FDA Prepares to Let Unproven Peptides Slide, Despite Internal Warnings

The FDA has submitted an “Interim Access Policy” on peptide drugs to the White House for review, a move that would grant the agency enforcement discretion over a class of injectable compounds its own scientists found lack adequate safety and efficacy data. Under the plan, the FDA would effectively choose not to enforce existing restrictions, sending a signal to compounding pharmacies that they can resume manufacturing the drugs without fear of regulatory action. HHS did not respond to requests for comment.

The proposal directly contradicts a 2023 determination by FDA staff scientists, who concluded that a dozen popular peptide drugs posed risks and struck them from the list of compounds specialty pharmacies are permitted to compound. Despite that finding, demand for the peptides has grown, fueled by sellers making unsupported claims about appearance, energy, and injury recovery. The drugs have become a fixture of the Make America Healthy Again movement, with prominent MAHA figures marketing peptide products. RFK Jr., who described himself as a “big fan” of peptides, pledged upon taking office to end what he called the FDA’s “war” on the compounds.