Safety Alerts & Recalls

What does this mean?

The FDA provides this guidance if you are using NRT or plan to use NRT to help quit smoking:

1) There are no significant safety concerns associated with using 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. If you are using an OTC NRT while trying to quit smoking but slip up and have a cigarette, you should not stop using the NRT. You should keep using the OTC NRT and keep trying to quit.

2) NRT users should still pick a day to quit smoking, and begin using the OTC NRT product on that "quit" day, even if you aren't immediately able to stop smoking.

3) 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 you feel the need to continue using the NRT for longer in order to quit, it is safe to do so in most cases, but you should speak to your healthcare provider.

4) You are advised to consult your healthcare provider if you feel the need to use an OTC NRT for longer than the time period recommended in the label.

Since the labeling for OTC NRTs may not change immediately, please make sure to read the packaging and labeling of any NRT product you purchase.

You can also talk to your healthcare provider (such as your doctor, nurse, or pharmacist) if you have any questions or concerns about NRT, especially if you are thinking about quitting smoking and need help with selecting a product or program to help you quit.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

FDA Allows Changes to the Warnings and Directions for Use of Nicotine Patches, Gum, and Lozenges

The Food and Drug Administration (FDA) has reviewed the safety data on nicotine replacement therapy (NRT) products that are used to help people stop smoking and has decided to delete some of the warnings and limitations that are currently included in the label.

Nicotine gum, transdermal nicotine patch, and nicotine lozenge products are the three types of NRT that are approved by FDA for over-the-counter (OTC) purchase by adult consumers ages 18 and above. These products help people quit smoking by supplying controlled amounts of nicotine to ease withdrawal symptoms.

For more information, please visit: more information here

Source: FDA
Publication Date: 2013-04-01
Last Updated: 2013-04-01

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