US FDA Releases Preview Of PATH 2025 Study Webinar

US FDA releases preview of PATH 2025 study webinar

The latest data from the 2024 National Youth Tobacco Survey (NYTS) released by the US FDA shows that the use of tobacco products by teenagers has dropped to the lowest level in 25 years, especially the use of e-cigarettes has dropped significantly. At the same time, the FDA announced that it will hold a PATH research webinar in January 2025 to explore the trend of tobacco product use and its impact on public health.

On December 18, the US Food and Drug Administration (FDA) released the results of the 2024 NYTS data study and announced the notice of the upcoming PATH (Population Assessment of Tobacco and Health) webinar.

The use of tobacco products by teenagers is at its lowest level in 25 years, but differences still exist

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

In 2024, about 2.25 million middle school and high school students have used at least one tobacco product in the last 30 days, compared with 2.8 million in 2023. A significant decline in e-cigarette use was the main reason (2.13 million teens used e-cigarettes in 2023, falling to 1.63 million in 2024). Cigarette use also reached its lowest level since the survey was recorded, with only 1.4% of students reporting current use in 2024.

Progress varied by population. Female students saw significant declines in tobacco product, e-cigarette, and multiple tobacco product use between 2023 and 2024, with Hispanic students also showing declines over the same time period. However, among non-Hispanic Native American or Alaska Native students, use of all tobacco products increased, while non-Hispanic white students also saw an increase in nicotine pouch use.

PATH Study: Wave 7 PATH Study Biomarker Data File Released

The U.S. Food and Drug Administration (FDA) Center for Tobacco Products and the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), released the seventh wave of the Biomarker Restricted Use Data File (BRUF) collected between January 2022 and April 2023. Researchers can apply to access the data. For the first time, the seventh wave of biomarker data files are included.

The first wave of sample data has also been expanded to include adults who have used tobacco products experimentally or chronically.

FDA to hold major webinar 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 webinar. Over the past decade, this longitudinal study has tracked major changes in tobacco product use, including dramatic rises and falls in e-cigarette use, the emergence of new products such as nicotine pouches, and growing concerns about the simultaneous use of multiple tobacco products. The webinar will provide an overview of the PATH study and highlight how the scientific evidence it generates guides FDA's regulatory activities and public health efforts.

In new commentary and public meeting, NIH and FDA leaders call for innovative smoking cessation treatments

FDA and NIH leaders issued a new commentary in the Annals of Internal Medicine calling for innovation in the development of smoking cessation treatment products. The article emphasizes the need for active participation in smoking cessation research, including clinicians, academia, industry, public health, patient advocacy groups, and others. Discuss recommendations and opportunities to advance research and development of smoking cessation therapies, particularly the need to study the long-term health effects of e-cigarettes and their toxicology. In addition, the FDA and NIH held a public meeting in October titled "Advancing Smoking Cessation: Priorities for FDA and NIH," focusing on the development of innovative smoking cessation products to help adults and youth. The public comment period has been reopened until December 20, 2024, for the public to share insights, data, and recommendations on advancing the development of innovative smoking cessation products and therapies to help youth and adults.

FDA Releases Regulatory Science Policy Memorandum Related to Premarket Application Review

In November, the FDA released additional regulatory science policy memoranda related to the agency's premarket application review. This release includes 13 memoranda from 2020 to 2023 that describe the process and priority approach used to file and review flavored e-cigarette and other premarket tobacco product applications (PMTAs), as well as the basis for supporting specific actions related to environmental assessments. These science policy memoranda provide FDA's views on specific topics at a specific point in time and can be updated due to policy changes.

In April, the FDA resumed issuing regulatory science policy memoranda. This is the fourth batch of memoranda issued in 2024, and including the memorandum issued today, the FDA has issued a total of 26 memoranda.