Nearly two years after Robert F. Kennedy Jr. vowed to end the FDA's crackdown on peptides, an unconventional advisory committee convened on July 23 to decide the fate of seven popular but banned compounds. The panel, which includes doctors and sellers of peptide therapies, voted to approve BPC-157,…
Approximately two years after Robert F. Kennedy Jr. promised to stop the Food and Drug Administration's campaign against peptides, he has assembled an unusual advisory committee. The panel is meeting this week to consider the regulatory future of several popular peptides, including compounds used for injury recovery, fat loss, and sleep. The FDA had previously banned these substances from compounding pharmacies.
Unlike typical FDA advisory panels, several members of this committee earn their living by prescribing, researching, or selling peptide therapies. This composition has raised questions about how the debate will unfold and whether conflicts of interest will influence the outcome. The committee includes doctors, peptide sellers, and pharmaceutical experts evaluating seven compounds that the FDA recently barred pharmacies from compounding in the United States.
On the first day of the meeting, July 23, the panel voted to approve the ever-popular "wolverine" shot, known as BPC-157, which is marketed for speedy recovery and wound healing. Other compounds being discussed during the two-day meeting include TB-500, touted for wound healing, and epitalon, advertised as a hack for insomnia. These are not GLP-1 drugs or insulin, both of which are FDA-approved peptides. Instead, they are lesser-studied injections that have gained traction in fitness and wellness circles.
Peptides are a broad category of substances. At the most basic level, they are signaling molecules that are not long enough to be considered proteins. The human body produces thousands of peptides every day. Insulin, GLP-1 drugs, and the growth hormone tesamorelin are all peptides that have already received FDA approval to treat certain conditions.
Beyond these approved uses, there is a gray market of peptides that have become popular as fitness and wellness hacks. One compound reportedly tans the skin, another is used to build lean muscle. The FDA maintains that each peptide deserves its own careful evaluation, including safety and efficacy testing, just like a drug.
The FDA has long played a game of whack-a-mole with peptide production and distribution. In 2023, under the Biden administration, 19 peptides were removed from the list of substances that U.S. compounding pharmacies can legally prepare, due to safety concerns. Last week, ahead of this meeting, the FDA released a fresh set of documents recommending against bringing the seven peptides in question back into compounding pharmacies nationwide. The agency reviewed the available clinical evidence for each peptide and raised concerns about both safety and efficacy.
The safety concerns center on the potential for immune reactions to peptides. James LaValle, a peptide practitioner and chair of the International Peptide Society who is scheduled to testify during the meeting, told reporters that there is a possibility that "your immune system wants to go a little bit haywire when you start injecting things." LaValle said that this is one of the biggest concerns from the FDA side. He noted that a lot of research is being done to try to be supportive and create assurances around that issue.
The FDA also cites a lack of evidence that these compounds actually work. The agency's argument, in a nutshell, is why allow products to be dispensed from compounding pharmacies that, at best, do not work, and at worst, could cause serious health problems. Peter Lurie, with the science advocacy group Center for Science in the Public Interest, stated that there is nothing inherent in peptides that makes them not susceptible to the conventional aspects of FDA regulation. He said that what the committee is asking is to "unleash upon the American public a group of products for which they haven't bothered to create any evidence of safety or effectiveness."
Industry leaders argue that peptides are here to stay, and that means better access and a safer supply are needed. Jeff Cohen, co-founder of the American Peptide Association, which provides clinical guidance for doctors and organizations, says that the FDA system of evaluating and approving drugs based on expensive, large-scale clinical trials is unrealistic for this industry. Cohen argues that so-called "n of 1" medicine, a system in which the consumer sits in the front seat of their care using trial and error to determine their own stack of medications, should be respected.
Cohen told reporters, "I think they should take a step back and say: how do we validate safety and efficacy for a product that is consumer-driven, that is all over the consumer space, without sacrificing consumer access?" Cohen said he has tried many peptides and wants the committee to preserve access while promoting a safer supply. Since many people get their peptides online through sellers operating in a gray "research purposes only" market, Cohen says it would be better to create a new set of standards for peptide sellers, ensuring purity and potency of these compounds.
"It's a reality. And if they act like it's not a reality, all they're going to do is drive people into darker areas of the world to source products that are not safe," Cohen said ahead of the FDA meeting. The push for access is not just about convenience; it reflects a belief among peptide enthusiasts that the current regulatory framework is ill-suited for products that have evolved through consumer demand rather than traditional drug development.
Several new members of the advisory committee run peptide-selling clinics and promote peptide therapy. Lurie commented on this conflict, saying, "It's unheard of for somebody who is selling a product to vote on an advisory committee on that very product." Although the committee's decisions are non-binding, the FDA has historically followed its recommendations.
The article also noted six peptide-prescribing doctors and clinic heads who could potentially win more business from the committee's decisions. The presence of these individuals on the panel underscores the unconventional nature of this meeting and the high stakes involved for both the peptide industry and the FDA's regulatory approach.
The outcome of this two-day meeting could set a precedent for how the FDA handles other peptides in the future. If the committee recommends allowing wider compounding of these seven compounds, it could signal a shift away from the agency's traditional stance. If it upholds the ban, it may reinforce the existing restrictions and push more consumers toward unregulated online sources. Either way, the debate reflects a broader tension between those who see peptides as valuable wellness tools and those who insist on rigorous safety and efficacy standards.
Peptides referenced: BPC-157, TB-500, Tesamorelin, Epithalon, Growth Hormone, GLP-1.
Vendors referenced: In Peptides.
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