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FDA Releases Draft Guidance on Inhaled NRTs

Last week, the U.S. Food & Drug Administration (FDA) released a draft guidance on the development of inhaled nicotine replacement therapies (NRTs) such as e-cigarettes, for harm reduction.

Diane Caruana

August 8, 2018

“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,” said FDA Commissioner Scott Gottlieb in a statement.

He added that the 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.”

“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.”Dr. Scott Gottlieb, FDA Commissioner

Aiming to evaluate potential toxins found in e-cigs

This release is the first of two draft guidance documents supporting the development of new orally inhaled NRTs for smoking cessation purposes. The guidance, “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products,” focuses on data recommended to be able to evaluate potential toxins that may be found in the devices. Any comments or suggestions regarding this guidance may be submitted within 60 days from the 3rd of August, when the draft was announced.

Any comments or suggestions regarding this guidance may be submitted within 60 days.

The second draft guidance should be released in the coming months. “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,” said Gottlieb.

“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 added.

Submit your comments

Electronic comments may be submitted at https://www.regulations.gov., while written comments may be posted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.