FDA's main ephedra page:
http://www.fda.gov/oc/initiatives/ephedra/december2003/
FDA's consumer advisory:
http://www.fda.gov/oc/initiatives/ep.../advisory.html
Quote:
|
The totality of the available data showed little evidence of ephedra's effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to significant adverse health outcomes, including heart ailments and strokes.
|
Quote:
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 under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy.
Today's announcement is a continuation of a process that started in June, 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than 7 days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products.
|
The answer to your question, James, is that ephedra isn't regulated as strictly as ephedrine is, because ephedra is classified as a dietary supplement and ephedrine is classified as a drug. FDA doesn't have much control over dietary supplements; FDA basically has to take the manufacturer's word for their effectiveness and safety, and they don't have to undergo the same rigorous clinical trials that drugs do. Every drug containing ephedrine has been proven safe and effective, or else it would not be on the market.
Additionally, if you read the labels of your medicines, most of them say not to take the drug for more than 7 days without a physician's supervision. If you notice in the quote above, FDA also recommended the same for ephedra, but of course people trying to lose weight are probably not going to stop taking it after 7 days. Also, if someone is overweight, they likely already have high blood pressure and other stresses to their circulatory system, which are aggravated by the side effects of ephedra.
Hybrid Mode
