FDA panel meets Wednesday to vote on access to seven unproven peptides

The Food and Drug Administration's Pharmacy Compounding Advisory Committee will convene on July 23–24 to vote on whether seven popular but unapproved peptides should be added to the Section 503A Bulk Drug Substances List, a move that would allow licensed compounding pharmacies to legally manufacture and dispense them with a prescription. The meeting arrives amid a clash between FDA career scientists who recommend against inclusion and a reconstituted panel whose members have drawn scrutiny for potential conflicts of interest.

The Stakes

The seven peptides under review — BPC-157, TB-500, KPV, MOTS-C, Emideltide, Semax, and Epitalon — are widely used in wellness and longevity circles but have never been approved as drugs by the FDA. The agency placed them and 12 others on a restricted Category 2 list in 2023, effectively barring compounding pharmacies from producing them. Health and Human Services Secretary Robert F. Kennedy Jr., who has called himself a "big fan" of the substances, pushed to reverse that decision, and in April the FDA removed 12 peptides from Category 2 and scheduled the current PCAC review.FDA Law Blog+3

In briefing documents released June 29, FDA staff scientists recommended against adding any of the seven peptides to the compounding list, citing insufficient human clinical trial data. For TB-500 and KPV, reviewers said they could find no published studies in which the substances had been tested in humans at all. For BPC-157 — promoted by Kennedy and podcaster Joe Rogan — scientists found the evidence too sparse to evaluate its proposed uses for tendinitis, Crohn's disease, or celiac disease.Velox Peptides+3

Panel Composition Under Fire

The committee's makeup has become a flashpoint. On June 29, the FDA updated its roster of advisors, adding nine new members — almost all of whom personally promote peptide use or have financial ties to clinics offering the treatments, according to reporting by the Associated Press and Ars Technica. The additions brought the total panel to 13 voting members, giving the new appointees enough votes to determine the outcome. STAT News ↘ 2.50% reported that several new advisors could financially benefit from a favorable recommendation. The Washington Post reported the FDA had internally raised conflict-of-interest concerns about the panel's composition.The Washington Post+3

What Comes Next

The public comment docket, FDA-2025-N-6895, closes today, July 22. Comments received by the earlier July 9 deadline were forwarded directly to committee members. The PCAC's vote is advisory and non-binding — even a favorable recommendation would not immediately restore compounding access. Formal notice-and-comment rulemaking would still be required, a process that under standard timelines can take more than a year. Reuters reported the meeting as part of a broader FDA effort to reconsider restrictions on the peptides at Kennedy's urging.OpenLoop Health, Inc.+5

The meeting will be webcast from FDA's White Oak Campus in Silver Spring, Maryland, with Day 1 covering BPC-157, KPV, TB-500, and MOTS-C, and Day 2 addressing Emideltide, Semax, and Epitalon.U.S. Food and Drug Administration+1