rewrite this title The government may soon lift restrictions on some peptide treatments

Peptide therapies for wellness and longevity are popular, but safety concerns led the FDA to place more stringent requirements on them. Now Health Secretary Kennedy says the rules will likely loosen.

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There is big excitement in the world of peptides. Some of these unapproved treatments have been touted for longevity and wellness, and the government could soon lift restrictions on a handful of them. NPR health correspondent Will Stone reports.

WILL STONE, BYLINE: Our bodies make peptides. They’re a string of amino acids. Many of the peptide therapies in question, though, haven’t passed muster with the Food and Drug Administration, which prohibits compounding pharmacies from producing some of the most popular ones with names like BPC-157, ipamorelin and MOTS-c. That could soon change.

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ROBERT F KENNEDY JR: I mean, I’m a big fan of peptides. I’ve used them myself.

STONE: That’s health secretary Robert F. Kennedy Jr. on Joe Rogan’s podcast in late February.

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KENNEDY: My hope is that they’re going to get moved to a place where people have access from ethical suppliers.

STONE: The argument from Kennedy and other peptide fans centers on prohibition. Because of FDA restrictions, people have flocked to sketchy suppliers, often overseas. That presents a new host of dangers as people inject themselves with potentially adulterated products. Kennedy said to expect an announcement on about 14 of these peptides within a couple of weeks. That was a month ago. Scott Brunner is CEO of the Alliance for Pharmacy Compounding.

SCOTT BRUNNER: It’s all over social media. The black market and the gray market are running amok. And we would argue that American consumers would be a lot better off if FDA would allow compounding of peptides that have a demonstrated track record of safety.

STONE: He says FDA will need to move these peptides into a category that green-lights production. People are taking peptides for all kinds of reasons, like tissue healing, improved immune function, fat loss, muscle growth and longevity. But experts like Eileen Kennedy question their efficacy and even their safety. Kennedy is a chemical biologist at the UNC Eshelman School of Pharmacy who studies peptides.

EILEEN KENNEDY: There isn’t evidence for a lot of these compounds.

STONE: At least not from well-controlled human trials. Instead, much of the data come from lab studies with animals.

KENNEDY: They haven’t gone through that rigor that’s needed to ultimately know if these will have other off-target effects.

STONE: Off-target meaning they could end up damaging major organs like the liver or kidneys. It’s also possible your body mounts a massive immune response. Yes, it’s true peptides are produced naturally in our body.

KENNEDY: That doesn’t equate to it being circulated in your bloodstream and potentially reaching other places that it couldn’t normally access.

STONE: She says, this is why drugs go through trials and safety concerns, including some reports of death, are why FDA placed restrictions on these during the Biden administration. But some clinicians have pressed ahead all the same. Dr. Edwin Lee is a prominent one. He lectures on peptides all over the world and offers them in his Florida practice, the Institute for Hormonal Balance.

EDWIN LEE: I’m really impressed with the regenerative properties of peptides.

STONE: Lee points to some small studies from his clinic, for example, with the popular BPC-157, as evidence of safety, but argues drug makers will never do multimillion-dollar trials because these can’t be patented. He says, there have always been doctors on the frontier of medicine.

LEE: Someone had to be the first open-heart. Someone had to be the first transplant. This is kind of like the first part of medicine. We are kind of in that Wild, Wild West.

STONE: Lee says he gets his peptides from compounding pharmacies that are making them despite the FDA’s ban. The universe of peptide providers is vast – high-end clinics, large wellness chains, med spas, even websites advertising research-grade peptides that aren’t supposed to be used by humans. Robin Feldman at UC Law San Francisco says it’s probably a good move to take these unapproved peptides out of the back alley because people are already using them.

ROBIN FELDMAN: The question will be whether the FDA can follow up enough so that consumers aren’t misled and more black market and shady producers don’t pop up on the scene.

STONE: A spokesperson for the Department of Health and Human Services did not say when any of these peptides would be reclassified. Will Stone, NPR News.

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