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FILE- In this Tuesday, April 27, 2010, file photo, smokers without medical insurance receive free nicotine patches and gum at the Remote Area Medical (RAM) clinic inside the Los Angeles Sports Arena in Los Angeles. The Food and Drug Administration said Monday, April 1, 2013, smokers who are trying to quit can safely use over-the counter nicotine gum, patches and lozenges for longer than previously recommended in a move to help millions of Americans kick the habit. (AP Photo/Damian Dovarganes, File)
FDA to relax restrictions on labels for nicotine products
First Published Apr 02 2013 09:49 am • Last Updated Apr 02 2013 09:49 am

Are you concerned that you have been chewing Nicorette longer than recommended on the box? Have you ever had a lapse and smoked a cigarette while wearing a nicotine patch? The Food and Drug Administration has a reassuring message for you: Don’t worry about it and keep trying to quit.

The agency announced Monday that it is relaxing some of the restrictions on labels for nicotine gum, patches and lozenges available over the counter. It is lifting a requirement that the products carry a strict limit on how long they can be used. And it is eliminating instructions that people stop using tobacco before starting one of the products.

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"If you are using an [over-the-counter nicotine replacement therapy] while trying to quit smoking but slip up and have a cigarette, you should not stop using [it]," the FDA said in its new consumer guidance. "You should keep using the [product] and keep trying to quit."

Smoking-cessation products contain the addictive substance nicotine but do not carry many of the other harmful chemicals found in cigarettes, chewing tobacco and snuff. The products, once available only by prescription, are now available over the counter.

Several anti-smoking groups lobbied for the changes and lauded the FDA’s decision as a step that will help more people kick the habit.

"These labeling changes recognize that cigarette smoking is extremely addictive, and most smokers make multiple attempts to quit before they succeed," Matthew Myers, president of the Campaign for Tobacco-Free Kids, one of the groups involved, said in a statement.

Typically, the FDA approves such changes at the request of product manufacturers. But these actions came at the urging of health professionals and activists, who said that research no longer supports such strict rules and that they present a barrier for people trying to quit.

Many smokers have a difficult time quitting in the eight, 10 or 12 weeks often listed as the limit for the safe use of over-the-counter smoking-cessation products, proponents said. And some stop using the products if they break down and have a smoke, fearing that it is not safe to double up.

Years ago, "there were some concerns [about] getting too much nicotine and getting sick from that," said Grail Sipes, senior regulatory counsel for the Office of Regulatory Policy at the FDA’s Center for Drug Evaluation and Research.

Recent studies, however, show that this is not as risky as once feared. In one study the FDA cited Monday, more than 1,000 participants reported only minor, passing symptoms after using nicotine gum for a year or longer. Another study found that the long-term use of nicotine gum did not increase or decrease the likelihood of developing cancer. Other studies suggest a low likelihood of abuse or dependence.


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"What we’re saying is if people want to use [the products] a bit longer, that’s fine," Sipes said. "In the same vein, if you want to use more than one [product] at once — a patch and also do gum — if you feel that that’s helping you, there’s not going to be a problem with that."



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