FDA Publishes Guidance on the Development of Nicotine Replacement Therapies

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As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.

FDA Commissioner Scott Gottlieb, MD, announced the publication of draft guidance on Feb. 21, 2019 as part of the agency’s support for the development of safe and effective novel nicotine replacement therapies (NRTs).  NRT products are designed to reduce nicotine withdrawal symptoms, increasing the chances of a person quitting smoking and, thereby, decreasing that person’s chances of developing smoking-related illnesses.

The new draft guidance addresses clinical drug development and trial design of NRT drug products. The document outlines ways products can be developed to reduce the risk of smokers relapsing. In the development of the guidance, FDA considered feedback about the use and label of NRTs from a public hearing held by the agency and comments received in response to a notice in the Federal Register.

According to Gottlieb, while existing NRTs such as gums, patches, and lozenges have been helpful tools for people trying to stop smoking, novel products with different characteristics or routes of delivery could offer additional opportunities for smokers looking to quit.


“We have an opportunity to build on these NRTs, with novel products that may provide an opportunity to save even more lives by empowering adults to safely and effectively quit smoking … This [opportunity] could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product. This would allow them to be marketed as a prescription or over-the-counter drug products with medical claims for smoking cessation or related indications – ultimately reducing the likelihood of someone continuing to suffer the clinical consequences of smoking. This is different from our regulation of e-cigarettes as tobacco products,” Gottlieb stated.

Source: FDA