FDA Warns Bayer Over Claims on 2 Aspirin Products

Oct. 28, 2008— -- WASHINGTON (AP) - Bayer is illegally marketing two aspirinproducts that make unsubstantiated health claims about fightingheart disease and osteoporosis, federal regulators said Tuesday.

The Food and Drug Administration issued a warning letter to theGerman conglomerate saying it never received approval for theclaims on its Bayer Aspirin with Heart Advantage and Bayer Women'sproducts.

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

The FDA warned the company that treatments for heart disease andosteoporosis must be reviewed by government scientists and cannotbe sold over the counter. Doctors traditionally recommend aspirinto treat aches and pains and as a blood thinner for patients withheart disease.

"The FDA will take enforcement action against manufacturersfound to be violating the law or attempting to circumvent the drugapproval process," said Mike Chappell, an FDA associatecommissioner.

A Bayer spokeswoman could not immediately provide commentTuesday morning.

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

The agency allows traditional pain relievers to be soldover-the-counter without review, as long as they include standarddirections and labeling for consumers. But the FDA said Bayer'sproducts overstepped those regulations by claiming that the addedingredients in each medicine help fight specific diseases.

In general, the FDA discourages firms from packaging drugs withdietary supplements because it gives the impression both have beenevaluated by the FDA, when in fact, the agency only regulatesdrugs.

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