When Bayer released its new Heart Advantage products with a split dose of aspirin and phytosterols, the dietary supplements industry took notice…so did the US Food and Drug Administration. The move placed the product in a grey zone—is Heart Advantage a dietary supplement or a drug? The same question can be asked of Bayer's low-dose aspirin with calcium. While Heart Advantage raised consumer awareness about the heart healthy benefits of phytosterols, combining an OTC with a supplement raised more than one FDA eyebrow.

In a recent warning letter, the FDA stated that the entire product is a drug. The FDA claims there is no provision under the US Food, Drug and Cosmetic Act or the Dietary Supplement Health and Education Act that exempts this product from drug status. In the warning letter, the FDA stated that the aspirin health claims to keep blood flowing freely claims combined with the supplement claims to help lower bad cholesterol may be interpreted by the consumer as medical advice. In a statement from the German-base Bayer, the company stands behind both claims and that neither is intended to replace medical advice.

In response, Steve Mister, president and CEO of the Council for Responsible Nutrition said: "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.?

CRN counters the FDA's claim that DSHEA and the Act do not adequately address combination drug-supplement products. "In 1994, the Agency stated in the Federal Register that 'FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances," said Mister. "Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem' (59 Fed. Reg. 395, 419, January 4, 1994). That statement has never been revoked. Since then, the FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency's appropriate concerns for safety.? Bayer will respond to the letters within 15 days, per the request by the FDA.