American Heart Association applauds move to ban ephedra
American Heart Association
Ephedra-based dietary supplements do more harm than good
Today's announcement by the Food and Drug Administration (FDA) of its decision to prohibit the sale of supplements containing ephedra marks a victory for American consumers' health and safety, according to the American Heart Association.
Joined by FDA Commissioner Mark McClellan, Ph.D., Secretary of Health and Human Services Tommy Thompson announced the FDA's intention to soon publish a final rule which would effectively ban the sale of dietary supplements containing ephedra within 60 days. In April 2003, the American Heart Association submitted comments in support of an FDA proposal to limit the manufacturing and marketing of ephedra-based dietary supplements, but stated its own view that the dietary supplements containing ephedra, a potent stimulant used in many over-the-counter weight loss and body building products, should be banned.
"We are pleased with the FDA's decision to ban these dietary supplements from stores' shelves," said American Heart Association President Augustus O. Grant, M.D., Ph.D. "It sends a clear message to consumers either using or considering the use of these products, who may be unaware of the potential risks. While they may believe they are doing something good for their health, in truth they could be putting themselves at serious risk."
Supplements containing ephedra are often used to enhance athletic performance and to lose weight, but a recent RAND Institute study indicated that there is no evidence that these supplements actually improve athletic performance. Additional studies cited by the FDA noted ephedra use raised blood pressure and stressed the circulatory system – effects linked to cardiovascular events such as heart attacks and strokes.
"Using magic weight loss pills as a quick fix is no solution for maintaining a healthy weight," added Dr. Grant. "Proper nutrition, physical activity and an overall healthy lifestyle are the keys to a healthy heart and good overall health. Simply being thin is not worth risking your life by using questionable products."
In its comments from April, the American Heart Association made clear that its comments refer only to over-the-counter dietary supplements, not prescription drugs containing ephedrine nor over-the-counter "drugs" containing pseudo-ephedrine (such as many non-prescription cough and cold medicines). While these over-the-counter drugs are regulated by the FDA, there are relatively few standards or guidelines for the manufacture and marketing of dietary supplements. The lack of standards and proper regulation of supplements means that consumers can't be sure how much ephedra these supplements actually contain and whether they contain other compounds with possible hazardous health effects.
"There is great uncertainty over the use of dietary supplements, and too often the public does not scrutinize the products they choose to use or their dosage instructions," added Dr. Grant. "Given the confusion surrounding ephedra and the threat it poses, today's decision by the FDA removes both the uncertainty and the risk."
For more information, or to contact American Heart Association, see their website at: www.americanheart.org
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