The Role of AI and Technology in Accelerating PMTA Reviews

As the U.S. Food and Drug Administration (FDA) seeks to modernise its regulatory processes, technology is emerging as a cornerstone of its strategy, particularly in addressing the long-standing challenges of the premarket tobacco product application (PMTA) pathway. For companies operating in the reduced-risk nicotine space, these technological developments may represent a much-needed turning point.

From Bottleneck to Opportunity

For years, the PMTA process has been criticised for its complexity, lack of transparency, and prolonged timelines. While robust scientific evaluation remains essential, the backlog of pending applications has delayed access to potentially safer nicotine products for adult consumers. The challenge for the FDA has been how to uphold scientific rigour while improving the efficiency of its reviews.

The answer, increasingly, lies in technology.

Introducing ELSA: AI for Application Reviews

Earlier this year, the FDA launched ELSA, its new Enterprise-Level Submission Analysis tool. This artificial intelligence platform is now being deployed across multiple FDA Centres to accelerate the review of high-volume, data-intensive applications.

For nicotine products, ELSA offers promising potential. By using machine learning to identify key data points, flag inconsistencies, and map applications against regulatory benchmarks, the process can be significantly streamlined, reducing the manual burden on reviewers. This is particularly important in PMTA reviews, where datasets are large and vary considerably by product type.

Although the tool is still being adapted for use within the Center for Tobacco Products (CTP), its deployment elsewhere in the agency signals a broader commitment to digital transformation. In a post-RIF environment where staffing has been significantly reduced, leveraging AI becomes not just beneficial but necessary.

National Priority Vouchers: Accelerating What Matters Most

Alongside its AI initiatives, the FDA recently introduced the National Priority Voucher programme. This initiative aims to prioritise and expedite reviews of products that could have the greatest public health impact, whether due to their innovation, population-level potential, or relevance to pressing regulatory gaps.

While originally developed in the pharmaceutical context, this model offers a blueprint for how CTP could manage its review queue more strategically. By identifying high-priority PMTAs, such as those involving switching studies or demonstrating meaningful harm reduction, the agency can allocate resources more efficiently while still protecting public health.

What This Means for Nicotine Product Manufacturers

Together, these innovations mark a shift in how the FDA approaches tobacco product reviews. For the reduced-risk nicotine industry, they represent an opportunity to engage with a more responsive and modernised regulatory system.

However, manufacturers must be prepared. A streamlined process still demands high-quality submissions. Clear, well-structured data; validated methods; and a thorough understanding of what the FDA expects will remain essential.

Those who invest in regulatory readiness and track the agency’s evolving digital tools will be best positioned to benefit from these changes.

Looking Ahead

As the second half of 2025 unfolds, the integration of AI and smart prioritisation strategies could help the FDA turn a corner. These tools have the potential to bring much-needed predictability and speed to PMTA reviews, enabling faster access to lower-risk alternatives for adult smokers and greater stability in the marketplace.

Technology will not replace scientific judgement, but it can empower it. And that may be the most important development in tobacco regulation this year.

For more information on how Broughton can support your PMTA submission, arrange a meeting with our regulatory expert here.