The Food and Drug Administration's Pharmacy Compounding Advisory Committee voted on 23 and 24 July to let compounding pharmacies manufacture six peptides that lack FDA approval. The decisions ignore the objections of career FDA scientists who spent two days detailing safety risks and the absence of clinical trial data.

The peptides and the pathway

Each of the six peptides has a following among wellness influencers and biohackers. BPC-157 is touted for healing and has been studied in ulcerative colitis; KPV is an experimental anti-inflammatory; TB-500 is marketed for muscle recovery; MOTS-c is linked to metabolism; semax is promoted for cognitive enhancement; and epitalon is pitched as a longevity aid. The committee voted to remove all six from the FDA's Category 2 list of bulk drug substances considered too unsafe for compounding pharmacies to produce, even with a prescription. A seventh peptide, emideltide, was denied.

The votes direct the FDA to add the substances to a list that allows so-called compounding pharmacies, normally reserved for exceptional cases, to make them at scale. That prescribing pathway has already fuelled a copycat GLP-1 drug boom and now threatens to do the same for a new class of unproven injectables.

Kennedy's role and the stacked committee

Health Secretary Robert F. Kennedy Jr. had pledged to end what he called the FDA's 'war on peptides', and his office named eight new members to the advisory committee, six of whom had ties to the pharmacy or telehealth industries. Paul Kim, a partner at consultancy Kendall Square Policy Strategies, told the Financial Times that the panel was stacked with people who stand to benefit.

“The conflicts here are astonishing. It is political theatre at this point.”

FDA scientists reminded the panel that none of the peptides had passed the agency's standard safety and efficacy reviews, and they argued that any hazards would be hard to track in a market overseen mainly by state pharmacy boards.

Businesses already lining up

Companies connected to Kennedy's Make America Healthy Again movement are poised to benefit. Enhanced Group, a telehealth company with Donald Trump Jr. among its investors, is preparing to sell peptides. Its founder Christian Angermayer appeared at a MAHA event in November. Olympia Pharmaceuticals, a Florida-based compounder, has made multiple contributions to a MAHA political fundraising group run by a Kennedy associate, including one payment just a month after the FDA signalled it might loosen peptide restrictions. Olympia's chief executive sits on the MAHA group's board.

The committee recommendations are not binding, but if Kennedy grants final approval, the peptides would enter a lightly regulated market that analysts at Needham have described as a multibillion-dollar opportunity for pharmacies, telehealth providers and drugmakers.

Safety warnings and the gray market

One study cited by The New York Times found that dietary supplements, which are similarly under-regulated, cause thousands of emergency department visits each year and are a common cause of liver injury. Peptide proponents argue that patients are already buying unregulated versions online from China, and that allowing licensed compounding pharmacies to make them under state and federal guidelines would reduce risk. A self-described gray-market supplier told the panel he would continue using the drugs regardless.

“I gave myself an injection this morning. I believe in it, and I'm going to get it by whichever means possible.”

The two-day meeting ended with cheers from peptide supporters in the audience. The final decision now rests with Kennedy, who has the power to overrule the FDA.