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FDA to Mull the Use of Color on Product Labeling and Packaging

February 9, 2005

The FDA has issued a public call for information on the use of color on pharmaceutical labeling and packaging to determine if the practice is one that warrants further action from the agency.

As part of this effort, the Center for Drug Evaluation and Research has scheduled a public hearing for March 7 to discuss a number of general issues related to the use of colored labeling and packaging. Color is typically used on labeling and packaging to help classify, differentiate and identify pharmaceutical products.

The main purpose of the March meeting is to gather information from the public so the FDA can weigh the pros and cons of color use, FDA Director of the Division of Medication Errors and Technical Support Carol Holquist said. Holquist said the FDA currently does not have enough information to make an informed decision about what steps, if any, the agency should take on the issue.

Holquist noted that if the reaction from the public was overwhelmingly negative about the use of color on pharmaceutical packaging, the agency might consider developing guidance on the issue. But until then, the FDA "simply doesn't have enough information to go anywhere with it," she said.

To view a copy of the meeting announcement, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0036-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0036-nm00001.pdf).