Kennedy Bypasses FDA to Let Pharmacies Freely Make Six Unproven Peptides
US Health Secretary Robert F. Kennedy Jr. has issued a rule allowing specialty pharmacies to produce and sell six peptide drugs, despite FDA scientists saying evidence of effectiveness is lacking and risks are possible. Peptide sellers welcomed the move, while health policy groups criticized it.
US Health Secretary Robert F. Kennedy Jr., who heads the Department of Health and Human Services (HHS), has put in place a rule allowing specialty compounding pharmacies, which prepare customized drug formulations, to make and sell six peptide drugs. The move overrules scientists at the Food and Drug Administration (FDA). It matters because the peptides' effectiveness remains unproven and safety concerns have not been resolved.
The rule, titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," was made available on the Federal Register on Wednesday, with formal publication set for October 30. It does not change the peptides' regulatory status. Instead, HHS says it will no longer take enforcement action against pharmacies that produce them. The six are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
Background
In 2023, the FDA removed these peptides from the list of substances compounding pharmacies may use, citing safety concerns. The new rule avoids the need to formally reverse that decision. The peptides are popular among supporters of Kennedy's Make America Healthy Again movement, and several prominent figures in it sell them. Kennedy has said he uses some of them and called himself a "big fan."
Rationale
HHS cites a July vote by an FDA advisory panel to restore the peptides to the list. Before that vote, however, Kennedy added eight new members to the 12-member committee, and at least six of them have ties to peptide-related businesses or clinics. The policy also describes the safety concerns as largely hypothetical rather than based on observed harm in humans, though few studies in humans exist. Kennedy argues that supplying the peptides through pharmacies will steer people away from gray and black markets.
Reactions
Peptide sellers, including wellness clinic operator Brigham Buhler, celebrated on X. Critics, including the Center for Science in the Public Interest and Americans for Safe and Effective Medicines, warn of mounting reports of harm, weaker incentives for clinical trials and inadequate oversight.
