FDA Releases Draft Guidance on Inhaled Nicotine Replacement Therapies

The guidance focuses on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products, including products such as e-cigarettes.

The U.S. Food & Drug Administration released draft guidance on Aug. 3 supporting the development of inhaled nicotine replacement therapies, with the agency's commissioner, Dr. Scott Gottlieb, saying in a statement that "as a public health agency, there is no greater impact we can have to improve the health of our nation than to significantly reduce the rate of tobacco-related disease and death." FDA is "developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction. A key part of this framework are steps to pave the way for products that help currently addicted smokers move away from the deadliest form of nicotine delivery," he added.

The agency is taking a closer look at its approach to the development and regulation of nicotine replacement therapy (NRT) products, which are regulated as drugs and are designed to safely reduce withdrawal symptoms associated with quitting smoking, he explained. About 70 percent of adult smokers in the United States want to quit, and nearly half try to quit each year, but few succeed, Gottlieb noted. Use of FDA-approved NRT products is generally considered to double the likelihood of a successful quit attempt, but most existing NRTs – such as gums, patches, and lozenges – have been approved for more than 20 years. With novel forms of nicotine delivery being developed, it's possible new kinds of NRTs can offer additional opportunities for smokers to quit combustible tobacco, he said.

The new release is the first of two draft guidance document supporting the development of novel inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs. The guidance, "Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products," focuses on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products, including products such as e-cigarettes that are intended for smoking cessation and other long-term uses that would make them subject to regulation as drugs.

The second draft guidance will be released this fall; FDA seeks public comment on them. "We want to strike the right balance between enabling a viable, efficient path for these products to be regulated as drugs – where we have substantial tools to evaluate their safety and efficacy for their intended use as smoking cessation products. At the same time, we want to make sure we’re asking sufficient questions about the long-term health effects of these inhaled products, especially their effect on the lungs, to ensure that they are safe for their intended use. This information will help FDA advance this new guidance," he explained.

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