FDA: No warning required for nicotine gum, patches

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The Food and Drug Administration said Monday that manufacturers of products designed to help people quit smoking can alter or remove previously required safety warnings that may be discouraging people from trying to kick the habit.

Specifically, the agency said it is no longer necessary to tell consumers they should not be using a nicotine replacement therapy product such as gum, the patch or lozenges if they are also still smoking, chewing tobacco, using snuff or another product that contains nicotine.

If a smoker were to “slip up” and use a cigarette while trying to quit with an NRT product, he should still continue to use the NRT, the agency says. Public health officials had told the FDA that some smokers would quit using them after a relapse, fearing the health risks from the warnings.

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,” FDA Commissioner Margaret Hamburg said.

The agency also said that while consumers should use the gum, patch or lozenges for the recommended amount of time, typically 8-12 weeks, it is acceptable to use them for longer if needed and if done under consultation with a doctor.

The agency said there was limited data available on use of NRT products when they hit the market 30 years ago as prescription-only items. Consumers could begin buying them over the counter in the late 1990s.

But extensive research shows the products contain a controlled supply of nicotine intended to reduce withdrawal symptoms and “do not appear to have significant potential for abuse or dependence,” according to the FDA.

FDA officials indicated they wanted to remove the warnings so smokers would not be dissuaded from quitting. According to the agency, about 45 million Americans smoke and tobacco use is responsible for about 440,000 deaths per year in the U.S..

The FDA said companies still will need to submit their new warnings to the agency for approval.

GlaxoSmithKline said in a statement that it expects to send to the FDA new labels for its popular Nicorette gum and NicoDerm patches “as soon as possible.”

The company “commends the FDA on this action and believes this is a positive step to help more smokers quit.”

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