Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environment. The authors also examine areas in need of further research and debate. As more complex products are considered for OTC status, it is even more important to ensure that OTC labels are comprehensible. As understanding and the validity of methods to evaluate consumer comprehension improve, so should the quality of labels offered to consumers.
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