FDA Plans Simplified Labeling For OTCs

The US Food and Drug Administration has published proposed rules for"new, greatly improved" labels on over-the-counter drugs. The simplified labeling will make information about the products' risks and benefits, and how they should be used, easier to read and understand. The public comment period is four months; if the rule becomes final, companies would have two years to use their old packaging and introduce the new labels. Some lower-selling products that might be economically burdened by the change would have an extra year to comply.

The proposal's main provisions involve the new label format, whose main features are: - uniform, standardized headings, subheadings and a standardized order of information; - simplified language, eg, "lung" can be used for "pulmonary," and "throw away" for "discard;" and - a new bulleted, easier-to-read format, including a minimum type size and face. The aim is for consumers to be able to see, easily and quickly, the drug's proper use and side effects and when to see a doctor.

The plan follows several years of FDA interaction with industry and consumer groups. Labeling incorporating easy-to-comprehend features has been introduced voluntarily by a few firms, which say it has helped their marketing. While past efforts have improved some OTC labels, the FDA said a lack of consistency and concern over current comprehensibility convinced it that the proposed reforms would better ensure that people receive clear, consistent, reliable product information. Health and Human Services Secretary Donna Shalala says the new labels will help consumers choose the right medicine and avoid harmful mistakes.