The FDA Is Now Using Agentic AI for Safety Reviews

The FDA ensured us that the technology has "built-in guidelines — including human oversight — to ensure reliable

Key Takeaways

  • The Food and Drug Administration (FDA) has announced that it is expanding use of artificial intelligence to include agentic AI capabilities.
  • The agentic AI will be used to “help them ensure the safety and efficacy of regulated products.”
  • The government agency deployed an AI model for employees in May, which is now used by 70% of staffers.

Government oversight, thy name is AI. The Food and Drug Administration (FDA) in the US has announced that it is substantially expanding use of artificial intelligence by adding agentic AI to the review and inspection process.

It’s no secret that AI is being not-so-slowly injected into every aspect of life in 2025, and government agencies have been surprisingly quick to get on board.

However, given the technology’s persistent inclination towards errors and hallucinations, many experts are a bit concerned about having AI involved in keeping food and drug approvals safe.

FDA Announced Use of Agentic AI

In an announcement on Monday, the US Food and Drug Administration (FDA) revealed that it is now providing staff members with access to agentic AI capabilities to assist in the safety review and inspection process.

“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators. There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.” – Marty Makary, FDA Commissioner

This not the first instance of the FDA announcing its use of AI. In fact, the agency launched an AI model for employees in May, dubbed Elsa, which is now reportedly used by 70% of staffers.

What Will Agentic AI Do at the FDA?

According to the announcement from the FDA, the technology will be used “to streamline their work and help them ensure the safety and efficacy of regulated products.”

The agency is so enthused about getting the technology integrated into the safety and inspection process that it is launching a two-month challenge encouraging employees to create AI models and present them at an event in January.

 

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Don’t worry, though. The FDA also ensures us that the technology will have “built-in guidelines — including human oversight — to ensure reliable outcomes.”

AI Errors and Hallucinations

Using AI for some business operations, like streamlining sales or fast-tracking customer support interactions, is fine. But when it comes to things like food safety, people are understandably a bit trepidatious.

That’s because the technology is nothing if not prone to errors. Since launching in 2022, AI models like ChatGPT have been defined by their hallucinations, citing fake sources, providing incorrect answers, and generally getting it wrong when it matters most.

Even worse, the companies powering these AI models are far from concerned about the negative impacts of the technology. In fact, a recent study found that nearly every company working on a major AI platform is missing the mark on safety.

All that to say, AI hasn’t proven that it can get the job done without creating more work for human employees checking its every output. Until it does, we need to be very skeptical of using it for things like food and drug safety inspections.

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Written by:
Conor is the Lead Writer for Tech.co. For the last eight years, he’s covered everything from tech news and product reviews to digital marketing trends and business tech innovations. He's a feature, reviews, and news contributor for Android Police, and he has hosted tech-focused events for SXSW, Tech in Motion, and General Assembly, to name a few. He also cannot pronounce the word "colloquially" correctly. You can email Conor at conor@tech.co.
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