Career scientists at the U.S. Food and Drug Administration have flagged safety concerns and a lack of solid evidence for a set of popular peptide therapies, even as Health Secretary Robert F. Kennedy Jr. presses to loosen restrictions on them, according to NPR, which cited agency documents.
The peptides — including BPC-157, TB-500 and MOTS-c — have grown popular among influencers and some clinicians, who promote them for uses such as wound healing, obesity, ulcerative colitis and migraines. In their review, FDA scientists wrote that there is insufficient evidence to support changing the regulatory status of any of the seven peptides under consideration, NPR reported.
How peptides moved to an unregulated market
The Biden administration restricted these and other peptides in 2023, placing them in a category that effectively bars compounding pharmacies from making them. Since then, NPR reported, users have increasingly turned to an unregulated market, sometimes buying products from suppliers overseas.
Leadership and scientists diverge
The episode places Kennedy's position at odds with the conclusions of the FDA's own career reviewers. Kennedy has signaled support for easing access to peptides; the reviewers, who report to him, reached the opposite conclusion in their assessment of the evidence.
An advisory panel is scheduled to review the seven peptides over two days, on July 23 and 24. NPR reported that the panel includes members with ties to the peptide industry, among them people who work for companies that sell injectable peptides.
What to watch
The panel's recommendations, and how the FDA weighs them against its scientists' caution, will indicate whether the products become easier to obtain legally. It is not yet clear how the agency will reconcile its reviewers' findings with the political push to expand access.