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March 11, 1999

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With this new regulation I am unveiling today, we will ensure that the labels on medicine we buy over the counter are no longer written in language that is over our heads. Starting here and now, when children wake up sick in the middle of the night, parents won't have to read a dictionary to read the directions, and people will not need a magnifying glass to find out what is in their medicine.

Vice President Al Gore
March 11, 1999

Today, Vice President Al Gore announces that the Clinton Administration is unveiling a landmark Federal Drug Administration (FDA) regulation that requires over-the-counter drug products to use a new label with larger print and clearer language, making it easier for consumers to understand product warnings and comply with dosage guidance. The Vice President will also announce that the FDA will launch a new national public information campaign to help consumers learn more about over-the-counter drugs and the information provided by the new labels.

Misuse Of Over-The-Counter Medications Is Common And Potentially Dangerous. Each year, Americans purchase five billion over-the-counter drug products for a variety of ailments. Approximately 100,000 over-the-counter drugs can be used to treat routine illnesses without a prescription, requiring consumers to make their own judgment about what drug to take, how to take it, and whether or not to give it to children. Although generally safe, misuse of over-the-counter medications results in more than 170,000 hospitalizations each year at a total cost of $750 million. Studies show that better consumer education and information would reduce this figure by half.

Providing Consumers With Critical Information About Over-The-Counter Drug Products. Today, the Vice President announces new regulations providing easy to understand labeling for over-the-counter drugs. The new FDA regulation provides consumers with the essential information necessary to make informed decisions about their family's health care. The new labels:

  • Require a standardized, easy-to-follow format. The regulation requires labels to list ingredients in the same place on every product and explain which ingredients are used to treat specific symptoms;
  • Include critical information about the drug product. The new labels will clearly present a drug's ingredients, dose, and warnings, making it easier for consumers to understand essential information about the medication's expected effectiveness and associated risks, determine appropriate dosage for children and adults, and compare the content of different products;
  • Increase the size of the label so it can be easily read. The regulation specifies the minimum type size for labels in order to make them easier to read, based on studies that included older people and demonstrated how important type size is to reader comprehension;
  • Allow for a modified format for smaller packages. The regulation also allows packages that are too small to use standardized labels to use a modified version that includes the most essential information on the new label.

These new labels, which applies to all 100,000 over-the-counter drugs and drug cosmetics, will begin to appear on some products this spring, the majority of products within two years, and all products within six years.

Increasing The Public's Awareness On How to Use And Read New Labels. The Vice President is announcing that the FDA will soon launch a new public education campaign to help consumers use the new labels to learn more about over-the-counter medications and to encourage them to ask their health care providers questions about the medications. This campaign, which targets the elderly, child care providers, and health professionals, will include the placement of public service announcements (PSAs) in newspapers and magazines, radio PSAs, and the distribution of brochures and posters on the new labels through professional organizations.

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