FDA Gives Bayer AG Warning About OTC Aspirin Products

October 29, 2008

The U.S. Food and Drug Administration (FDA) has sent a warning letter to Bayer AG about two OTC aspirin products...............Washington (ChattahBox) – The U.S. Food and Drug Administration (FDA) has sent a warning letter to Bayer AG about two OTC aspirin products.

The products are aspirin products known as Bayer Aspirin with Heart Advantage, and Bayer Women’s Low Dose Aspirin + Calcium.

They are sold over-the-counter and are also considered to be dietary supplements.

The FDA sent the warning letter after they felt the company was misleading in promotions.

Bayer has defended the products and the promotion surrounding them.

The Bayer Aspirin with Heart Advantage says that it can control cholesterol.

The other claims in question are that the other aspirin drug makes bones stronger, and fight osteoporosis.

The FDA wrote in their October 27th warning letter “These statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used.”

The FDA is seeking clear action as Bayer has to respond within 15 days.


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