An advisory committee voted narrowly on Thursday to recommend that the Food and Drug Administration reclassify four popular peptide therapies, potentially allowing compounding pharmacies to legally dispense the unapproved substances. According to federal proceedings, the panel’s eight-to-six vote with one abstention followed an 11-hour meeting regarding the substances BPC-157, KPV, and TB-500, while a fourth peptide, MOTs-C, received a seven-to-five vote in favor with two abstentions.
FDA Advisory Panel Recommends Reclassifying Unapproved Peptides
The panel evaluated the unapproved peptides after hearing data presentations from FDA staff alongside testimony from patients, health care practitioners, clinics, and pharmacies. Three of the four evaluated peptides cleared the panel for addition to the agency’s bulks list. According to committee disclosures, several panel members maintain ties to telehealth clinics and peptide-related businesses. The advisory group scheduled evaluations for three additional peptides on Friday.
Did you know? Peptides are essentially smaller versions of proteins. They have surged in popularity for uses ranging from skin rejuvenation and hair growth to gut health and injury recovery, despite a lack of scientific evidence supporting those claims.
Influence of Wellness Influencers and the Gray Market
Peptide therapies have gained traction through endorsements from wellness influencers, podcasters, and Health and Human Services Secretary Robert F. Kennedy Jr., who stated he is a “big fan” of the treatments. BPC-157 and TB-500 are frequently paired by users as a “Wolverine stack” intended to accelerate recovery after injuries. According to the World Anti-Doping Agency, BPC-157 poses health risks to athletes because researchers have not studied it extensively in humans.
These substances largely exist in an unregulated gray market. The Biden administration previously banned compounding pharmacies from producing 20 peptides in 2023 due to safety concerns. Currently, they can be legally sold online strictly for “research use only” and “not for human consumption,” though marketing efforts often imply otherwise. Major international suppliers include China and India, with some operations shifting from crypto-funded fentanyl production to peptide manufacturing.
Conflicting Testimony on Compounding Safety and Access
During the meeting, FDA scientists advised against allowing compounding pharmacies to produce any of the seven peptides under review, citing insufficient evidence of safety and efficacy. Proponents countered that allowing U.S. compounding pharmacies to make the items gives patients access to regulated, higher-quality options via prescription.
“I’m not going to tell you that the evidence for BPC-157 is strong. It isn’t, and I won’t overclaim it,” said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers, according to meeting transcripts. “What I’d ask is that you not read thin as non-existent.” His company is preparing to launch peptide treatments if the FDA grants approval.
Other healthcare figures warned that compounding approval could create distinct complications. John Hertig, chair of the Collaborative for Evidence-Based Medicines, testified that letting compounders produce the substances signals agency endorsement. “That gets very confusing for our patients,” he said, adding that a thriving gray market will likely persist regardless of regulatory changes, pointing to similar ongoing consumer demand for gray-market GLP-1 drugs.
Frequently Asked Questions
What are peptides?
Peptides are essentially smaller versions of proteins.
Why did the FDA advisory committee vote on peptides?
The panel voted to determine whether certain unapproved peptides should be added to the agency’s bulks list, which would allow compounding pharmacies to legally create custom medications for patients.
Are these peptide therapies currently approved by the FDA?
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