Is peptide liberation day near, at long last?
For the past month, wellness and longevity enthusiasts have eagerly waited for the federal government to loosen restrictions on some of the trendy and unapproved therapies.
Their excitement stems from Health Secretary Robert F. Kennedy Jr.'s comments in late February on Joe Rogan's podcast, signaling that he expected the Food and Drug Administration to change the status of "about 14" of these peptides within a "couple of weeks" so that consumers can access them from "ethical suppliers."
Peptides are a string of amino acids, smaller than a protein, that are produced naturally by our body. Interest in synthetic versions of some of these has skyrocketed with people touting them for tissue repair, skin health, longevity and more.
To make good on Kennedy's promise, the FDA will have to place the peptides in question on a curated list of drug ingredients that explicitly authorizes compounding pharmacies to make them. Currently the FDA does not permit pharmacies to compound some of the most popular peptides — such as BPC-157, ipamorelin, MOTs-C and others due to safety concerns and a lack of data.
When asked for comment by NPR, Emily Hilliard, press secretary for the Department of Health and Human Services, did not offer any details about the timeline for reclassifying the products. She said the FDA's goal is to ensure Americans have access to products "produced under appropriate quality standards."
A growing unregulated market
The compounds that have gained prominence in the wellness and longevity space target a number of different biological pathways. For example, some promote growth hormones, while others modulate the immune system.
They're injected subcutaneously and often taken together in what are called "stacks," based on complementary properties.
Because of FDA's prohibition, peptide fans often purchase them from overseas and from websites that offer research-grade peptides that aren't intended for use by humans. All of this has raised a host of new risks for consumers.
"The reality is people are getting them, and they're getting them from very disreputable sources where they don't know what's in them," says Dr. Myles Spar, an integrative medicine specialist and chief medical officer at WndrHLTH. "They're injecting themselves with things that are potentially dangerous."
Spar doesn't prescribe these unapproved peptides in his own practice, but offers guidance to his patients who do use them. He says he hopes the FDA change will give patients more support.
"It's all over social media. The black market and the gray market are running amok," says Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which is pushing for the changes. "American consumers would be a lot better off if the FDA would allow compounding of peptides that have a demonstrated track record of safety."
This regulatory maneuver wouldn't ultimately change their status as unapproved drugs, though. They have largely not been tested for safety or efficacy in human trials.
While people are taking peptides for all kinds of reasons — tissue repair, skin health, body composition, immune function, longevity and so on, the evidence base mostly comes from lab work done with animals or cell cultures, along with some small studies involving humans.
Without rigorous testing, it's unknown if the compounds could have unintended, harmful effects, says Eileen Kennedy, a chemical biologist at the UNC Eshelman School of Pharmacy who studies peptide therapies.
These could include toxicity to major organ systems like the liver and kidneys, or a life-threatening immune response, she says.
(GLP-1 weight-loss drugs, which are peptides, have been thoroughly tested and FDA-approved.)
Proponents of these peptide therapies contend they have a better safety profile because they're known compounds that our bodies already make. But Kennedy, the chemical biologist, says this logic doesn't necessarily mean they will be safe when injected in higher doses and then circulated in the bloodstream, "potentially reaching other places they couldn't normally access."
"Even if it may have anti-inflammatory properties as injected into your knee and we see some reduced swelling there, if it causes liver failure, it's a concern, right? These types of things just have to be evaluated," she says.
The frontiers of medicine
But these cautions have not stemmed the appetite for the therapies.
Clinicians who offer peptides argue it's unrealistic to limit these treatments until there's high-quality human data. Because many of the compounds can't be patented, there's no incentive for drugmakers to run multimillion dollar trials on safety and efficacy, says Dr. Edwin Lee, an endocrinologist who lectures on peptides all over the world and offers them in his Florida-based practice, the Institute for Hormonal Balance.
"It will never happen," he says.
"I'm really impressed by the regenerative properties of peptides," he adds.
Lee believes the FDA didn't give these compounds a fair shake back in 2023 when the agency put many of them on a list that prohibited pharmacies from making them. He points to some small studies from his clinic, for example with the popular BPC-157, as evidence of safety. And he notes certain peptides like thymosin alpha 1 have more human data behind them.
He acknowledges that he's operating on the frontiers of medicine.
"If you go back in [the history] of medicine, someone has to be the first one to try Tylenol. Someone has to be the first one to undergo surgery," he said, "There's always someone who has to do this — this is kind of like the first part of medicine. We are in that wild, wild West."
He's concerned that the "image of peptides will be tarnished" because people will get injured or die from taking dangerous substances sold on the gray market.
His peptides come from compounding pharmacies that are making them despite the federal restrictions. "They know they shouldn't but they've done it until they get the letter from the FDA to shut down," he says.
Even if these compounds are reclassified as expected, it may take months for compounding pharmacies to ramp up the supply because they will need to stock up on pharmaceutical-grade ingredients, says Brunner who represents the industry trade group.
"If the FDA flipped a switch tomorrow, you're going to have prescribers and patients dashing to their compounding pharmacy only to be frustrated," he says.
Robin Feldman, an expert in FDA law at UC Law San Francisco, says it's "probably a good move" to take these unapproved peptides out of the "back alley and into the light" because of the current dangers to consumers.
"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," she says.
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