Friday, April 15, 2005

Safety of food and dietary supplements

It looks like people might be able to obtain ephedra again. A previous FDA ruling banning it has been partially struck down by a federal judge in Utah (article link):
The case was brought by Nutraceutical, a Park City, Utah-based company. In a prepared statement, company President Bruce Hough said that the decision was about protecting the public's access to safe dietary supplements, which, under the law, are treated as food, not drugs. That means that to pull them from the market, the FDA must prove that the drug is not safe. The court decided that the FDA may have proved that for higher doses of ephedra, as high as 100 milligrams, but not for the lower doses of 10 milligrams.
Needless to say, cardiologists have something to say about this decision. Prediman K. Shah, at Cedars-Sinai Medical Center in Los Angeles:
"It's a dangerous drug that can be abused. It has serious cardiovascular risks, and I don't see any reason why they should even have it on the market as an unregulated supplement. It is a stimulant. Just like cocaine triggers heart attacks or strokes, so can ephedra."
Steven Nissen, a cardiologist at the Cleveland Clinic:
"The problem is that the law is designed to allow companies with dangerous products to sell them until somebody can absolutely prove that they're harmful," Nissen says. "How are these drugs any different than prescription drugs? These drugs don't have to show benefit, and they have to be proven harmful. How does that make any sense?"
These doctors advocate the idea of requiring the same rigorous testing of dietary supplements that is required of prescription drugs, namely they should have to be proven to be safe and effective in order to be sold. Naturally, the dietary supplement industry disagrees: they maintain that supplements should continue to be classified as foods, which would mean that they could only be banned if they are proven to be harmful.

But neither side is really being honest. Firstly, the effect of requiring pharmaceutical-grade testing on herbal supplements would be to remove them from the market, which is precisely what the drug industry wants. The reasoning is fairly obvious: this type of testing is very expensive, and is therefore only cost-effective if the substance being tested is patented. Dietary supplements are not patented, so there is little likelihood that anyone out there would be willing or even able to shell out the millions of dollars needed to test them.

Secondly, there is a larger aspect of the problem, which is not even being mentioned in this debate. Foods can be sold until someone proves them to be harmful. And, as has been demonstrated in this case, obtaining such proof can be difficult, even in cases where experts agree that the substance is dangerous. This doesn't just apply to dietary supplements, but to all food substances. A company can put anything it wants in your food, unless and until someone proves that it is dangerous to do so. This covers everything from dead bugs to synthetic animal hormones, to genetically modified foods, and the criterion for what constitutes "dangerous" is apparently pretty high. Clearly, what is needed is a lowering of the bar, in the name of protecting the food supply. The dietary supplement issue is only part of a much larger and more serious problem.

[For the record, I don't particularly care about ephedra one way or the other, except as part of the larger issue. Also, I think the bar could stand some raising with respect to drug testing as well. When I used the term "rigorous" above, I was using it pretty loosely. But that is a seperate issue.]


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