NCHR Written Comment to FDA on Modified Risk Tobacco Product (MRTP) Applications for ZYN Nicotine Pouch Products

Testimony & Briefings

January 21, 2026

Re: Docket number FDA-2025-N-0835
Modified Risk Tobacco Product Applications for ZYN Nicotine Pouch Products Submitted by Swedish Match U.S.A., Inc.

The National Center for Health Research (NCHR) appreciates the opportunity to submit this public comment regarding the Modified Risk Tobacco Product (MRTP) applications submitted by Swedish Match U.S.A., Inc. for ZYN nicotine pouch products.

NCHR is a nonprofit research organization that bridges the gap between scientific evidence and public policy to ensure that medical products and consumer health technologies are evaluated through rigorous, independent analysis. Our staff have medical, scientific, statistical, public health, and FDA policy expertise and we carefully reviewed the relevant research on ZYN.

We explain below why our scientific analysis concludes that the available evidence does not support granting Modified Risk Tobacco Product authorization for ZYN nicotine pouches. The application lacks the long-term evidence required to demonstrate reduced risks of oral cancer or serious cardiovascular and cerebrovascular concerns. In addition, the smoking habits of many adults, adolescents and children who are also using tobacco pouches, the rising popularity of ZYN among children, teens, and young adults and the documented harm shown in the Poison Control Centers data provides additional evidence that the statutory population-health standard has not been met.

Our analysis below focuses on population-level impact, youth use patterns, limitations of the clinical and epidemiologic evidence, evidence of oral and cardiovascular health risks, documented pediatric exposures, and the evidentiary standards for reduced-risk authorization.

  1. Under Section 911 of the Tobacco Control Act, Modified Risk Tobacco Product (MRTP) authorization requires evidence that a product will benefit the health of the population as a whole, not simply reduce exposure to selected toxicants in individual users. That population standard has not been met in the data provided to the FDA. 

ZYN use by children and adults is rising rapidly. According to the 2024 National Youth Tobacco Survey, approximately 480,000 middle and high school students reported current nicotine pouch use. This is often not experimental or occasional use: over 22% reported daily use, and nearly 30% used pouches on 20 or more days in the past month (NYTS 2024). A study published last year reported increasing middle and high school students’ use and frequent co-use with e-cigarettes and/or cigarettes, rather than substitution for cigarettes, directly undermining the population benefit required for MRTP claims (JAMA Network Open, 2025).

In prior MRTP reviews, the U.S. Food and Drug Administration has cautioned that epidemiologic trends observed in Sweden cannot be directly extrapolated to the U.S. context because of differences in social, cultural, and market conditions. This is a particular problem because the data was of a different product and there are substantial differences between General Snus and ZYN.  In addition,  the Swedish studies were focused on adults and in the U.S. ZYN is especially popular with children and teenagers. For all these reasons, reliance on the Swedish epidemiologic research results is not appropriate for evaluating ZYN’s population-level impact.

  1. The proposed claims of lower risks of serious diseases are unsubstantiated and inappropriate because of the lack of long-term data in Sweden and the lack of long-term U.S. health outcomes data. Swedish Match seeks to claim reduced risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis, but these diseases are associated with decades of exposure, not with the short-term use of a product that was not nationally available in the U.S. until 2019. It is well established that most adult smokers started smoking in their teens or early adulthood, and yet they rarely are diagnosed with lung cancer, COPD, cardiovascular diseases, or other serious diseases until they are middle aged or older. It is therefore inappropriate to base claims of lower risks on Swedish data of 20 years or less of a different product and the available evidence is short-term on U.S. nicotine pouch users and limited to  toxicant comparisons, biomarkers, perceptions, and brief observational follow-up,  which cannot support reduced-risk claims for diseases that typically develop decades after exposure.

Oral health is of particular concern. Published studies of Swedish nicotine pouch users have reported a higher prevalence of oral mucosal lesions, evidence of local inflammation with elevated inflammatory biomarkers, and findings consistent with microbial dysbiosis and periodontal effects. In contrast,  some industry-cited findings claim safety by focusing on the absence of plaque acidogenesis, which does not measure oral cancer risk and cannot support claims of reduced malignancy. These findings represent short-term biologic signals of tissue irritation and altered oral ecology, which are incompatible with claims of safety and do not constitute clinical or epidemiologic evidence of reduced risk for long-latency outcomes such as oral cancer or other serious diseases. In addition, most are not based on ZYN users. Taken together, the available evidence, which is relatively short-term and based on surrogate endpoints, does not demonstrate that ZYN nicotine pouches, as actually used, reduce the risk of oral cancer or other serious disease outcomes.

  1. Being “tobacco-free” does not mean harmless, and this is particularly important for cardiovascular and cerebrovascular risk. Both the European Society of Cardiology and the American Heart Association have emphasized that nicotine itself is toxic to the heart and blood vessels, regardless of delivery form. In addition, the American Heart Association and other experts warn that modern oral nicotine products remain addictive, may adversely affect cardiovascular risk pathways, and lack long-term outcome data, while noting that nicotine can raise blood pressure, increase heart rate, and impair vascular function-mechanisms directly relevant to myocardial infarction and stroke.

Moreover, independent chemical analyses of nicotine pouches have identified dozens of non-nicotine constituents per product, including compounds with known toxicologic concern, underscoring that reduced combustion does not equate to safety. In the absence of long-term statistically significant evidence demonstrating reduced cardiovascular or cerebrovascular events among nicotine pouch users, allowing claims of reduced risk of heart disease or stroke misleads consumers and fails to meet the MRTP population health standard.

  1. In addition to concern about the popularity of ZYN among children and teens that potentially results in a life-threatening nicotine addiction, there are short-term, real-world harms for children of all ages. FDA safety communications and national poison center surveillance show sharp increases in nicotine pouch exposures, with approximately 70 percent occurring in children under five years of age, most commonly through unintentional ingestion (FDA consumer update, 2025; Pediatrics, 2025). Young children are uniquely vulnerable to nicotine toxicity because of their low body weight and immature physiology, and even small amounts of nicotine can cause vomiting, seizures, cardiovascular instability, and other serious adverse effects. These exposures are not theoretical; they are occurring in real-world household settings as flavored nicotine pouches become more widely available. These pediatric harms occur whether or not an adult smoker in the house switches from cigarettes and therefore must be included in FDA’s population-level MRTP assessment. Authorizing reduced-risk claims will inevitably increase household exposures as well as parents’ perceived safety of these products for their children.
  1. ZYN’s marketing practices and product design are inconsistent with Section 911’s public health standard. Under Section 911 of the Tobacco Control Act, Modified Risk Tobacco Product authorization requires evidence that marketing a product with reduced-risk claims will advance public health, including by reducing nicotine addiction and supporting cessation among current tobacco users without increasing uptake or dependence among non-users.

Rather than promoting nicotine de-escalation or cessation, ZYN’s rewards programs (described on zyn.com and in social media) and 2 different nicotine strengths appear designed to maximize continued use and dependence. The shift from lower-dose to higher-dose products, combined with loyalty and rewards incentives, is fundamentally inconsistent with the public health intent of harm reduction and undermines any claim that these products advance public health.

These concerns are reinforced by market data demonstrating that ZYN’s growth reflects rapid commercial expansion rather than smoking cessation or complete switching. A peer-reviewed analysis published in JAMA Network Open found that overall U.S. nicotine pouch sales increased 10-fold from 126.06 million units during the 5 months between August and December 2019 to 808.14 million units in the first three months of 2022. During those years, ZYN accounted for 58.8% of total unit share, far exceeding competing brands.

Taken together, ZYN’s program rewarding more purchases (which is especially popular with students), offering both a lower and higher dose of  nicotine, and dominant market growth pattern indicate it is increasing and sustaining nicotine exposure. Importantly, the applicant has not demonstrated that this rapid growth corresponds with reductions in cigarette smoking, increased cessation, or decreased overall nicotine dependence at the population level. These real-world use patterns are incompatible with the statutory requirement that MRTP authorization advance public health. The evidence does not support granting reduced-risk claims for ZYN nicotine pouch products. Compared to current use, which has increased dramatically in recent years, advertising claims of lower risk that is allowed with MRTP authorization is expected to increase ZYN use and nicotine addiction, especially among children and teens, since research clearly shows that the label encourages a misperception of safety.

In conclusion, the evidence submitted in support of the MRTP applications for ZYN nicotine pouch products does not meet the statutory standard under Section 911 of the Tobacco Control Act. ZYN’s growing popularity among middle school and high school students is similar to the early stages of the vaping epidemic among children and teens that occurred prior to the COVID pandemic restrictions that reduced such use.  There are no long-term data supporting the claims that these products are safer than combustible cigarettes in terms of cancer, cardiovascular disease, stroke, or other serious health outcomes among U.S. users. At the same time, data suggesting likely risks of oral cancer, the cardiovascular and cerebrovascular toxicity of nicotine regardless of delivery form, and preventable harms to young children through accidental exposure represent population-level risks independent of any potential individual benefit among adult smokers. We therefore strongly urge that the FDA help reduce nicotine-addiction among children, teens and adults by not granting Modified Risk Tobacco Product authorization for ZYN nicotine pouch products.

Respectfully submitted,
National Center for Health Research
Washington, D.C.

 

References:

  1. S. Food and Drug Administration. (n.d.). Modified risk tobacco products (MRTP).
    https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products
  2. Gentzke, A. S., Cornelius, M., Jamal, A., et al. (2024). E-cigarette and nicotine pouch use among middle and high school students—United States, 2024. MMWR Morbidity and Mortality Weekly Report, 73(35). https://www.cdc.gov/mmwr/volumes/73/wr/mm7335a3.htm
  3. Han, D. H., Lee, S., & Seo, D. C. (2025). Trends in nicotine pouch use and co-use with e-cigarettes among U.S. adolescents, 2023–2024. JAMA Network Open, 8(1), e2333311.
  4. S. Food and Drug Administration. (2026). Modified risk applications for ZYN nicotine pouches now under FDA scientific review. https://www.fda.gov/tobacco-products/ctp-newsroom/modified-risk-applications-zyn-nicotine-pouches-now-under-fda-scientific-review
  5. S. Food and Drug Administration. (2016). Technical project lead review and decision summary: Modified risk tobacco product application for General Snus. https://www.fda.gov/tobacco-products/ctp-newsroom/modified-risk-applications-zyn-nicotine-pouches-now-under-fda-scientific-review
  6. Barrington-Trimis, J. L., Liu, F., Unger, J. B., et al. (2025). Oral nicotine product use and vaping progression among adolescents. Pediatrics, 155(6), e2024070312.
  7. Rungraungrayabkul, D., Gaewkhiew, P., Vichayanrat, T., Shrestha, B., & Buajeeb, W. (2024). What is the impact of nicotine pouches on oral health: A systematic review, vol. 24. BMC Oral Health. BioMed Central Ltd.
  8. European Society of Cardiology. (2025). Vapes, pouches, heated tobacco, shisha, cigarettes: Nicotine in all forms is toxic. https://www.escardio.org/The-ESC/Press-Office/Press-releases/vapes-pouches-heated-tobacco-shisha-cigarettes-nicotine-in-all-forms-is-tox
  9. Stokes, A., Auer, R., Goodman, M., et al. (2025). Smokeless oral nicotine products: A scientific statement from the American Heart Association. Circulation.
  10. American Heart Association. (2025). Triple threat: E-cigarettes, oral nicotine pouches, and heat-not-burn products. https://www.heart.org/en/healthy-living/healthy-lifestyle/quit-smoking-tobacco/triple-threat-e-cigarettes-oral-nicotine-pouches-and-heat-not-burn-products
  11. S. Food and Drug Administration. (2025). Store nicotine pouches safely to prevent accidental exposure to children and pets. https://www.fda.gov/consumers/consumer-updates/properly-store-nicotine-pouches-prevent-accidental-exposure-children-and-pets
  12. S. Food and Drug Administration. (2025). FDA authorizes marketing of 20 ZYN nicotine pouch products after extensive scientific review. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review
  13. Lyu, J. C., Ozga, J. E., Stanton, C. A., Hrywna, M., Ganz, O., Ross, J. C., … & Ling, P. M. (2025). Advertising the leading US nicotine pouch brand: a content analysis of ZYN advertisements from 2019 to 2023. Tobacco Control.
  14. Majmundar, A., Okitondo, C., Xue, A., Asare, S., Bandi, P., & Nargis, N. (2022). Nicotine pouch sales trends in the US by volume and nicotine concentration levels from 2019 to 2022. JAMA Network Open, 5(11), e2242235-e2242235.
  15. La Capria, K., Hamilton-Moseley, K. R., Phan, L., Jewett, B., Hacker, K., Choi, K., & Chen-Sankey, J. (2024). Perceptions of FDA-authorized e-cigarettes and use interest among young adults who do not use tobacco. Tobacco prevention & cessation, 10, 10-18332.
  16. Wackowski, O. A., Rashid, M., Greene, K. L., Lewis, M. J., & O’connor, R. J. (2020). Smokers’ and young adult non-smokers’ perceptions and perceived impact of snus and e-cigarette modified risk messages. International journal of environmental research and public health, 17(18), 6807.

 

Click here to read our oral testimony to the FDA on the Modified Risk Tobacco Product applications for ZYN nicotine pouch products.