"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 dictonary to read the directions. And people won't need a magnifying glass to find out what's in their medicine."
-- Vice President Gore
VICE PRESIDENT GORE UNVEILS NEW SAFETY LABELING REQUIREMENTS FOR OVER-THE-COUNTER MEDICATIONS (fact sheet)
March 11, 1999
Today, Vice President Gore is announcing that the Clinton Administration is unveiling a landmark 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 also announced that 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. The new regulation and campaign, that builds on the President's record of improving consumer protections and health will provide Americans with important information about their medications in a user friendly way and takes a critical step towards preventing the tens of thousands of unnecessary hospitalizations caused by misuse of over-the-counter medications each year.
MISUSE OF OVER-THE-COUNTER MEDICATIONS IS COMMON AND POTENTIALLY DANGEROUS
- More and more Americans use over-the-counter medications to treat routine illnesses. Each year, Americans purchase five billion over-the-counter drug products for a wide variety of ailments, ranging from headaches to arthritis to sore throats. Approximately 100,000 over-the-counter drugs can be used to treat routine illnesses without a prescription, requiring consumers to make their own judgement about what drug to take, how to take it, and whether or not to give it to their children.
- Misusing over-the-counter drugs can be dangerous. Although over-the-counter drugs are generally very safe, their misuse causes over 170,000 hospitalizations each year at an annual cost of $750 million. Studies estimate that half of these hospitalizations could be prevented by better consumer education and information. These unacceptably high hospitalization rates underscore how important it is that consumers understand the information provided by drug product labeling.
- Children and the elderly are at particular risk of accidentally misusing an over-the-counter drug. The current required labeling information varies considerably among over the counter drug products. As a result, consumers often have difficulty finding, reading, and understanding critical information about these products. One study reported that 70 percent of caregivers were unable to measure the correct dose of medication for their child, indicating that many children may be at risk of being over or under medicated. In addition, studies have shown that a significant number of older Americans, who take more over-the-counter medications than the rest of the population, cannot read the small compressed type on many product labels. Because of this, they are at increased risk of taking the wrong dose of a medication or of taking an over-the-counter medication that adversely interacts with a prescription medication they are taking.
PROVIDING CONSUMERS WITH CRITICAL INFORMATION ABOUT OVER-THE-COUNTER DRUG PRODUCTS
Today, the Vice President announced:
- 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 regulation clearly presents 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 type 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; and
- Allow for a modified format for small packages. The regulation allows packages that are too small to use the standardized label to use a modified version that includes the most essential information on the new label.
This new label, which applies to all 100,000 over-the-counter drugs and drug cosmetics, will begin to appear on some of these products this spring and will be on the majority of products within two years. All over-the-counter drugs will be required to adopt the new labeling within the next six years. FDA is also recommending that drug manufacturers include a phone number for consumers to call if they have questions about the product.
- A new public information campaign to teach consumers how to use the new labels. The Vice President announced 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 to their health care providers questions about their medications. This campaign, which targets the elderly, child care providers, and health professionals, will include the placement of public service announcements in newspapers and magazines, radio PSAs, and the distribution of brochures and posters on the new labels through professional organizations, such as the National Association of Chain Drug Stores and the Nonprescription Drug Manufacturers Association.
- Awarded FDA with a "plain language" award for these new improvements. As part of his reinventing government initiative, the Vice President also gave Dr. Debra Bowen of the Food and Drug Administration a plain language award for developing a clear new format to help consumers improve their health.