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FDA Changing Labeling Rules for Tobacco Alternatives
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On Monday, the Consumer Updates of the U.S. Food and Drug Administration informed that the labels of nicotine replacement therapy products may soon change. The proposed changes have come in the wake of smokers getting misled by some warnings like “Do not Use – if you continue to smoke, chew tobacco, use snuff or use [a different NRT product] or other nicotine containing products.” Critics have often said that such warnings were unscientific and prompted people to quit therapy if they occasionally happened to pick up or smoke a cigarette or use tobacco.

While the clause mentioned above is going to be scrapped in its entirety under the newly proposed rules, another clause “stop smoking completely when you begin using [the NRT product]” would be substituted with “begin using [the NRT product] on your quit day.”

The FDA website mentioned, “The changes that FDA 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.”


NRTs are FDA-approved tobacco alternatives for adults aged over 18 who want to quit smoking.

FDA Commissioner Margaret A. Hamburg said, “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 … 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.”

NRT products usually come in the form of nicotine chewing gums or nicotine patches, as well as nicotine lozenges and mini-lozenges.

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The FDA also mentioned that there are no significant safety concerns associated with 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. Rather than quitting therapy because you happened to be tempted into smoking a cigarette while trying to quit and on NRT, the FDA advises not to quit therapy and keep trying to quit tobacco.

GlaxoSmithKline PLC, a global leader in providing safe tobacco alternatives like the Nicorette chewing gum and the NicoDerm skin patch welcomed the FDA decision. The consumer healthcare division of GSK issued a statement on FDA’s change to labeling rules for over-the-counter nicotine medications stating the company “commends the FDA on this action and believes this is a positive step to help more smokers quit and will work with the FDA to implement these changes to product labeling as soon as possible. The changes help eliminate barriers for smokers and include updates to the warnings and directions sections in the current label.”



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