Banning ephedra just the first step for FDA

The federal government has outlawed products containing ephedra, but Congress still must change the way dietary supplements are regulated.

Editorial. Feb. 9, 2004.

The Food and Drug Administration's ban of dietary supplements containing ephedra is a big consumer protection victory. But the American public deserves much more.

The December action, long sought by the American Medical Association, takes dozens of dangerous products off the market. More than 18,000 people reported negative reactions to supplements containing ephedrine alkaloids. The most serious of these incidents included stroke, heart attack and even death.

But these injuries need not have occurred. Indeed, the nation's experience with ephedra -- an adrenaline-like stimulant -- points out the law's inability to protect people from potentially hazardous dietary supplements.

The FDA regulates these products under the Dietary Supplement Health and Education Act of 1994. This law gives the agency the authority to take action against dangerous dietary supplements. But instead of requiring manufacturers to demonstrate that their products are safe and effective before they hit the shelves, it only allows the FDA to prove that risky products are unsafe after the fact. By the time the government can act, the damage to consumers has been done.

The agency cannot even force supplement manufacturers to report adverse events. It must rely on voluntary efforts by product makers and complaints from consumers and health professionals. The FDA estimates that voluntary reporting captures only 1% of adverse events.