Rockville, MD (Oct. 28)—The US Food and Drug Administration sent Warning Letters to Bayer HealthCare (Morristown, NJ) about the company’s “Bayer Women’s Low Dose Aspirin + Calcium” and “Bayer Aspirin with Heart Advantage” over-the-counter (OTC) products. FDA says the products are unapproved new drugs that require approved new drug applications to be legally marketed. The drugs’ labels list uses that the agency has not approved, and the products should not be sold OTC because they require a healthcare professional’s diagnosis and supervision, according to FDA.

“The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug-approval process,” said Mike Chappell, FDA’s acting associate commissioner for regulatory affairs, in an agency press release.

Bayer Heart Advantage combines aspirin and phytosterols in a single tablet, and Bayer Women’s combines aspirin and calcium carbonate in a single tablet. Each product is labeled as a combination of a drug and a dietary supplement, and FDA regulates such products as drugs.

FDA says both drugs’ labels make unapproved claims. The labeling for Bayer Heart Advantage says the product’s phytosterols are intended to lower blood cholesterol. The calcium in Bayer Women’s is intended to strengthen bones to fight osteoporosis, according to the product’s label. In a press release, FDA notes that direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and thus require approved new drug applications to be legally marketed. In addition, products that are labeled to fight or otherwise treat osteoporosis also require FDA approval.

Some drugs can be marketed without FDA approval under the agency’s OTC-drug monograph system. These drugs must comply with applicable regulations that set requirements for labeling, formulation, and the indications for which the drugs can be marketed. According to FDA, Bayer Heart Advantage and Bayer Women’s do not meet the conditions in any applicable OTC monograph, and the agency thus considers the products illegal, unapproved new drugs.

In addition, FDA asserts that Bayer Heart Advantage and Bayer Women’s are misbranded because their labeling lacks adequate directions for use by consumers. The products require diagnosis and supervision by a healthcare professional to safely treat heart disease and osteoporosis, the agency says, and it is impossible for OTC drug-product labeling to contain adequate directions for their intended uses. The products also are misbranded because their labels contain inadequate warnings and contradictory directions.

FDA is not aware of significant adverse events associated with these products.

Reps. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of its Subcommittee on Oversight and Investigations, vowed to continue their investigation into the safety and effectiveness of Bayer Aspirin with Heart Advantage.

“We remain curious as to why Bayer, in light of previous, well-publicized FDA decisions on such combination products, decided to market its product without prior FDA approval,” said Dingell.

“The FDA appears to have responded to our investigation with appropriate action against Bayer Aspirin with Heart Advantage,” said Stupak. “While we appreciate the Warning Letter being sent, the FDA should not rely solely on Congressional oversight to notify them of such concerns. We need an FDA that is proactive rather than reactive when it comes to protecting public health.”