Tuesday, the Food and Drug Administration (FDA) warned Bayer that two of their aspirin medicines were being marketed without the company having ever presented any proof of the benefits they claimed the drugs had.

Federal regulators sent two warning letters to Bayer, stating that Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Health Advantage had not been in any way proven effective in fighting heart disease and osteoporosis, since the manufacturer had not submitted any information or research concerning the matter.

Every treatment for the aforementioned conditions has to be reviewed by government scientists and selling meds that deal with these diseases over the counter is banned.

Bayer is to answer the FDA’s letters within fifteen working days, as the Administration has requested.

Nevertheless, the company has stated that the drugs had never been aimed at replacing professional advice and treatment prescribed by doctors, adding that the advertisements for their products urged people to consult their physicians before going on the aspirin-based pills. Moreover, Bayer Aspirin with Heart Advantage ads notify people that it does not replace cholesterol-lowering medication.

Although the letters the FDA has sent are not legally binding, they are not to be ignored, since federal health officials can go on to file legal charges against the companies who fail to reply to their warnings.

German drugmaker Bayer now has two options to choose from so that to meet the FDA’s demands: either to stop selling the drugs or to conduct research and clinical trials to prove their effectiveness and submit the results for federal reviewing.