The FDA’s recent rollout of its AI assistant, Elsa, has made headlines—but not for the right reasons. Instead of revolutionizing how the agency processes information, Elsa has been criticized as rushed, inaccurate, and overpromised. Staffers told reporters that it frequently gave wrong or incomplete summaries, wasn’t ready for scientific use, and lacked basic safeguards. Built on Anthropic’s Claude model and developed by Deloitte for tens of millions of dollars, Elsa was supposed to streamline the agency’s work. Instead, it’s become a warning sign.
For small businesses watching from the sidelines, this high-profile stumble offers some valuable lessons.
First, it’s clear that AI is not a magic fix. No matter how much money or hype is behind it, AI won’t replace people—or processes—without a thoughtful, grounded strategy. The FDA’s experience shows that skipping steps, like proper testing and defining clear policies, can quickly backfire. And while it’s easy to get caught up in big promises about automation and cost savings, the reality is that success comes from small, practical improvements that actually fit how your business works.
At the same time, the fact that a massive government agency struggled doesn’t mean AI is out of reach for smaller organizations. In many ways, it’s the opposite. Small businesses have the advantage of being able to test and adapt quickly. You don’t need a multimillion-dollar budget to make an impact—just the right solution for the right job.
The key is starting with something focused and useful. Maybe that’s an AI voice assistant that handles missed calls. Maybe it’s a chatbot that responds to common customer questions. When used thoughtfully, AI can be an extra set of hands—one that works 24/7 and doesn’t need time off. But it has to be the right fit, and it has to be set up for success.
The FDA’s troubles with Elsa don’t mean AI is broken. They just remind us that technology, no matter how advanced, still depends on smart human decisions. And that’s something small businesses can get right—without the red tape.
Curious what the right AI solution could look like for your business?
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