U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Tobacco Products
  3. CTP Newsroom
  4. NIH and FDA Leaders Call for Innovation in Development of Smoking Cessation Treatments
  1. CTP Newsroom

NIH and FDA Leaders Call for Innovation in Development of Smoking Cessation Treatments

Commentary Emphasizes that Engagement Across Stakeholders is Critical to Accelerate Smoking Cessation and Reduce Smoking-Related Disease and Death

October 15, 2024

In a new commentary in the Annals of Internal Medicine, leaders at the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA) highlight recommendations and opportunities to promote innovation in research and development of smoking cessation therapies, for which there is an urgent need. The authors provide an update on regulatory pathways for smoking cessation treatment, as well as an overview of innovative therapeutic targets, research gaps, and opportunities. They emphasize that active engagement across clinicians, academia, industry, public health, patient advocacy groups, and other stakeholders is critical.

Cigarette smoking kills nearly 500,000 Americans each year, and over 28 million adults currently smoke in the United States. Though most adults who smoke report that they want to quit, only 31% of those interested in quitting receive counseling and/or medications, and less than 8% effectively quit each year.

The commentary authors highlight recommendations to address these gaps, including from FDA’s 2023 nicotine replacement therapies guidance. To spark greater innovation in the development of smoking cessation products, the authors highlight the importance of considering meaningful study endpoints in addition to abstinence in smoking cessation trials. For instance, clinically meaningful reductions in smoking, especially if such reductions increase the probability of eventual cessation.

The authors also emphasize the urgent need for greater research on e-cigarettes, including on long-term health outcomes and rigorous toxicology studies. In addition, they discuss ongoing initiatives at NIH and FDA that aim to facilitate innovative research on smoking cessation, including among groups that have been historically underrepresented in research trials.

The commentary is publishing in advance of an FDA and NIH Joint Public Meeting on advancing smoking cessation priorities, which is being held on Monday, Oct. 21, from 9 a.m. to 4:30 p.m. EDT. Registration for the meeting is available here.

Back to Top