FDA changes advisory on using NRT products long-term

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The Food and Drug Administration is admitting it s been too cautious by mandating certain warning labels on nicotine replacement therapy (NRT) products such as the patch and nicotine gum and perhaps the labels have even deterred people from trying the cessation aids.

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.

The agency says more than nearly 30 years of research and use shows that nicotine replacement products like the patch, nicotine gum and nicotine lozenges do not appear to have significant potential for abuse or dependence.

Also contrary to the FDA s current labeling there s no significant safety concern in using over-the-counter nicotine replacement therapy at the same time as smoking. If you are using an OTC NRT while trying to quit smoking but slip up and have a cigarette, you should not stop using the NRT. You should keep using the OTC NRT and keep trying to quit, the FDA says.

The FDA is now allowing companies that make the current forms of nicotine-replacement therapy the patch, gum and lozenges to change their packaging to reflect all this.

ACSH s Dr. Gilbert Ross says he approves of the changes, but adds that it just exposes the hypocrisy of the FDA. They just decided, based on no scientific data, that it s now OK to use NRT long-term, and even to use it without becoming smoke-free. Yet, they insist on having long-term clinical trials before deciding that e-cigarettes are also OK, and they ignore the voluminous data from the widespread use of snus to reduce the harm of using nicotine products.