Canadian doctors already prescribe the unapproved drugs through a compounding loophole
A US drug-safety panel has recommended letting specialized pharmacies produce six experimental peptides, setting aside warnings from government scientists that the injectable compounds lack proof of safety or benefit.
The Food and Drug Administration's Pharmacy Compounding Advisory Committee reached that position through a run of close votes on July 23 and 24, CNN reported, with the panel narrowly agreeing to open a path for the compounds.
The votes carry weight but do not bind the agency, which will make the final call on each substance.
According to CNN, the committee reviewed seven peptides nominated for the FDA's 503A Bulks List, the roster of ingredients that compounding pharmacies may use to prepare customized medications for patients holding valid prescriptions.
The panel backed six of them, including two forms of BPC-157 as well as KPV, TB-500, MOTS-c, epitalon and Semax, with margins running from 7-4 to 8-6 and one member abstaining on most votes.
It rejected emideltide, a sleep-inducing peptide, on a 6-7 vote.
The recommendations broke sharply from the agency's own scientists.
In briefing documents released before the meeting, FDA staff said there was too little evidence on effectiveness and safety to justify the additions and proposed keeping every peptide off the list, CNN reported.
AP News noted that regulators found no human studies of TB-500 and described the available BPC-157 research as short, small and exploratory in dose.
The panel's makeup drew scrutiny. In the weeks before the hearing, the office of US Health Secretary Robert F. Kennedy Jr. nominated eight new members to the committee, six of whom have sold peptide products, some of them banned, The New York Times reported.
Kennedy, who oversees the FDA, has called himself "a big fan of peptides" and has pressed to loosen the restrictions, according to CNN.
"I think we have seen an extraordinary abuse of the advisory committee process to secure ends that have no basis in science," said Peter Lurie, president of the Center for Science in the Public Interest, in comments reported by the Times.
The debate turned largely on where the real risk sits.
Supporters on the panel argued that a regulated compounding route would pull patients away from an unregulated online market.
Hal Mohammed, global chief medical officer of Gameday Men's Health, told the Friday session that "keeping this in a regulated pharmacy is not the risk in the room," and that the gray market "operates in the open because we let it," CNN reported.
Others were unconvinced. Elizabeth Rebello of the University of Texas MD Anderson Cancer Center said the panel risked "responding to a market-induced demand rather than a decision based in solid science."
Peptides are short chains of amino acids that the body uses to build proteins and support growth, metabolism and healing.
Some, such as insulin and the GLP-1 drugs behind Ozempic and Wegovy, are approved medicines, CNN reported, but the compounds before the committee are not FDA-approved and remain sold as research-grade products.
The agency restricted several of them in 2023 over safety concerns, and the Times reported that the products, mostly injections, are still marketed online for claims ranging from tendon repair to brain health.
The regulatory gap already exists here.
CBC News reported that Health Canada warns against unauthorized peptides yet found doctors prescribing BPC-157 through a loophole: the regulator bars its sale as an injectable drug and has not approved it as a natural health product, but permits it to be compounded as a pill or topical treatment with a doctor's prescription.
Health Canada told CBC that "BPC‑157 has not been authorized, its safety, efficacy, and quality have not been assessed … and there is limited scientific evidence to support its use, including a lack of established human dosing protocols."
Academics quoted by CBC called the situation untenable.
"Nobody's minding the store," said Stuart Phillips, a kinesiology professor at McMaster University, who told the broadcaster the compound "slips through as a compounded natural health product, where the federal safety check basically doesn't happen."
Timothy Caulfield, research director of the Health Law Institute at the University of Alberta, put it more bluntly to CBC: "It's maddening."
What comes next in the US remains open.
The FDA will weigh the votes, discussion and public comments before ruling on each peptide, AP reported, and analysts expect any near-term move to take the form of a temporary enforcement policy rather than formal rulemaking, which can take years.
"I think it's more than likely that the process will end up at the result that Secretary Kennedy wants," Nathan Beaver, an attorney who specializes in FDA matters, told AP.
