The Nicotine Steering Committee which was established in September 2017, had been entrusted with creating a more flexible framework that enables the development of safe and effective nicotine replacement therapies (NRTs) that could help smokers quit combustible cigarettes.
First draft guidance released last year
In August 2018, the committee released the first of two draft guidances on the development of inhaled nicotine replacement therapies (NRTs) such as e-cigarettes, for harm reduction. The release titled, “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products,” focused on the data recommended to be able to evaluate potential toxins that may be found in these products.
“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 Gottlieb in a statement at the time.
He had added that the FDA was “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.”
Second draft lays framework for outcomes of cessation products
Meanwhile, the second draft guidance which was issued last week, “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products,” helps to lay out a framework for new potential clinically relevant outcomes for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term.
The FDA said that this draft guidance took into consideration the input received at a public hearing in January 2018, and is intended to serve as a focus for continued discussions among the FDA, pharmaceutical companies, the smoking cessation research community, and the public.
Read Further: US Food and Drug Administration