FAREWELL TO EPHEDRA

The deadly supplement remained on the market so long because of a
loophole in the law that puts consumers at unnecessary risk.

It took too long, but the federal government finally decided to ban
ephedra, a substance found in some supplements sold to dieters and
linked to dozens of deaths. Health and Human Services Secretary Tommy
Thompson announced Tuesday that a rule banning ephedra-laced products
would be coming soon, and he warned consumers to avoid such
supplements in the meantime. "Today's action puts companies on notice
of our intentions, and it tells consumers that the time to stop using
ephedra products is now," he said.

Actually, the time to take ephedra off the market was years ago. Since
1993, the Food and Drug Administration (which Thompson oversees) has
collected information about adverse reactions to ephedra, such as
heart attack and stroke. Ephedra also has been linked to more than 100
deaths. One of those deaths finally caught the nation's attention.
During spring training a year ago, Baltimore Orioles pitcher Steve
Bechler died of heat stroke after taking a diet product containing
ephedra.

That death, as the others, was a tragedy, but it shouldn't have come
as a surprise. Two years earlier, using the agency's own records as
proof of the risk, consumer advocacy group Public Citizen petitioned
the FDA to ban ephedra products. Now, the regulatory agency is
catching up with three states, sports organizations including the NFL,
NCAA and International Olympic Committee and retailers such as General
Nutrition Centers that have already issued their own bans.

Better the FDA acted late than not at all, of course. As Thompson
noted, many Americans will turn to diet products to lose weight gained
over the Christmas holiday, and they should avoid those containing
ephedra, or its active ingredient ephedrine. A powerful stimulant, it
raises a person's heart rate and blood pressure, and it has been
linked to "significant and substantial adverse health effects like
heart problems and strokes," according to the FDA.

The agency said its actions were slowed because the law regulating
herbal medicines doesn't require manufacturers to report adverse
health events to the agency. That is only one of the loopholes in the
law - called the Dietary Supplement Health and Education Act - that
puts consumer health at risk. Unlike prescription drugs or even
over-the-counter medications, nutritional supplements don't need to
prove their safety before going on sale. So the FDA has to wait for
injuries and deaths before it can act against an unsafe product.

Already, substitutes to ephedra that may also carry the same health
risks are being sold, said Dr. Sidney Wolfe, director of Public
Citizen's Health Research Group. "The big issue is (the supplement
industry) can escape testing in advance to prove their products are
safe and effective," Wolfe explained. "Without that, you are going to
have the body-count approach that you do today."

The ephedra deaths and the FDA's delayed response should spur Congress
(or at least shame it) into rewriting the supplement law so that
consumers can be protected before their lives are at risk