FRANKFORT, Ky. (4/1/13) – When nicotine replacement therapy (NRT) products were first marketed almost 30 years ago to help people stop smoking, there wasn't a lot of data available on how long consumers could safely use them, and whether they could be used in combination with other NRTs or continued smoking.
That has changed in the intervening years as researchers conducted studies and clinical trials.
Now, the Food and Drug Administration—after reviewing scientific research on the safety of NRT products sold over the counter (OTC)—has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.
The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence.
The changes being recommended by FDA include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT.
NRTs are FDA-approved for adults ages 18 and over who want to quit smoking. Smokers' dependence on nicotine prevents many who try to quit from being successful, and these products supply controlled amounts of nicotine to ease withdrawal symptoms.
"The agency heard from several public health groups that the labeling for OTC NRT products may stop consumers who are trying to quit smoking from using them," says FDA Commissioner Margaret A. Hamburg, M.D. "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."
Information provided by the FDA
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