FDA panel recommends wider access to peptides despite safety concerns, Stanford expert says

OAKLAND, Calif. - A panel of outside experts told the U.S. Food and Drug Administration this week that it should make six types of peptides more available to the public — a recommendation that contradicts advice from the agency's own scientists.

Peptides are amino acids, or protein building blocks, that can be used as a type of medicine, sometimes injected directly into the body. Health influencers have touted their use for everything from muscle repair and improved energy to better sleep and skin. Some of the newly recommended peptides are classified as doping substances by international sports authorities.

Rachele Pojednic, a faculty member at Stanford University and chief science officer at Restore Hyper Wellness, said the peptides in question have not undergone the same testing as approved medications such as insulin or GLP-1 drugs.

"These particular peptides have actually not gone through all of the safety and clinical testing that the ones that you might take as true medications have," Pojednic said. "And that's the major concern by the FDA panel, the scientists and the clinicians that recommended not to move them forward to bring out into the commercial space because they just have not been through the testing."

Pojednic said claims made by social media influencers about the peptides' benefits are largely unsupported by clinical research.

"There's a lot of information on Reddit right now about these peptides, but there isn't a lot of good clinical human subjects data," Pojednic said. "So this is the problem is that people that are seeing these headlines are left to kind of go out on a bit of a wing and a prayer and hope that what these claims the influencers are making are actually true."

She said some peptides have preclinical data from studies in cells or animals, but lack human data, adding that influencer claims are "really just hype" building on repetition rather than evidence.

Beyond injection-site soreness, Pojednic pointed to a more serious safety concern: many of the peptides are growth hormone secretagogues, meaning they prompt the body to produce more growth hormone.

"The problem is, is once you inject something like this into your body, you can't control what grows," Pojednic said. "The concern of many of these clinicians and scientists is if you have some precancerous lesion or some kind of DNA damage, it could actually lead to diseases like cancer in the future."

Pojednic also said there is limited data on proper dosing.

"We actually don't have good ideas around dosing," she said. "How much should you actually be taking? Should you take it every day? Should you cycle on, should you cycle off? Again, if you come back to the Reddit threads, there's a lot of people that are making their best guess out there, but really we don't have those clinical studies to define when, how, and who should be using these peptides."

Part of the FDA panel's argument for expanding access is that the peptides are already available through a so-called gray market online. Pojednic said that market presents its own risks, since raw peptide material is often shipped from labs in India or China without rigorous testing of what's actually in the vial.

"You don't know what's in that vial when you get it, which is a real problem," Pojednic said. She said moving the peptides into the regulated 503A pharmacy and prescription system would create a supply chain that can be trusted and allow clinicians to oversee administration and track safety data — work she said she is involved in through real-world data collection on wellness therapeutics.

"I think both things need to be happening at the same time," she said, referring to further research and improved access through regulated channels.