FDA OKs Longer-Term Use of Nicotine Replacement Products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) is giving consumers the green light to use over-the-counter nicotine gum, patches and lozenges longer than the labels direct.

According to the current labels on nicotine replacement products, consumers should stop use after 12 weeks, at most. However, the FDA announced today that the makers of nicotine gum and other nicotine replacement products can now change the labels to let consumers know they can use the products for longer periods as long as they are talking to their doctor, The Associated Press reported.

The FDA is also suggesting the removal of the warning that consumers should not use a nicotine replacement product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine — including another nicotine replacement product.

Nicotine replacement products, designed to help people stop smoking by supplying controlled amounts of nicotine to ease the withdrawal symptoms, were first approved about 30 years ago. The products have moved from prescription to over-the-counter within the last 17 years. When they were first approved for over-the-counter use, little reliable data existed on the safety of long-term use, or the safety of using more than one product containing nicotine at the same time, the FDA explained.

According to the news report, the agency said many in the public health arena voiced concern that the current labels were barriers to smokers who were trying to quit, because they would relapse if they stopped using the nicotine replacement products after the suggested time period. Also, consumers would abandon their attempt to quit if they had a cigarette while using nicotine replacement products.

The agency hopes the recommended changes will “allow more people to use these products effectively for smoking cessation and that tobacco dependence will decline,” FDA Commissioner Margaret Hamburg said in a statement.

The makers of nicotine replacement products must seek approval to change their labels, but the FDA said the companies can cite the studies used by the agency, according to the AP.

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.”


1 comment so far ↓

#1 Candy Girl on 04.03.13 at 6:42 PM

Interesting move by FDA. New head of FDA’s Center for Tobacco Products (“CTP”), Mitch Zeller, was instrumental in allowing NRT products to first be sold OTC when he was at FDA in the 90’s. This should be a boon to big pharma- who were his clients during his recent stint with Pinney Associates. OTC NRT is a specialty of Zeller.

Leave a Comment