FDA Scientists Question Evidence for Peptides Backed by RFK Jr. Ahead of Advisory Panel

Career scientists at the U.S. Food and Drug Administration have concluded that there is not enough evidence to let compounding pharmacies produce a group of popular peptides, a position that puts the agency's own staff at odds with Health Secretary Robert F. Kennedy Jr. In review documents posted ahead of a public advisory meeting, FDA reviewers said the available human studies for seven nominated peptides do not provide enough support on safety or effectiveness, according to reporting by NPR and Reuters.

The staff review flagged 'potential safety concerns and a lack of consistent data' and found insufficient evidence to change the regulatory designation for any of the seven substances, NPR reported. The peptides were moved into a restrictive category in 2023, when the FDA cited difficulty characterizing the ingredients, manufacturing impurities, the potential for immune reactions and, for some substances, an absence of human exposure data.

The peptides on the agenda are BPC-157, TB-500, KPV, MOTS-c, emideltide (also described as delta sleep-inducing peptide, or DSIP), semax and epitalon, according to Prism News. The committee is scheduled to take up BPC-157, KPV, TB-500 and MOTS-c on July 23 and emideltide, semax and epitalon on July 24 at the agency's White Oak campus in Silver Spring, Maryland. Peptide Science Daily has separately reported on the mechanics of that meeting and the Section 503A bulk drug substances list at issue. None of the seven peptides is an FDA-approved drug.

For BPC-157, one of the most widely discussed of the group, FDA scientists did not find enough data to evaluate its use for tendinitis and could not assess its use for Crohn's disease or celiac disease, according to NBC News. That finding matters because Kennedy and the podcast host Joe Rogan have both said publicly that BPC-157 can heal tendon injuries, NBC News reported.

Kennedy has made his support plain. He has called himself 'a big fan of peptides' in comments to Rogan and has said he would like the FDA to let compounding pharmacies offer the substances again, according to the Associated Press. In February 2026 he widened the dispute, contending the agency had acted improperly in 2023 when it classified a set of peptides as too unsafe for compounders, according to Prism News.

The composition of the panel has drawn scrutiny. The Associated Press reported that the advisory committee will include members who promote peptides commercially, among them Dr. Haleem Mohammed, who runs Florida clinics that sell peptide injections; Dr. Gabriel Alizaidy, who charges for peptide and hormone consultations and promotes compounds such as BPC-157 on social media; and Bobby Harshbarger, a Tennessee state senator and pharmacist whose family business sells compounded medications.

Clinicians outside the process have echoed the caution in the staff review. 'Not a day goes by where I don't have a number of patients asking me about peptides,' Dr. Alexander Weber, an orthopedic surgeon at the University of Southern California, told NPR. 'My stock answer is that we just don't have enough data to support their use.'

Consumer advocates have urged the agency to hold its position. Dr. Robert Steinbrook, director of Public Citizen's Health Research Group, wrote that 'there is no credible reason to believe that peptides that were deemed unproven or unsafe in 2023 are miraculously safe and effective in 2026,' and argued that by convening the committee the FDA is 'bowing to the wishes of RFK Jr.'

The committee's recommendations are advisory and non-binding, although the FDA generally follows them, and the agency has not announced a decision on any of the nominated substances. Compounded preparations are not FDA-approved and are not reviewed by the agency for safety, effectiveness or manufacturing quality before they reach patients. As of publication the July meeting remained a procedural step in an unresolved regulatory process.