Peptides are inching closer to the mainstream.
A panel of experts on Thursday narrowly recommended that the Food and Drug Administration reclassify four popular peptides—including one endorsed by podcaster Joe Rogan—to allow certain pharmacies to legally dispense them.
In an at-times emotionally charged meeting that lasted more than 11 hours, members of an FDA advisory committee heard data presentations from FDA staff on four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—as well as testimony from health care practitioners, patients, pharmacies, and clinics.
Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s bulks list, meaning compounding pharmacies can use them to create custom medications for patients. (The fourth peptide—MOTs-C—received a seven-to-five vote in favor, with two abstentions.) The advisory panel, which includes several members tied to peptide-related businesses and telehealth clinics, will consider three more peptides on Friday.
Peptide therapies have been growing in popularity thanks to the endorsement of podcasters, wellness influencers, and Health and Human Services secretary Robert F. Kennedy Jr., who has said he’s a “big fan.” Essentially smaller versions of proteins, peptides are being touted for everything from skin rejuvenation and hair growth to gut health and injury recovery despite a lack of scientific evidence to back up these claims.
Many peptides currently exist in an unregulated gray market after the Biden administration banned compounding pharmacies from producing 20 peptides out of safety concerns in 2023. They can be legally sold online for “research use only” and “not for human consumption,” yet their marketing heavily implies otherwise. China and India are major suppliers of peptides, with some crypto-funded fentanyl labs switching gears to produce them.
During the meeting, the FDA’s own scientists recommended against allowing compounding pharmacies to produce any of the seven peptides being considered due to a lack of evidence showing they are safe and effective. Peptide proponents meanwhile testified that US compounding pharmacies should be able to produce them so that patients can access safer, regulated options with a prescription.
“I'm not going to tell you that the evidence for BPC-157 is strong. It isn't, and I won't overclaim it," said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers. “What I'd ask is that you not read thin as non-existent.” The company is actively preparing to launch peptide treatments in anticipation of the FDA greenlighting some peptides.
Among the peptides approved, two are particularly popular with podcasters and influencers. BPC-157 and TB-500 are paired as part of a so-called “Wolverine stack” to help improve recovery after injuries. Committee members were asked to evaluate BPC-157, which is thought to promote tissue repair, for ulcerative colitis. The World Anti-Doping Agency says BPC-157 poses a risk to athlete health because it has not been studied extensively in humans.
Some health care providers testified that patients of theirs had turned to the gray market to buy peptides and ended up with products that were laced with illicit substances. But while FDA approval may help reduce some of those risks, other commenters said it could create new ones.
John Hertig, chair of the Collaborative for Evidence-Based Medicines, said allowing compounders to make these peptides sends the message that the FDA is approving them. “That gets very confusing for our patients,” he said, adding that the existence of a gray market isn’t a reason to allow compounders to make these peptides.
He argued that there will still be a gray market even if the FDA allows for compounding of these peptides, citing that patients still seek out gray market GLP-1 drugs despite several FDA-approved drugs on the market.
Adriane Fugh-Berman, a physician and professor at Georgetown University, also challenged the idea that allowing legal versions would eliminate this gray market. “Would the government endorse companies manufacturing heroin because it would be cleaner than what's sold on the street?” she said. “Just because the market is large, doesn’t mean it should be legalized. It means that a product should be studied.”
The experts who voted against adding these four peptides to the bulks list cited a lack of data to support their use.
Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, was one of the committee members who voted against allowing the four peptides to be compounded, citing unknowns around safety and confusion for the public.
“I'm just concerned that we're entering a Pandora's box here,” she said.
For now, the panel’s recommendations are just that. A formal FDA decision will likely not come for several months.
