Could clarity for US ENDS companies be imminent?

The latest statement from FDA Commissioner, Scott Gottlieb, outlines the agency’s actions to ensure sound regulation of tobacco products, and an effective application review process that considers the impact on public health. Within this, intended developments of the Premarket Tobacco Product Application (PMTA) pathway are suggested. 

What does the latest FDA communication say about PMTAs?

FDA say that they are ‘committed to issuing foundational rules that make the science-based regulatory review process more efficient, predictable and transparent for manufacturers, while upholding the agency’s public health mission’.

The majority of the latest statement refers to the Substantial Equivalence (SE) route, currently inappropriate for ENDS products. However, closing paragraphs refer to PMTAs and requirements for ENDS companies. Here’s what they say they ‘intend’ to do:

• Issue regulations outlining the information they expect to be included in PMTAs
• Explore product standards for ENDS
• Propose rulemaking requiring manufacturers to establish tobacco product manufacturing practices
• Finalize guidance on how they intend to review PMTAs for ENDS

What’s the timeline for these new developments?

You’ll need to read between the lines to answer this one. Words such as ‘explore’ and ‘propose’ suggest some areas are still work in progress. Proposed rulemaking in relation to manufacturing practices, in particular, comes as no surprise to our team. We believe that Chemistry, Manufacturing and Controls (CMC) type information – an important element of marketing applications in the pharmaceutical sector, is likely to be a critical to any successful PMTA submission. Hence this needs to be considered in the early stages.

As for clarity for ENDS companies, the FDA’s intention to ‘finalize’ guidance on how they will review PMTAs sounds positive. There’s certainly been a flurry of FDA announcements lately and it seems their comprehensive plan to tackle the leading cause of preventable death has gained some momentum.   

Ready to develop & deliver your PMTA strategy

Broughton offer an integrated team of scientific and regulatory experts to deliver your PMTA submission, managing and generating the data you require for all workstreams. We understand your project is not generic, so neither is our approach. We’ll develop a scientific strategy aligned with the specific requirements of your products and your business. Book a meeting with us today to discuss how you can get started.