Changes Coming for Nicotine Replacement Therapy Labels

The FDA has decided that some warnings and limitations specified in the directions for use on the labels of OTC nicotine replacement therapy (NRT) products are no longer necessary to make sure they are used safely and effectively to quit smoking. NRT products are approved for adults >18 years of age who want to quit smoking. These products supply controlled amounts of nicotine to alleviate withdrawal symptoms.

After reviewing scientific research on the safety of NRT products sold OTC, results have shown that they do not appear to have significant potential for abuse or dependence. The recommended changes include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other nicotine-containing products–including another NRT.

The three types of FDA-approved over-the-counter NRT include: nicotine gum (eg, Nicorette; GlaxoSmithKline), transdermal nicotine patch (eg, Nicoderm CQ; GlaxoSmithKline and Habitrol; Novartis), and nicotine lozenge products (eg, Commit Lozenge; GlaxoSmithKline). The FDA is allowing companies who manufacture these OTC products to make several changes to the warnings and limitations in the directions for use to allow some flexibility on how they are used and for how long.

The labeling changes are not set to take effect immediately, so consumers should continue to consult with health care professionals regarding any questions or concerns with NRT products.  

For more information visit www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM346012.pdf