FDA issues warning to Bayer regarding sale of not-yet-approved aspirins

10/28/2008

WASHINGTON The Food and Drug Administration has issued warning letters to Bayer HealthCare concerning two unlawful, OTC aspirin products, the agency said in a release Tuesday.

The two products, Bayer Women’s Low Dose Aspirin Plus Calcium and Bayer Aspirin with Heart Advantage contain aspirin with either calcium or phytosterols and are unapproved new drugs requiring an approved application for the company to market them, the FDA said. In addition to being labeled for use as pain relievers, both are labeled as reducing the risks of heart disease. Bayer Women’s is also labeled for use in fighting osteoporosis. Still, the FDA has not approved either product for these uses.

“The FDA considers these products new drugs, and thus, they must undergo the FDA’s drug approval process,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”

Under its OTC drug monograph system, the FDA allows marketing of some drugs without prior agency approval. These drugs must comply with regulations that set requirements for the drugs’ labeling and formulation, as well as the uses for which they can be marketed.

The FDA said the two Bayer drugs did not meet the conditions in any OTC monograph and did not have FDA approval, making them unapproved new drugs.

Bayer launched Aspirin with Heart Advantage earlier this year. Controversy over the product’s marketing erupted when the American Herbal Products Association sent a letter to the FDA challenging the launch of the product and requesting that the agency clarify its policy on OTC products combining drugs and dietary supplements, Drug Store News reported in June. At the same time, however, the Council for Responsible Nutrition did not object to the product's launch.

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