The Food and Drug Administration is taking the first step toward potentially allowing compounding pharmacies to produce seven peptides that are currently restricted because of the agency’s previous warning over safety concerns.
The agency’s expert advisory panel on pharmacy compounding is scheduled to discuss whether the peptides should be used in compounding for purposes for ulcerative colitis, wound healing, inflammatory conditions, obesity, insomnia and more, according to a Federal Register notice posted Wednesday announcing a late July meeting.
Health Secretary Robert F. Kennedy Jr. is a self-professed “big fan” of peptides and has said he wants to make them more broadly available.
The chains of amino acids have grown increasingly popular and have been increasingly marketed for antiaging and health benefits. But many of the claims are untested and some forms of peptides have not undergone clinical trials for their safety or efficacy, public health experts say. Influencers and telehealth companies have also pushed combinations of these smaller versions of proteins in a practice known as “peptide stacking” — a practice that is also largely untested.
Some peptides have been turned into drugs that have been studied and approved for use, most notably insulin and some weight-loss drugs called GLP-1s — which stands for glucagon-like peptide-1. But unapproved injectable peptides that are becoming more popular are at issue.
In 2023, the agency added more peptides to a category considered too risky for compounding, meaning they should not be used as active ingredients in drugs because of potential safety concerns. Compounding pharmacies prepare customized medications that aren’t commercially available to meet the needs of individual patients.
But there are unscrupulous actors in the peptide space that are selling directly to patients without a prescription, according to Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding, a trade group.
“Compounding pharmacies are being hammered by patients and prescribers to prepare these peptide drugs, and legally, they can’t do it. Not yet, anyway,” he wrote in an email. “And that is stimulating the illicit, non-pharmacy actors in the gray market.”
The Pharmacy Compounding Advisory Committee, which provides advice and recommendations to the FDA, has vacancies on its roster, suggesting there could be new people added to the panel. The FDA also announced it will hold another advisory committee meeting to consider five more peptides by the end of February 2027.
Kennedy has spoken about using peptides himself, noting in an appearance on Joe Rogan’s podcast in February that he “used them to really good effect on a couple of injuries.”
Kennedy said on the podcast that he hoped to make 14 of them more accessible and argued in his appearance that by making these available to compounding pharmacies, they will be safer than on the gray market, which includes some products flooding in from overseas.
“My hope is that they’re going to get moved to a place where people have access from ethical suppliers,” he said.
Kennedy had telegraphed such a move years ago, when he posted on X in October 2024: “FDA’s war on public health is about to end. This includes its aggressive suppression” of peptides, along with other substances.
The FDA had previously written on its website about popular peptide BPC-157, which advisers will now review, saying that “the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.”
The Department of Health and Human Services did not immediately respond to comment.
But scientists warn that without more study of such compounds, which have not undergone rigorous clinical trials typical of FDA-approved drugs, moving to allow compounding pharmacies to produce them could put the American public at risk.
“There’s just so little data that it’s hard to even put your finger on all the possible risks,” said Paul Knoepfler, a professor at the University of California at Davis School of Medicine focused on stem cells.
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