Excerpted from Sacramento Bee, Wednesday, 5 February 2003.

Editorial: Unsafe At Any Dose; Ephedra Is Dangerous, And Unregulated

Bee Editorial Staff -- Of all those herbal supplements on the nation's store shelves, one substance is responsible for 64 percent of the adverse reactions, according to a new study to be published in the Annals of Internal Medicine.

The problem pills are the ones that contain the stimulant ephedra, also known by its Chinese name, Ma huang. The federal Food and Drug Administration knows of at least 100 cases of consumers who may have died because of taking the drug. Ephedra can accelerate the heartbeat and constrict blood vessels. Makers of supplements containing ephedra have been battling lawsuits from victims and their families who contend they led to heart attacks and strokes.

This new study underscores an old problem: the regulation of these supplements, or the lack thereof. Congress in the 1990s essentially deregulated the supplement industry, allowing any maker to peddle any product without any proof it was either safe or effective. It then became the burden of the FDA to prove a drug was unsafe.

So, when is ephedra safe? Not at the suggested dosage, this new study says. What more proof does an agency need? The Bush administration last June asked the FDA to study ephedra, a reasonable but overdue first start. And in California, Gov. Gray Davis last year signed legislation banning sale of herbal products containing ephedra to minors.

The supplement industry seems willing to swallow a warning label. Tens of thousands of Americans are taking these products, many to lose weight, absent proof of effectiveness and mounting evidence of dangers. As one of the new study's authors said, "The benefits for ephedra are not at all well established. It is a minimal benefit that goes away when you stop using the product. And the risks are really substantial."

How about putting that on the side of the bottle -- until the FDA gets around to banning it altogether?

Excerpted from Sacramento Bee, Wednesday, 5 February 2003.