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FDA Releases Preview of 2025 PATH Study Webinar

FDA Releases Preview of 2025 PATH Study Webinar

Data from the National Youth Cigarette Survey (NYTS) released by the US FDA in 2024 show that the use of youth cigarettes has dropped to its lowest level in 25 years, especially since the use of vapes has dropped significantly. At the same time, the FDA announced that it will host a PATH Research Network workshop in January 2025 to explore trends in the use of cigarette products and their impact on public health.

On December 18, the U.S. Food and Drug Administration (FDA) published a notice of the 2024 NYTS Data Study Findings and Publication (Population Assessment of Tobacco and Health, Tobacco and Health Population Assessment) webinar in the upcoming PATH.

Youth tobacco use is at its lowest level in 25 years, but disparities remain.

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

In 2024, about 2.25 million middle and high school students used at least one tobacco product in the last 30 days, compared to 2.8 million in 2023. The main reason is a significant decline in e-cigarette use (2.13 million teens used vapes in 2023, down to 1.63 million in 2024). Tobacco use reached its lowest level ever recorded by the survey, with only 1.4% of students reporting current use in 2024.

Progress is different for different groups of people. The use of tobacco products, vapes, and various tobacco products by female students decreased significantly between 2023 and 2024, with Spanish students showing a simultaneous decline. However, the use of different tobacco products increased among non-Hispanic Native American or Alaska Native students, while the use of nicotine packs by non-Hispanic white students also increased.

PATH Study: The 7th wave of PATH study biomarker data file is released

The U.S. Food and Drug Administration’s (FDA) National Institutes of Health Cigarette Product Display and (NIH) National Institute on Drug Abuse (NIDA) have published the seventh wave of Biomarker Restricted Use Data Files (BRUF) collected between January 2022 and April 2023. Researchers can request access to this information. The seventh wave of biomarker data files is included for the first time.

The first sample was also expanded to include adults who had tested or used cigarette products for a long time.

FDA is about to hold a major webinar to conduct the PATH study.

The FDA will discuss key findings of the Tobacco and Health Population Assessment Study (PATH) in a webinar on January 9, 2025. The longitudinal study has tracked dramatic changes in cigarette product use over the past decade, including the rapid rise and fall in vape use, the emergence of new products such as nicotine packs, and the growing focus on various cigarette products. The workshop will provide a brief overview of the PATH research and indicate how the scientific evidence generated guides FDA’s regulatory activities and public health efforts.

NIH and FDA leaders call for innovative smoking cessation treatment options in new reviews and public meetings

In a new review published in the Annals of Internal Medicine. FDA and NIH leaders call for innovation in the development of smoking cessation treatments. The article emphasizes the need for active participation in smoking cessation research, including by 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 vapes and their toxicology studies. In addition, the FDA and NIH hosted a public meeting in October titled “Advancing Smoking Cessation: Priorities for FDA and NIH,” which focused on the development of innovative smoking cessation products to help adults and adolescents. The public comment period has 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 adolescents and adults.

FDA publishes Regulatory Science Policy Notepad related to premarket application review.

In November, the FDA released additional regulatory science policy notepads related to the review of premarket applications by agencies. This release includes 13 notebooks from 2020 to 2023. These pads describe the process and priority approach for filing and reviewing applications (PMTA) for flavored vapes and other cigarette products before marketing, as well as the basis for supporting specific actions related to environmental assessments. These science policy notepads provide the FDA’s views on a particular topic at a particular point in time and can be updated as a result of policy changes.

In April, the FDA resumed publication of the regulatory Science Policy Memorandum. This is the fourth batch of notebooks to be released in 2024, including the notebooks released today, and the FDA has released 26 notebooks.

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