An advisory committee for the Food and Drug Administration has narrowly voted to add six peptides to a drug compounding list.
Over a two-day hearing on Thursday and Friday, the Pharmacy Compounding Advisory Committee voted to recommend that BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax be added to an approved list of ingredients that specialty pharmacies can use to make custom medications.
The decision could reshape how Americans access peptides, siding with popular demand over warnings from the agency’s own scientists.
The vote is non-binding and will still need sign off from the FDA. Robert F. Kennedy Jr, who oversees the FDA as the Health and Human Services Secretary, has expressed his support for peptides.
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. But others have exploded in popularity online despite a lack of robust data, with influencers suggesting they can help build muscle, improve metabolism and more.
The panel rejected adding a seventh peptide, emideltide, to the list, citing especially weak evidence. The compound was proposed as an under-the-skin injection to treat narcolepsy and opioid withdrawal, yet clinical studies used an intravenous route, which puts an injection directly into a vein.
The studies consisted of a single patient case report for narcolepsy and two small, uncontrolled studies for opioid withdrawal. The FDA also noted emideltide is poorly understood and that well-tested, approved treatments already exist for both conditions.
The votes exposed a deep divide between the outside advisers, appointed under the Kennedy-led HHS, and the FDA’s own reviewers. Six of the eight recently appointed members run clinics that offer peptides.
Stock photo of a woman holding BPC-157 peptide injection pen at home.
Martin-dm/STOCK PHOTO/Getty Images
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 the compounds could trigger harmful immune reactions.
The committee members who voted yes framed their support as a way to reduce harm, steering consumers away from a booming online black market, where many people already buy these compounds from overseas sellers as unregulated “research chemicals,” with no doctor involved and no guarantee of what’s in the vial.
“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 strongly pushed back, warning that adding these peptides to the list could set a dangerous precedent.
“Would the government endorse manufacturing heroin because it’s cleaner than what is sold on the street?” Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University, said during public testimony. “Just because a market is large doesn’t mean that a product should be legalized. It means that a product should be studied.”
What it means for patients
Adding these peptides to the list does not turn them into supplements anyone can grab off a store shelf nor does it mean the FDA has declared them safe or effective.
Instead, it opens a narrow, regulated path. Specially licensed compounding pharmacies that mix customized medications for individual patients could legally buy the raw ingredients and prepare them for someone with a doctor’s prescription.
Landing on the list does require some safeguards, such as confirming where ingredients come from and testing them for contamination.
But these custom-mixed products still skip key protections that come with standard FDA-approved drugs, including ongoing tracking of dangerous side effects and clear safety labeling.
What happens next
The recommendations are not binding. Before anything becomes official, the FDA must review the meeting records, public comments and votes, then publish proposed rules and open them for feedback, a process that can take up to a year.
However, top public health officials could speed things along. Kennedy has publicly backed wider access to peptides, casting restrictions as unnecessary barriers that may push patients to the grey market.
The logo of the US Food and Drug Administration (FDA) is seen on a sign outside the agency’s White Oak campus in Silver Spring, Maryland, on July 17, 2025.
Issam Ahmed/AFP via Getty Images
The recommendations are a major win for the fast-growing telehealth, wellness and medical spa industries, which stand to profit from offering more treatments.
Drug manufacturers oppose the move, warning it creates a loophole around the years of clinical trials normally required to approve a medication.
For now, safety advocates and scientists worry patients will mistake a spot on the list for an official stamp of approval.
“When you write a script for TB-500, what form do you think your patients are getting? Does anyone know? I certainly don’t,” Russell Wesdyk, associate director for Regulatory Affairs at the FDA’s Center for Drug Evaluation and Research, said during the hearing. “If you don’t know what it is and I don’t know what it is, how do I put it on the list?”
Yonathan Daniel, M.D., is an internal medicine resident physician at NYU Langone Health and a member of the ABC News Medical Unit
Leave a Reply