FDA says longer use of nicotine gum is OK

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RICHMOND, Va. (AP) — The Food and Drug Administration says smokers who are trying to quit can safely use over-the counter nicotine gum, patches and lozenges for longer than previously recommended in a move to help millions of Americans kick the habit.

Current labels suggest consumers stop smoking when they begin using the products and that they should stop using them after 12 weeks.

The federal agency said Monday that the makers of gum and other nicotine replacement products can change the labels that say not to smoke when using the products. The FDA also said the companies can let consumers know that they can use the products for longer periods as part of a plan to quit smoking, as long as they are talking to their doctor.

Nicotine replacement products, designed to help people stop smoking by supplying controlled amounts of nicotine to ease the withdrawal symptoms, were first approved about 30 years ago and have since gone from prescription to over-the-counter within the last 17 years. However, when they were approved for over-the-counter use little reliable data on the safety of long-term use or use of more than one product containing nicotine, the FDA said.

In recent years, the agency said, a number of stakeholders in public health have suggested the current labels were barriers for smokers that are trying to quit because they'd relapse if they stopped using the nicotine-replacement products after the suggested time period, and they'd abandon their attempt to quit if they had a cigarette while using them.

In a statement on Monday, FDA Commissioner Margaret Hamburg said the agency hopes the recommended changes will "allow more people to use these products effectively for smoking cessation and that tobacco dependence will decline."

The makers of the nicotine replacement products must seek approval to change their labels, but the FDA said the companies can cite the studies used by the agency.

A spokeswoman for GlaxoSmithKline, the leading seller of nicotine-replacement therapy products under the Nicorette and NicoDerm brands, did not immediately respond to a message seeking comment.

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Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.

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