US FDA Simplifies OTC Labels

Proposals that drugmakers in the USA should simplify over-the-counter medicine labels have been put forward by the Food and Drug Administration, in order to make it easier to read and understand the information and thus reduce confusion in choosing medications. The agency will work with its advisory panel for several years to look into different designs, including providing less technical language, more pictures, diagrams and bolder print.

William Soller, Nonprescription Drug Manufacturers' Association senior vice president, said the $111 billion OTC drug industry was committed to good label readability. He did question, however, if the move to "boxless" packages for ecological reasons would mean there would be enough room for dosage information, safety warnings and other information. He did stress that the industry is willing to work with the FDA. Drugmakers, meantime, said that concerns such as possible misinterpretation of pictures and the potential for exposure to product liability could be worked out.

Examples of the proposed labels were displayed at an advisory committee meeting, which discussed the plan; standard information categories such as usage, warnings and ingredients were presented in bullet form and were separated by bold lines. The agency noted that current labels on aspirin contain more than 500 words, including some words like "precaution" and "interaction" which some consumers do not understand.