FDA Relaxes Labeling Requirements for Nicotine Replacement Therapy Products

Warnings and limitations currently placed on the labels of nicotine replacement therapy (NRT) products no longer need to be so restrictive, the Food and Drug Administration (FDA) has recently determined. After years of requiring various warning labels on NRT products, the FDA has released a statement that it is now allowing changes to these labels to reflect the fact that although any nicotine-containing product is potentially addictive, research has shown that NRT products sold over the counter (OTC) do not appear to have significant potential for abuse or dependence. Companies manufacturing these over the counter NRTs may update their labels to allow for longer use and more flexible conditions of use.

NRT Therapy Products

Three forms of nicotine replacement therapy products (nicotine gum, transdermal nicotine patch, and nicotine lozenge products) are subject to the new, relaxed regulations. The changes include removal of a warning that consumers who still smoke, chew tobacco, or use snuff or other nicotine-containing products, should not use nicotine replacement therapy products. Other suggested label changes relate to the timing of initiation of nicotine replacement therapy and the duration of nicotine replacement therapy use, which, in most cases, is safe for longer than the duration indicated on the label.

“The agency heard from several public health groups that the labeling for over the counter nicotine replacement therapy products may stop consumers who are trying to stop from using them,” FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. “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.”

Patients should still consult with their physicians about which NRT therapies will work best for them and discuss any questions about smoking cessation therapies. The FDA noted that, although it is relaxing the label requirements, it has not seen evidence to support the statement that these products are safe for all smokers. Labels may not change immediately, so consumers should be sure to read the packaging and labeling of any NRT product.