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DRUG LABELING
New Labels
for Over-the-Counter Medicines; Author Receives Plain Language Award
Consumers will soon find it easier to use the drugstore medications
they use and give their families. HHS Secretary Donna E. Shalala
announced on March 11 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.
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. 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.
In many cases, OTC drugs with the new labeling will begin appearing
on the shelves within the next two years. All of the more than 100,000
OTC drugs will be required to adopt the new labeling within the
next six years. 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 other materials; these will be posted to this page as
they are produced.
Updated: January 03, 200106 May 2003 10:35:00 -0400
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