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FDA Proposes Easier to Read Over-the-Counter Drug Labels


March-April 1997

The Food and Drug Administration proposed changes (Federal Register: February 27, 1997 (Volume 62, Number 39), pages 9023-9062) on February 26 to make labels on over-the-counter (OTC) drugs easier for consumers to read and understand (David Stout, "U.S. Acts to Simplify Labels on Medicine," New York Times, February 27, 1997, p. A18; Associated Press, "FDA Proposes Making Cramped Drug Labels Less Difficult to Digest," Washington Post, February 27, 1997, p. A3; Marlene Cimons, "FDA seeks overhaul of drug-labeling rules," Houston Chronicle, February 27, 1997, p. 11A).

The proposed changes would take effect in the middle of 1999, two years after the end of a 120-day period allotted for public comment. The pharmaceutical industry and the FDA have been working cooperatively on the proposed regulation. According to Meg Grattan, a spokeswoman for the Nonprescription Drug Manufacturers Association, "Nonprescription drug manufacturers are fully committed to making product labels as user-friendly as possible. This is a pro-consumer action, but it's also a win-win for the industry." According to the FDA, the proposed changes would cost $14 million, while the manufacturers say the cost would be $100 million.

Currently, some companies voluntarily use simpler labeling. In 1990, California approved legislation that asked, but did not mandate, manufacturers of OTC drugs to make their labels more readable. The FDA proposal, if approved, would be mandatory for all OTC drug products sold. Manufacturers would be given two years from the time of the final rule to put new labels on their products.

The new labels would contain the currently required essential information, but would be clearer and easier to read. Labels would include warnings about a drug's side effects, information about drug combinations that should be avoided, and instances when a doctor should be consulted. The labels would be in larger type, with more white space, in a standardized format (streamlined, with a new bulleted, easier-to-read design, minimum type size and type style) and written in simpler language. Dosages and other directions for use would be boxed on the bottom of the label.

A growing number of nonprescription drugs are now available, and Americans are four times more likely to attempt to treat their own health problems than they are to consult a doctor. According to Dr. David A. Kessler, the Commissioner of the Food and Drug Administration, about $18 billion worth of nonprescription drugs are sold every year in the United States. This number is increasing as the FDA changes the status of more drugs from prescription to nonprescription. Many OTC drugs are bought at grocery stores and convenience stores where there is no pharmacist available to give information and advice. Most illnesses are initially treated with some form of self-care in the form of self-medication, about 60% of which are purchased OTC. The FDA says current labels present a special problem for the elderly, who have great problems reading the tiny print currently used on the labels. The elderly consume about 30% of all OTC medications, and according to the FDA, that figure will grow substantially in the next few years.