An FDA advisory panel has narrowly endorsed the addition of four unproven peptides to the agency's bulk list, despite concerns over their safety and efficacy.
Washington DC, United States Jul 24, 2026 ALN: Peptides are inching closer to the mainstream.
A panel of experts on Thursday narrowly recommended that the Food and Drug Administration (FDA) reclassify four popular peptides—including one endorsed by podcaster Joe Rogan—to allow certain pharmacies to legally dispense them. This recommendation marks a significant moment in the evolving landscape of peptide therapies, which have garnered increasing attention in recent years.
In an at-times emotionally charged meeting that lasted more than 11 hours, members of an FDA advisory committee heard data presentations from FDA staff on four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—as well as testimony from health care practitioners, patients, pharmacies, and clinics. The complexity of the discussions reflected the ongoing debate surrounding the safety, efficacy, and ethical implications of these substances.
Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s bulks list, meaning compounding pharmacies can use them to create custom medications for patients. The fourth peptide—MOTs-C—received a seven-to-five vote in favor, with two abstentions. The advisory panel, which includes several members tied to peptide-related businesses and telehealth clinics, will consider three more peptides on Friday, potentially expanding the list of approved substances.
Peptide therapies have been growing in popularity thanks to endorsements from various public figures, including podcasters and wellness influencers. Prominent among these is Health and Human Services Secretary Robert F. Kennedy Jr., who has openly expressed his support for peptide therapies, describing himself as a “big fan.” This kind of high-profile endorsement has contributed to the increasing public interest in peptides, which are essentially smaller versions of proteins and are being touted for a wide range of applications—from skin rejuvenation and hair growth to gut health and injury recovery. However, many of these claims lack robust scientific backing, raising questions about the validity of the marketed benefits.
Many peptides currently exist in an unregulated gray market following the Biden administration's decision to ban compounding pharmacies from producing 20 peptides out of safety concerns in 2023. This has led to a situation where these substances can be legally sold online for "research use only" and "not for human consumption," yet the marketing of these products often heavily implies otherwise. The global supply chain for these peptides is also concerning, with China and India identified as major suppliers. Alarmingly, some illicit labs, previously focused on producing substances like fentanyl, have shifted their operations to manufacture peptides, further complicating safety and regulatory issues.
During the meeting, the FDA’s own scientists recommended against allowing compounding pharmacies to produce any of the seven peptides being considered due to a lack of evidence showing they are safe and effective. Proponents of peptide therapies, on the other hand, argued that allowing US compounding pharmacies to produce these substances could provide patients with safer, regulated options when prescribed by a healthcare professional.
“I'm not going to tell you that the evidence for BPC-157 is strong. It isn't, and I won't overclaim it," said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers. The company is actively preparing to launch peptide treatments in anticipation of the FDA greenlighting some peptides. This statement underscores the tension between the existing scientific skepticism and the commercial interests at play in the burgeoning peptide market.
Among the peptides approved, two—BPC-157 and TB-500—are particularly popular with podcasters and influencers. They are often paired as part of a so-called “Wolverine stack,” which is marketed to help improve recovery after injuries. The committee was specifically asked to evaluate BPC-157, which is thought to promote tissue repair, particularly for conditions like ulcerative colitis. However, the World Anti-Doping Agency has raised concerns about BPC-157, stating that it poses risks to athlete health due to the lack of extensive human studies.
Some healthcare providers testified that patients of theirs had turned to the gray market to buy peptides and ended up with products that were laced with illicit substances, raising significant safety concerns. While FDA approval may help reduce some of those risks, other commenters cautioned that it could create new ones. John Hertig, chair of the Collaborative for Evidence-Based Medicines, articulated this concern, stating that allowing compounders to make these peptides sends the message that the FDA is endorsing their use. “That gets very confusing for our patients,” he said, emphasizing that the existence of a gray market should not be a justification for allowing compounding of these peptides.
Hertig further argued that there will still be a gray market even if the FDA allows for compounding of these peptides. He cited the example of patients still seeking out gray market GLP-1 drugs, despite the availability of several FDA-approved drugs on the market. This indicates a deeper issue with patient trust and the perceived efficacy of approved medications.
Adriane Fugh-Berman, a physician and professor at Georgetown University, also challenged the notion that allowing legal versions would eliminate the gray market. “Would the government endorse companies manufacturing heroin because it would be cleaner than what's sold on the street?” she posed rhetorically. “Just because the market is large doesn’t mean it should be legalized. It means that a product should be studied.” Her comments reflect a broader ethical debate about the responsibilities of regulatory bodies in the face of unregulated markets.
The experts who voted against adding these four peptides to the bulk list cited a lack of data to support their use. Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, was one of the committee members who voted against allowing the four peptides to be compounded, citing unknowns around safety and potential confusion for the public. “I'm just concerned that we're entering a Pandora's box here,” she said, highlighting the potential long-term implications of such a decision.
For now, the panel’s recommendations are just that—recommendations. A formal FDA decision will likely not come for several months, leaving the future of peptide therapies in a state of uncertainty. The decision will not only impact the compounding pharmacies and the patients they serve but also set a precedent for how similar substances might be handled in the future. As the landscape of peptide therapies continues to evolve, stakeholders from various sectors, including the pharmaceutical industry, healthcare providers, and patients, will be watching closely to see how the FDA navigates these complex issues.
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