A slate of popular peptide therapies has won the backing of a key advisory panel to the federal government — a step that could eventually open up broader access to the experimental drugs.
In a marathon two-day meeting last week, the panel of doctors, academics and pharmacists recommended the Food and Drug Administration reclassify almost all of the compounds under consideration so that specialized pharmacies in the U.S. could begin offering them.
Seven different peptide therapies — none of which are FDA-approved drugs — were under consideration.
Currently, these peptides can't be made in the U.S., except for research purposes, leading many peptide users to buy unvetted substances sold online, with disclaimers such as "for research use only" and "not for human consumption."
By narrow margins, the panel voted in favor of all but one. The FDA isn't required to follow advisory committee recommendations but typically does.
The outcome represents a win for Health Secretary Robert F. Kennedy Jr., who has publicly supported peptide therapies, and the broader wellness and longevity industry, which stands to profit substantially.
These peptides are promoted for a wide range of uses and are often taken together, including for injury recovery, muscle growth and fat loss, improving athletic performance, enhancing metabolism and more.
If the agency takes the panel's recommendations, clinicians could have the ability to prescribe six peptide therapies: BPC-157, MOTS-c, KPV, TB-500, Epitalon and Semax.
A compound called Emideltide, sometimes used for insomnia, was the only one to receive a down vote.
The panel's endorsement of peptides was a striking rejection of the FDA's stance against them.
While the level of evidence for each compound varies, all of them lack the kind of large, well-controlled trials in humans that are necessary to establish safety and effectiveness, which is required for drug approvals. Peptides are strings of amino acids — smaller than a protein — that often act as signaling molecules in our bodies and carry out many critical functions.
They can be synthesized and delivered as drugs, often by injection. Some of those, like insulin, are naturally occurring in the body. Others are modified versions, as with the blockbuster GLP-1 obesity drugs.
Scientists for the agency spoke extensively about the lack of reliable data for any of the seven peptides before the committee. They advised the panel to vote no.
In some cases, they couldn't find any published clinical studies in humans — and there were safety concerns like the potential to encourage cancer growth or to trigger a massive immune response.
A "foundational challenge" was simply defining the substances, because the chemical composition for peptides labeled with the same name varied considerably, explained FDA official Russell Wesdyk.
"You will see many, many different forms," he said. "We can't create quality standards until we actually know what it is."
The divide among the experts on the panel was a study in contrasts.
Ahead of the meeting, eight new members were appointed. Most have ties to the peptide industry and include physicians who work for medical practices and companies that promote them.
In almost all cases, they voted in favor of lifting restrictions.
A spokesperson for the Department of Health and Human Services pushed back on criticism about potential conflicts of interest and said all underwent the standard ethics and vetting process.
"I think it's about patient access," said Dr. Asare Christian, one of the panel members who runs a Pennsylvania-based clinic that advertises peptide protocols and hormone optimization.
That sentiment was echoed throughout the many hours of public comment.
Compounding pharmacies, large telehealth providers and others from the industry underscored the perils of the unregulated marketplace, with some offering anecdotes of patients obtaining unmarked vials from sketchy suppliers.
"What we are advocating for is not the Wild West," said Brigham Buhler, who runs a telehealth company that offers hormone optimization and peptides and is an ally of Secretary Kennedy.
"What we are advocating for is to slow down or shut down the gray and black market and to allow patients to have a safe and effective manufacturing process," he told the panel.
But some panelists were skeptical of that argument.
"I'm concerned that we are responding to market-induced demand rather than a decision based in solid science," Dr. Elizabeth Rebello, an anaesthesiologist at the University of Texas MD Anderson Cancer Center, commented after casting a no vote.
The FDA committee was tasked with reviewing data that supports using these peptides to treat a variety of specific conditions, such as BPC-157 for treating ulcerative colitis, an inflammatory bowel disease.
However, if the FDA ultimately reclassifies them and they are produced by compounding pharmacies in the U.S., clinicians would have discretion to write prescriptions outside of those narrow indications.
During the meeting, industry groups — and some on the panel — repeatedly criticized the FDA presentations for not reflecting more recent scientific data on the substances, including results from other human studies that had been submitted ahead of time.
FDA staff said they had considered everything submitted by the meeting deadline and would still take new information into account as they weigh next steps.
The decision to place the products on the FDA's official list for compounding doesn't come close to the standards for drug approval, but some worry that nuance will not be clear to the public, which may not be aware of the limited data for humans.
"I think this endorsement can be potentially harmful and I cannot in good conscience vote yes," said Dr. Brian Lee, a member of the panel and an associate professor at the Keck School of Medicine of USC.
If the FDA moves to reclassify the peptides so that compounding pharmacies can make them, it will be through a formal rulemaking process that could stretch into next year or 2028. There is a possibility that Kennedy could invoke special authority to make them available sooner.
The panel is scheduled to meet again in February to consider additional peptide therapies.
Copyright 2026 NPR
