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Nonprescription Drugs to Get New, Easy-to-Understand Labels

To help consumers make informed decisions about the medications they use and give their families, HHS Secretary Donna E. Shalala announced today a final Food and Drug Administration regulation to provide new, easy-to-understand labeling on nonprescription drugs. Secretary Shalala made the announcement with Vice President Al Gore at the White House.

The regulation calls for a standardized format that will improve the labeling on drugs Americans use most--nonprescription, or over-the-counter (OTC) drugs. By clearly showing a drug�s ingredients, dose and warnings, the new labeling will make it easier for consumers to understand information about a drug's benefits and risks as well as its proper use.

"When a sick child needs an over-the-counter medicine in the middle of the night, parents shouldn't have to struggle to decipher the label," said Secretary Shalala. "Written in plain language and presented in a user-friendly format, the new label conveys essential information for patients and consumers."

FDA proposed its OTC labeling regulation in February 1997. It developed the new label format based on almost 2,000 comments received on the proposed regulation and through several years of agency work with consumer and industry groups. The rule has been developed so that all OTC drugs have labeling that is easy to read and understand. The new labeling will also provide consumers with better information for selecting the most appropriate OTC medication for their condition and understanding its benefits and risks.

"All medicines have benefits and side effects," said Jane E. Henney, M.D., Commissioner of Food and Drugs. "The improved label will make it easier for patients and consumers to select the appropriate over-the-counter product, and it will help them use that product more effectively."

Titled "Drug Facts," the new labeling makes it easier for consumers to identify active ingredients, which will be listed at the top, followed by uses, warnings, directions and inactive ingredients. FDA recommends that drug manufacturers include a phone number for consumers to call for more information or for answers to their questions. The requirement for listing inactive ingredients will allow consumers to select products that do not contain ingredients to which they are allergic. The rule also sets minimum type sizes and other graphic features for the standardized format, including options for modifying the format for various package sizes and shapes.

Dr. Deborah Bowen, the author of the regulation, received a Plain Language Award from Vice President Al Gore for her use of plain language to communicate the substance of the regulation. The Vice President gives the awards to federal employees who fulfill the mandate of the Presidential Memorandum on Plain Language by writing or rewriting federal documents to make them easy for the public to understand and use.

FDA is developing a public education campaign to help consumers understand how the new labels can be used to learn more about OTC medications. This educational campaign will include print and radio public service announcements, consumer brochures, point-of-purchase posters and other exhibit materials. FDA will also work in partnership with national health and professional organizations such as the Nonprescription Drug Manufacturers Association to disseminate this information across a wide range of education networks.

In many cases, OTC drugs with the new labeling will begin appearing on the shelves within the next two years. All OTC drugs will be required to adopt the new labeling within the next six years.