Peptides are powerful next 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 occasionally tense meeting that lasted more than 11 hours, FDA advisory committee members heard data presentations from FDA staff on four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—as well as testimony from healthcare professionals, patients, and pharmacies.
Members voted eight to six, with one abstention, to add three of the four peptides to the organization’s bulk list, meaning compounding pharmacies can use them to create personalized medicines for patients. (A fourth peptide—MOTs-C—received seven to five votes in favor, with two abstentions.) The advisory panel, which includes several members tied to peptide-related businesses and telehealth clinics, will consider the other three peptides on Friday.
Peptide therapies have been growing in popularity thanks to the adoption of podcasters, health advocates, and Health and Human Services Secretary Robert F. Kennedy Jr., who said he is “a big fan.” A small form of protein, peptides are credited with everything from skin rejuvenation and hair growth to gut health and injury recovery despite a lack of scientific evidence to support these claims.
Most of the peptides currently exist on the unregulated gray market after the Biden administration refused to allow pharmacies to produce 20 peptides due to safety concerns by 2023. They can be legally sold online for “research use only” and “not for human consumption,” however their marketing largely says otherwise. China and India are the main suppliers of the peptides, and some crypto-funded fentanyl labs are shifting gears to produce them.
During the meeting, the FDA’s own scientists recommended against allowing compounding pharmacies to produce any of the seven peptides under consideration due to the lack of evidence showing that they are safe and effective. Peptide supporters, meanwhile, have argued that pharmacies across the US should be able to produce them so patients can access safe, prescription-only options.
“I’m not going to tell you that the evidence for 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. All I can ask is that you don’t read he is young like absent.” The company is preparing to launch peptide therapies in anticipation of the FDA greenlighting certain peptides.
Among the approved peptides, two are very popular with podcasters and influencers. BPC-157 and TB-500 are paired as part of the so-called “Wolverine stack” to help improve recovery after injury. Committee members were asked to test BPC-157, which is thought to promote tissue repair, for ulcerative colitis. The World Anti-Doping Agency says BPC-157 poses a risk to the health of athletes because it has not been studied extensively in humans.
Some healthcare providers have testified that their patients have turned to the gray market to buy peptides and ended up with products laced with illegal substances. But while FDA approval could help reduce some of those risks, some commentators say it could create new ones.
John Hertig, chairman of the Collaborative for Evidence-based Medicines, said that allowing compounders to make these peptides sends a message that the FDA approves them. “That is very confusing for our patients,” he said, adding that the existence of a gray market is not a reason to allow compounders to make these peptides.
He pointed out that there will still be a gray market even if the FDA approves the synthesis of these peptides, pointing out that patients are still looking for a gray market for GLP-1 drugs despite the few FDA-approved drugs on the market.
