FDA Loosens Restrictions on Smoking-Cessation Aids

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FDA Loosens Restrictions on Smoking-Cessation Aids

By Valerie Tejeda 04/02/13

Nicotine gum, lozenges and patches are now deemed safe for longer periods of time.

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FDA says chew away! Photo via

Using multiple smoking-cessation aids at once, and over a longer period of time, is now deemed safe by the FDA. The agency announced on Monday that it is relaxing restrictions for nicotine gum, lozenges, and patches, including lifting a strict limit on how long these products can be used. And people will no longer be instructed to stop smoking entirely before using nicotine replacement therapy. “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 says in its new consumer guide. “You should keep using the product and keep trying to quit.” Right now, many smoking-cessation products are suggested for use for up to 10-12 weeks, but many consumers reportedly quit the products if they pick up smoking again, fearing it's unsafe to double up on nicotine. “Years ago there were some concerns [about] getting too much nicotine and getting sick from that,” says Grail Sipes, senior regulatory counsel for the Office of Regulatory Policy at the FDA’s Center for Drug Evaluation and Research. However, new studies show that it is not as risky to mix nicotine products as previously thought. “What we’re saying is if people want to use the products a bit longer, that’s fine,” says Sipes. “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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