FDA Deploys AI and Slashes PMTA Review Times for Tobacco Products
On May 7, 2026, the U.S. Food and Drug Administration (FDA) announced a massive operational overhaul, integrating advanced artificial intelligence and unified data platforms to accelerate regulatory science. This technological leap coincides with a major update from the Center for Tobacco Products (CTP), which confirmed that new efficiencies have already drastically reduced premarket tobacco product application (PMTA) review times.
To streamline workflows for scientific reviewers and investigators, the FDA launched Elsa 4.0, a significant upgrade to its internal AI system. Simultaneously, the agency introduced HALO (Harmonized AI & Lifecycle Operations for Data), a unified platform that consolidates over 40 disparate application and submission portals across all FDA centers.
According to Chief AI Officer Jeremy Walsh, this integration fundamentally shifts how FDA staff interact with data. “Previously, FDA staff would bring data to Elsa. Now, Elsa sits on top of our data,” Walsh stated, emphasizing that this will help deliver meaningful treatments and regulatory decisions faster.
Operating within a highly secure Google Cloud Platform environment, Elsa 4.0 does not train on input data or industry submissions. Its newly expanded capabilities include:
- Custom AI agents and document generation.
- Quantitative data analysis and chart creation.
- Secure web search and optimized querying in large document repositories.
- Voice-to-text dictation and OCR conversion for scanned images.
These agency-wide technological improvements mirror the aggressive efficiency measures being implemented within the CTP. Acting Director Bret Koplow reported that the center is successfully applying lessons learned from evaluating nearly 27 million tobacco products over the past five years.
- Read more: List of FDA Authorized E-Cigarette Vapes
In 2025, the CTP reduced its application backlog by approximately 70%. Koplow highlighted several critical milestones in the PMTA process:
- Zero Acceptance Queue:Â For the first time in years, newly received PMTAs immediately enter the first phase of review, eliminating months of waiting for applicants.
- Accelerated Filing Reviews:Â New efficiencies have been adopted for the second phase of review, particularly for electronic nicotine delivery systems (ENDS) and nicotine pouches.
- Streamlined Scientific Decisions:Â The CTP is now separating products within a single submission. If certain products qualify for marketing granted orders (MGOs) while others need more data, the approved products are authorized immediately rather than waiting for the entire batch.
- Supplemental PMTA (sPMTA) Pilot:Â A new process will expedite reviews for minor modifications to already-authorized products, such as basic electronic technology improvements.
The most striking evidence of this accelerated timeline is the CTP’s innovative nicotine pouch pilot program, launched in September 2025. By December, the agency had issued authorizations for six new nicotine pouch products—a record three-month turnaround for a PMTA scientific review.
This speed was achieved through real-time communication, allowing applicants to compile and submit missing information while the scientific review was actively underway. Because of its massive success, the CTP will not add more products to the pilot, but will instead apply these real-time communication protocols to all future nicotine pouch PMTAs.
The FDA notes that thorough submissions are still required, and the back-and-forth process remains necessary. Any newly authorized products resulting from these expedited reviews will be continually updated on the FDA’s authorized nicotine pouches registry.
- Reference:
FDA Expands AI Capabilities and Completes Data Platform Consolidation
CTP Acting Director Statement: New Steps Forward in Accelerating Innovation and Efficiency in Product Review
