Consumer Comprehension of OTC Medication Labels and the Scope for Improvement in Font Size

Abstract

Background: On March 17, 1999, the FDA mandated a new standardized format called “Drug Facts” and a minimum font size of 6 points for the labeling of over-the-counter (OTC) medications. Yet, some text legibility studies report consumer preference for font sizes of at least 10 points. The possibility therefore exists that the minimum font size mandated by the FDA might be too small for certain consumers to read. Objective: To compare the effectiveness of 3 labeling formats—old, new, and simulated labels (SLs)—using the OTC medication Label Evaluation Process Model (LEPM). Methods: A within-subjects experimental design was used. SLs designed for this study contained similar information as the new labels plus a larger font size. English-speaking consumers viewed these label formats and completed a questionnaire that requested consumer demographic information and measured their responses on 5 domains of the LEPM: ease of use, product knowledge, attitude toward product label, product evaluation, and purchase intention. These 5 domains were the dependent variables for this study. The independent variable was the label format. Data were analyzed using the SAS 9.1 software. A multivariate analysis of variance (ANOVA) followed by a univariate ANOVA determined the effect of label format on the dependent variables. Results: Each label format differed significantly from the others in terms of ease of use, attitude, product evaluation, and purchase intention, with the highest mean scores reported for SLs. SLs were the only label format that significantly improved consumers' product knowledge. Conclusions: Although the new standardized OTC labels are an improvement from the old unstandardized label format, there is a need for further improvement in OTC medication labeling, especially regarding the font size on these labels.