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FDA targets Bayer for making unsupported claims about two of its products

It doesn't happen nearly as often as it should, but, sometimes, the FDA does slap Big Pharma on the wrist. Of course, they seem to pick their battles by targeting the companies that try to incorporate natural substances into their products.

The latest company to find itself in the hot seat is Bayer. According to the FDA, the pharmaceutical giant is making unsubstantiated claims about the health benefits of two of its recently released products, Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage (which contains phytosterols).

On the package labeling for Low Dose Aspirin + Calcium, Bayer states that calcium "helps strengthen bones to help fight osteoporosis." In the case of their Aspirin with Heart Advantage, Bayer takes it one step further by claiming that both the aspirin and the added phytosterols help boost heart health.

While Bayer isn't winning any awards for ethics by tacking calcium and phytosterols onto its aspirin and acting like they invented two new wonder drugs, it is true that calcium strengthens bones and that phytosterols protect your heart. Of course, we know all too well that as far as the FDA is concerned, the truth doesn't matter -- what matters is the agency's piggy bank. And apparently, Bayer hasn't forked over enough cash for the FDA to grant these new drugs its "approval."

What's even more maddening is that, unlike supplement manufacturers who make calcium and phytosterol supplements, Bayer can afford to pay the price for FDA approval. And, unfortunately, many people are more likely to rely on "FDA approved" products, so when and if Bayer does get their new formulas approved, they're likely to be big sellers.

In the meantime, I don't know about you, but I'd much rather leave the stomach-churning aspirin behind and opt for the "un-approved" calcium or phytosterols (sans aspirin) that are actually doing all the work.

Source:
"FDA warns Bayer on marketing of 2 aspirins," The New York Times (www.nytimes.com), 10/29/08

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