The Fda And Ephedra Essay

1745 words - 7 pages

The U.S. Food and Drug Administration (FDA) is the part of the Department of Health and Human Services that is responsible for safety regulations for foods, drugs, vaccines, Bio-medical products, blood products, radiation-emitting Technology, cosmetics, veterinary products, and dietary supplements. (2) With the FDA having all of these duties it is easy to see how some things may slip by, but this does not free them of all blame. The FDA has been under the microscope lately due to the E coli and salmonella outbreaks. But one of the big problems it’s had over the past couple years is the topic of dietary supplements and if they should be monitored by the FDA.Ephedrine based supplements caught the eye of the FDA when people started dying from heart attacks and heat exhaustion due to taking the supplement. To understand why the FDA chose to ban this drug one must first understand the drug and what it does to the human body. Ephedra is a thermogenic and a stimulant, which increases heart rate, constricts blood vessels thus increasing blood pressure, stimulates the brain, and makes the bronchial tubes expand which makes breathing easier. The weight loss properties come from the thermogenic characteristics which cause an increase in metabolism and body temperature. (5)The first concerns about the ephedra based supplements arose in 1997 when the FDA proposed a ban on supplements containing 8mg or more of ephedrine alkaloids and more detailed labeling on low dose ephedra products. They also proposed that the health risks be labeled also, including heart attack, stroke, and death. (4) But after battling with the ephedra based supplement companies’ public relations group, known as the Ephedra Education Council, the FDA withdrew its proposal in 2000. That same year the New England Journal of Medicine discovered cases of heart attacks and strokes all due to ephedra use. Most of the victims were young adults who were using ephedra in the dosages specified on the bottles. After all of the evidence that was put on the mainstream why did it take the FDA until April 12, 2004 to issue a rule banning the sale of supplements containing ephedra? (2) This proves that there is an obvious malfunction in the way the FDA places bans on drugs and supplements.People didn’t have to die to realize that this drug should have been banned or even regulated; the FDA should have put a microscope on the ephedra supplement industry and investigated the cases of adverse effects more in depth. Maybe if they would have done that the product would have been off shelves quicker. Even if they couldn’t get it off of shelves, if they made it more of a priority in their investigations to find support that the product was worthy of regulation maybe ephedra would have become a mainstream problem instead of the victims and FDA’s.The FDA’s Battle with EphedraThe FDA is a very big organization with many responsibilities and that’s why ephedra might have lasted on...

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