FDA Bans All Sales of Dietary Supplements Containing Ephedra (Ma Huang).
The FDA announced today that they have issued a Consumer Alert advising consumers to immediately stop buying and using ephedra products. Also, the FDA has begun notifying manufacturers that it intends to publish a final rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the
effect of banning the sale of these products as soon as it becomes effective, 60 days after publication. The earliest the ban could take effect is March of 2004.
To read the entire FDA press release, go to:
Commentary:
The FDA has tried on several occasions to prove a link between ephedra use and the over 1,600 "adverse effects" reports involving ephedra products. They have failed in every attempt. So now, it seems, they just said Screw it, let's ban it anyway - because we can.
Industry estimates of ephedra users range from 20 million to as much as 40 million people per year (the FDA's own data suggests 3 BILLION servings per year). Let's call it 30 million users. When 30 million people consume ANYTHING the odds are several thousand are going to have an "adverse symptom" (which includes anything from mild headache and insomnia to heart attack or stroke). In fact, according to the FDA, there have been 155 reported deaths by individuals using a ephedra product. According to the US Census Bureau, about .8% (.008) of the US populations dies each year. That would mean that, based on statistical averages, among a random sampling of any 30 million people, 240 THOUSAND of them will die of something during the year! In fact, there is still no hard evidence of any cause-and-effect relationship between ephedra use and these "adverse effects" other than the circumstantial fact that those who had these adverse effects happen to be taking a ephedra product. Based on this logic, the FDA should ban water. After all, 99.9% of all those who died last year were consuming water at the time! (The other .1% died of
dehydration).
For a more balanced review of this matter check out the following link:
Len Clements
MarketWave, Inc.
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