Elizabeth S. Reames | 6/24/2005 6:26:03 PM
Following its recent consumer alert about ephedra, the Food and Drug Administration (FDA) will issue a rule to ban the sale of dietary supplements containing ephedrine alkaloids. LSU AgCenter nutritionist Dr. Beth Reames says consumers should stop buying and using ephedra products now.
"Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury," Reames says.
Ephedra, also called Ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years, ephedra products have been extensively promoted for use to aid weight loss, enhance sports performance and increase energy.
FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body, Reames explains. 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 also have 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," the LSU AgCenter nutritionist points out.
According to the Federal Food, Drug and Cosmetic Act, a dietary supplement product is adulterated if it or a dietary ingredient within it presents a significant or unreasonable risk of illness or injury under conditions of use suggested in the labeling or under ordinary conditions of use.
Under the Dietary Supplement Health and Education Act of 1994, the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk to prevent it from being marketed; in contrast, for drugs that have similar pharmacologic properties to ephedra, manufacturers bear the burden of proof of showing that the drug is safe and effective before it can be marketed.
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 in February 2003, 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 the FDA. Additional materials relating to the announcement are available online at www.fda.gov.
For information on related family and consumer topics, contact an extension agent in your parish LSU AgCenter office. Also, log on to the Family and Consumer Sciences section under the Louisiana Cooperative Extension Service at the LSU AgCenter Web site: http://www.lsuagcenter.com/.