My colleagues at UCSF and Stanford and I have submitted this public comment to the FDA on its prposed nicotine standard urging that the standard be extended to all tobacco products (PDF). The regulations.gov Comment Tracking Number: mfj-v5cz-15yf.
The scope of FDA’s proposed tobacco product standard setting a maximum level of nicotine in tobacco products should be expanded to include all nicotine delivery products that are not authorized by the FDA Center for Drug Evaluation and Research for cessation, including, but not limited to, e-cigarettes and nicotine pouches
Docket No. FDA-2024-N-5471 for “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.”
Pamela Ling, MD; MPH; Stanton A. Glantz, PhD; Lauren Lempert JD, MPH; Dorie E. Apollonio, PhD, MPP; Maya Vijayaraghavan, MD, MAS; Vira Pravosud, PhD, MPH, MS; Wendy Max, PhD; Stella Bialous, RN, DrPH; Lynn D. Silver, MD, MPH; Heather Leutwyler, RN, PhD, FNP-BC, CNS; Sharon Hall, PhD; Jeremiah Mock, MSc, PhD; Janice Tsoh, PhD; Bonnie Halpern-Felsher, PhD, FSAHM; Valerie Yerger, ND; Matt Springer, PhD
University of California, San Francisco
Stanford University School of Medicine
September 13, 2025
The FDA should expand the scope of the proposed tobacco product standard for nicotine yield to include all nicotine delivery products that are not authorized by the FDA Center for Drug Evaluation and Research (CDER) for cessation, including, but not limited to, e-cigarettes and nicotine pouches. By excluding these products, the proposed standard is likely to drive not only current smokers, but also current non-smokers, including youth, young adults, and former smokers, to initiate using highly addictive newer nicotine delivery products and promote dual use, which could increase harm beyond just smoking.
FDA specifically requested comment on excluding non-combusted products from the proposed rule (page 5101):
FDA is not including noncombusted tobacco products, such as ENDS (which include e-cigarettes) and smokeless tobacco products, in the scope of this proposed product standard. FDA’s approach in proposing this product standard for cigarettes and certain other combusted tobacco products seeks to protect public health by reducing combusted tobacco product use (and therefore reducing exposure to harmful toxicants created through combustion) while potentially less harmful, noncombusted tobacco products remain available for people who do not quit all tobacco-product use. As such, at this time, FDA is focusing this proposed rule on nicotine levels in cigarettes and certain other combusted products because combusted tobacco products are responsible for the majority of death and disease due to tobacco use. Importantly, this action would also help to prevent people who experiment with cigarettes and cigars (mainly youth) from moving beyond experimentation, developing an addiction to nicotine, and progressing to regular use of combusted tobacco products as a result of that addiction. We request comments, data, and research regarding the proposed scope of this rule.
The Family Smoking Prevention and Tobacco Control Act section 907 requires the FDA to determine that proposed tobacco product standards are “appropriate for the protection of the public health.” This involves weighing the potential harms of nicotine-naïve non-users initiating the use of the product and/or current users changing their usage in ways that cause increased harm, against any potential benefits of current users completely stopping smoking. In its proposed rule, FDA did not adequately consider the likelihood that non-users, especially nicotine-naïve youth and young adults, will be driven to using newer nicotine delivery products, including e-cigarettes and nicotine pouches, start consuming high levels of nicotine, and thus become addicted to nicotine products which can create substantial health harms that they otherwise would have not been exposed to, or that initiation with these newer nicotine delivery products will lead to subsequent smoking or dual use.
E-cigarettes should be included in the nicotine product standard
As of 2024, e-cigarettes were the most popular tobacco product among youth in the US, with 3,870,000 (14.0 %) middle and high school students using e-cigarettes.[1] E-cigarettes are available in hundreds of flavors attractive to children[2],[3],[4] and are available in nicotine levels as high as a pack of cigarettes in a single pod,[5] making them extremely addictive.[6],[7] A study of national sales data found that between January 2017 and March 2022, the monthly average nicotine strength of disposable e-cigarettes increased substantially and has exceeded prefilled pods since May 2020. E-cigarettes with menthol flavor and youth-appealing flavors, like fruit, also had sharp increases in monthly average nicotine strength.[8] Both the nicotine concentration and size of e-cigarette vaping devices increased, while prices fell between 2017 and 2022, facilitating increasing nicotine consumption.[9],[10] A new study published in 2025 of the national Monitoring the Future data found in 2024, most US youths with past-30-day vaping reported using e-cigarettes with very high nicotine concentrations or not knowing the concentration. The study found dose-response associations of nicotine concentration with frequent, chronic vaping and poly-tobacco use, and youths who vaped ultrahigh (≥6%) vs very high (5%) nicotine e-cigarettes had incrementally increased risk of using various nicotine products and frequent, chronic vaping patterns.[11]
Providing e-cigarettes to smokers in the real world creates more dual users than smokers who “completely switch” from cigarettes to e-cigarettes.[12] Dual use is associated with higher risks than just smoking.[13] Consistent with earlier RCTs conducted in a clinical environment, this study found a statistically significant increase in the odds of no longer smoking cigarettes among the people randomized to receive free e-cigarettes compared to the people randomized to receive no product: OR 1.8 (95% confidence interval 1.0-2.2). In absolute terms, at 6 months, 14% of the smokers given free e-cigarettes had stopped smoking cigarettes compared to 8% of the control group.[14] Thus, for every 100 people given free e-cigarettes, 6 more stopped smoking cigarettes than would have quit anyway, thanks to the e-cigarettes. However, as shown in all the earlier studies, these “stoppers” included “switchers” who stopped smoking cigarettes but were consuming e-cigarettes and “quitters” who had stopped smoking cigarettes without continuing to consume nicotine from e-cigarettes. Considering any nicotine use, there was no significant difference in having quit (stopped using nicotine: 8% of e-cig group vs 6% of control group; p=0.510).
The results for dual use were even more important. At 6 months, 45% of the people who received e-cigarettes were dual users compared to just 11% of the control group (OR 6.8, 95% CI 4.2-10.9, p<0.001). In other words, for every person who stopped smoking cigarettes (including switchers who continued using e-cigarettes and quitters who did not smoke cigarettes or use e-cigarettes) in the group that had been provided e-cigarettes, 2.7 smokers became dual users. This compares with 1.8 in the control group. This difference is even more pronounced for quitters (stopped smoking and stopped e-cigs): For every quitter in the e-cigarette group, there were 5.7 dual users, compared to 1.8 in the control group.
Therefore, the FDA’s approach designed to move conventional cigarette smokers to e-cigarettes is flawed and will not protect public health, because cigarette smokers who end up becoming dual users with e-cigarettes will be exposed to more harm than if they smoked cigarettes alone.
Nicotine pouches
Nicotine pouch use has exploded in the US.[15],[16] The 2024 National Youth Tobacco Survey (NYTS) found that an estimated 840,000 (3.5%) of US middle and high school students had ever used nicotine pouches, up from an estimated 580,000 (2.3%) in just the year prior.[17] [18] Among US 9th-12th grade high school students, the prevalence of past-30-day use of nicotine pouches increased by 40% in just one year, from 1.5% (1.0–2.1) in 2023 to 2.4% (2.0–2.9) in 2024. The 2024 prevalence estimates reported in NYTS likely underestimate the actual prevalence rate today among US youth, particularly among older high school students.
Analysis of Monitoring the Future data for 10th and 12th graders showed that between 2023 to 2024, exclusive nicotine pouch and dual use of pouches plus e-cigarettes increased significantly. Between 2023 and 2024, the prevalence of nicotine pouch use among 10th and 12th graders roughly doubled for lifetime use (2.3% to 4.0%), past-12-month use (1.7% to 3.2%), and past-30-day use (0.8% to 1.8%), with the prevalence of past-30-day use among 12th graders rising in just one year from 1.4% to 3.4%. Older students were a higher risk of using nicotine pouches. The adjusted risk ratios for nicotine pouch use were significantly higher for 12th graders compared to 10th graders: lifetime 1.48 (95% CI 1.07, 2.04), past 12 months 1.60 (95% CI 1.14, 2.23), and past 30 days 1.65 (1.11, 2.44). The analysis showed that rural students are at particularly high risk of starting to use nicotine pouches. The prevalence of nicotine pouch use among students living in rural areas increased rapidly in just one year to high levels across all measures: lifetime 7.5% to 11.2%, past 12 months 7.2% to 9.7%, and past 30 days 4.4% to 7.7%. Among students living in rural areas, compared to students living in urban areas, the adjusted risk ratios were significantly higher for all measures: lifetime: 2.26 (95% CI 1.34, 3.80), past 12 months: 2.52 (95% CI 1.19, 4.26), and past 30 days: 3.01 (95% CI 1.70, 5.33). The study also showed that students who aimed to achieve a lower level of education were at higher risk of using nicotine pouches. Among students who did not plan to attend a 4-year college, the prevalence of nicotine pouch use increased rapidly for all measures: lifetime 5.4% to 8.0%, past 12 months 3.9% to 6.9%, past 30 days: 2.5% to 3.9%.[19]
Children and teens are particularly susceptible to initiating use of nicotine pouches because these products are easy to hide. Nicotine pouches are made with many enticing fruity and minty/mentholated flavors, making them especially attractive to youth. Of particular concern, nicotine pouches are available in nicotine levels as high as 47.5 mg/pouch, with nicotine delivery comparable to other tobacco products, making them extremely addictive.[20] [21]
In 2023, Belgium banned the sale of nicotine pouches based on concerns of youth uptake of nicotine pouches, followed in 2025 by the Netherlands and the State of South Australia.
Adolescents using low-nicotine cigarettes are likely to seek alternative nicotine sources, so including other nicotine products in the FDA standard is important.[22]
Conclusion
The proposed product standard that would establish a maximum nicotine level of 0.7 mg/g in conventional cigarettes and certain other combustible tobacco products, but set no limit on the nicotine levels newer nicotine delivery products that are not authorized by the FDA Center for Drug Evaluation and Research (CDER) for cessation, including, but not limited to, e-cigarettes and nicotine pouches level will likely increase demand for these highly addictive youth-appealing products. FDA accepts this likelihood on the assumption that there will be a reduction in overall public harm. As discussed above, there is direct evidence contradicting this assumption for e-cigarettes, and as discussed in our comment on FDA’s proposal to exempt heated tobacco products (HTPs) from the proposed standard[23] (and appended to this comment by reference), there is direct evidence that this assumption is not correct for HTPs.
The likelihood of increased youth and young adult initiation and promotion of relapse to smoking among adults is particularly concerning. A product standard that reduces the nicotine level in these newer nicotine delivery products that are not authorized by the FDA CDER for cessation will help deter tobacco companies from using the loophole to expand consumers’ use of nicotine products and deter cessation.
The FDA should not exclude newer nicotine delivery products that are not authorized by the FDA CDER for cessation, including e-cigarettes and nicotine pouches, from maximum nicotine level standards. The FDA should, instead, establish maximum levels of nicotine for newer nicotine delivery products that are at parity with the maximum levels of nicotine the FDA establishes for conventional cigarettes.
If, at some point in the future, there is compelling evidence that allowing higher levels of nicotine in e-cigarettes, nicotine pouches, and other newer nicotine delivery products that are not authorized by the FDA CDER for cessation will not result in youth use and is appropriate for the protection of public health, the FDA could consider amending the standard.
[1] Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924. DOI: http://dx.doi.org/10.15585/mmwr.mm7341a2
[2] Zhu S, Sun JY, Bonnevie E, et al. Four hundred and sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco Control 2014;23:iii3-iii9.
[3] Ali FR, Seidenberg AB, Crane E, Seaman E, Tynan MA, Marynak K. E-cigarette Unit Sales by Product and Flavor Type, and Top-Selling Brands, United States, 2020–2022. MMWR Morb Mortal Wkly Rep 2023;72:672–677. DOI: http://dx.doi.org/10.15585/mmwr.mm7225a1
[4] Monitoring E-Cigarette Trends in the United States: Urgent Action Needed to Protect Kids from Flavored E-Cigarettes. CDC Foundation, November 21, 2024. https://tobaccomonitoring.org/wp-content/uploads/2024/11/2024MonitoringE-CigaretteTrendsUS-1.pdf.
[5] Prochaska JJ, Vogel EA, Benowitz N. Nicotine delivery and cigarette equivalents from vaping a JUULpod. Tob Control. 2022 Aug;31(e1):e88-e93. doi: 10.1136/tobaccocontrol-2020-056367. Epub 2021 Mar 24. PMID: 33762429; PMCID: PMC8460696.
[6] Cho YJ, Mehta T, Hinton A, et al. E-Cigarette Nicotine Delivery Among Young Adults by Nicotine Form, Concentration, and Flavor: A Crossover Randomized Clinical Trial. JAMA Netw Open. 2024;7(8):e2426702. doi:10.1001/jamanetworkopen.2024.26702.
[7] Falarowski, C., Pieper, E., Rabenstein, A. et al. Disposable e-cigarettes and their nicotine delivery, usage pattern, and subjective effects in occasionally smoking adults. Sci Rep 15, 16270 (2025). https://doi.org/10.1038/s41598-025-97491-5
[8] Xu Wang, Ramesh Ghimire, Sundar S Shrestha, Mateusz Borowiecki, Sherry Emery, Katrina F Trivers, Trends in Nicotine Strength in Electronic Cigarettes Sold in the United States by Flavor, Product Type, and Manufacturer, 2017–2022, Nicotine & Tobacco Research, Volume 25, Issue 7, July 2023, Pages 1355–1360, https://doi.org/10.1093/ntr/ntad033
[9] Diaz MC, Silver NA, Bertrand A, et al. Bigger, stronger and cheaper: growth in e-cigarette market driven by disposable devices with more e-liquid, higher nicotine concentration and declining prices. Tobacco Control 2025;34:65-70.
[10] Monitoring E-Cigarette Trends in the United States: Urgent Action Needed to Protect Kids from Flavored E-Cigarettes. CDC Foundation, November 21, 2024. https://tobaccomonitoring.org/wp-content/uploads/2024/11/2024MonitoringE-CigaretteTrendsUS-1.pdf.
[11] Cho J, Miech RA, Harlow AF, et al. Nicotine Concentration of E-Cigarettes Used by Youths. JAMA Netw Open. 2025;8(3):e252215. doi:10.1001/jamanetworkopen.2025.2215
[12] Hanewinkel R, Glantz SA. Clinical trial shows that giving smokers free e-cigarettes creates more dual users than switchers or quitters. EClinicalMedicine. 2024 Feb 1;68:102452. doi: 10.1016/j.eclinm.2024.102452. PMID: 38333538; PMCID: PMC10850401.
[13] Glantz SA, Nguyen N, Oliveira da Silva AL. Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes. NEJM Evid. 2024 Mar;3(3):EVIDoa2300229. doi: 10.1056/EVIDoa2300229. Epub 2024 Feb 27. PMID: 38411454; PMCID: PMC11562742.
[14] Carpenter MJ, Wahlquist AE, Dahne J, Gray KM, Cummings KM, Warren G, Wagener TL, Goniewicz ML, Smith TT. Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial. EClinicalMedicine. 2023 Aug 15;63:102142. doi: 10.1016/j.eclinm.2023.102142. PMID: 37753443; PMCID: PMC10518503.
[15] Han D, Harlow AF, Miech RA, et al. Nicotine Pouch and E-Cigarette Use and Co-Use Among US Youths in 2023 and 2024. JAMA Netw Open. 2025;8(4):e256739. doi:10.1001/jamanetworkopen.2025.6739.
[16] Nicotine Pouch Data Briefs, April, 2025. CDC Foundation. https://tobaccomonitoring.org/wp-content/uploads/2025/08/Nicotine-Pouch-Brief-4.20.2025.pdf
[17] : Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182. DOI: http://dx.doi.org/10.15585/mmwr.mm7244a1
[18] Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924. DOI: http://dx.doi.org/10.15585/mmwr.mm7341a2
[19] Han D, Harlow AF, Miech RA, et al. Nicotine Pouch and E-Cigarette Use and Co-Use Among US Youths in 2023 and 2024. JAMA Netw Open. 2025;8(4):e256739. doi:10.1001/jamanetworkopen.2025.6739.
[20] Felicione NJ, Ozga JE, Eversole A, Hart JL, Tackett A, Hrywna M, Halquist M, Stanton CA. Oral Nicotine Pouches: Rising Popularity and State of the Science. Public Health Rep. 2025 Apr 28:333549251313668. doi: 10.1177/00333549251313668. Epub ahead of print. PMID: 40293136; PMCID: PMC12037535.
[21] Mallock-Ohnesorg N, Rabenstein A, Stoll Y, Gertzen M, Rieder B, Malke S, Burgmann N, Laux P, Pieper E, Schulz T, Franzen K, Luch A, Rüther T. Small pouches, but high nicotine doses-nicotine delivery and acute effects after use of tobacco-free nicotine pouches. Front Pharmacol. 2024 May 22;15:1392027. doi: 10.3389/fphar.2024.1392027. PMID: 38841367; PMCID: PMC11150668.
[22] Cassidy RN, Tidey JW, Jackson KM, Cioe PA, Murphy SE, Krishnan-Sarin S, Hatsukami D, Colby SM. The Impact of Reducing Nicotine Content on Adolescent Cigarette Smoking and Nicotine Exposure: Results From a Randomized Controlled Trial. Nicotine Tob Res. 2023 Apr 6;25(5):918-927. doi: 10.1093/ntr/ntac279. PMID: 36482794; PMCID: PMC10077938.
[23] Ling P, Glantz SA, Lempert L. Apollonio DE, Vijayaraghavan M. Pravosud V, Benowitz N, Max W, Bialous S, Silver LD, Leutwyler H, Hall S, Mock J, Tsoh J, Halpern-Felsher B, Yerger V, Springer M, Chaffee BW. FDA’s proposed tobacco product standard setting a maximum level of nicotine in tobacco products will help prevent youth from becoming addicted to conventional cigarettes, help adult smokers quit, and will reduce tobacco-related diseases and deaths, Docket No. FDA-2024-N-5471 for “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.” September 13, 2025.
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