E-DRUG: U.S. FDA'S REGULATIONS ON OTC DRUG LABELS
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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, U.S. Vice President Al Gore and Health and
Human Services Secretary Donna E. Shalala announced recently a final FDA
regulation to provide new, easy-to-understand labeling on
nonprescription drugs.
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 and about the
proper use of the drug.
"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 from 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 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.
FDA has developed 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.
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