naturopathydigest.com -- FDA Hold Hearings on Safety of Children's Cough and Cold Medicines

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FDA Hold Hearings on Safety of Children's Cough and Cold Medicines

Two U.S. Food and Drug Administration committees will be holding a public meeting Oct. 18-19, 2007, to discuss safety issues and questions regarding use of over-the-counter cough and cold medications for children under the age of 6.

The Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee will be discussing a citizen petition brought before the FDA in March proposing an amendment to the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products (CCABADP) in 21 CFR Part 341. This would require labeling for over-the-counter anti-tussive, expectorant, nasal decongestant, antihistamine and combination cough and cold products to state:

These products have not been found to be safe or effective in children under 6 years of age for treatment of cough and cold.

These products should not be used for treatment of cough and cold in children under 6 years of age.

The petition also calls on the FDA Commissioner to:

Provide a statement to the public explaining that over-the-counter anti-tussive, expectorant, nasal decongestant, antihistamine and combination cough and cold products have not been shown to be safe and effective for the treatment of cough and cold in children under 6 years of age.

Notify manufacturers of these products whose labeling: 1) uses such terms as "infant" or "baby"; or 2) displays images of children under the age of 6 that;

Such marketing is not supported by scientific evidence; and

Manufacturers will be subject to enforcement action at any time.

The meeting will be held from 8 a.m. to 5 p.m. at the National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Ave., Silver Spring, MD. The contact individual is Darrell Lyons: darrell.lyons@fda.hhs.gov.
Interested individuals may make presentations, either oral or written, regarding these issues. Written submissions must be received by Oct. 3, 2007. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of their evidence or arguments, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 25, 2007.
For a full copy of the citizens' petition, along with other supporting documentation, please click here.