April 10, 2013
FDA Lifts Some Warnings for OTC Nicotine
Replacement Therapy

Washington, D.C.—New guidance from the FDA will change how pharmacists counsel customers attempting to quit smoking.

The FDA announced that it is no longer requiring a warning against use of nicotine replacement therapy (NRT) in consumers who are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT.

After reviewing scientific research on the safety of NRT products sold OTC, the FDA said it determined that, although any nicotine-containing product is potentially addictive, research and long-term use have demonstrated that OTC NRT products do not appear to have significant potential for abuse or dependence.

The agency noted that when the warnings went into effect 30 years ago, there wasn't a lot of data available on how long consumers could safely use NRTs or whether they could be combined with other NRTs or use of nicotine-containing products, such as cigarettes.

“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,” said FDA Commissioner Margaret A. Hamburg, MD. “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.”

NRTs, which supply controlled amounts of nicotine to ease withdrawal symptoms, are FDA-approved for adults ages 18 and over who want to quit smoking.

Three types of NRTs are available OTC: nicotine gum, transdermal nicotine patch, and nicotine lozenge products.

Nicotine gum and patches were first FDA-approved as prescription products between 1984 and 1992. The NRT gum and patch products were switched to OTC marketing between 1996 and 2002, based on scientific research showing that these products were safe for use without a prescription, with the nicotine lozenge approved for OTC use in 2002 and the mini-lozenge in 2009.

In light of the label changes allowed by FDA, pharmacists can inform customers that there are no significant safety concerns associated with using more than one OTC NRT at the same time, or using an OTC NRT at the same time as another nicotine-containing product—including cigarettes. In fact, the FDA recommends that smokers be told that if they slip up and have a cigarette while trying to quit, they should not stop using the NRT but should keep using the product and trying to quit smoking.

Tobacco users also are advised to begin using the NRT product on a “quit” day of their choosing, even if they aren’t immediately able to cease their habit.

While the FDA still recommends use of NRT products for the length of time indicated in the label—e.g., 8, 10, or 12 weeks—the agency said it believes extended use is safe in most cases but recommends consultation with a health care professional.

It also cautions that all labels for OTC NRTs will not change immediately, and recommends that consumers consult health care professionals if they have questions about how to proceed in their efforts to quit smoking.

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