FDA has sent warning letters to Bayer HealthCare, Morristown, NJ, concerning what it considers to be two unlawful, over-the-counter (OTC) aspirin products—Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage.

According to the agency, the products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be marketed legally.

In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease, FDA stated. Bayer Women’s is also labeled for use in “fighting” osteoporosis.

According to product labeling, the 400 mg of phytosterols contained in Bayer Heart Advantage are intended to lower blood cholesterol, and the calcium in Bayer Women’s is intended to strengthen bones to fight osteoporosis.

FDA argues that direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA and cannot be legally marketed for OTC use, the agency said.

Earlier this month, the U.S. House of Representatives Energy and Commerce Committee began investigating whether Bayer has misled the public by marketing the combination product directly to consumers. Bayer has maintained that its advertisements tell consumers to consult their doctors before using Bayer Aspirin with Heart Advantage and warns it does not replace cholesterol medications. FDA concedes it is not aware of significant adverse events associated with these products.

Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval as long as long as these drugs comply with applicable monographs. FDA claims these products do not meet the conditions in any applicable OTC monograph, and thus considers them unapproved new drugs.

Steve Mister, president and CEO with the Washington, D.C.-based Council for Responsible Nutrition (CRN), defended combination products stating: “CRN continues to believe that combination 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.”
 
The American Herbal Products Association called on FDA earlier this year to clarify its marketing policy for products that combine OTC medicines and dietary supplements.

CRN’s Mr. Mister further said these combination products “can demonstrate the continuum of healthcare and the interactive roles that prevention and treatment can play for maintaining good health. It would be unfortunate if overly formalistic interpretations of labeling regulations carried the day and kept these beneficial products from consumers.”