Nearly three years ago, the FDA banned 19 peptide drugs from compounding pharmacies, warning of cancer risks, organ damage, and adverse events including death. Now the agency is preparing to reconsider — and by all available signs, no new safety or efficacy data prompted the reversal.

Robert F. Kennedy Jr. did.

The Health and Human Services secretary has scheduled advisory committee meetings for July to evaluate seven peptides, including BPC-157 and TB-500, marketed for injury recovery, wound healing, and inflammation. A second round follows in February 2027. What’s missing from the Federal Register docket, according to Ars Technica, is any significant new clinical evidence for reviewers to assess.

The science on these substances hasn’t meaningfully advanced since 2023. What has changed is political authority.

Kennedy, who has no medical or scientific background, has described himself as a “big fan” of peptides and told podcast host Joe Rogan in February that he used them on injuries with “really good effect.” He has called the FDA’s original restrictions illegal, claiming the agency lacked a “safety signal.”

Three former FDA officials tell a different story. They say the 2023 decision was backed by documented safety concerns — adverse events in human studies of six individual peptides, some fatal, alongside a broad absence of clinical data. The agency’s own advisory panel voted overwhelmingly against allowing compounding of these substances. FDA regulators agreed, writing that the peptides “present significant safety risks.”

Former FDA acting commissioner Janet Woodcock warned that reversing course without proper evidence would break a decades-old compact. “It would be a disruption of the societal pact we have had since 1962 that drugs will be studied to see if they work before they are marketed in the U.S.,” she told ProPublica.

The panel conducting the July review currently has three voting members and six vacancies, including the chairperson — slots Kennedy could fill before the meeting convenes.

Sources