The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities to all agency employees, a move expected to streamline complex, multi-step regulatory tasks — including pre-market reviews, post-market surveillance, inspections, and compliance activities that would be of interest to those in the tobacco and nicotine industries.
The new systems allow staff to build multi-model AI workflows capable of planning, reasoning, and executing tasks under human oversight. The tools are optional and operate within a secure GovCloud environment, with no training on industry-submitted data.
In an email to StatNews, an FDA spokesperson called the tool “exploratory” and said that the AI agents do not make regulatory decisions. “All outputs from AI are reviewed and validated” by FDA staff “before being incorporated into any official regulatory action, ensuring that the AI remains a support tool rather than a decision maker,” he wrote.
The deployment follows the success of Elsa, an internal LLM tool launched in May and now used by more than 70% of FDA personnel. The agency is also launching a two-month Agentic AI Challenge, with selected projects to be showcased in January 2026.
FDA Commissioner Marty Makary said the upgrades mark a major step in modernizing regulatory operations, while Chief AI Officer Jeremy Walsh highlighted the potential to accelerate and validate safety assessments across all FDA-regulated sectors — including tobacco.
