FDA Proposes Easy-To-Understand OTC Labels

WASHINGTON-Accurate and clearly-understandable drug labeling plays an important role in the proper administration of medications. Currently, no universal labeling system is used on the drugs obtained without a prescription (over-the-counter drugs).

FDA yesterday proposed new, greatly improved labels for drugs on which Americans depend for the vast majority of their day-to-day health care needs. The new labeling of over-the-counter (OTC) drugs, for which consumers spend $18 billion a year, will provide consumers with easier-to-read and understand information about the products' benefits and risks, and how they should be used.

"Today's action is important for anyone who ever takes a pain reliever, cough syrup or any of the thousands of other over-the- counter items on the market," said Donna E. Shalala, Secretary of Health and Human Services. "The information on the new, much more understandable labels will help consumers to choose the right medication and avoid harmful mistakes."

The main provision of the proposed regulation involves the new label format. Its main features include:

  • Uniform, standardized headings, subheadings and a standardized order of information
  • Simplified language for certain words or phrases, for example: "throw away" instead of "discard"; "lung" instead of "pulmonary"; "hole in" instead of "perforation of"
  • A new bulleted, easier-to-read format, including a minimum type size and type style

"This proposal is the latest effort by FDA to give consumers accurate, reliable information about products that affect their health," said David A. Kessler, Commissioner of Food and Drugs.

According to the American Pharmaceutical Association's Handbook of Nonprescription Drugs, four times as many of today's health problems are handled by consumers treating themselves with OTC drug products than by consumers seeing a physician, and 60-95 percent of all illnesses are initially treated with some form of self-care, including self-medication with OTC drug products.

Moreover, according to this same source, although 60 percent of the medications purchased by consumers in the United States are OTC, these purchases account for less than 2 percent of the U.S. health care dollar, making it likely that, as a low-cost alternative, OTC drug use will continue to grow. This is especially true among the elderly who comprise 12 to 17 percent of the population buying OTC drugs but consume about 30 percent of all OTC medications. The elderly are projected to consume as much as 50 percent of all OTC medications by the year 2000.

The proposed rule results from several years of agency work with consumers and industry groups. Although past efforts have brought improvements in some OTC drug labeling, a lack of consistency and concerns about readability and comprehensibility of current OTC labeling convinced the agency that these proposed reforms would better ensure the goal of providing consumers with clear, consistent, reliable product information.

The public will have 120 days to comment on this proposed rule, under which OTC drug manufacturers generally would be allowed two years from the date a final rule is published to put the new label into practice. In addition, some products with lower sales that might be economically burdened by this labeling change requirement would have an extra year to comply.

Last Editorial Review: 12/31/1997