Kennedy Jr. permits pharmacies to sell six peptides over FDA scientist objections

Health Secretary Robert F. Kennedy Jr. has finalized a policy allowing specialty pharmacies to sell six specific peptide drugs. The rule appeared in the Federal Register on Wednesday, with final publication scheduled for October 30. This decision overrides the position held by scientists within the Food and Drug Administration.

The six substances are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. These compounds are popular among supporters of Kennedy's MAHA movement. Many prominent figures in that group, as well as allies of the Health Secretary, sell the products. Kennedy has stated he uses some of the peptides himself and called himself a big fan.

FDA experts disagree with the leadership on these substances. They state there is insufficient evidence to prove the peptides work. The agency also warns the drugs may be dangerous. In 2023, safety concerns led the FDA to remove the six peptides from the list of drugs compounding pharmacies are permitted to make. Compounding pharmacies create customized formulations for individual patients or produce specialty drugs in bulk.

The new rule does not formally reverse the 2023 decision. It sidesteps the need for a formal reversal. The document is titled Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. It leaves the regulatory status of the peptides unchanged. Instead, it changes how the rule is applied.

The Department of Health and Human Services will no longer take enforcement action against compounding pharmacies for making these six peptides. This gives pharmacies a green light to produce and sell them freely. The FDA's earlier removal of the drugs from the approved compounding list remains in place, but the threat of federal enforcement is lifted.

This move follows an earlier step by Kennedy. He quietly proposed the rule earlier this month. It has now been issued in its final form. Alongside the Federal Register notice, HHS posted a detailed explanation of the policy. That document outlines the rationale for easing enforcement on the six selected peptides.

The outcome creates a gap between the department's leadership and its scientific agency. FDA experts say the evidence on effectiveness is lacking and the drugs carry risks. The policy now in effect allows pharmacies to make and sell the peptides without fear of federal enforcement.