Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said when nicotine replacement therapy products were first marketed some 30 years ago to help people quit smoking, there wasn't a lot of data on how long consumers could safely use them, and whether they could be used in combination with other NRTs or continued smoking.
However, after reviewing scientific research on the safety of these products sold over the counter the FDA decided some warnings and limitations specified in the directions are no longer necessary to make sure they are used safely and effectively to quit smoking, Woodcock said.
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 NRT products sold over the counter do not appear to have significant potential for abuse or dependence.
NRTs are FDA-approved for adults ages 18 and older 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 FDA said.
"The agency heard from several public health groups that the labeling for over-the-counter NRT products may stop consumers who are trying to quit smoking from using them," Dr. Margaret A. Hamburg, commissioner of the FDA 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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