FDA Commissioner Releases Statement on Nicotine Replacement

Cites desire of most smokers to quit in the near future

Last week, FDA Commissioner Scott Gottlieb release a statement regarding his agency’s effort to support development of nicotine replacement therapies in an effort to help smokers quit cigarettes.

“We know that about 70 percent of adult smokers in the U.S. want to quit,” said Gottlieb. “In fact, nearly half try to quit each year.

“But few succeed.”

Gottlieb continued by outlining some of the agency’s steps to aid smokers in quitting—safety and efficacy studies, among others. He also announced the first of two draft guidances: “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.

“We’re interested in public comment,” said Gottlieb. 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.”

“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,” summarized Gottlieb. “Through the U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco, we’re developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction.”

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