FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next?

The vote is non-binding and will still need sign off from the FDA.

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.

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 sayi