OTC Drug-Supplement Combo Products Now Caught in Regulatory Quagmire
Dec 1, 2008 12:00 PM
FDA’s recent warning to Bayer leaves industry divided as to how to pursue opportunity and could signal new regulatory stance for supplements
The products have all the right stuff to rise to blockbuster status: They are backed by solid science; they meet a consumer need and provide convenience; and they carry a strong marketing message. Yet, all bets on products made with over-the-counter (OTC) drugs and dietary supplement ingredients are currently pending, following the recent warning letters the U.S. Food and Drug Administration (FDA) sent to pharmaceutical giant Bayer regarding its Bayer Aspirin with Heart Advantage and Bayer Women's Aspirin Plus Calcium products. The FDA's message to Bayer was simple: Cease selling the products — which have been supported with extensive marketing and advertising campaigns — or conduct the necessary clinical trials to gain required agency approval.
In the wake of the FDA's reaction to these products, the dietary supplement industry has been left divided as to whether the OTC drug-supplement category will survive and what to do next to keep its potential alive.
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