A CHANGE IS NEEDED

The FDA Needs More Authority To Act Quickly To Address Questionable Products

The Food and Drug Administration's move this week to ban ephedra has been a
long time coming -- too long.

Congress needs to change the law that prevented the FDA from acting sooner
on ephedra. For years, the dietary supplement has been linked to serious
health problems and death.

The law, passed in 1994 under heavy lobbying from the supplement industry,
ties the hand of the FDA in regulating such products to protect the public.

The 1994 law took the safety standard that applies to prescription and
over-the-counter drugs and turned it upside down. While drug makers must
prove their products are safe before selling them, supplement makers are
under no such obligation. Instead, the FDA is barred from restricting sales
of a supplement without proof that it poses an "unreasonable risk" to
public health.

Yet, like drugs, some supplements can have powerful effects on the body.
Ephedra, for example, can speed up the heart rate and raise blood pressure.

FDA Commissioner Mark McClellan said his agency first tried to restrict
ephedra sales in 1997. But to meet the burden of proof under the 1994 law,
the agency had to review thousands of reports of adverse reactions and
commission an independent study.

At a minimum, Congress needs to change the 1994 law to require supplement
makers to tell the FDA about potential side effects, as drug makers already do.

Otherwise, how long will it take the FDA to learn of -- and act on -- other
dangerous supplements?