CRN backs Bayer combination products as functional health supplements

WASHINGTON The Council for Responsible Nutrition last week spoke out against warning letters issued to Bayer Consumer Healthcare by the Food and Drug Administration regarding its dietary supplement/over-the-counter combination products Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin Plus Calcium.

“CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated health care and wellness,” Steve Mister, president and chief executive officer of CRN said. “Our hope is that the 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 noted that the FDA in 1994 stated in the Federal Register that the “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. 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.” 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.

In its warning letters issued Oct. 28, the FDA charged that the products are unapproved new drugs requiring an approved application for the company to market them. “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.”