Testing the FDA's Mandate for Over-the-Counter Medication Labels

ABSTRACTThe Food and Drug Administration (FDA) has recently attempted to improve the safety of over-the-counter (OTC) drugs by creating a regulation aimed at redesigning their labels. One portion of this regulation attempts to improve the legibility of OTC labels by individually specifying certain elements of their design. The FDA's approach looks at the elements of label design as distinct entities that can be isolated and manipulated to improve legibility. Reality does not match the simplicity of this approach. Legibility is the overall goal in a complex system of interrelated elements that come together to create a message. This research challenges the regulation by using an instrument that measures what is truly important: the legibility of the label.