An FDA advisory panel voted narrowly this week to recommend adding six peptides to an approved list of ingredients that specialty pharmacies can use to make custom medications. The vote was non-binding and requires final sign-off from the FDA.
According to ABC News, the Pharmacy Compounding Advisory Committee voted over a two-day hearing Thursday and Friday to recommend that BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax be added to the list. A seventh peptide, emideltide, was rejected. That compound had been proposed as an under-the-skin injection to treat narcolepsy and opioid withdrawal, but clinical studies used an intravenous route instead. The evidence included a single patient case report for narcolepsy and two small, uncontrolled studies for opioid withdrawal.
Peptides are strings of amino acids, smaller than a protein. Some, like insulin and GLP-1s, are FDA-approved medicines that have been rigorously tested. Others have grown popular online through influencers who claim they can help build muscle, improve metabolism and more, despite a lack of robust clinical data.
The votes revealed a significant divide between the outside advisers and the FDA's own scientists. Six of the eight recently appointed committee members run clinics that offer peptides. FDA staff scientists had unanimously opposed every peptide being added to the list, citing a lack of solid clinical trial data, inconsistent recipes from batch to batch and the risk that the compounds could trigger harmful immune reactions.
Committee members who voted yes argued that approving the peptides would reduce harm by steering consumers away from an online black market, where many people already purchase the compounds from overseas sellers as unregulated research chemicals.
"As a physician, I have to make sure that I'm keeping patients as safe as possible," panel member Dr. Haleem Mohammed said on Thursday. "So, when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? That's what I lose sleep at night over."
Public health advocates and agency scientists pushed back, warning that adding these peptides to the list could set a dangerous precedent. Robert F. Kennedy Jr., who oversees the FDA as Health and Human Services Secretary, has expressed support for peptides.
The decision could reshape how Americans access peptides if the FDA approves the recommendation.
