Thursday, April 14, 2005
(Washington, D.C.) – Consumers Union is urging the Food and Drug Administration to pursue all legal and regulatory options to prevent ephedra from returning to the market after a federal district judge today struck down the ban on the dietary supplement, which has been linked to more than 150 deaths.
“The FDA did the right thing in taking ephedra off the market, and it should fight hard to make sure this hazardous supplement stays off the market,” said Chuck Bell, program director for Consumers Union, publisher of Consumer Reports.
The case is an important test of whether FDA has adequate authority to ban, remove or restrict dietary supplements that pose serious hazards to members of the public. The Dietary Supplement Health and Education Act (DSHEA), the law that governs supplements, clearly states that the FDA has the authority to remove dietary supplements that “[present] a significant or unreasonable risk of illness or injury under…conditions of use recommended or suggested in labeling.” The law also states that FDA has the authority to remove supplements that “pose an imminent hazard to public health or safety.”
“To make sure dangerous dietary supplements like ephedra stay off store shelves, Congress must strengthen the FDA’s authority to take prompt and effective action on dangerous supplements,” Bell said. “The FDA should have the ability to require manufacturers to demonstrate the safety of their dietary supplements before they are sold.”
Bell said DSHEA also should be amended to require manufacturers to report to the FDA all serious adverse events caused by their products. Right now, such reporting is voluntary, so regulators have to rely on the companies to tell them about safety problems with their products.
In May, 2004, Consumers Reports published a list of 12 hazardous supplements that pose serious risks to consumers. “We are still waiting for FDA to take action against the supplements on that list,” Bell said.
Chuck Bell, 914-830-0639
Elisa Odabashian, 415-572-0036