RICHMOND, Va. -- The U.S. Food & Drug Administration (FDA) said Monday that after reviewing scientific research on the safety of nicotine replacement therapy (NRT) products sold over the counter (OTC), it has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.
Several types of FDA-approved smoking cessation products are available, both with and without a prescription. Three types of NRT are approved by the FDA for consumers to buy OTC: nicotine gum, transdermal nicotine patch and nicotine lozenge products.
The FDA first approved nicotine gum and patches as prescription products between 1984 and 1992. These products were shown to be safe and effective for use when someone first stops using cigarettes, and then uses the NRT to help manage the symptoms of withdrawal, usually for eight to 12 weeks, depending on the product, it said.
The FDA said that the changes it is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence.
"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," said FDA commissioner Margaret A. Hamburg. "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 changes that the FDA is recommended include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine--including another NRT.
NRTs are FDA-approved for adults ages 18 and above who want to quit smoking. Smokers' dependence on nicotine prevents many who try to quit from being successful, and these products supply controlled amounts of nicotine to ease withdrawal symptoms.
The NRT gum and patch products were switched to OTC marketing between 1996 and 2002, based on scientific research showing that these products were safe for use without a prescription. The nicotine lozenge and mini-lozenge were approved directly for OTC use in 2002 and 2009, respectively.
The FDA said that it is allowing the companies that make these OTC products to make several changes to the warnings and limitations in the directions for use on their labels to allow some flexibility on how they are used and for how long.
For consumers, according to the FDA, this means that there are no significant safety concerns associated with using more than one OTC NRT at the same time, or using an OTC NRT at the same time as another nicotine-containing product--including a cigarette. "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," the agency said.
NRT users should still pick a day to quit smoking, and begin using the OTC NRT product on their "quit" day, even if they aren't immediately able to stop smoking, it said.
Users of NRT products should still use the product for the length of time indicated in the label, said the FDA; however, if they feel they need to continue using the product for longer in order to quit, it is safe to do so in most cases. It advised consumers to consult their health care professional if they feel the need to use an OTC NRT for longer than the period recommended in the label.
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, reported the Associated Press.
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.''
Meanwhile, AP reported that 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.
[Editor's Note: CSP Daily News does not endorse the opinions, assertions, conclusions or recommendations of the FDA in this announcement.]
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