Robert F. Kennedy Jr. spent part of a recent episode of The Joe Rogan Experience describing how peptides — short chains of amino acids, injected for purported performance and recovery benefits — had helped him heal injuries. "Really good effect," he said on the podcast. Now the FDA appears poised to make those same compounds easier to get.
The agency is moving to restore 14 peptides to the list of products that compounding pharmacies can produce, according to The New York Times and Ars Technica. A 2023 policy removed them from the FDA's allowed list, citing insufficient evidence of safety and benefit. The reversal would hand compounding pharmacies — which make custom formulations for individual patients — a green light to sell products that have never cleared the FDA's standard drug approval process.
"It's 100 percent bro science," said Dr. Noah Raizman, an orthopedic surgeon in the Washington area, in an interview with The New York Times. Eric Topol, director of the Scripps Research Translational Institute, was more measured but no less skeptical. "The data on these peptides is just woefully minuscule," Topol told Ars Technica. "Maybe one of them actually does something good. But right now, we just know that they are a liability."
The peptides in question include BPC-157 (Body Protection Compound-157), which has been studied in rodents for gut and musculoskeletal injury but has never completed a large human trial, and growth-hormone-releasing peptides like CJC-1295 and Ipamorelin, which have limited clinical data in humans. Compounding pharmacies have sold them as research-use-only products or directly to consumers willing to email a clinic. The 2023 removal made that harder by excluding them from the FDA's approved compounding list — the category that lets pharmacies produce custom formulations of drugs meeting certain standards.
The FDA's rationale then was straightforward: the compounds lacked adequate evidence. Peptides that stimulate growth hormone carry known risks including insulin resistance, joint pain, and potential cardiac effects. The agency was tightening compounding oversight broadly, and removing compounds with thin evidence bases fit that direction.
Now the direction has changed. Under Kennedy, who leads the Department of Health and Human Services and has spoken openly about his own peptide use, the agency is moving to restore them. The timing is notable: a cabinet secretary publicly endorsing compounds on a popular podcast, then overseeing a regulatory reversal that makes those same compounds more commercially available through a channel with less oversight than an FDA-approved drug.
What changes practically if the reversal takes effect: compounding pharmacies can produce these peptides for individual patients under a prescription, without the FDA having reviewed clinical trial data for safety and efficacy. That's the distinction between FDA-approved drugs and compounded products. The former have been tested. The latter have not.
Kennedy's office and the FDA did not immediately respond to requests for comment on the timeline or whether any new evidence was reviewed. The HHS Secretary has not disclosed whether his reported personal use was part of a formal medical relationship or a self-directed experiment.
The peptide market has grown substantially over the past decade, driven partly by longevity enthusiasts and fitness communities sharing protocols on social media. The 2023 restriction squeezed that channel. A restoration would expand it. It also fits a broader HHS posture under Kennedy that has emphasized deregulation and expanded access to unproven interventions — generating praise from patient advocates frustrated by slow approval processes and criticism from physicians who worry patients trade safety for speed.
The policy reversal also raises a straightforward question about process: the 2023 removal was based on insufficient evidence. If the evidence hasn't changed, what has?
A different kind of FDA decision is landing at the same time, with opposite implications for access.
In February 2026, the FDA published the Plausible Mechanism Framework — the first formal approval pathway for individualized therapies targeting ultra-rare genetic diseases. The framework was designed to help patients like KJ Muldoon, a toddler who received a personalized gene editing treatment in 2025 for CPS1 deficiency, an urea cycle disorder affecting roughly one in 800,000 to one in 1.2 million newborns. KJ appeared at Rare Disease Day at the NIH on March 2, 2026, walking with only very mild symptoms — a striking improvement for a child who would typically face severe neurological damage from the condition.
But the framework comes with a catch. The FDA is simultaneously requiring manufacturing and quality control standards that academic teams cannot meet without industry partners. Kiran Musunuru, a gene editing researcher at the University of Pennsylvania who worked on KJ's treatment, said in a press release that academic teams aiming to take individualized therapies through to FDA approval will likely need close partnerships with industry to succeed in this space.
The distinction matters: the same FDA willing to relax standards on unproven peptides is raising them high enough that the scientists who built KJ's one-of-a-kind therapy may not be able to replicate the feat without a pharmaceutical company attached. Ultra-rare disease advocates spent years arguing that the FDA needed a pathway for treatments designed for a single patient. The Plausible Mechanism Framework is that pathway. But it was built for a world where the academic lab and the manufacturing facility can be the same institution — and that world no longer exists.
The CHOP and Penn team that treated KJ achieved a 30 to 40 percent correction rate in liver DNA in preclinical studies, a promising result that led to the personalized treatment. Whether that level of correction translates into durable benefit will take years of follow-up to know. What is already clear is that the next child like KJ will need more than a skilled academic lab to navigate the approval process. They will need a partner with industrial-scale manufacturing — the kind of resources that come with pharmaceutical company infrastructure.
Two FDA moves, one week: loosen the gate on compounds with no clinical trial data, tighten it on a therapy that showed genuine clinical benefit in a child. Neither decision is random. Together they describe an agency reshaping its priorities around access — but making very different bets about which kinds of access are worth the risk.
