An FDA advisory committee voted narrowly to recommend loosening restrictions on four peptides: BPC-157, KPV, TB-500, and MOTS-c. The vote came despite strong objections from FDA career scientists who cited a lack of evidence on the compounds' identity, safety, and efficacy. The recommendation would…
A Food and Drug Administration advisory committee voted by a slim margin on July 23, 2026, to recommend relaxing restrictions on several popular peptides. The FDA’s Pharmacy Compounding Advisory Committee gave its approval to four compounds: BPC-157, KPV, TB-500, and MOTS-c. The vote occurred during a daylong meeting in which FDA career scientists repeatedly voiced strong objections, citing insufficient evidence for these treatments as well as unresolved safety concerns.
The committee’s votes do not make these peptides FDA-approved drugs. Instead, the recommendation is to add them to a list of substances that compounding pharmacies are permitted to prepare. The final decision will be made by the FDA in the form of a proposed rule. On the following day, Friday, the committee planned to consider three additional peptides: emideltide, epitalon, and semax.
Throughout the meeting, a recurring point of contention was the fundamental lack of clarity about what these peptides actually are chemically. FDA officials stated that there is no universally accepted chemical formula for several of the peptides under review, which made it extremely difficult for the agency to evaluate their safety and effectiveness. “We’ve never faced a problem of, ‘What is it?’” Russell Wesdyk, an FDA official, told the panel on Thursday morning.
The ambiguity surrounding the chemical identity became a key obstacle. FDA scientists repeated the message that they simply lacked the basic data to perform a standard assessment. This gap in information did not dissuade some committee members from voting in favor of the peptides, however. Dr. Gabriel Alizaidy, a clinical researcher at the online clinic Maximus, which offers peptides, explained that he voted yes on BPC-157 because he was “frankly disappointed at how incomplete the data was.”
FDA scientists presented their reviews focusing on specific intended uses for each peptide. BPC-157 was assessed for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis. The scientists detailed what they described as a lack of reliable evidence supporting those uses.
During public comment periods that preceded each peptide presentation, proponents of the compounds offered what they characterized as additional data for alternative uses. That data was not always included in the FDA scientists’ presentations, a decision that irritated some committee members. Wesdyk defended the process, stating that scientists reviewed everything that arrived by the deadline. “There’s no attempt to conceal anything or not use something,” he said, adding that the agency would continue to evaluate new data as it comes in.
Yet at several points during the day, FDA scientists stated that there simply was no data for them to assess for certain peptides. This led to frustration among some panel members. Josh Mailman, president of the Neuroendocrine Tumor Research Foundation board of directors, said during a discussion about KPV: “I’m voting on something here, but I don’t know what that something is. It’s kind of like a black box to me.” Mailman voted no.
The committee’s composition drew attention because eight panel members were appointed under Health Secretary Robert F. Kennedy Jr. Among those eight, six run clinics that offer peptides. One committee member, Tennessee state Senator Bobby Harshbarger, is the son of Representative Diana Harshbarger, a Republican from Tennessee who last year wrote to Kennedy asking that compounders be allowed to make certain peptides.
For the votes on BPC-157, KPV, and TB-500, all eight of the new Kennedy appointees voted yes. An additional six members voted no, and one person abstained. For MOTS-c, the tally was slightly different: seven of the new appointees voted yes, five people voted no, and two people abstained, including one of the new appointees.
Committee members expressed a wide range of reasons for their votes. Some yes votes echoed language often used by Kennedy. Dr. Haleem Mohammed, the chief medical officer at Gameday Men’s Health, a men’s health clinic in Florida that offers peptides, said he voted yes for BPC-157 “for patient safety, you know, the greater good and medical freedom.” Earlier in the day, he had cited concerns about the gray market, where peptides are not FDA-approved but are frequently bought online from vendors who label them “for research use only,” a legal workaround to sell compounds that are claimed not to be intended for humans. “As a physician, I have to make sure that I’m keeping patients as safe as possible,” Mohammed said. “So when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? And that’s what I lose sleep at night over.”
David Pope, the chief pharmacy officer at Xifin Pharmacy Solutions in Georgia, explained that his yes vote for BPC-157 was meant “to put this decision back into the hands of the patient, the physician and the pharmacist.”
Other members strongly disagreed. Dr. Brian Lee, an associate professor of medicine at the Keck School of Medicine of the University of Southern California in Los Angeles, voted no. He argued that the public might view the committee’s votes, and any eventual FDA sign-off, as endorsements of the products. He warned that some of the compounds may be no more effective than a placebo. “For effectiveness, we know that 30% of patients on placebo will have a self-reported response or even objective response,” Lee said.
Dr. Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, also registered strong opposition. On her no vote for KPV, she said: “I’m concerned that we’re responding to a market-induced demand rather than a decision based on solid science.” After a later vote on TB-500, she added: “I’m also concerned with the argument that patients are getting it anyway. That actually goes against the Hippocratic oath, which is do no harm and if we don’t know if we’re causing harm, that’s an issue.”
Peptides have surged in popularity in recent years, promoted by the wellness industry and high-profile figures including Health Secretary Robert F. Kennedy Jr. and podcaster Joe Rogan. These compounds are advertised for a range of uses, from anti-aging and better sleep to faster healing. However, they have largely existed in what is called a “gray market.” They are not FDA-approved drugs, but they are often sold online by vendors who label them “for research use only” as a legal workaround, allowing them to market compounds that they claim are not meant for human consumption. Kennedy has argued that allowing the peptides to be compounded would move people away from the gray market and toward safer, regulated products.
The committee’s recommendation is a step toward that goal, but the final say rests with the FDA, which will develop a rule proposal based on the advisory panel’s input. The meeting highlighted deep divisions between agency scientists, who stressed the lack of evidence, and some committee members, who prioritized patient access and medical freedom.
Peptides referenced: BPC-157, TB-500, MOTS-c, Epithalon, Semax.
Related reading: FDA Peptide Shift and Leadership Change Could Affect Hims and Hers Health, FDA Panel Endorses Broader Peptide Use Despite Safety Concerns, FDA Advisers Endorse First of Seven Peptides for Regulatory Flexibility, FDA Panel Reviews Peptides, Considers Loosening Rules for Unapproved Therapies.