruled that a 1994 federal dietary supplement law places more restrictive rules on the FDA in determining whether to ban foods, as opposed to drugs.

Dietary supplements are considered food under the law, and the government has to prove they are unsafe. Meanwhile, drug manufacturers have to prove to the government that pharmaceuticals they wish to market are safe. The government, Campbell wrote, did not meet its burden when it leveled a ban on the sale of supplements containing ephedra. "The (FDA's) statement that a safe level cannot be determined is simply not sufficient to meet the government's burden."

While legal distinctions can be drawn regarding the differing regulation of drugs and "food," this issue should ultimately be determined by science. Campbell has referred the matter to the FDA, which must establish what are safe and dangerous levels of ephedrine. The agency also should explore other legal and regulatory options it may have to keep dangerous supplements off the market in the future.

Research has demonstrated that ephedra can accelerate heart rate and constrict blood vessels even in seemingly healthy people, but it is particularly risky for people with heart disease or high blood pressure. It also poses risks for people who engage in strenuous exercise. The death of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago, was linked to ephedra use.

Until the FDA establishes some benchmarks, consumers need to beware of possible risks posed by the incorrect use or overuse of supplements. Many supplements contain herbs, minerals and other substances that have been used for thousands of years in various cultures. But unlike prescription drugs that undergo rigorous studies and hearings before they are made available to consumers, there is not a similar body of medical research for supplements. They may be highly effective in some people or they may cause adverse reactions with prescription or over-the-counter medications.

As the FDA examines its role in regulating supplements, consumers must act as their own best advocates, which means consulting with health-care providers or other credible sources.