FDA OTC Label Change Proposal Discussed

The US Food and Drug Administration published its proposals forrevising over-the-counter product labeling on February 27, and there has been little time allowed for comment. So the main purpose of the Nonprescription Drug Manufacturers Association inviting the FDA's chief representative to a meeting was clearly to try and get more time for considered reactions.

However, this was apparently to no avail, as Michael Weintraub, director of the Office of Drug Evaluation V, said that if there was a delay, it would not come from him. For 25 years the industry had known there would be further, major changes in labeling requirements, he said, but added that the FDA did not want to make any mistakes by moving too quickly.

Nevertheless, companies ranging from giant Procter & Gamble to small makers of sunblock lip balm told the meeting of their still not totally successful attempts to miniaturize while simultaneously improving comprehension, the ultimate goal of the current exercise. With far more ex-prescription drugs now available OTC, and consumers self-prescribing for various reasons, the need for clear, easily understandable labels for packages of all sizes has grown enormously.