Peptides are under scrutiny in an FDA meeting running July 23-24Olena Malik/Getty ImagesAn unconventional FDA panel is reviewing peptide safety, focusing on banned therapeutic peptides.The FDA raised concerns over peptide safety, citing immune reactions and a lack of evidence of efficacy.Better access to peptides could open up a multibillion-dollar market for telehealth companies.Nearly 2 years after Robert F. Kennedy Jr. vowed to end the FDA's "war" on peptides, he has convened an unusual FDA advisory committee.A panel is meeting this week to weigh the future of several popular peptides — including trendy compounds prized for injury recovery, fat loss, and sleep that the FDA has banned.Unlike a typical FDA panel, several members make their living prescribing, researching, or selling peptide therapies, raising questions about how the debate will unfold.The compounds under review aren't GLP-1 drugs or insulin — both FDA-approved peptides. These are lesser-studied injections that have gained traction in fitness and wellness circles.Under Kennedy's leadership, this team of doctors, peptide sellers, and pharmaceutical experts is evaluating 7 compounds that the FDA recently barred pharmacies from compounding in the US. On the first day of the meeting, July 23, the panel voted to approve the ever-popular "wolverine" shot, BPC-157, marketed for speedy recovery and wound healing. Others being discussed during the two-day meeting include TB-500 (touted for wound healing) and epitalon (ostensibly a hack for insomnia).Here's a breakdown of the big issues and power players you need to know to wrap your head around the fiery debate.What is a peptide?Peptides are an incredibly broad category of substances.At the most basic level, they're signaling molecules that aren't long enough to be considered proteins. Our bodies produce thousands of peptides every day.Insulin, GLP-1 drugs, and the growth hormone tesamorelin are all peptides that are already FDA-approved to treat certain conditions.There is also a gray market of peptides that have gained popularity as fitness and wellness hacks — there's one that ostensibly tans your skin, and another that people use to build lean muscle.The FDA says each peptide deserves its own careful evaluation, including safety and efficacy testing, just like a drug.The FDA's case against these peptidesThe US Food and Drug Administration has long played whack-a-mole with peptide production and distribution.In 2023, under the Biden Administration, 19 peptides were removed from the list of substances that US compounding pharmacies can legally prepare due to safety concerns.Last week, ahead of the meeting, the FDA released a fresh string of documents recommending against bringing the seven peptides in question back into compounding pharmacies nationwide.The FDA reviewed the available clinical evidence for each peptide and raised concerns about both its safety and efficacy.The safety concerns center on the potential for immune reactions to peptides, the possibility that "your immune system wants to go a little bit haywire when you start injecting things," as peptide practitioner James LaValle, who is scheduled to testify during the meeting, told Business Insider."I think that's one of the biggest concerns from the FDA side," LaValle, who chairs the International Peptide Society, said. "There's a lot of research that's being done to try to be supportive and create assurances around that."The FDA also cites a lack of evidence that these compounds really work. The argument, in a nutshell: Why allow products to be dispensed from compounding pharmacies that, at best, don't work, and at worst, could cause serious health problems?"It's not true that there's something inherent in peptides that makes it not susceptible to the conventional aspects of FDA regulation," Peter Lurie with the science advocacy group Center for Science in the Public Interest told Business Insider."What they're 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."The industry's case for better peptide access — the key to a multibillion-dollar marketIndustry leaders argue that peptides are here to stay, and that means we need better access to peptides and a safer supply.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 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."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 told Busin
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