Peptides are inching near the main stream.
A panel of experts on Thursday suggested little that Food and Drug Administration rearrange four popular peptides—including one endorsed by podcaster Joe Rogan—to allow certain pharmacies to legally dispense them.
In a sometimes emotional 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 health care providers, patients, and pharmacies.
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 make specific drugs for patients. (The fourth peptide—MOTs—C—received seven to five votes in favor, with two abstentions.) The advisory panel, which includes several members associated with peptide-related businesses and health clinics, will consider three more peptides on Friday.
Peptide therapies have been growing in popularity thanks to endorsements by advertisers, health lobbyists, and Health and Human Services Secretary Robert F. Kennedy Jr., who has said he is a “huge fan.” Smaller versions of proteins, peptides are touted for everything from skin rejuvenation and hair growth to gut health and wound healing despite a lack of scientific evidence to support these claims.
Many peptides currently exist on the unregulated gray market after the Biden administration banned compounding pharmacies from producing 20 peptides due to safety concerns by 2023. They can be legally sold online for “research use only” and “not for human consumption,” but their marketing implies otherwise. China and India are the main suppliers of the peptide, with some crypto-financed fentanyl labs switch gears to produce them.
During the meeting, FDA scientists themselves recommended against allowing pharmacies to produce any of the seven peptides under consideration due to the lack of evidence showing that they are safe and effective. Peptide proponents meanwhile argued that US pharmacies should be able to produce them so that patients have access to safe, controlled prescription 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 deny it,” said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers. “I would ask that you did not study thin like it doesn’t exist.” The company is actively preparing to launch a peptide treatment in anticipation of the FDA’s approval of several 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 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 the athlete’s health because it has not been widely studied in humans.
Some health care providers testified that their patients turned to the gray market to buy peptides and ended up with products laced with illegal substances. But while the FDA’s approval could help reduce some of those risks, some commentators said it could create new ones.
John Hertig, chairman of the Evidence-Based Medicine Partnership, said allowing integrators to make these peptides sends a message that the FDA approves. “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 said that there will still be a gray market even if the FDA allows the inclusion of these peptides, citing that patients are still looking for a gray market for GLP-1 drugs despite several FDA-approved drugs on the market.
