A controversial plan by Health Secretary Robert F. Kennedy Jr. to ease access to unproven peptide drugs, including those he favors, faced significant opposition from most Food and Drug Administration (FDA) scientific staff. The policy, which recently underwent White House regulatory review, aims to direct the FDA not to enforce existing regulations against specialty pharmacies selling certain injectable peptides. These peptides are currently considered illegal drugs as they lack FDA approval for safety and effectiveness.FDA drug staffers warned that this initiative, driven by Kennedy's Department of Health and Human Services (HHS), could undermine the agency's mission to keep unproven health products off the U.S. market. The policy would allow pharmacies to compound substances like BPC-157 and TB-500, which are marketed for injury healing and muscle building but are considered doping substances by sports authorities. Kennedy himself has expressed support for peptides and used BPC-157 for a muscle injury.Initially, HHS sought a regulation to deem these peptides safe for compounding, but FDA officials citing major safety concerns from scientific staff, rejected this. The new approach avoids a direct confrontation by simply instructing the FDA not to enforce its rules against compounding pharmacies for these substances. While FDA staffers provided technical assistance and suggested safety guardrails, including requiring ingredients from FDA-regulated factories and adverse event reporting, the move is unusual as compounding decisions usually rest with the FDA, not HHS.The FDA previously warned about the safety risks of unproven peptides and in 2023, added several, including BPC-157 and TB-500, to a list of substances not recommended for compounding due to potential allergic reactions, kidney damage, and tumor growth. The current policy, despite incorporating some FDA-suggested safety measures, is seen by critics as circumventing the agency's rigorous scientific review process. This shift in authority over drug compounding, typically handled by the FDA, raises concerns about consumer safety and the integrity of drug regulation.