Current labels suggest consumers stop smoking or using other products containing nicotine when they begin using the products to help them quit and that they should stop using nicotine replacement products after 12 weeks at most.
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 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.
GlaxoSmithKline, the leading seller of nicotine-replacement therapy products under the Nicorette and NicoDerm CQ brands, called the FDA's action a "positive step to help more smokers quit." It plans to work with the FDA to make changes to its product labeling "as soon as possible."
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
Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.