OTCS, Switch, and the Impact of Dietary Supplements

Abstract

As recently as five years ago, ‘consumer self-care’ was almost exclusively the province of over-the-counter (OTC) medicines. Today, with the advent of the Dietary Supplement Health and Education Act of 1994, dietary supplements provide expanded consumer self-care opportunities. Foods are also claiming health benefits. Sensible health care policy requires that the Food and Drug Administration (FDA) take account of this new self-care product continuum in its prescription (Rx)-to-OTC switch decision making. It is well recognized that consumers want to be and can be educated to care for themselves in a variety of health care situations using foods or dietary supplements. The same principle should be presumed to hold true for an OTC drug in parallel health care situations, where the drug is properly tested and labeled for consumer use through FDA’s comprehensive drug review process.