FDA Panel Narrowly Endorses Four Unproven Peptides for Compounding

Following an emotionally charged, 11-hour meeting on Thursday, a Food and Drug Administration advisory panel voted 8–6 (with one abstention) to recommend adding three peptides—BPC-157, KPV, and TB-500—to the agency's bulks list, which would permit compounding pharmacies to create custom medications with them. A fourth peptide, MOTs-C, received a 7–5 vote with two abstentions. The panel is scheduled to consider three more peptides on Friday.

Peptide therapies have surged in popularity thanks to endorsements from podcasters like Joe Rogan, wellness influencers, and Health and Human Services Secretary Robert F. Kennedy Jr., who has called himself a "big fan." Marketed as smaller versions of proteins, peptides are touted for skin rejuvenation, hair growth, gut health, and injury recovery, despite a lack of robust scientific evidence.

Currently, many peptides exist in an unregulated gray market after the Biden administration banned compounding pharmacies from producing 20 peptides in 2023 due to safety concerns. They are legally sold online for "research use only" and "not for human consumption," but marketing often implies otherwise. China and India are major suppliers, with some former fentanyl labs switching to peptide production.

FDA scientists had recommended against allowing compounding of any of the seven peptides under consideration, citing insufficient safety and efficacy data. However, proponents—including Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers—argued that legal access would provide patients with safer, prescription-based options. "I'm not going to tell you that the evidence for BPC-157 is strong. It isn't," Vinjamoori said, but added that the lack of evidence should not be equated with nonexistence.

Critics warned that FDA approval could create false perceptions of safety. John Hertig of the Collaborative for Evidence-Based Medicines argued that allowing compounding would send a confusing message that the FDA endorses these peptides. Adriane Fugh-Berman, a Georgetown University physician, questioned whether the government would legalize heroin just because the street product is impure. "Just because the market is large doesn’t mean it should be legalized," she said.

Committee members who voted against the move, like anesthesiologist Elizabeth Rebello of the University of Texas MD Anderson Cancer Center, cited unknowns about safety and potential public confusion. "I'm just concerned that we're entering a Pandora's box here," she said.

The panel's recommendations are non-binding. A final FDA decision is expected in several months.