Manufacturers' compliance with the US Food and Drug Administration's Over‐the‐counter Human Drugs: Labeling Requirements

The use of over-the-counter (OTC) medications is increasing every year among consumers for symptomatic relief of ailments. Consumers have difficulties in reading and comprehending information on the OTC medication packages. A standardized format to present information on OTC medication packages was necessary; hence the FDA announced guidelines, Over-the-counter Human Drugs: Labeling Requirements, on 11 March 1999. Manufacturers have been given 6 years since 1999 to comply with the FDA guidelines. The objective of our study was to evaluate marketed OTC medication packages to determine the extent of adoption of the FDA guidelines by manufacturers. Packages (n ± 104) of OTC medication products from three different categories, viz. pain relievers, cough and cold remedies and stomach remedies, were evaluated for general information, written information and product claims. The Compugraphic point system scale was used to measure the font size of written information. In addition variables recommended by the FDA, such as bullets, paragraphs and hyphenations, were also evaluated. All the variables were coded in a database and analysed using the SAS (Version 8.2) statistical package. The study found that some manufacturers have adopted the FDA guidelines. However, many manufacturers did not implement several aspects of the guidelines. Although manufacturers still have a few more years to adhere to the guidelines, early implementation could benefit the consumers. Copyright © 2003 John Wiley & Sons, Ltd.