You Might Be Able to Purchase Peptides Soon—but That Doesn’t Mean They’re FDA-Approved

6 min readFor the peptide-curious, there’s always been one major hurdle: You technically shouldn’t be able to get them in the United States. In response, some people have turned to the gray market, ordering these experimental compounds online from foreign countries and getting back unregulated vials that sometimes contain what they order and other times are tainted with substances like MDMA.That all may change soon, at least for BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. Late last week, an advisory committee to the Food and Drug Administration (FDA) met and recommended that the agency allow compounding pharmacies to start making those six. There are still a few more steps that need to happen before that becomes official (the FDA needs to review public comment, propose a rule, and get it accepted by the White House), but it’s possible that within a year’s time, getting select peptides will be as simple as going to Hers, your local med spa, or your doctor and asking for a prescription.But just because you can doesn’t necessarily mean you should. It turns out, these peptides potentially ending up on the compounding list says almost nothing about their effectiveness—and even less about their safety. Here’s what you need to know, according to experts.This wasn’t your standard FDA committee process.After two days of hearings, the Pharmacy Compounding Advisory Committee voted to recommend that six out of seven proposed peptides move to the 503A bulk drug compounding list. Seems simple enough, but this process was unique in a few ways.First, this isn’t typically the way drugs come to market. Medications mostly end up on the 503A bulk list for patients who need custom formulations of already-approved meds because of issues including allergies to certain ingredients. “It’s meant for a very small group of patients, not mass distribution,” says Reshma Ramachandran, MD, an assistant professor at Yale School of Medicine and co-director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency.Before the meeting, FDA scientists released briefing documents that strongly advised against making these peptides available due to lack of evidence and safety concerns, meaning the advisory committee went against their own experts. “The most abnormal thing here is the advisory committee overruling FDA scientists in a wholesale fashion,” says Howard Sklamberg, an Arnold & Porter Life Sciences & Healthcare Regulatory partner and former deputy commissioner for Global Regulatory Operations and Policy at the FDA.The advisory committee recently underwent some personnel changes. In the weeks leading up to the meeting, Secretary of Health and Human Services Robert F. Kennedy Jr. (RFK Jr.) appointed eight new members to the group—six of whom have ties to the peptides industry. (RFK Jr. is also a fan of the compounds.)“If you look at the vote, it pretty much matches with their conflicts in terms of whether or not they were favorable toward the peptides,” Dr. Ramachandran says. Typically, she says, committee members are required to disclose their conflicts of interest before a meeting, but that didn’t happen this time around.Regardless, that does not make these peptides FDA-approved.And that’s an important distinction. Getting FDA approval is a rigorous process. It requires clinical trials, in-depth review of both the safety and efficacy of each drug, and continuous monitoring afterward. Without that process, “we have no confirmation that these peptides are safe, effective, or of minimum quality standards,” says Dr. Ramachandran. This fact could totally be glossed over—leaving patients in the dark or even giving them the wrong message entirely. “The worry that I have is that, if FDA does give this pathway, it gives a sense of legitimacy to these peptides despite not having the evidence around them,” Dr. Ramachandran says.Despite the budding enthusiasm from people like RFK Jr., influencers, and random people online about peptides, there isn’t a whole lot of research to confirm about their benefits just yet. In his role as the chief of sports medicine in the department of orthopedic surgery at Keck Hospital of the University of Southern California, Alexander E. Weber, MD, has received a lot of questions from patients about whether peptides could help their healing process.This year, he was part of a team that conducted a review on a group of peptides that may be able to help patients recovering from orthopedic sports injuries, including BPC-157 and TB-500. “We quickly came to the conclusion that there's just zero clinical data,” Dr. Weber says. “There are no rigorous scientific studies on the peptides in question.”But it’s not just that we can’t confirm the true benefits of the peptides—we also don’t know what the risks are. The result: “Patients effectively become guinea pigs,” Dr. Ramachandran says.One of the biggest concerns with some of the peptides is cancer. “Peptides do so many things—including regulating cell replication and death—that impact cancer risk,” says Jennifer Manne-Goehler, MD, a physician at Mass General Brigham and an assistant professor of medicine at Harvard Medical School. Without long-term studies, we don’t fully know how they could affect cancer pathways, but it’s a top concern, she says.Another, more immediate problem in this case is that, without clinical trials and research, there isn’t a set formula for how compounding pharmacies should make these peptides. “Typically with bulk compounding, you would have what's called a lithograph, the defined composition of that compound,” says Eileen J. Kennedy, PhD, the Eshelman Distinguished Professor and chair of the University of North Carolina Eshelman School of Pharmacy. Without it, the structure of the drug might be just wrong enough to cause problems. If just one element is out of place, Kennedy says, the compounded drug could have different effects or toxicities.Without FDA approval, patients lose a lot of critical safeguards.It’s worth mentioning that obtaining a med through a compounding pharmacy is still very different from getting an FDA-approved and regulated drug. After being thoroughly tested through multiple clinical trials for safety and efficacy, manufacturers of FDA-approved drugs are inspected and continuously monitored to ensure they’re meeting what’s called current good manufacturing practices, or CGMP, says Sklamberg.Manufacturers undergo regular inspections, are part of a more robust surveillance system, and are required to report and track adverse events. They also have strict rules on how to make the medications, from what equipment they use to how people are trained to how to react when something goes wrong. “That is a much more protective set of regulations for manufacturing than applied to typical compounded drugs,” Sklamberg says.Ultimately, we just don’t know how it’s going to play out. “I am really worried that we're not going to see how harmful this is until it affects a lot of people, until there's some really bad behavior related to this,” Dr. Ramachandran says.We don’t know if—or when—these peptides will formally be added to the 503A list.Historically, the agency tends to go in accordance with its advisory committee. If it does in this case, it could “open up a can of worms,” Sklamberg says. For example, other drug makers might pursue this approach going forward, compared to the more rigorous FDA approval pathway.Realistically, Sklamberg says, Americans could get access to these peptides in 2027. When that happens, one major risk is that the compounding pharmacy peptide boom will outpace the FDA’s ability to monitor them. “If they proliferate but the FDA's ability to oversee them does not proliferate, you are going to have people who get hurt,” Sklamberg says.As for Dr. Ramachandran, Dr. Weber, and Dr. Manne-Goehler: They won’t be prescribing these medications to patients even if the FDA puts them on the compounding list—and they wouldn’t recommend you take them either. There just isn’t enough data about safety or long-term effects.“The number one thing we learn in medical school is first do no harm,” Dr. Manne-Goehler says. “Why would I give someone something I can't give them safely? I would never do this.”