We recently told you about some concerns the FDA had with Bayer regarding its marketing of aspirin products using unsubstantiated claims. The company has been marketing Bayer Women's Low Dose Aspirin Plus Calcium and Bayer Aspirin with Heart Advantage products, both combinations of aspirin and a supplemental product. Bayer Women's contains calcium and Bayer Heart Advantage contains phytosterols.
The company has now received official warning letters from the FDA, since Bayer has not substantiated the claims that the over-the-counter products are effective against either osteoporosis or heart disease, and the FDA now says that Bayer cannot market either product in the U.S. legally.
"Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products," according to a FDA statement, which also said that government scientist must review treatments for heart disease and osteoporosis.
The company says it continues to stand behind the claims it is making on the two products and that it would respond to the FDA letters within 15 business days.