Bayer Healthcare Taken to Task for Marketing Unapproved Over-The-Counter Medications

The U.S. FDA issued two warning letters to Bayer Healthcare on October 28, 2008, giving the company 15 days to investigate and respond. Bayer has been marketing its Bayer Women’s Low Dose Aspirin Plus Calcium (Bayer Womens) as not only assisting in the prevention of heart disease, but also provides a source of dietary calcium to reduce the risk for osteoporosis. Bayer has also been heavily advertising its newest aspirin product, Bayer Aspirin with Heart Advantage (Bayer Heart Advantage), claiming that the supplemental physosterols also help lower bad cholesterol.

Under the US FDA regulations, although Bayer Aspirin itself has been approved for use as an over-the-counter medication for years, Bayer cannot randomly add supplements to the drug for sale without first seeking FDA approval and fully complying with the labeling and advertising requirements. (See 10/27/2008 Bayer Heart Advantage Warning Letter and 10/27/2008 Bayer Womens Warning Letter.) The US FDA made it clear that the supplements added in both products could be marketed individually as dietary supplements, but that by inclusion with the aspirin, both products constitute a drug under federal regulations and thus fail to satisfy federal regulation for approval and labeling. Thus, Bayer has been informed that both products are misbranded and not properly approved for over-the-counter sale as packaged. It should be noted that the US FDA action here is not the result of any adverse reactions reported as a result of the use of either drug.

This is one more example of the drug companies’ use of direct consumer marketing gone bad. Bayers' representations on the health benefits for these products have not been established at the dosages listed on the packages and may not provide the benefits consumers expect. Consumers must hold drug companies accountable for truth in advertisements and full compliance with the US FDA regulations, which are intended to ensure consumer safety.

If you or a family member has taken Bayer Aspirin with Heart Advantage or Bayer Women’s Low Dose Aspirin Plus Calcium, please contact our office at our toll free number. We are particularly interested in talking to consumers who are regular users of either of the following products, even if you have not suffered any physical harm.