FDA May Revise Over the Counter NRT Warning Labels

Dear Colleagues,

The Food and Drug Admin­istration—after reviewing scientific research on the safety of nicotine replacement therapy (NRT) prod­ucts sold over the counter (OTC) — has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.

Specifically:

• FDA has determined that it is safe to use NRT at the same time as other nicotine-containing products, including tobacco products such as cigarettes and chewing tobacco, or another form of NRT
• FDA has determined that users of NRT products should still use the product for the length of time indicated in the label— for example, 8, 10 or 12 weeks. However, if they feel they need to continue using the product for longer in order to quit, it is safe to do so in most cases. Consumers are advised to consult their health care professional if they feel the need to use an OTC NRT for longer than the time period recommended in the label.

NAQC is pleased that FDA has taken action at this time. We believe this action will allow more people to use OTC NRT effectively and to be more successful in quitting.

For a link to the FDA’s "Consumer Updates” article summarizing the changes, see http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm345087.htm.

Regards,

Linda A. Bailey, JD, MHS
President and CEO
North American Quitline Consortium