Apr. 1 2013
WASHINGTON, DC – The Food and Drug Administration (FDA) today has taken important steps to help more smokers quit by revising the required labeling of over-the-counter nicotine replacement therapies (NRTs) to eliminate language that could discourage effective use of these products. Specifically, manufacturers will no longer have to include labeling statements that warn against any smoking or other tobacco use while using NRTs or use of more than one NRT product, and that strictly limit the duration of treatment with these medications.
These labeling changes recognize that cigarette smoking is extremely addictive, and most smokers make multiple attempts to quit before they succeed. The changes will help more smokers to safely and effectively use NRT products to quit smoking. An FDA consumer update specifically states, "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."
Current labeling discourages smokers trying to quit from continuing to use these therapies when they relapse. In addition, many smokers are unable to quit within the length of time approved for these products. These restrictions may be preventing smokers from using NRT products – including nicotine gum, patches and lozenges – in ways that could significantly increase the number who quit successfully.
According to the U.S. Public Health Service's Clinical Practice Guideline, Treating Tobacco Use and Dependence, long-term NRT use is effective. These guidelines recognize that continued use of such medicines is preferable to a return to smoking because they do not contain the many non-nicotine toxins that are found in cigarettes. The clinical practice guidelines also discuss a number of studies that show some patients benefit from the combined use of smoking cessation products, including different NRT products.
According to today's FDA announcement, a thorough review of the scientific evidence led to a determination that these current labeling statements are no longer necessary to ensure the safe and effective use of over-the-counter NRT products. The revised labeling advises consumers to consult their health care provider if they feel a need to continue using NRT for longer than the recommended course of treatment. The FDA was careful to ensure that the revised labeling encourages smokers to quit, not to use these products as a supplement to continued smoking.
These labeling changes are in response to citizen petitions filed with the FDA, including one petition submitted by the Campaign for Tobacco-Free Kids, American Cancer Society Cancer Action Network, American Lung Association and Legacy. We applaud the FDA's Center for Drug Evaluation and Research for its thorough consideration of these issues and for taking constructive action to help more smokers quit. We urge the FDA to continue making it a priority to maximize the effectiveness of existing smoking cessation treatments and to encourage the development of innovative new treatments.
It is urgent that the FDA make smoking cessation a priority because tobacco use is the nation's number one cause of preventable death, killing more than 400,000 Americans and costing the nation $96 billion in health care bills each year. While the U.S. has made tremendous progress in reducing smoking, about 44 million American adults still smoke. Surveys have found that about 70 percent of current smokers want to quit and about half of all smokers try to quit each year, but only a small percentage succeed. The FDA's actions today will help more smokers succeed in taking this life-saving step.