Peptides are gradually gaining traction in mainstream healthcare.
On Thursday, an expert panel narrowly recommended that the Food and Drug Administration (FDA) reclassify four popular peptides, including one supported by podcaster Joe Rogan, allowing certain pharmacies to legally dispense them.
During a lengthy, emotional meeting lasting over 11 hours, FDA advisory committee members reviewed data from the FDA on four unapproved peptides: BPC-157, KPV, TB-500, and MOTs-C. They also heard testimony from healthcare professionals, patients, pharmacies, and clinics.
The members voted 8-6 (with one abstention) in favor of adding three out of the four peptides to the agency’s bulk list. This classification enables pharmacies to create custom medications for patients. The fourth peptide, MOTs-C, had a closer vote at 7-5, with two abstentions. An advisory committee is set to evaluate three additional peptides on Friday.
Peptide therapy is becoming increasingly popular, bolstered by endorsements from podcasters, health influencers, and even Secretary of Health and Human Services Robert F. Kennedy Jr., who is an outspoken “huge fan.” Peptides—smaller segments of proteins—are claimed to offer benefits ranging from skin rejuvenation and hair growth to gut health and enhanced injury recovery, despite limited scientific backing for these assertions.
Many peptides are found on the unregulated gray market following the Biden administration’s 2023 ban on the manufacture of 20 peptides by compounding pharmacies due to safety concerns. While peptides can be sold online for “research use only” and “not for human consumption,” marketing often implies otherwise. Major suppliers, such as China and India, dominate the peptide market, with some labs previously focused on fentanyl now shifting to peptide production.
During the meeting, the FDA’s scientists cautioned against allowing compounding pharmacies to produce the seven peptides under review, citing insufficient safety and effectiveness evidence. Peptide advocates argued that allowing U.S. pharmacies to manufacture these peptides could provide patients with safer, regulated options under prescription.
“I’m not claiming that the evidence for BPC-157 is robust; it isn’t, and I won’t exaggerate it,” stated Ananth Binjamouli, chief medical officer at Hims & Hers, a telemedicine provider. “What I want to emphasize is, don’t just rely on the literature. thin as does not exist.” The company is preparing to launch peptide therapeutics, anticipating FDA approval for specific peptides.
Among the approved peptides, BPC-157 and TB-500 are notably popular within the podcasting and influencer communities. These peptides are often marketed together as the “Wolverine Stack,” purported to speed recovery post-injury. Committee members assessed BPC-157 for its potential to encourage tissue repair, particularly in cases of ulcerative colitis. The World Anti-Doping Agency has flagged BPC-157 as posing health risks to athletes due to insufficient human research.
Some healthcare providers shared that patients have sought out the gray market for peptide purchases, which has led to products containing illegal substances. While FDA approval could mitigate some risks, others voiced concerns about potential new risks emerging.
John Hartig, president of the Collaborative for Evidence-Based Medicines, warned that allowing compounding pharmacies to produce these peptides would imply FDA endorsement. “This could create confusion for patients,” he said, arguing that the existence of a gray market does not justify enabling manufacturers to create these peptides.
He emphasized that even if the FDA permits the production of these peptides, the gray market will likely persist. “Patients continue to seek gray market GLP-1 medications, despite the availability of several FDA-approved options,” he concluded.
Source: www.wired.com