WASHINGTON, D.C.—On Friday, January 26, the U.S. Food and Drug Administration (FDA) held a public hearing on the FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how to promote innovation in these products and how they should be used and labeled. AACR Tobacco and Cancer Subcommittee member Dorothy K. Hatsukami, PhD, Associate Director of Cancer Prevention and Control at the University of Minnesota Masonic Cancer Center, presented a summary of the AACR’s Tobacco and Cancer Subcommittee’s comments to the FDA. The summary of Dr. Hatsukami’s presentation is below.
The AACR Tobacco & Cancer Subcommittee recommends improving the appeal and nicotine delivery of NRT to increase uptake and efficacy of these smoking cessation products. The subcommittee also recommends approving NRT for combination treatments, including use of short-acting and long-acting medications, and considering long-term use of NRT to completely substitute for cigarettes in order to reduce harm to health or to present relapse to smoking. Furthermore, since almost half of smokers who are planning to quit in next 12 months are interested in gradual reduction, the subcommittee recommends that the FDA consider a reduce-to-quit approach with NRT, which has been shown to be more effective than placebo. The AACR is not recommending cigarette reduction that does not lead to complete cigarette cessation as a harm reduction approach.
Finally, there are significant misperceptions or lack of knowledge among smokers and health care providers regarding the safety of NRT. These misperceptions impact uptake and optimal use of NRT, which ultimately leads to the reduced efficacy of smoking cessation products. Therefore, the Subcommittee recommends adding a simplified label on NRT packages that conveys their relative risk compared to cigarettes, such as “Nicotine replacement therapy is substantially less harmful to health than cigarette smoking,” to clarify these misperceptions and increase smokers’ willingness to use NRT as part of their attempt to quit smoking.
Dr. Hatsukami’s presentation will be archived here. The slides from her presentation to the FDA are available here.