Monday, April 25, 2005

Banning Ephedrine-Containing Products

Here's an article about the recent federal court decision to overrule an FDA ban on an ephedrine containing product. Herbal supplements are categorized as foods by federal guidelines and are therefore not regulated in the same way as medications.

Accordingly, they are not subject to FDA safety, purity or efficacy standards. About the only control the FDA has with such supplements is when they are contaminated with other forbidden toxins. Essentially what this means is that companies manufacturing herbal supplements and vitamins don't have to establish that their products are safe let alone efficacious. In addition, the companies can make many claims about their benefits without any proof whatsoever. In fact, companies aren't even required to establish the exact amount or quality of the substances in the supplements.

Obviously, medications are held to much higher standards and claims in package inserts are much more tightly regulated.

What this district court ruling basically did was re-establish that the FDA has no jurisdiction under current law.

I think the vast majority of physicians are opposed to this and feel that herbal and nutritional supplements should be held to the same standards when it comes to safety and efficacy (and at least purity) as medications. Unfortunately, the supplement lobby argues that since there is little academic and industrial motivation to actually study these substances, it's unfair that they should be held to the same standards.

To me this is preposterous. If the supplement manufacturers want to market their products, why shouldn't they have to spend the money to demonstrate safety and efficacy? If the product isn't patentable (as is the case with most supplements), companies obviously will be reluctant to spend such money. So what? If the price of these substances go up, so be it. The claims made should be no less sustainable than with medications. At the very least safety must be established. To me this is just common sense.

Such a change will be incredibly unpopular politically and I doubt that congress and any sitting president will have any desire to confront the vast numbers of constituents who believe in and use such supplements. Many people swear by their properties despite a lack of evidence and despite the well-established existence of a placebo effect.

Of course, just because the benefit of some of these ingredients hasn't been established, that doesn't prove that something doesn't work as labeled. But as a scientifically-minded person who also believes in the first precept of the Hippocratic oath, I subscribe to the rule of first do no harm. Some of these supplements (with data suggesting so) may in fact do just that.

Personally, I feel the federal district court made the only ruling it could make given the existing law and was only acting within its proper purview. The true solution is to simply change the law.



Blogger Fred Mangels said...

Congressman Ron Paul's commentary on the issue of supplements can be seen at

April 26, 2005 8:19 AM  

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