Peptides advance little by little closer to the mainstream. On Thursday, a panel of experts narrowly recommended that the Food and Drug Administration reclassify four popular peptides, including one backed by podcaster Joe Rogan, to allow certain pharmacies to legally dispense them. In a sometimes emotionally charged meeting that lasted more than 11 hours, members
Peptides advance little by little closer to the mainstream.
On Thursday, a panel of experts narrowly recommended that the Food and Drug Administration reclassify four popular peptides, including one backed by podcaster Joe Rogan, to allow certain pharmacies to legally dispense them.
In a sometimes emotionally charged meeting that lasted more than 11 hours, members of an FDA advisory committee heard presentations of data from FDA staff on four unapproved peptides (BPC-157, KPV, TB-500, and MOTs-C), as well as testimony from healthcare professionals, patients, pharmacies and clinics.
Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s bulk list, meaning compounding pharmacies can use them to create personalized medications for patients. (The fourth peptide, MOTs-C, received seven votes in favor and two abstentions.) The advisory panel, which includes several members with ties to peptide-related companies and telehealth clinics, will consider three more peptides on Friday.
Peptide therapies have been gaining popularity thanks to endorsements from podcasters, wellness influencers and Health and Human Services Secretary Robert F. Kennedy Jr., who has said he is a “big fan.” Peptides, essentially smaller versions of proteins, are touted for everything from skin rejuvenation and hair growth to gut health and injury recovery, despite a lack of scientific evidence to support these claims.
Many peptides currently exist on an unregulated gray market after the Biden administration banned compounding pharmacies from producing 20 peptides for safety reasons in 2023. They can be legally sold online for “research use only” and “not for human consumption,” but their marketing clearly implies otherwise. China and India are major suppliers of peptides, with some cryptocurrency-funded fentanyl labs shifting gears to produce them.
During the meeting, the FDA’s own scientists recommended not allowing compounding pharmacies to produce any of the seven peptides under consideration due to a lack of evidence showing they are safe and effective. Meanwhile, peptide advocates testified that American compounding pharmacies should be able to produce them so patients can access safer, regulated options with a prescription.
“I’m not going to tell you that the evidence on BPC-157 is strong. It’s not, and I’m not going to overstate it,” said Anant Vinjamoori, chief medical officer at telehealth provider Hims & Hers. “What I would ask you is that you do not read slim as non-existent.” The company is actively preparing to launch peptide treatments in anticipation of the FDA giving the green light to some peptides.
Among the approved peptides, two are particularly popular among podcasters and influencers. BPC-157 and TB-500 are paired as part of the so-called “Wolverine stack” to help improve recovery after injuries. Committee members were asked to evaluate BPC-157, which is believed to promote tissue repair, for ulcerative colitis. The World Anti-Doping Agency says BPC-157 poses a health risk to athletes because it has not been widely studied in humans.
Some healthcare providers testified that their patients had turned to the gray market to purchase 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, president of the Collaboration for Evidence-Based Medicines, said allowing compounds to produce these peptides sends the message that the FDA is approving them. “That’s very confusing for our patients,” he said, adding that the existence of a gray market is not a reason to allow preparers to produce these peptides.
He argued that there will still be a gray market even if the FDA allows the combination of these peptides, citing that patients are still seeking GLP-1 drugs on the gray market even though there are several FDA-approved drugs on the market.
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