December 31, 2003
In announcing its decision yesterday morning to ban dietary supplements containing ephedrine alkaloids, the Food and Drug Administration (FDA) acknowledged its authority under the current law to remove products it determines to be unsafe. This is an important message to industry and to consumers who may have been misinformed or confused on this issue.
Over the past decade there has been an ongoing disagreement between experts, some of whom have concluded that ephedra is appropriate for use by well informed adults and others who believe that the herb should be banned. FDA has the responsibility and the authority to serve as the arbiter in this controversy, and has now made its decision. The agency has not yet provided any communication as to how it has arrived at its conclusion, but AHPA will evaluate this information as soon as it is available for review.
Importantly, at three separate times during yesterday's press conference, Secretary Thompson mentioned that he believes FDA should have the authority to access adverse event reports associated with dietary supplements. This position is not inconsistent with AHPA’s Citizen Petition, submitted to FDA on March 20, 2003, in which it was requested that FDA establish a requirement for dietary supplement companies to submit serious adverse event reports to FDA. AHPA will continue to work toward the development of such a system.
About AHPA: Founded in 1983, the American Herbal Products Association is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA's mission is to promote the responsible commerce of herbal products.