Opinion: STAT+: A surprising bright spot at the FDA on regulating unproven stem cells

Back in June 2025, Robert F. Kennedy Jr., then just months into his tenure as health secretary, revealed on a podcast that he had received unproven stem cell treatments in the Caribbean to treat his throat condition. At the time, I worried that it signaled clinics selling questionable stem cell treatments in the U.S. would escape Food and Drug Administration scrutiny moving forward.

Much to my surprise, the FDA has done well so far during Trump 2.0 on two big fronts related to the problem of unproven stem cell clinics. In a time of ideologically and politically driven decision-making in medical regulations, the FDA’s recent science-based successes here are all the more surprising, worth discussing, and even celebrating a bit.

The U.S. has a major problem with stem cell clinics and related firms selling a variety of unproven and non-FDA-approved cellular products. The best estimate, drawn from a paper counting clinics a few years ago, is that there are more than 2,000 such firms across the country.

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