FDA Issues Warning Letters to Bayer HealthCare

On October 28, two of Bayer HealthCare’s (Leverkusen, Germany) over-the-counter products were met with warning letters from FDA (Rockville, MD). Two of the company’s OTC aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage) - require “new drug application” in order to be marketed legally.

Both products, containing aspirin with either phytosterols or calcium, are intended for use in heart disease risk reduction. Bayer Women's is also labeled for use in "fighting" osteoporosis, although neither product has been approved by the FDA for such uses.

"The marketing of these unapproved drugs is troubling," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

While FDA allows some drugs to be marketed without first obtaining agency approval, the products must comply with regulations that set requirements for the drugs' labeling, formulation and use. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. According to FDA, Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. In addition, the products have been called “misbranded” because their labeling lacks sufficient directions for consumer use.

Effects of the two products are unknown, although FDA is concerned because neither product has been approved by the agency for consumer use. Companies failing to comply to FDA warning letters risk enforcement action, such as injunctions and/or seizure of illegal products.

Steve Mister, of the Council for Responsible Nutrition (CRN; Washington DC.), defended the dietary supplement industry by releasing this statement: “Dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness. Our hope is that FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”

In a statement released by Bayer, the company reinforced its claim that “all our communications on product benefits prominently feature information for consumers to check with their physicians to determine if the product is right for them.”