FDA Announces 2024 NYTS Data and PATH Webinar

On December 18th, the Food and Drug Administration (FDA) released the 2024 NYTS data research results and announced an upcoming webinar for the PATH (Population Assessment of Tobacco and Health) network.

Teen Tobacco Product Usage Rates are at Their Lowest Level in 25 Years, but Disparities still Exist

The use of tobacco products among middle and high school students in the United States has dropped to its lowest level in 25 years, according to data released by the 2024 National Youth Tobacco Survey (NYTS). In the past year alone, at least 500,000 fewer students are using tobacco products.

In 2024, approximately 2.25 million middle and high school students reported using at least one tobacco product in the past 30 days, compared to 2.8 million in 2023. A significant decrease in e-cigarette use is the main factor for this decline, with 2.13 million adolescents using e-cigarettes in 2023 compared to 1.63 million in 2024. Cigarette use also reached its lowest level in survey history, with only 1.4% of students reporting current use in 2024.

Progress varies among different groups. Between 2023 and 2024, there was a significant decrease in the use of tobacco products, e-cigarettes, and various tobacco products among female students. Hispanic students also showed a downward trend during the same period. However, among non-Hispanic American Indian or Alaska Native students, the use of various tobacco products has increased, and non-Hispanic white students have also seen an increase in the use of nicotine pouches.

PATH Study: Release of the 7th Wave of PATH Study Biomarker Data File

The Food and Drug Administration's Center for Tobacco Products and the National Institute on Drug Abuse, a subsidiary of the National Institutes of Health, have released the seventh wave of the Biomarker Restricted Use Files (BRUF) collected between January 2022 and April 2023. Researchers can apply to access this data. This is the first time the seventh wave of biomarker data files has been included.

The first wave of sample data was also expanded to include adults who had previously experimented with or used tobacco products long-term.

FDA is Set to Hold a Large-scale Online Seminar on PATH Study

On January 9, 2025, the FDA will discuss key findings from the Population Assessment of Tobacco and Health (PATH) study in a web seminar. Over the past decade, this longitudinal study has tracked significant changes in tobacco product use, including the sharp increase and decrease in e-cigarette use, the emergence of new products such as nicotine pouches, and the growing concern about the concurrent use of multiple tobacco products. The seminar will provide an overview of the PATH study, highlighting how the scientific evidence it has generated guides FDA regulatory activities and public health efforts.

In recent comments and public meetings, leaders of the NIH and FDA have called for innovative smoking cessation treatments.

Leaders from the FDA and NIH have published a new commentary in the Annals of Internal Medicine, calling for innovative approaches in the development of smoking cessation treatments. The article emphasizes the need for active participation in smoking cessation research from stakeholders including clinicians, academia, industry, public health, and patient advocacy groups. Discussions and recommendations are made to promote research and development of smoking cessation therapies, with a focus on studying the long-term health effects of e-cigarettes and their toxicology. Furthermore, the FDA and NIH held a public meeting in October titled "Advancing Tobacco Cessation: Priorities for FDA and NIH," which focused on the development of innovative smoking cessation products to assist both adults and youth. The public comment period has been extended until December 20, 2024, allowing the public to share insights, data, and recommendations on advancing innovative smoking cessation products and therapies to help youth and adults.

FDA Issues Regulatory Science Policy Memorandum Related to Pre-market Application Review

In November of this year, the FDA released additional regulatory science policy memoranda related to premarket application reviews by the agency. This release included 13 memoranda from 2020 to 2023, outlining processes and prioritization methods for filing and reviewing premarket tobacco product applications (PMTAs) for flavored e-cigarettes and other products, as well as the basis for specific actions supporting environmental assessments. These scientific policy memoranda provide the FDA's views on specific topics at particular points in time, which may be updated due to policy changes.

In April, the FDA resumed the release of regulatory science policy memoranda. This is the fourth batch of memoranda released in 2024, including the one released today, bringing the total number of memoranda released by the FDA to 26.