The FDA has issued two warning letters to Bayer for not submitting proof that the Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Health Advantage are useful in fighting heart disease and osteoporosis in women.

"These are not FDA-approved products," agency spokeswoman Rita Chappelle said. "They are selling products that are illegal."

The FDA has given a warning to Bayer to remove the medicines from the shelves or else face legal action.

But Bayer defended the medications and its right to market them.

"We stand behind both products and all marketing claims made in their support," the German drugmaker said in a statement.

“The F.D.A. will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process,” said Michael A. Chappell, an F.D.A. associate commissioner.

The company spokesman refuted the claim of the FDA by saying, “All of our communication on product benefits prominently features information for consumers to check with their physicians to determine if the product is right for them.”  

The F.D.A. ensures that the drug manufacturing companies follow the regulations for manufacturing and marketing. Any company that violates the FDA specifications is issued warning letters. The letters do not have any not legal binding. But the FDA holds rights to sue companies if the warnings are ignored.