A Food and Drug Administration advisory panel has recommended expanding the use of six unproven peptides, a move that critics warn could open a backdoor for wellness and telehealth companies to bring unapproved drugs to the commercial market.
The panel’s votes direct the FDA to place these peptides on the list of substances that compounding pharmacies—specialized facilities that custom-mix medications—are permitted to produce for patients. While such compounding is traditionally reserved for exceptional cases, it has evolved into a booming industry largely focused on copycat versions of GLP-1 weight-loss drugs.
The decisions alarmed FDA scientists who spoke at length during sessions on Thursday and Friday. However, the moves are likely to be welcomed by Health Secretary Robert F. Kennedy Jr., signaling a growing openness within the Trump administration to products championed by wellness influencers. The peptides in question are primarily administered via injection and have not undergone the FDA’s rigorous approval process.
The committee endorsed four peptides on Thursday and two additional ones on Friday, while rejecting broader use of a rarely utilized peptide.
During the meetings, FDA scientists emphasized that the peptides under review lacked proof of safety or efficacy and could pose risks to patients.
Federal scientists warned that any emerging hazards would be difficult to track, as the recommended action would shift peptide use into a lightly regulated market overseen primarily by state pharmacy boards.
Peptides have become a personal priority for Mr. Kennedy, who has used the substances and advocated publicly and privately for broader access. His office took the unusual step of appointing eight new members to the committee that convened this week, including six individuals who market peptides using terms such as “revolutionary” or claim they can “enhance disease resistance.”
These substances are chains of amino acids that signal cells to perform functions such as reducing inflammation or boosting collagen production. Fully vetted, FDA-approved peptides include insulin and GLP-1 agonists.
Unproven peptides such as BPC-157 and MOTS-c have gained popularity among social media influencers, who film themselves unboxing the products and touting benefits for skin tone and overall health. Some creators refer to peptides as “peppers” to evade content moderation and openly mock the FDA.
Other consumers are patients who feel let down by the conventional medical system and distrust the pharmaceutical industry. They purchase peptides from longevity clinics, alternative health providers, and platforms like TikTok, where the drugs are sometimes sourced from unregulated overseas labs and labeled “research grade.”
In 2023, the FDA effectively banned the peptides reviewed this week due to safety concerns. Previously, the compounds had been nominated for inclusion on the list of substances permissible for compounding but were not accepted by the agency.
Matthew Lash, an FDA compliance official, stated during Friday’s hearing that adding them to the list of legally compoundable substances would constitute a novel regulatory action.
“I don’t think we know what the potential explosion of use would look like,” he said.
The panel’s advisers, including temporary voting members, do not have the final say; FDA scientists and officials typically finalize such decisions with the commissioner’s sign-off. However, Mr. Kennedy has expressed interest in making the determination himself, according to two individuals familiar with the matter who were not authorized to speak publicly.
The FDA has struggled to keep pace with compounding pharmacies and telehealth providers as they have expanded into a multibillion-dollar industry that markets directly to consumers.
Representatives from major telehealth companies, including Hims & Hers and Noom, testified at the hearings and signaled their interest in marketing the peptides under consideration.
John Hertig, a pharmacist and board chair of the Collaborative for Evidence-Based Medicines, warned that the additions would constitute an end-run around the FDA’s rigorous approval process.
“This creates a parallel pathway to bring products to the public with far less rigor, fewer science-backed studies, and truly puts the entire patient safety system at risk,” he said.
He added: “Once it’s on the list, you lose control.”
The most notable vote favored epitalon, a peptide marketed for longevity that has been flagged as potentially increasing cancer risk.
Cell studies have shown that epitalon can lengthen telomeres, a process associated with increased lifespan. However, FDA scientists cautioned that long-term, continuous exposure to epitalon could be carcinogenic.
Among the seven members voting in favor were physicians who sell peptides, including Dr. Melissa Loseke, president and chief medical officer of the Re-new Institute in Omaha, and Dr. Kris Wusterhausen, founder of the Resurge Clinic in Weatherford, Texas.
The Re-new Institute’s website describes peptide therapy as a “cutting-edge longevity treatment” that helps the body “reduce inflammation, improve cognition and accelerate recovery.” The Resurge Clinic markets them for lowering body fat, increasing lean muscle, repairing tendons and ligaments, enhancing sexual performance, and protecting against UV light.
Dr. Asare Christian, founder of a Philadelphia-area clinic selling peptides for “longevity,” said Friday that he voted for every peptide because he treats patients with pain, which is typically managed with opioids, acetaminophen, or gabapentin—treatments that carry their own risks.
“That’s why I’m making all these choices,” he said, adding that “a lot of the things that have been said here haven’t really stressed a significant safety signal.”
Many committee members with financial ties to peptides, along with witnesses favoring expanded access, called for quality guardrails such as mandatory adverse-event reporting and purity testing. The FDA emphasized it lacks the authority to impose such conditions on unapproved drugs, stating that Congressional action would be required.
On Friday, the panel voted against broadening the use of emideltide, a sleep-inducing peptide naturally produced in the brain and linked to circadian rhythms. Small human studies, mostly from the 1980s, showed mixed results for insomnia with no reported adverse events. However, because the peptide acts on the opioid pathway, some scientists raised concerns about its addictive potential.
The committee also voted 8 to 5 in favor of widespread compounding of semax, marketed as a treatment for neurological conditions such as strokes, migraines, and facial nerve pain, as well as mental health disorders.
Animal studies suggest semax may have anti-clotting and pain-relieving effects, but the limited human research has yielded mixed results. Although human studies have primarily examined semax as a nasal spray, the committee endorsed it for both spray and injection formulations.
The FDA has stated that the final decision will be issued via a proposed rule, allowing for public comment.
Dr. Reshma Ramachandran, an assistant professor at Yale School of Medicine who was not involved in the hearings, expressed concern about how telehealth platforms might adopt these peptides. She cited a recent study finding that such services often issued GLP-1 prescriptions with minimal patient interaction, sometimes within five minutes.
“If the FDA moves to allow compounding of these peptides, you can expect these telehealth platforms to act as peptide pill mills, with clinician oversight existing in name only, not in practice,” she wrote in an email.