In February, Robert F Kennedy Jr appeared on Joe Rogan's podcast and voiced support for peptides, the unproven treatments popular in biohacking circles. Last week, a panel within Kennedy's FDA recommended that six of seven popular but unproven peptides be reclassified to allow compounding pharmacies to sell them legally, bypassing standard safety and efficacy testing.
How the recommendation works
The panel used a reclassification method that moves peptides from a category of significant safety risk to one that permits compounding without prior FDA approval. This would let compounding pharmacies produce and sell injectable peptides before their safety or benefit is proven. The decision still requires final FDA approval.
Compounding pharmacies: from bespoke drugs to profit centers
Compounding pharmacies historically made personalized medications for patients with allergies or special needs. But after a 2012 fungal meningitis outbreak linked to a compounding facility that killed 64 people, the FDA gained oversight over bulk compounders. Still, many remain uninspected: as of July, 81% of new bulk compounders had not been inspected. Errors are more common at compounding pharmacies than at large drug manufacturers, according to research.
Political and financial ties
Several members of the advisory committee have financial ties to the peptide industry. Mark Mikhail, CEO of a major compounding pharmacy, was appointed to the pro-Kennedy MAHA PAC and has advocated for deregulation. Christina Madison, a pharmacist and former instructor, said: “Follow the money… You’re definitely seeing these strategic alliances.” Companies like Hims & Hers have seen stock prices surge over 125% since Kennedy announced his intent to expand peptide access.
Safety concerns and historical context
Janet Woodcock, former FDA chief deputy commissioner, warned that the reclassification would disrupt the “societal pact” that drugs be studied before marketing. Rogan has promoted peptides like BPC-157 and TB-500, known as the “Wolverine stack,” for recovery. Kennedy called the Biden-era FDA's restriction of these peptides “illegal” and said he was “very anxious” to make them more available. Meanwhile, patients already seek out peptides after seeing them on social media. Detroit-area pharmacist Mohammed Chammout said: “People every day ask[ed] me, ‘Can I get this peptide? How do I buy it?’” He described the current situation as “the wild west.”
Market implications
If the FDA finalizes the change, the peptide market could balloon to billions annually. Compounding pharmacies and telehealth companies are poised to profit, selling drugs that patients may pay out of pocket for, as insurance is unlikely to cover unapproved treatments. The FDA stated it is considering the committee's recommendations and will consult with the United States Pharmacopeia before a final decision.
