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Key Points
- CSUR, the research institute that supported Juul and NJOY’s successful PMTA applications, analyzes the FDA’s pilot program streamlining nicotine pouch review.
- The FDA’s pilot excludes behavioral data at the premarket stage, focusing on product characteristics, consistency, stability, and abuse liability.
- CSUR underscores that companies receiving a Marketing Granted Order (MGO) must still collect and submit behavioral and real-world evidence under Section 910(f) of the FD&C Act to demonstrate continued public-health appropriateness.
Nicotine Pouch Premarket Tobacco Product Application (PMTA) pathway in the United States – A new way forward?
Andrea Patton PhD, Gabriel Barnard BA, Neil McKeganey PhD
The premarket tobacco product application (PMTA) pathway to legally authorize a new tobacco product for sale in the United States (US) has often been subject to criticism for the length of time the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has taken to review applications and the limited number of new tobacco products that have received a marketing granted order. Of the 26 million applications submitted, 1.1 million were accepted for scientific review and of these, 81 (1 in 14,000 reviewed) new tobacco products have received a marketing granted order (MGO). As an applicant you have a greater chance of being struck by lightening over the course of your lifetime (1 in 10,000)1 than your new tobacco product receiving authorization to be sold within the US. With approximately 28 million adults in the US continuing to smoke combustible cigarettes, the PMTA process needs to change to enable legal access to a wider range of less harmful alternatives that can help these adults completely switch away from or reduce their combustible cigarette consumption than currently exists.
Last month, the Trump Administration took some steps in the right direction by launching a pilot scheme to expedite the scientific review of four nicotine pouch brands. While this pilot scheme may present a faster route to legally market nicotine pouches in the US, CTP’s acting director Bret Koplow said the statutory legal public health standard outlined in Section 910(c)(2)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act remained - the candidate product must be deemed “appropriate for the protection of the public health” (APPH). Reviewers of Philip Morris International’s Zyn Ultra, Altria’s on! and on! Plus, Reynolds’ Velo mini, and Turing Point Brand’s Fre and ALP nicotine pouches will focus on the information considered essential to begin scientific review: core product characterization, manufacturing consistency and stability, and abuse-liability data. However, this list of core evidence to initiate scientific review contains one notable difference – no behavioral data. At present, behavioral data is required in a PMTA so FDA can understand how many adults who smoke intend to use the product, and whether use of the product will assist in completely quitting or substantially (>50%) reducing daily combustible cigarette consumption. Behavioral data is also required to understand how many unintended users i.e. youth, and adults who have formerly or never smoked are using the product or intend to use the product if authorized for sale. So, why would a streamlined premarket review process for nicotine pouches exclude behavioral data?
Youth use of the nicotine pouch product category is low – 1.8% (equivalent to 480,000) of US middle and high school students (“youth”) reported using a nicotine pouch on at least one of the past 30 days in 2024, and this was not statistically significantly higher compared to current use among youth in 2023.2 So, coupled with low current use among youth, if a nicotine pouch applicant can demonstrate that the consumer is not exposed to high levels of harmful or potentially harmful chemicals, the product does not represent a higher abuse liability compared to combustible cigarettes, and the product is manufactured according to appropriate industry standards then FDA could conclude that the risk of the product is suitably low to grant authorization. The product’s effectiveness or benefit in helping adults who smoke combustible cigarettes stop or transition away combustible cigarette use could then be tested in a real-world environment. Real-world data would provide insights into how well the candidate nicotine pouch products perform across diverse populations as they are used in the everyday lives of adults who smoke.
Submitting these essential behavioral data post marketing authorization would align with the current post market surveillance requirement under Section 910(f) of the FD&C Act. Once authorization for a nicotine pouch is granted, annual post market surveillance reports are required to be submitted to FDA, beginning 12 months from the date of the marketing granted order, to help FDA determine if the marketing of the new tobacco product continues to be APPH or whether there are any grounds to withdraw or suspend the order. Since post market reporting is a stipulation of marketing authorization, continued annual surveillance of the unintended (e.g. youth) and intended (adults who smoke) user populations would generate the evidence required to allow FDA to determine if an authorized new tobacco product remains APPH. If youth use of the nicotine pouch product category were to increase, and/or the product was being used by adults who smoke to increase rather than reduce their nicotine consumption then FDA could revisit the decision as to whether the authorized nicotine pouches remained APPH.
With impetus from the Trump administration to speed up the PMTA scientific review process in which FDA could meet the 180-day review target, we could see more nicotine pouch products authorized for legal sale which is good news for adults who smoke combustible cigarettes. For applicants, the clock starts ticking for the first annual post market surveillance report as soon as marketing authorization is received. CSUR recommends consulting with our scientific research leads to find out how our behavioral research can support your regulatory obligations.
References
- Jensen JD, Thurman J, Vincent AL. Lightning Injuries. StatPearls. StatPearls Publishing Copyright © 2025, StatPearls Publishing LLC.; 2025.
- Jamal A, Park-Lee E, Birdsey J. Tobacco Product Use Among Midde and Hifh School Students - National Youth Tobacco Survey, United States, 2024. Morbidity and Mortality Weekly Reports. 2024;73(41):917-924.
About the Centre for Substance Use Research (CSUR)
CSUR is a globally renowned tobacco harm reduction and regulatory science organization. CSUR designs and conducts studies supporting PMTAs and MRTPAs, including much of the pivotal perception and behavioral research underpinning JUUL and NJOY’s applications, currently the only non-tobacco flavored ENDS products authorized for US marketing.
The above information was provided by CSUR.
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