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FDA Denies Plan in Works to Restrain Cough and Cold Medicines

www.medpagetoday.com

The FDA has clarified reports by some major media suggesting that the agency has plans for new regulations on over-the-counter cough and cold medications for children.

In an unusual press release, the agency pointed out that the recommendations it posted on its Website, as part of a 356-page briefing document, were merely unvarnished views of staffers. They were drafted in preparation for deliberations a couple of weeks hence by the FDA's Nonprescription Drug Advisory Committee on over-the-counter cough and cold medications.

Contrary to the impression conveyed by the press reports, the FDA said, nothing had happened yet. The staff recommendations to discourage decongestant use by children younger than two years old, and antihistamines by those younger than six, were essentially talking points for a meeting that hasn't happened.

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