Diet Supplement Ephedra Banned (cont.)
FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. FDA's evaluation also reflects the available studies of the health effects of ephedra. This includes many studies reviewed by the RAND Corporation, which found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety risks. Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
FDA's notification reflects the agency's recent comprehensive evaluation of the science as well as a public comment period intended to cap years of debate about the risks and safety of ephedra in dietary supplements. In 1997, FDA first proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. FDA modified this proposed rule in 2000, and last February the agency announced a series of comprehensive actions designed to protect Americans from the potentially serious risks of dietary supplements containing ephedra. To solicit comments on new evidence about ephedra as well as on a proposed warning statement, last February's actions included publishing a Federal Register notice outlining FDA's concerns and reopening the comment period.
Following publication of this notice, FDA received and reviewed tens of thousands of comments. The agency has also reviewed a comprehensive RAND Corporation report on the data on ephedra and a series of adverse event reports that it was unable to obtain more quickly because under the Dietary Supplement Health and Education Act such adverse event reports are not required to be submitted to FDA.
"We are going to issue a rule that clarifies and applies a legal standard that that has never been used before. Using the challenging standard provided under the law, we have done all we can to make sure our regulatory action will succeed," said Dr. McClellan.
FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids alerting them of this future rule.
While working on the forthcoming rule, FDA has been actively protecting the public health through a series of high-profile enforcement actions aimed at addressing the public health danger. Dietary supplement enforcement actions include inspections that resulted in voluntary compliance, voluntary recalls, warning letters, seizures and injunctions, criminal enforcement and joint enforcement actions with the Federal Trade Commission and the Department of Justice. In conjunction with FDA's actions to date, classes of ephedra products have already been removed from the market (for example, many products marketed for enhancing sports performance), the demand for ephedra products has declined significantly, and many companies have already ceased marketing. (More detail on these actions can be found at http://www.fda.gov/ola/2003/dietarysupplements1028.html).
Source: HHS Press Release, December 30, 2003
Last Editorial Review: 12/30/2003