FDA Releases Guidance on Nicotine Replacement Therapy Product Development

electronic cigarette
electronic cigarette
The FDA aims to support the development of novel inhaled nicotine replacement therapies to combat the public health crisis of tobacco use in the United States.

The US Food and Drug Administration (FDA) has released the first of 2 draft guidelines aimed at supporting the development of inhaled nicotine replacement therapies. The development of these products, which would be regulated as new drugs, is a critical part of the agency’s strategy on nicotine, according to FDA Commissioner Scott Gottlieb, MD, in a press release.

The draft guidelines, titled “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products,” focus on data necessary for determining possible toxicities associated with and to inform the development of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems such as e-cigarettes.

The Nicotine Steering Committee, created by the FDA in September 2017, has been investigating new, evidence-based opportunities to advance therapeutic nicotine products for cessation of combustible tobacco product consumption. Proposed efficacy and safety studies are now being evaluated, as are product use and labeling. The purpose of these evaluations is to offer a clear pathway for companies interested in bringing to market safe and effective smoking cessation products.

“These guidances are one part of larger policy efforts to address the public health crisis of tobacco usage in this country,” Dr Gottlieb noted. “We want to explore what new steps we can take using our regulatory policies to enable opportunities for innovation, while making sure these products are demonstrated to be safe and effective for their intended use.”

Related Articles

Release of the second draft guidance is expected in the fall of 2018, at which time a framework for new, potential clinically relevant outcomes for products to aid in smoking cessation (eg, reducing the likelihood of a smoker returning to using cigarettes long term and showing a positive effect on cardiovascular measures) will be established.


Statement from FDA commissioner Scott Gottlieb, MD, on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes [news release]. Silver Spring, Maryland; US Food and Drug Administration; August 3, 2018.