Peptides are progressing closer to the mainstream.
On Thursday, a group of experts 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.
During a sometimes emotional 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 professionals, patients, pharmacies and clinics.
Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s list of bulk products, meaning compounding pharmacies can use them to create personalized medications for patients. (The fourth peptide – MOTs-C – received a seven-to-five vote, with two abstentions.) The advisory committee, which includes several members linked to peptide-related companies and telehealth clinics, will review three more peptides on Friday.
Peptide therapies are growing in popularity thanks to support from podcasters, wellness influencers and Health and Human Services Secretary Robert F. Kennedy Jr., who has declared himself “a huge fan.” Essentially 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 in an unregulated gray market after the Biden administration banned compounding pharmacies from producing 20 peptides over safety concerns in 2023. They can be legally sold online for “research purposes only” and “not for human consumption,” but their marketing strongly implies otherwise. China and India are major suppliers of peptides, with some fentanyl labs funded by cryptocurrencies. shift 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 demonstrating their safety and effectiveness. Proponents of peptides, meanwhile, testified that U.S. pharmacies should be able to produce them so patients can access safer, regulated prescription options.
“I’m not going to tell you that the evidence in favor of BPC-157 is strong. It’s not, and I’m not going to exaggerate it,” said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers. “What I would ask you is that you don’t read thin as non-existent.” The company is actively preparing to launch peptide treatments in anticipation of the FDA green light for certain peptides.
Among the approved peptides, two are particularly popular with podcasters and influencers. BPC-157 and TB-500 are combined as part of a “Wolverine Stack” to help improve recovery from injury. Committee members were asked to evaluate BPC-157, believed to promote tissue repair, in the treatment of ulcerative colitis. World Anti-Doping Agency declares BPC-157 presents 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 purchase peptides and ended up with products containing 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 Collaborative for Evidence-Based Medicines, said allowing compounders to make these peptides sends the message that the FDA approves them. “It becomes 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 argued that there would still be a gray market even if the FDA allows these peptides to be combined, citing that patients are still seeking gray market GLP-1 drugs despite several FDA-approved drugs on the market.
Adriane Fugh-Berman, a physician and professor at Georgetown University, also disputed the idea that allowing legal versions would eliminate this gray market. “Would the government support companies manufacturing heroin because it would be cleaner than what is sold on the streets? she said. “Just because the market is large doesn’t mean it needs to be legalized. It means a product needs to be studied.”
Experts who voted against adding these four peptides to the bulk 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 combination of the four peptides, citing unknowns regarding safety and confusion for the public.
“I just worry that we’re entering Pandora’s box here,” she said.
For now, the panel’s recommendations are just that. A formal decision from the FDA likely won’t come for several months.