By J. Preston Campbell, PhD
Action on Smoking and Health (ASH). (2021). Hidden costs: The economic burden of cigarette smoking on U.S. healthcare. https://ash.org/hidden-costs-healthcare/
Alacrita Consulting. (2024). Valuing pharmaceutical assets: When to use NPV vs. rNPV. https://www.alacrita.com/whitepapers/valuing-pharmaceutical-assets-when-to-use-npv-vs-rnpv
BioPharma Vantage. (2025). Master pharma & biotech discount rates. https://www.biopharmavantage.com/pharma-biotech-discount-rates
Broughton Group. (2025, February 20). Demystifying the PMTA pathway for nicotine pouches: Key challenges and opportunities. https://www.broughton-group.com/blog/demystifying-the-pmta-pathway-for-nicotine-pouches-key-challenges-and-opportunities
Delnevo, C. D., Hrywna, M., Wackowski, O. A., & Steinberg, M. B. (2024). Prevalence of nicotine pouch use among US adults. JAMA Network Open. https://jamanetwork.com/journals/jama/fullarticle/2820917
Food and Drug Administration. (2021a). PMTA final regulatory impact analysis. https://www.fda.gov/media/152622/download
Food and Drug Administration. (2021b). Modified risk tobacco product applications: Draft guidance for industry. https://www.fda.gov/media/190651/download
Food and Drug Administration. (2025a, January 15). FDA authorizes marketing of 20 ZYN nicotine pouch products [Press release]. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scie
Food and Drug Administration. (2025b). FDA pilot program will fast-track certain nicotine pouch PMTAs. Summarized by Tobacco Law Blog. https://www.tobaccolawblog.com/2025/10/fda-pilot-program-will-fast-track-certain-nicotine-pouch-pmtas/
Food and Drug Administration. (2025c). Modified risk tobacco products. https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products
Food and Drug Administration. (2026, January 12). FDA authorizes 6 nicotine pouch products, completing review in record time [Press release]. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-6-nicotine-pouch-products-completing-review-record-time
Food and Drug Law Institute (FDLI). (2023). FDA review of new tobacco products: A public health narrative. https://www.fdli.org/2023/08/fda-review-of-new-tobacco-products-a-public-health-narrative/
Goniewicz, M. L., et al. (2025). The effects of oral nicotine pouches on cigarette smoking behavior. PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC12377922/
Hartmann-Boyce, J., et al. (2025). Oral nicotine pouches for cessation or reduction of use of other tobacco or nicotine products. Cochrane Database of Systematic Reviews, CD016220. https://pmc.ncbi.nlm.nih.gov/articles/PMC12549188/
JJCC Group. (2026, February 5). PMTA submission pricing: Understanding the true cost. https://jjccgroup.org/pmta-submission-pricing-guide/
Leonard Davis Institute (LDI), University of Pennsylvania. (2025, April 23). FDA needs to reboot rules for less harmful tobacco alternatives. https://ldi.upenn.edu/our-work/research-updates/fda-needs-to-reboot-rules-for-less-harmful-tobacco-alternatives-after-bidens-del
Maciosek, M. V., et al. (2022). The cost-effectiveness of nicotine replacement therapy sampling programs. PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC9585132/
Mallock, N., et al. (2019). Levels of selected analytes in the emissions of “heat not burn” tobacco products relevant to human health risk assessment. Archives of Toxicology, 93, 2145–2149.
Masiero, G., et al. (2025). Cost-effectiveness analysis of e-cigarettes compared to nicotine replacement therapy. Nicotine & Tobacco Research. https://academic.oup.com/ntr/article-abstract/27/3/466/7756831
SGS Group. (2025, March 13). UAE mandates ECAS certification for tobacco-free nicotine pouches. https://www.sgs.com/en-sa/news/2025/03/uae-mandates-ecas-certification-for-tobacco-free-nicotine-pouches
Snusforumet. (2021, June 27). New study: Nicotine pouches have 99% lower toxicity than cigarettes. https://snusforumet.se/en/new-study-nicotine-pouches-have-99-lower-toxicity-than-cigarettes/
World Health Organization. (2023). Tobacco. https://www.who.int/news-room/fact-sheets/detail/tobacco
Xu, X., Bishop, E. E., Kennedy, S. M., Simpson, S. A., & Pechacek, T. F. (2015). Annual healthcare spending attributable to cigarette smoking: An update. American Journal of Preventive Medicine, 48(3), 326–333. https://pmc.ncbi.nlm.nih.gov/articles/PMC4603661/
