FDA proposes OTC drug label overhaul

The new format will enable consumers to tell at a glance the proper use of the drug, its side effects, and when to see a doctor before using. Comparisons among drugs will also be easier. Some companies already use a simplified label, but FDA wants a uniform format that is easily recognized and understood by consumers, Dr. Ilisa Bernstein, an FDA senior science policy advisor, tells Packaging World. The proposed makeover continues a strategy that FDA began six years ago in requiring improved nutrition labeling on food packaging. The uniform labeling format has standard graphics, subheadings, a standardized order of information, a 6-point minimum typesize, a specific type style and simplified language. Warnings are more prominent to reduce adverse drug reactions caused by improper use. The label would appear on the secondary packaging such as a folding carton containing a bottle, or on the bottle itself if there is no carton. The proposal, published in late February 1997, includes a four-month comment period, with a final rule expected by the end of 1997. Drug manufacturers would have two years to comply, or three years for lower-volume products with less than $25ꯠ in annual sales.