The U.S. Food and Drug Administration has entered the AI era with the launch of Elsa, an internal artificial intelligence system designed to modernize how the agency oversees food safety and drug regulation.
Deployed ahead of schedule in June 2025, Elsa is a large language model-powered tool that operates within a high-security GovCloud environment. The system assists FDA employees—from scientific reviewers to field investigators—by summarizing adverse event reports, comparing product labels, and identifying high-priority inspection targets.
"Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30," said FDA Commissioner Marty Makary. "Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers."
For food safety, Elsa's impact could be particularly significant. Food recalls currently take several weeks to be officially classified and communicated to the public—in some cases, three to five weeks or longer. By helping FDA staff scan safety reports and identify high-risk trends more quickly, Elsa may substantially shorten this timeline, improving how and when consumers are notified about contamination events.
Importantly, the AI models do not train on data submitted by regulated industries, safeguarding sensitive research and proprietary information. The tool is designed to augment, not replace, human experts; reviewers remain responsible for directing the AI assistant and verifying its outputs.
Elsa's deployment comes at a time of rising consumer interest in AI's role in food production. A December 2024 survey found that 83% of consumers want companies to disclose when AI is used in food development or production. While Elsa itself isn't involved in food product development or label writing, it represents a significant shift in how food safety decisions are made behind the scenes.
"The introduction of Elsa is the initial step in the FDA's overall AI journey," the agency stated. "As the tool matures, the agency has plans to integrate more AI in different processes to further support the FDA's mission."