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FDA Allows Change to Nicotine Replacement Therapy Labels

FDA Allows Change to Nicotine Replacement Therapy Labels

Changes will include removal of warning not to use tx if smoking, chewing tobacco, using snuff

TUESDAY, April 2 (HealthDay News) -- The U.S. Food and Drug Administration will allow companies which manufacture over the counter nicotine replacement therapies to update labels allowing longer use and more flexible conditions of use.

After reviewing the evidence, researchers from the FDA are allowing the manufacturers of the three forms of nicotine replacement therapy products (nicotine gum, transdermal nicotine patch, and nicotine lozenge products) to update the labels on their products. The changes, based on evidence from decades of research and use, reflect the fact that these over the counter products do not appear to have significant potential for either abuse or dependence.

The changes include removal of a warning that consumers who still smoke, chew tobacco, or use snuff or other nicotine-containing products, should not use nicotine replacement therapy products. Other changes relate to the timing of initiation of nicotine replacement therapy and the duration of nicotine replacement therapy use, which, in most cases, is safe for longer than the duration indicated on the label.

"The agency heard from several public health groups that the labeling for over the counter nicotine replacement therapy products may stop consumers who are trying to stop from using them," FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. "FDA hopes the recommended changes will allow more people to use these products effectively for smoking cessation and that tobacco dependence will decline in this country."

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