The FDA has just approved these unproven peptides

Peptides are small close to the mainstream.

A group of experts on Thursday partially recommended that Food and Drug Administration change four more popular peptides– including one endorsed by podcaster Joe Rogan – allowing other pharmacies to legally dispense them.

In a sometimes very sensitive meeting that lasted more than 11 hours, members of the FDA advisory committee heard explanations from FDA staff on four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—as well as testimony from health professionals, patients, and pharmacies.

Members voted eight to six, with one against, to add three of the four peptides to the agency’s over-the-counter list, meaning compounding pharmacies can use them to create traditional medicines for patients. (The fourth peptide—MOTs—C—received seven to five votes in favor, with two objections.) The advisory group, which includes several members tied to the peptide industry and telehealth clinics, will consider three more peptides on Friday.

Peptide therapy has been gaining popularity due to the acceptance of the public, health advocates, and Secretary of Health and Human Services Robert F. Kennedy Jr., who has said that it is “a big fan.” Small proteins, peptides are being touted for everything from skin rejuvenation and hair growth to gut health and wound healing even though there is no scientific evidence to back this up.

Many peptides are currently available on the 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” and “not for human use,” however their advertising means otherwise. China and India are the biggest exporters of the peptides, with crypto-backed fentanyl labs change gears to create them.

At the meeting, FDA scientists recommended not to allow pharmacies to produce the seven peptides that are being considered due to the lack of evidence that they are safe and effective. Peptide advocates testified that US pharmacies need to make sure patients have access to safe, controlled drug 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 beat it,” said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers. “All I can ask is that you don’t count it less if it doesn’t exist.” The company plans to launch a peptide treatment in anticipation of the FDA’s review of other peptides.

Among the approved peptides, two are the most popular with podcasters and influencers. BPC-157 and TB-500 are included as part of the “Wolverine stack” to aid recovery after injury. Committee members were asked to evaluate BPC-157, which is thought to promote muscle repair, for ulcerative colitis. The World Anti-Doping Agency says BPC-157 it poses a risk to the athletes’ health because it has not been studied in depth in humans.

Other health care providers testified that their patients turned to the flea market to buy peptides and found products covered in illegal substances. But while the FDA’s approval could help reduce some of the risks, some commenters said it could create new ones.

John Hertig, chairman of the Collaborative for Evidence-based Medicines, said allowing integrators to produce these peptides sends a message that the FDA approves them. “This is very confusing for our patients,” he said, adding that the existence of a gray market is not a reason to allow manufacturers to produce these peptides.

He also said that there will still be a gray market even if the FDA allows the combination of these peptides, saying that patients are still looking for a gray market for GLP-1 drugs even though there are several drugs approved by the FDA on the market.