FDA Warns Bayer Over Claims on 2 Aspirin Products

WASHINGTON (AP) - Bayer is illegally marketing two aspirin products that make unsubstantiated health claims about fighting heart disease and osteoporosis, federal regulators said Tuesday.

The Food and Drug Administration issued a warning letter to the German conglomerate saying it never received approval for the claims on its Bayer Aspirin with Heart Advantage and Bayer Women's products.

The Heart Advantage product combines aspirin with the plant extract phytosterois, which the label touts as a proven cholesterol-lowering supplement. Bayer Women's combines aspirin with calcium carbonate and is labeled to "fight" osteoporosis.

The FDA warned the company that treatments for heart disease and osteoporosis must be reviewed by government scientists and cannot be sold over the counter. Doctors traditionally recommend aspirin to treat aches and pains and as a blood thinner for patients with heart disease.

"The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process," said Mike Chappell, an FDA associate commissioner.

A Bayer spokeswoman could not immediately provide comment Tuesday morning.

The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.

The agency allows traditional pain relievers to be sold over-the-counter without review, as long as they include standard directions and labeling for consumers. But the FDA said Bayer's products overstepped those regulations by claiming that the added ingredients in each medicine help fight specific diseases.

In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.

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The latest FDA action comes two weeks after Democrats on Capitol Hill first drew attention to the claims on Bayer's Heart Advantage. Reps. John Dingell and Bart Stupak, both of Michigan, earlier this month sent a letter to Bayer's U.S. executives, demanding they turn over any evidence that the product has a positive effect on cholesterol and heart disease.

"It's shameful that consumers have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns," Stupak said in a statement accompanying the letter to Bayer.

Dingell, who chairs the House Energy and Commerce Committee, has been investigating drug advertising and the FDA's oversight of pharmaceutical manufacturers for over a year. Stupak chairs the subcommittee on oversight and investigations.

(Copyright 2008 by The Associated Press. All Rights Reserved.)

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