An FDA peptide panel narrowly voted Thursday to recommend that four unapproved peptides, BPC-157, KPV, TB-500 and MOTs-C, be added to the agency’s bulk substances list, a move that would let certain compounding pharmacies make them for patients with prescriptions if the Food and Drug Administration follows the advice.
The recommendation does not make the peptides FDA-approved drugs. It would instead affect whether compounders can legally use the substances to prepare customized medications. A formal FDA decision is expected to take several months, according to the meeting discussion.
The vote came after an advisory committee meeting that ran more than 11 hours and included presentations from FDA staff and testimony from health care providers, patients, pharmacies and clinics. Three of the peptides received eight votes in favor, six against and one abstention. MOTs-C received seven votes in favor, five against and two abstentions.
What did the FDA peptide panel vote on?
The panel voted on whether the peptides should be placed on the FDA’s bulks list. That list matters because compounding pharmacies can use listed substances to make patient-specific medications, a different regulatory lane from the one used for FDA-approved drugs.
The four peptides are part of a broader group of seven under review. The committee is set to consider three more peptides on Friday. FDA scientists recommended against allowing compounding for all seven, citing insufficient evidence that they are safe and effective.
Peptides are short chains of amino acids, smaller than proteins. In the wellness market, sellers and influencers pitch them for skin, hair, gut health, injury recovery and other uses, even where clinical evidence is thin or missing. Health and Human Services Secretary Robert F. Kennedy Jr. has said he is a “big fan” of peptides, and podcaster Joe Rogan has endorsed at least one of the peptides under discussion.
Why are BPC-157 and TB-500 controversial?
BPC-157 and TB-500 have become popular in podcast and influencer circles, including as a so-called “Wolverine stack” promoted for recovery after injuries. The committee considered BPC-157, which proponents say may aid tissue repair, in the context of ulcerative colitis.
The World Anti-Doping Agency has warned that BPC-157 poses a risk to athletes because it has not been extensively studied in humans. That is the part of the peptide boom that tends to get lost between supplement-style marketing and medical-sounding claims: a compound can be popular online and still lack the evidence base regulators usually want before patients start injecting or ingesting it.
The market is already messy. The Biden administration barred compounding pharmacies from producing 20 peptides in 2023 over safety concerns. Many peptides are still sold online under labels such as “research use only” and “not for human consumption,” while marketing often points customers toward human use. WIRED has reported that China and India are major peptide suppliers and that some crypto-funded fentanyl labs have moved into peptide production.
Who argued for and against compounding?
Supporters told the committee that legal compounding would give patients access to products made by US pharmacies rather than pushing them toward the gray market. Anant Vinjamoori, chief medical officer of Hims & Hers, told the panel the evidence for BPC-157 is not strong, while arguing that limited evidence should not be treated as no evidence. Hims & Hers is preparing peptide treatments in anticipation of possible FDA action.
Opponents said the recommendation could make patients think the FDA had endorsed the peptides as safe and effective. John Hertig, chair of the Collaborative for Evidence-Based Medicines, argued that the existence of gray-market products is not a reason to authorize compounding, noting that patients still seek gray-market GLP-1 drugs even though FDA-approved versions exist.
Adriane Fugh-Berman, a physician and Georgetown University professor, also challenged the safety argument. She said a large market should lead to study of a product, not legalization by default.
Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center and a committee member who voted against adding the four peptides, cited unresolved safety questions and public confusion. The FDA now has to decide whether the panel’s narrow vote is enough to move these compounds out of regulatory limbo.
This story draws on original reporting from WIRED.
