Staying the Course Amid PMTA Pilot Developments

We wanted to provide clarity regarding FDA’s recently announced nicotine pouch pilot program. While the headlines may suggest a shift in requirements, here are a few important considerations:

• Unless you are in the pilot, nothing has changed yet. Only four companies were selected, and we are not expecting to know the results of the pilot until the new year.  

  
  

• No clarity over the details. If and when new "recommendations” emerge, no one knows what the details of these will be, likely not even CTP. There is no assurance that any relaxed standards will extend to your application, as there are so many variables to be considered – some of which we outline below. 

  
  

• Risk of delay. The FDA’s announcement has caused much excitement in the Nicotine Pouch space and ARAC anticipates that it will engender more PMTA applications. That would offset, to some extent, any increased reviewing capacity FDA gains as a result of ‘fast-tracking’ the selected applications from these 4 companies. Furthermore, if there is an increase in applications, not everyone in the queue will fare similarly. We know from the press release regarding the MDO of Blu that FDA considers historical authorizations when adjudicating the outcome of an application. Thus, the benchmark for authorization may increase over time, as applicants at the back of the line need to demonstrate superiority over authorized earlier movers. In any scenario, a “wait-and-see” approach will jeopardize timelines, sales, and market share. Ironically, those who wait, hoping for an expanded “fast-track” to all nicotine pouch products, may in fact be beaten to the market by those submitting now with the same level of scientific evidence as what we confidently believe is contained within the pilot program applications. 

  
  

• No certainty of change. If FDA later concludes – as we believe they will, based on our knowledge of the pilot program companies’ past applications – that candidate product use and/or “switching” studies were included, CTP may well conclude that other applicants in the sub-category should continue to do likewise. If not, there will likely be legal implications which could further delay changes to evidentiary standards. 

  
  

• No free rides. If, after the pilot ends, and the FDA decides to push some of the data regarding population-level effects into post-market surveillance systems, that too is a substantial undertaking. Are you ready to deliver real-time updates to CTP related to adverse events, product issues, youth uptake, and user profiles? If not, we’re ready to build and manage this system for you.  

  
  

• Product type matters. This pilot focuses narrowly on nicotine pouches and does not apply to other product categories.   

  
  

• The type of nicotine pouch product matters. Any candidate product that deviates from the FDA’s “archetype” that is the focus of the pilot program, whether in nicotine strength, flavors, and pouch type (dry vs. wet) - will likely still be required to produce and submit a robust scientific application, including data on product use/CPD reduction or switching data. 

  
  

• Bottom line: While ARAC is closely tracking these developments, we advise clients to stay the course. Waiting comes with higher costs — lost sales, lost market share, and potentially a higher bar for authorization, particularly if nicotine pouch products flood the market quickly leading to a price-war.

We remain available to strategize with you about the best path forward. Click here to CONNECT with ARAC.