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FDA: OK to use nicotine replacement therapies for longer than 12 weeks

The Food and Drug Administration announced on Monday that nicotine replacement therapies (NRTs) like nicotine gum, patches and lozenges can be used for longer than the 12 weeks at most previously recommended.

The FDA is hoping the new ruling will help Americans kick the habit. Current labels suggest consumers stop smoking or using other products containing nicotine when they begin using the over-the-counter products to help them quit and place a three-month time frame restriction.

Now, if people feel they need to use the product for a longer period of time or need more than one NRT at the same time, the FDA says it is okay. There are also no significant safety concerns when using an NRT and another nicotine product at the same time. If someone trying to quit slips up and smokes a cigarette, the FDA said they should not stop using the NRT and continue on their smoking cessation plan.

"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," FDA commissioner Dr. Margaret A. Hamburg said on the FDA website. "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 federal agency 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 existed 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.

More than 45 million Americans smoke cigarettes and about half try to quit every year, according to the Centers for Disease Control and Prevention.

Smoking is the leading cause of preventable illness and death in the U.S. and is responsible for the majority of the nation's lung cancer deaths. It's also a factor in heart attacks and a variety of illnesses.

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

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 provide comment.

The move by the FDA comes less than a week after government health officials launched the second round of a graphic ad campaign designed to get smokers off tobacco. The CDC campaign cost $48 million and includes TV, radio and online spots as well as print ads and billboards.

The ads feature sad, real-life stories: There is Terrie, a North Carolina woman who lost her voice box. Bill, a diabetic smoker from Michigan who lost his leg. And Aden, a 7-year-old boy from New York, who has asthma attacks from secondhand smoke.

Last year's similar $54 million campaign was the agency's first and largest national advertising effort. The government deemed it a success: That campaign triggered an increase of 200,000 calls to quit lines. The CDC believes that likely prompted tens of thousands of smokers to quit based on calculations that a certain percentage of callers do actually stop.

Meanwhile, the FDA said it is missing a Monday deadline to submit three tobacco-related reports to Congress, which the agency said are nearing completion. It also is missing another deadline to publish a consumer-friendly list of the levels of dangerous chemicals found in cigarettes and other tobacco products, as well as tobacco company testing and reporting requirements for ingredients and additives.

There are no penalties for forgoing the deadlines outlined in the 2009 law that gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing

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