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A Food and Drug Administration (FDA) advisory panel has recommended loosening restrictions on several peptides, despite warnings from government scientists that evidence for their safety and effectiveness remains thin.
Peptides have become increasingly popular among wellness influencers and celebrities in recent years, who have cited them as being antiaging, anti-inflammatory and supportive of longevity. The panel's guidance would open the door for certain pharmacies to produce substances—such as BPC-157, KPV and TB-500—and give them to patients via a prescription.
The FDA's Pharmacy Compounding Advisory Committee voted 8-6 on Thursday, with one abstention, to recommend adding BPC-157, KPV and TB-500 to the agency's 503A bulk drug substances list.
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The vote does not mean the peptides have become FDA-approved drugs. Instead, it is a nonbinding recommendation that, if adopted, could allow state-licensed compounding pharmacies and physicians to make them under certain conditions. While the FDA is not required to follow the panel's recommendations, it often does.
On Friday, a spokesperson for the Department of Health and Human Services (HHS) told Newsweek that the FDA convened the Pharmacy Compounding Advisory Committee to evaluate available evidence, including newly submitted information, on the peptides' potential benefits, risks and safety. The spokesperson said the committee's recommendations would help inform the agency's decision-making process.
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What Has Health Secretary, Experts Said About Peptides?
Health Secretary Robert F. Kennedy Jr. has described himself as a "big fan" of peptides, previously vowing to overturn FDA restrictions put in place under the Biden administration. The health secretary also added new members to the agency's advisory panel, several of whom allegedly have peptide-related business ventures, the news outlet MedPage Today reported.
The HHS spokesperson told Newsweek that all committee members "underwent the same ethics review and vetting process required of all FDA advisory committee members" and that candidates who could not meet ethics requirements "were removed from consideration."
The spokesperson also said the FDA is "committed to robust, transparent discussions about the products it regulates to ensure Americans can make informed decisions about their health."
Some experts are deeply concerned about the panel's recommendation. Dr. Pieter Cohen, an associate professor of medicine at Harvard University, told Newsweek that there is "absolutely not" enough evidence that these peptides are safe for human use. He added that there also was not enough evidence to support claims that they had muscle healing, longevity or antiaging benefits.
"The safety of these compounds are unknown in humans," Cohen said. "If they were to increase the risk of cancer or heart disease, we wouldn't know."
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What Are Peptides?
Peptides are short chains of amino acids, the same building blocks that make up proteins. Some occur naturally in the body and help regulate processes such as inflammation, appetite, pigmentation, tissue repair and hormone signaling.
BPC-157, short for body protection compound 157, is derived from amino acids found in human gastric juice, but it does not have the same structure as known intestinal peptides. A 2025 study published by the National Institutes of Health described BPC-157 as having antioxidant, anti-inflammatory and wound-healing effects in preclinical models in animals, but it emphasized that comprehensive human clinical studies were lacking.
KPV is a three-amino-acid peptide, derived from an amino acid hormone made in the pituitary gland. Much of the KPV research to date has investigated whether it can reduce gut, skin and wound inflammation in cell and animal models. But again, researchers have emphasized that this does not translate directly to effects on human biology.
TB-500 is commonly described as a synthetic fragment related to thymosin beta-4, a naturally occurring amino-acid peptide found in many human cells. It has been associated with cardiac repair, stroke recovery and wound repair in preclinical studies. However experts caution that one meaningful human dataset relates to full-length thymosin beta-4, not necessarily the TB-500 fragment sold in wellness settings, and that clinical review of TB-500 in humans remains thin.
Why Are People Using Peptides?
Peptides have become popular in wellness and "biohacking" circles, where they are marketed for muscle recovery, injury healing, antiaging, sleep, energy and longevity, even though many of these claimed uses are not supported by FDA-approved indications.
The claims are therefore driven predominantly by cell or animal models, which have indicated that peptides have the potential to reduce inflammation and oxidative stress and the potential for wound healing and tissue regeneration. However, most of these peer-reviewed studies repeatedly stress that promising preclinical findings do not establish safety or efficacy in humans.
That aside, demand appears to be rising across the broader peptide and peptide-supplement market. For example, Market Research Future estimated the broader peptides market at $43.12 billion in 2024 and projected growth to $91.79 billion by 2035. The market analysis company said the North American market remained the largest at present, but that the Asia-Pacific region was showing the fastest market growth.
Growing interest in peptides is also demonstrated in analysis of U.S. Google searches for the compounds. The peptides website, peptidesexplorer.com, found that in the U.S., the search term "how to get peptides" was the largest growing search term of all those analyzed—with a growth of 1,019 percent between March 2025 and February 2026.
The term with the highest number of searches in February 2026 was "are peptides safe," with 27,100 searches in the U.S. that month—suggesting that while interest in peptides use is rising, so are concerns around their safety.
What Are Peptides Safety Concerns?
FDA scientists have raised concerns that there is limited evidence that the BPC-157, KPV and TB-500 peptides are safe or effective for medical use, and that in some cases the chemical identity of the substances is not well characterized.
They also warned of immunogenicity risk for injectable formulations, which means a risk of triggering an immune response in the body.
The advisory panel is set to vote on another three peptides on Friday. These are emideltide, which is used for opioid withdrawal, chronic insomnia and narcolepsy; semax, for conditions such as migraines; and epitalon, for insomnia.
Of these peptides and the three the panel previously voted on, emideltide is considered the most heavily researched, as the FDA said it has been studied in humans since at least 1981.
However, despite the length of investigation, studies have been inconclusive of its benefits, and FDA staff have noted that the agency "did not identify nonclinical toxicity studies to inform safety considerations for potential clinical uses of emideltide."
Dr. Caleb Alexander, a professor of epidemiology at Johns Hopkins University, told Newsweek that "there is next to no published data regarding these products, the peer-reviewed evidence base isn’t just thin, it is almost non-existent."
Dr. Peter Lurie, president and executive director of the U.S. non-profit Center for Science in the Public Interest, also told Newsweek that there is not enough evidence to know whether these products are safe for human use. He also said the FDA reviews "establish that for all of the seven peptides the evidence for efficacy is either extremely thin or non-existent."
Lurie said that there are several risks consumers face when buying peptides currently, including "contaminants, especially infection, due to poor compounding practices, wasteful expenditures of funds of products that are not known to work, and, perhaps most importantly, diversion from actually effective products approved by FDA."
He added that he thought there "should be research on these and patients can enroll in trials. In principle, companies could file an Investigational New Drug application and generate some data, but these people are more interested in pursuing a fast buck."
Is This How Experimental Drug Reviews Usually Work?
Cohen said the proceedings were "a complete inversion" of the usual experimental drug review process. He said, "Typically, the panel is a group of experts who carefully debate the evidence of safety and efficacy to decide if the benefits outweigh the risks."
"To begin with, experimental new drugs that lack evidence of efficacy or safety would not be presented to an FDA panel," Cohen said. "If they were, the panel would have voted against approval."
"The peptide decisions undermine the very principle that the FDA will approve drugs only after careful clinical trials have been completed," he continued, adding that he did not think peptides should be made available via prescription in this way.
Alexander said "this isn’t what the bulk compounding list was designed for. It was never intended as an on-ramp to the marketplace."
He said the compounding list was "intended as a means for pharmacists to compound a drug for an individual patient when the standard product won’t suffice—a child who cannot swallow a tablet, a patient allergic to a dye in the commercial formulation."
"It’s shocking to think that the FDA could allow for these products to be added to the compounding list when the evidence is so thin, and when the main argument to do so is one of 'harm reduction'," he added. "By those standards, what’s to keep any substance from being added—the criteria become so cheapened that it’s unclear what would prevent any substance from being added so that we can learn more about it."
Contact Newsweek editors on this story: Sam Stevenson and Shakeema Edwards.
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