Tuesday, September 25, 2007

Supplements recalled because they might actually work

In the unregulated, charlatan-filled world of dietary supplements, there's no telling what's in a bottle of pills. So perhaps it's not surprising that the FDA recently recalled two dietary supplements not because they were ineffective, but rather because they might actually deliver on their marketing promises.

The supplements in question, Axcil and Desirin, were pulled because they contained sildenafil, the active ingredient in the erectile dysfunction drug, Viagra. Supplements can't contain drugs because that would make them, well, drugs, not supplements. Of course if they contained medications, they might actually have some medical benefit too, but that might be asking too much from the crazy world of supplements, where claims of effectiveness are allowed but proof is not required.

According to the Axcil website, which has now been taken down, the supplement "is a scientifically formulated, breakthrough dietary supplement containing a proprietary standardized botanical extract that acts synergistically to promote erectile function and sexual desire in men." We know Viagra works quite well for this, so delete the "botanical extract" nonsense and technically this becomes a legitimate claim, just so long as they're illegally including sildenafil in their supplement pills.

Desirin makes a similar pitch, except it's targeted at women. But we know Viagra helps promote sexual function in females too, so again, this is essentially a legitimate claim.

To put this situation in other terms, the FDA seemed to have no problem when Axcil and Desirin were on the market with their unproven claims. It was only when the supplements actually contained a medication that might help -- Viagra -- that the FDA objected.

It should also be noted that even if the "proprietary standardized botanical extract" that was supposedly in these supplements had been shown in legitimate scientific studies to have some medical benefit without the addition of Viagra, this still wouldn't mean much for consumers. Supplements are not regulated, which means consumers have no way of knowing if the supplement they purchase in a store is the same compound used in the research.

The substance in the bottle could differ in concentration or the amount of active ingredients. The supplements could even contain no active ingredient. Or dirt. Or pocket lint. Who knows, maybe pocket lint actually does help treat cancer symptoms. I can at least make that claim on a bottle of pocket lint pills. Just so long as my supplements don't contain any actual anti-cancer medications, presumably the FDA won't stop me.

Of course, this isn't the FDA's fault. Their hands have been bound by Congress, which in an act of stupidity unbelievable even for Capitol Hill, passed a law keeping FDA out of supplements and allowing manufacturers to sell dietary supplements without proving either their safety or their effectiveness. This might be a good reason to steer clear of supplements, but unfortunately millions of Americans can't resist the Siren C of this industry, which racks up billions of dollars per year peddling substances that may be worthless or even dangerous. Anybody want to buy some pocket lint?

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