FDA Panel Narrowly Backs Unapproved Peptide Drug BPC-157 in Landmark Vote

WASHINGTON (AP) — A federal advisory panel voted Thursday to recommend broadening access to BPC-157, an unapproved peptide injection that has gained a massive following among wellness influencers, athletes, and public figures including Health Secretary Robert F. Kennedy Jr. and podcaster Joe Rogan. The 8-6 vote by the FDA’s Pharmacy Compounding Advisory Committee marked a significant departure from previous FDA positions and reflected the influence of a reconstituted panel stacked with members who have financial ties to the peptide industry.

Context: The Rise of Unregulated Peptides

Peptides are short chains of amino acids that serve as the building blocks of proteins, triggering hormones inside the body needed for growth, metabolism, and healing. While the FDA has approved several peptides as medications — including insulin for diabetics and GLP-1 drugs like Ozempic — the substances under review this week have never undergone the agency’s standard drug approval process.

Instead, they have circulated for years in a thriving gray market, sold online as “research chemicals” to evade FDA oversight. Social media platforms are brimming with testimonials from people claiming the injections helped them build muscle, recover from injuries, or look younger. Joe Rogan has publicly praised BPC-157 for treating his elbow tendonitis, telling his podcast audience: “I had tendonitis in my elbow, I started using BPC-157 and it was gone in two weeks.”

The Vote and the Panel’s Unusual Makeup

The two-day meeting, held at the FDA’s White Oak Campus in Silver Spring, Maryland, is reviewing seven peptides for potential inclusion on the Section 503A Bulk Drug Substances List — a designation that would allow specialty pharmacies to legally produce and distribute their own formulations. On Thursday, the panel voted 8-6 (with one abstention) to recommend broadening access to BPC-157, evaluated for ulcerative colitis. The vote is non-binding; the FDA makes the final decision.

The outcome reflected the unusual composition of the committee. Previous PCAC panels were composed primarily of academics from Duke, Harvard, and Johns Hopkins. The reconstituted panel, appointed under Kennedy’s influence, includes more than a half-dozen new members with ties to peptide businesses or clinics — doctors who run peptide clinics, pharmacists who sell compounded medications, and consultants who advise on peptide use. All of those with industry ties voted in favor of BPC-157.

“I voted yes because it’s time to put this decision back in the hands of the patient, the physician and the pharmacist,” said David Pope, chief pharmacy officer of Xifin Pharmacy Solutions, who voted in favor.

FDA Scientists Raise Red Flags

The vote came despite a highly critical review from FDA career scientists, who recommended against inclusion for all seven peptides under consideration. In briefing documents, FDA staff cited inadequate characterization, missing quality data, insufficient or absent human clinical trial evidence, small and poorly controlled studies, immunogenicity risks, and adverse event reports.

Five studies of BPC-157 reviewed by the agency “were of short duration, had small sample sizes and evaluated doses that were likely exploratory in nature,” the staffers said.

Russell Wesdyk, an associate director in FDA’s drug center, highlighted a fundamental problem with regulating the substance: “There’s no way to know what the substance actually is, was or will be tomorrow because that name has no legal meaning.”

Dr. Eric Topol, director of the Scripps Research Translational Institute, offered a blunt assessment of the broader peptide trend: “None of them are proven. None of them have gone through what would be considered adequate clinical trials, but nonetheless many people are taking these. It’s actually quite extraordinary.”

Kennedy’s Influence and the MAHA Movement

The peptide review is the latest example of how Kennedy and his deputies are reshaping U.S. health policy in the mold of the “Make America Healthy Again” (MAHA) movement. Kennedy has described himself as a “big fan” of peptides, vowed to overturn FDA restrictions, and his allies have been highly critical of federal expert panels — even as the new panel includes members with more direct financial conflicts than the academic-heavy panels it replaced.

Nathan Beaver, an attorney specializing in FDA issues, said the outcome is likely aligned with Kennedy’s goals: “We’re still going through this process, but I think it’s more than likely that the process will end up at the result that Secretary Kennedy wants.”

The meeting continues Friday with reviews of three additional peptides: Emideltide (DSIP) for opioid withdrawal and insomnia, Semax for migraines and cerebral ischemia, and Epitalon for insomnia. A second PCAC meeting is expected before February 2027 to review five more peptides, including LL-37, GHK-Cu, and Melanotan II.

What Comes Next

Even if the panel recommends inclusion for all seven peptides, the formal process — Notice of Proposed Rulemaking, public comment period, and final rule — typically takes 12 to 24 months. FDA-watchers say the most likely near-term outcome is a temporary enforcement discretion policy, reassuring pharmacies that they won’t be targeted for compounding the peptides under review.

Proponents argue that regulated compounding is safer than the current gray market, where consumers buy injectable substances of unknown quality and purity, often imported from China. Brigham Buhler, a wellness clinic owner whose clients include Rogan, told the panel: “It’s crucial to allow patients to have safe and effective access to these treatment options. Individuals who have gotten these resources are going to continue to utilize these products.”

Critics, however, warn that millions of Americans could gain access to injectable substances with minimal human safety data. Both BPC-157 and TB-500 are considered doping substances by the World Anti-Doping Agency (WADA), raising questions about potential use in sports. Dr. Anita Gupta of Johns Hopkins School of Medicine, a former PCAC member, urged caution: “Patients should be really asking their health care professionals: Are these medications safe long term? That’s the question I would ask if I was a patient.”

The FDA will review the votes, discussion, and public comments before making a final decision on each peptide. The docket for public comment, which attracted approximately 1,860 submissions, closed July 22.