1997.02.26 : FDA Proposes New, Easy to Understand Labeling for OTC Drugs

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Date: February 26, 1997
FOR IMMEDIATE RELEASE
Contact:  Food and Drug Administration --(301) 443-3285
Consumer Hotline: (800) 5324440

FDA Proposes New, Easy to Understand Labeling for OTC Drugs

FDA today proposed new, greatly improved labels for drugs on which Americans depend for the vast majority of their daytoday health care needs. The new labeling of overthecounter (OTC) drugs, for which consumers spend $18 billion a year, will provide consumers with easiertoread 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 thecounter 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, easiertoread 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 6095 percent of all illnesses are initially treated with some form of selfcare, including selfmedication 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 lowcost 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.

Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.