Dec. 30, 2003
Ephedra Ban Comes Too Late; FDA Should Have Acted Much Sooner
Statement of Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group
Today's announcement by the FDA to ban the dietary supplement ephedra, which comes more than two years after we petitioned the agency to do so, shows the dangerous cowardice of FDA Commissioner Mark McClellan and HHS Secretary Tommy Thompson, who waited to act until receiving reports of more than 155 deaths of ephedra users instead of acting much earlier. All the scientific evidence and legal authority to ban ephedra was in place at the time of our petition, which we filed in September 2001. One reason major manufacturers have stopped selling ephedra is that the companies have become uninsurable because of massive losses in product liability cases. Several weeks ago, the last major manufacturer of ephedra dietary supplements - Metabolife - announced that it would no longer sell ephedra. When we filed our petition, there were reports of 81 ephedra-related deaths. Now, after that number has nearly doubled and very little ephedra is being manufactured, the FDA finally announces a ban. This is an inexcusable dereliction of responsibility by an agency that has acted more like an ephedra sales extension agency than the public health agency it is supposed to be.