Two aspirin products being sold over-the-counter by Bayer Healthcare have not received U.S. Food and Drug Administration (FDA) "new drug" approval for their marketed uses, and the manufacturer has received two warning letters from the FDA, the agency announced Tuesday.
The warning letters concern "Bayer Women's Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage". Both are labeled as pain relievers, but also as reducing the risk of heart disease, a use that has not been approved by the FDA, according to an FDA Press Release (Bayer Women's Low Dose Aspirin + Calcium is also labeled for "fighting" osteoporosis, another use that has not been approved by the agency). In addition to being marketed illegally, both aspirin drugs are also considered "misbranded" by the FDA, because "use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use", and because their labeling is misleading and carries inadequate warnings, according to the FDA.
The New York Times reports that the F.D.A. "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 sue companies if they are ignored."