RFK Jr. eases access to six unapproved peptides over objections from FDA scientists

A policy without FDA approval

On Wednesday, 28 October 2026, the Department of Health and Human Services released a document saying it will not take enforcement action against doctors, pharmacies and other facilities that sell six peptide compounds. The six are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, none of which the FDA has approved as safe and effective. Compounding pharmacies combine or alter ingredients to tailor a medication to one patient, and some peptides, including insulin and GLP-1 weight-loss drugs, are already FDA-approved. The notice is titled as an enforcement discretion policy covering certain peptide bulk drug substances, and it does not change the legal status of the six peptides. The document concedes that such drugs can pose risks to patients, while arguing there is significant interest in their use.

Dissent inside the FDA

Six people familiar with the matter told the Associated Press that most FDA scientific staff opposed the move and had limited input in drafting it. The Guardian reported that the staff warned the plan could undermine the agency's mission of keeping unproven health products off the US market. According to the New York Times, no FDA scientists were present at a meeting on Tuesday, 27 October, that finalized the policy. HHS first wanted the FDA to draft a regulation adding BPC-157 and other peptides to the list of substances deemed safe for compounding, but FDA officials said the scientific staff had serious safety concerns and would not support that. HHS then shifted to enforcement discretion. Ars Technica reported that an FDA advisory panel voted in July to add the six peptides back to the list of drugs compounding pharmacies can make, and that Kennedy added eight members to the 12-member committee before that vote.

Kennedy's case for peptides

Kennedy has called himself a "big fan" of peptides, and he told podcaster Joe Rogan that he used them on a couple of injuries "with really good effect". The Guardian reported that he recently described using BPC-157 to treat a muscle injury. Peptides are short chains of amino acids that can influence hormone activity, digestion and tissue repair. HHS's rationale describes the safety concerns as largely inferential rather than based on observed harm in humans, a point Ars Technica linked to the scarcity of human studies. The department's document states its conclusion in the following words.

“The secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.”

What the policy would allow

The six peptides have been marketed for conditions including osteoporosis, insomnia and migraines. BPC-157 is proposed for ulcerative colitis, Epitalon for insomnia, KPV for wound healing and inflammation, MOTS-c for obesity and osteoporosis, Semax for migraines and TB-500 for wound healing. The plan would bypass standard FDA tests of whether compounds work better than a placebo and whether they might cause cancer or birth defects. HHS says the policy requires patient-specific prescriptions, traceable ingredients, quality testing and safety reporting. Emily Hilliard, an HHS spokeswoman, said in a statement that the policy does not grant FDA approval.

“The policy does not grant FDA approval or establish clinical safety and effectiveness.”

Next steps

The notice is scheduled for final publication in the Federal Register on 30 October. Once it is officially published, the public can submit comments for two weeks. The policy came from Kennedy's office rather than the FDA, and federal officials continue to work out permanent rules for the products.