HHS Will Let Small Pharmacies Make Six Unproven Peptides, Overriding FDA Scientists
Health Secretary Robert F. Kennedy Jr., who says he has used some of the compounds, is using "enforcement discretion" instead of rulemaking. Consumer groups warn it puts patients at risk.
The Department of Health and Human Services said Wednesday it will stop enforcing a ban on small compounding pharmacies making six popular peptides, a move that brings gray-market wellness drugs closer to the mainstream without going through the Food and Drug Administration's approval process.
Under the new policy, HHS will exercise what is known as enforcement discretion for the six compounds, essentially looking the other way when small pharmacies make them. Health Secretary Robert F. Kennedy Jr. has been a vocal supporter of peptides and has said he has used some of them himself. Peptides are strings of amino acids, shorter than proteins, that can exert powerful effects in the body. Some occur naturally and others are synthetic variations. Wellness influencers and some clinicians have promoted them for a wide range of uses, though the evidence for their safety and effectiveness is sparse.
The six peptides, and some of the unproven uses attached to them, are BPC-157 for ulcerative colitis, Epitalon for insomnia, KPV for wound healing, MOTS-c for metabolic health, Semax for migraine and TB-500 for wound healing. The policy does not change their legal status. It creates a path for pharmacies known as 503A compounders, and it does not apply to the larger 503B outsourcing facilities that produce higher volumes of medicines.
That split matters for supply. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, said people have been asking about these peptides for years, but his company never made them because compounding them was illegal. Now only its smaller compounding facility can, and only in small quantities. "We won't be able to meet demand," he said, adding that Olympia will likely compound just one of the six and needs to get its facility ready first. "I don't think all the [503]As in the country could meet the demand."
The administration's stated rationale is that compounding is safer than the illicit "research-use-only" peptides sold online, which are often sourced from suppliers overseas. The Alliance for Pharmacy Compounding, whose CEO Scott Brunner welcomed the decision, said it offers a "more accountable alternative" that brings patients into a system where "pharmacy standards, regulatory oversight, and serious adverse event reporting apply." Brunner cautioned it may take time before pharmacies can dispense the products, because ingredient suppliers and pharmacies must verify the active ingredients meet the policy's requirements.
The decision follows a split inside the government. In July, a panel of advisers to the FDA voted in favor of expanded access to the six peptides through compounding pharmacies, but at the same meeting the FDA's own scientists recommended against unwinding the existing restrictions.
Consumer advocates are alarmed. Public Citizen noted Kennedy appears to have acted unilaterally rather than through the typical rulemaking process. "By allowing unproven and potentially unsafe peptides to be manufactured, marketed and prescribed without concern about potential federal enforcement actions, Kennedy has undermined the FDA and threatened public health," said Dr. Robert Steinbrook, director of its Health Research Group. The Partnership for Safe Medicines filed a citizen petition last week urging the FDA to reject its advisory committee's recommendation, and said the decision "leaves Americans in a grey area" over whether peptides are safe.
