July 7, 2026

Written by Austin Tyner

Clinical Review by Dr. Vincent Angelico

The 2025 NYTS Data and its analysis by the FDA indicate historic sustained lows in youth use of nicotine and tobacco products. E-cigarette use among children and teens hit an all-time survey high in 2019 when over 5 million NYTS-surveyed youth (27.5% of high schoolers and 10.5% of middle schoolers) reported current use of e-cigarettes. As of 2025, the NYTS reports only 1.44 million current youth e-cigarette users (7.1% of high schoolers and 2.6% of middle schoolers), continuing the trend in use reduction. 

The 2025 NYTS data may be useful in PMTA applications because they provide important population-level context, highlighting a continued downturn in youth tobacco and nicotine product use. However, these trends should not be misconstrued as reducing an applicant's evidentiary burden. Notably, the 2025 NYTS also recorded persistently high rates of flavored product use among youth — a finding that continues to generate regulatory and public health debate, though one that equally underscores the broad consumer reach of flavored products across age groups and the potential role such products may play in transitioning adult smokers away from combustible cigarettes. FDA's APPH (Appropriate for the Protection of Public Health) standard remains product-specific and requires rigorous scientific evidence demonstrating that the product, its components, and its proposed marketing are appropriate for the protection of the public health, including evidence that expected benefits to adults outweigh potential risks to youth. 

This is exemplified in FDA's 2026 authorization of four Glas ENDS products, which illustrates the agency's commitment to the protection of youth from harms related to nicotine and tobacco product use. FDA emphasized that the products were authorized due to the applicant's age-gating technology, combined with FDA-required marketing restrictions, which were expected to mitigate youth use. The technology required age and identity verification using a government-issued ID, smartphone pairing via Bluetooth, device inoperability when separated from the phone, and random biometric check-ins; FDA also required adult-targeted advertising, reporting on youth-prevention measures, and continued monitoring, with the possibility of suspension or withdrawal if youth use increased.  

For potential applicants navigating the PMTA process, the 2025 NYTS data is more than a public health headline — it is a regulatory signal, and reading it correctly matters. The dataset's continued decline in overall youth use offers legitimate population-level context that applicants can and should incorporate, by citation, into their submissions. However, the data cuts both ways: persistently high flavored product preference among youth users, and the dominance of specific brands in that space, means the FDA will continue to scrutinize flavoring, device design, and marketing approaches. Applicants should note that the FDA uses this data as a benchmark against which product-specific evidence is weighed. The Glas authorization is instructive: it was not the population trends that unlocked approval, but the applicant's ability to demonstrate its product's commitment to APPH standards through testing, product design, and thorough documentation, which is always the standard that applicants should seek to meet. 

PMTA Applicant Takeaway

• Use the 2025 NYTS and relevant analysis as sources in the PMTA to evaluate the product against and to contextualize product efficacy, safety, and background. Understand that using this population data in complement to an already well-tested and compliant product makes for a stronger application. 
• Do not be lulled by downward-trending youth use into thinking applicant burden of proof is lessened. The FDA will not approve products that do not meet APPH standards. Be aware of products with heightened perceived youth appeal by the FDA, such as flavored nicotine and tobacco products. Ensure marketing compliance. 
• Follow the example of Glas. Take into consideration the incorporation of age-gating technology into product design. Ensure documentation of all elements relevant to APPH determination is thorough. 

How Accorto can help

Navigating the intersection of population-level data and product-specific evidentiary requirements is where experienced regulatory counsel becomes invaluable. Accorto is here to help. Our team excels in building informed, data-driven PMTA applications and GMP compliance programs engineered to help our clients meet the FDA’s APPH standard. 

Sources

Park-Lee, E., Dutra, L. M., Cowan, H., Levine, B., Sawdey, M. D., Cooper, M., Merson, B., Valverde, R., Bradfield, B., Lennon, J., Freedman, N. D., Ambrose, B. K., & Cullen, K. A. (2026). Tobacco product use among middle and high school students in the United States: National Youth Tobacco Survey, 2025. Nicotine & Tobacco Research. https://doi.org/10.1093/ntr/ntag116 

U.S. Food and Drug Administration. (2026, June 23). National Youth Tobacco Survey (NYTS). https://www.fda.gov/tobacco-products/youth-and-tobacco/national-youth-tobacco-survey-nyts 

U.S. Food and Drug Administration. (2026, June 23). National Youth Tobacco Survey: FDA publishes peer-reviewed journal article, releases 2025 findings. https://www.fda.gov/tobacco-products/ctp-newsroom/national-youth-tobacco-survey-fda-publishes-peer-reviewed-journal-article-releases-2025-findings 

U.S. Food and Drug Administration. (2025, January 22). Results from the annual National Youth Tobacco Survey (NYTS). https://www.fda.gov/tobacco-products/youth-and-tobacco/results-annual-national-youth-tobacco-survey-nyts 

U.S. Food and Drug Administration. (2026, June 23). National Youth Tobacco Survey (NYTS): Datasets. https://www.fda.gov/tobacco-products/youth-and-tobacco/national-youth-tobacco-survey-nyts#Datasets 

Wang, T. W., Gentzke, A. S., Creamer, M. R., Cullen, K. A., Holder-Hayes, E., Sawdey, M. D., Anic, G. M., Portnoy, D. B., Hu, S., Homa, D. M., Jamal, A., & Neff, L. J. (2019). Tobacco product use and associated factors among middle and high school students — United States, 2019. MMWR Surveillance Summaries, 68(12), 1–22. https://doi.org/10.15585/mmwr.ss6812a1 

Austin Tyner

Document Specialist

Austin Tyner is Accorto’s document specialist, supporting the quality and publishing team with document onboarding, formatting, and FDA submission readiness. She holds a BA in English and Comparative Literature, with a minor in Public Policy, from the University of North Carolina at Chapel Hill.

Dr. Vincent Angelico

Chief Science Officer & Co-Founder

Dr. Vincent Angelico is the Chief Science Officer and a co-founder of Accorto Regulatory Solutions. He holds a PhD in Analytical Chemistry and specializes in FDA regulatory strategy for tobacco harm reduction products, with deep experience in PMTA submissions, consumer behavior research, and population-health analysis for nicotine pouches and smoke-free alternatives. He has guided THR programs through every stage of the FDA review process, from initial product classification through substantive review and deficiency response.

This is a general regulatory and scientific analysis from Accorto Regulatory Solution. It reflects FDA decisions and public information available as of June 2026 and is not legal advice. Regulatory expectations change, so please confirm current FDA guidance and authorized product details before acting on anything here.