The evolving PMTA landscape for nicotine pouches
The recent FDA authorisation of on! PLUS nicotine pouches is a significant moment in helping meet tobacco harm reduction (THR) goals. They are the first products to pass a new, faster FDA programme, signifying a streamlined path to market for modern oral nicotine products. Here Chris Allen, CEO of Broughton, shares his key takeaways from the on! PLUS technical project lead (TPL) review and explains why it is an encouraging moment for THR.
The on! PLUS nicotine pouch authorisation by the FDA is a sign of things to come, with more authorisations likely to happen soon across the sector as its streamlined review process gets into full swing.
This marks a shift in approach where there will now be increased focus on enforcement and the rejection of frivolous applications. This facilitates a market environment that rewards responsible companies that are serious about creating high-quality products for the benefit of combustible and traditional oral tobacco product users.
After reviewing the FDA TPL review summary for the on! PLUS PMTAs, several important takeaways that signify the evolving PMTA landscape became clear.
Streamlined review process
One of the most striking aspects of the on! PLUS review was the timeframe it was completed in, and that it seemingly only proceeded through one substantive review cycle. This is a stark contrast to traditional PMTAs that span multiple years and review rounds.
In this case, the evaluation was completed efficiently and supported by frequent interaction between FDA and the applicant. The structure of the review suggests that issues were addressed more dynamically and proactively than the previous norm, with any issues addressed as and when they arose instead of deferring them to subsequent cycles. Ultimately, this enabled a much faster review outcome.
While the TPL review summary does not detail individual amendments, the number of rapid amendments strongly indicates ongoing scientific dialogue throughout the review. Rather than a formal back-and-forth through multiple deficiency letters, this approach reflects continuous engagement and is a clear example of how frequent communication can reduce review cycles without compromising scientific scrutiny.
Datasets and analysis
The on! PLUS TPL review relied heavily on data generated on the actual products under review. Manufacturing consistency, stability, and harmful and potentially harmful constituent levels were assessed at the product level rather than relying solely on category wide arguments. This highlights the importance of generating high quality, product-specific analytical datasets as part of successful PMTA submissions.
Notably, the FDA accepted a clinical bridging approach rather than requiring complete clinical datasets for every individual variant. Where products shared similar formulation and nicotine characteristics, data from representative products were used to support conclusions across the range. This highlights the value of a focused and well justified clinical strategy that aligns with FDA expectations around similarity.
However, while water activity data was accepted as a strong indicator of microbial stability, the microbial methods themselves were not fully validated for tobacco products. Although this did not prevent market authorisation for on! PLUS, it reinforces the importance of using adequately validated methods, particularly for microbiology, to avoid unnecessary risk in future PMTA submissions.
Assessing abuse liability
In the case of on! PLUS, abuse liability was assessed relative to moist smokeless tobacco. This comparator reflects a realistic consumer context and allowed the FDA to conclude that the products were likely to have lower abuse liability than an appropriate existing tobacco product category.
Furthermore, previous theories that the FDA may only be amenable to a maximum strength of 6 mg/pouch have now been proved wrong, with the on! PLUS authorisations for both the 6 and 9 mg strengths. This indicates that the FDA will not make direct assessments on label claims, but the scientific substantiation of appropriately designed products.
Stability data underpins multiple conclusions
The TPL review makes clear that stability data is central to demonstrating product quality over the proposed shelf life. The FDA relied on stability studies to confirm that key attributes, such as nicotine content, pH, moisture related parameters and chemical constituents, stayed in acceptable ranges over time. This supported the conclusion that the marketed product would remain consistent with the product evaluated during review.
The key message is that stability data is not supplemental material. It is critical to FDA confidence in product consistency and shelf life, and insufficient stability data would be likely to generate additional review questions or delay authorisation.
Child-resistant packaging
Although child-resistant packaging is not a statutory requirement, it was clearly a crucial element of the Appropriate for the Protection of Public Health (APPH) assessment. The FDA interprets APPH to mean that the marketing of a new product must have a net benefit to public health, weighing the risks and benefits to the wider population beyond just users of the product, so it is easy to see why child-resistant packaging would be greeted positively.
The TPL review highlights how certified child-resistant packaging helped mitigate the risk of accidental nicotine exposure in young children. This suggests that, while not mandated by law, child-resistant packaging is increasingly expected when making a credible public health argument and, therefore, should be built into submissions where reasonably possible.
It is clear from the on! PLUS TPL review that this is a significant milestone in the shared goal of THR, as the FDA’s new approach will make it more straightforward to bring products that benefit public health to market.
Author
Chris Allen, CEO of Broughton
Disclaimer: This article reflects the author’s analysis and is provided for informational purposes only; it does not constitute medical, legal, or official editorial advice from Life Science Daily News. The author is CEO of Broughton, a regulatory consultancy specialising in PMTA submissions.
Editor’s note: Tobacco harm reduction remains a contested area of public health policy. While regulatory authorisation of reduced-risk nicotine products is supported by some health bodies, others raise concerns about the long-term health effects of nicotine pouches and their potential appeal to non-smokers and young people.
