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FDA Takes Welcome Steps To Help More Smokers Quit

WASHINGTON, April 1, 2013 /PRNewswire-USNewswire/ -- The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids:


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 limits 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.

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