The U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland. —Valerie Plesch/Bloomberg—Getty ImagesIn a highly unusual move, a U.S. Food and Drug Administration (FDA) committee voted against FDA staff’s own advice in a meeting on July 23, recommending that two peptides, called BP-157 and KPV, be added to a list that will allow certain specialty pharmacies to dispense them. Currently, those peptides—and the other five being considered—are in a legal gray area. Here’s what to know.What are peptides?Peptides are short chains of amino acids, which are the building blocks of proteins. Peptide concoctions have grown in popularity over the past several years as injectable substances that proponents claim improve energy, sleep, sex drive, and more. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has supported reclassifying peptides to improve people’s access to them. However, experts have expressed concern that there is little scientific evidence to support the peptides being considered. Why is an FDA committee meeting about peptides? The FDA convened the committee meeting on July 23 and 24 to debate whether to recommend that seven popular peptides be included on a list, called the 503A bulks list, that would allow compounding pharmacies to dispense them. Many of the voting members on the committee consult with or are employed by companies that could promote or dispense peptides. Usually, these FDA panels are composed of academics and researchers. The committee’s recommendation is not a binding decision, and the addition of BP-157, KPV, and any other peptides to the list will still have to go through a lengthy public rulemaking process. But it is unprecedented for a drug to be put on the pathway to widespread adoption in this manner instead of having to go through the more arduous and evidence-based FDA drug approval process, experts say. Most drugs are not dispensed through compounding pharmacies at all but are instead approved by the FDA and manufactured by drug companies under strict FDA supervision. Why are these peptides being discussed?In 2023, the seven peptides being discussed—BPC-157, KPV, TB-500, MOTS-C, Emideltide, Epitalon, and Semax—were among more than a dozen that the FDA essentially banned compounding pharmacies from dispensing, saying that they “may present significant safety risks.” Compounding pharmacies are specialty pharmacies that produce drugs with a doctor’s prescription; they are not subject to the type of FDA oversight that drug manufacturers are, but are instead largely overseen by state boards of pharmacy. Since that 2023 ban, consumers have turned to alternative sources—including suppliers in China—which puts them in danger, advocates for peptides say. In testimony on July 23, Dr. Anant Vinjamoori, chief medical officer at the telehealth company Hims & Hers, said that a colleague had recently sent him a photo of a bodega in Queens selling peptides. “This is the real alternative to FDA's permission of legitimate pharmacies to compound peptides in controlled conditions,” he said. (Both Hims & Hers and Noom, a weight-management company, advocated before the vote for peptides to be allowed to be made at compounding pharmacies.)What did the committee decide?BP-157, a synthetic 15-amino acid peptide sometimes used to treat ulcerative colitis, and KPV, which is used for inflammatory conditions, were the first peptides considered on July 23 for addition to the 503A bulks list. Both were approved.On BP-157, eight members of the committee voted yes, six voted no, and one abstained. The “yes” votes were largely from committee members who represent or advise telehealth companies, which broadly stand to benefit financially from the widespread adoption of peptides. Many of the people who voted “yes” said they wanted compounding pharmacies to dispense peptides because the alternative—patients getting the drug in the gray market—was worse. “As a physician, I have to make sure that I'm keeping patients as safe as possible. That's my mandate, right? Do no harm,” said Dr. Haleem Mohammed, chief medical officer of Gameday Men’s Health, a telehealth firm, during the hearing. “So when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? And that's why I lose sleep at night.”Mohammed went on to vote “yes,” recommending that BP-157 be placed on the 503A bulks list. (He also voted “yes” on KPV.) He later said that he voted “yes” in part for “medical freedom.” That term was echoed by the American Academy of Peptide Medicine, an industry group that has been lobbying for the inclusion of peptides on the list; its founder later said in a statement that the committee “voted to restore medical freedom and medical liberty for all of us.” What did the opposition say?People opposing these peptides’ inclusion on the list argued that little has changed since the FDA prohibited compounding pharmacies from dispensing these seven peptides in 2023. In preparatory documents for the meeting, FDA staff said that it believed the evaluation criteria “weigh against” placing BPC-157 on the list because there was limited evidence about the peptide’s effectiveness and because there are other FDA-approved treatments for ulcerative colitis. The only trial FDA staff were able to find about the effectiveness of using BPC-157 to treat ulcerative colitis was a meeting abstract reporting on the results of a study using 46 people in which the peptide was given as an enema, not as an injection. FDA staff also said that the evaluation criteria “weigh against” placing KPV on the list. None of the studies that staff found in its evaluation of the peptide were in humans. “I'm concerned that we're responding to a market-induced demand rather than a decision based in solid science,” said committee member Dr. Elizabeth Rebello, executive director of anesthesiology, critical care, and pain medicine at the University of Texas MD Anderson Cancer Center.The FDA usually relies on clinical trials when it is looking at adding a substance to the 503A bulks list, which determines what ingredients compounding pharmacies can use in mixing drugs. There are not yet significant clinical trials for these peptides, but some doctors, patients, wellness influencers, and Kennedy have voiced support for opening up the market for these drugs.“The substance's supposed benefits are largely based on anecdotal evidence, and the interest in it appears to be driven by those who stand to benefit from increased demand,” said Nina Zeldes, a researcher at Public Citizen's Health Research Group, a nonprofit watchdog group, in testimony on the morning of July 23 opposing the inclusion of BP-157.What might this mean for peptides in the U.S.?An audible gasp rippled through the room after the tally of the votes was announced for BPC-157. Some committee members said that they worried about the implications of the FDA allowing itself to skip over clinical trials when permitting pharmacies to dispense medications. “As a consumer representative, I worry what placing a bulk substance on the list conveys in terms of FDA approval,” said committee member Todd Durham, senior vice president of clinical outcomes and research at the Foundation Fighting Blindness, who voted “no” on adding these peptides to the list.This vote could also create even more safety concerns by allowing consumers to buy non-FDA-approved medications from pharmacies that are not rigorously supervised by the FDA, says Shabbir Safdar, executive director of the Partnership for Safe Medicines, a public-health group that aims to protect consumers from counterfeit or unsafe medicines. He is concerned about the standards at 503A compounding pharmacies; one of the board members of the organizations, Dr. Kenneth McCall, published a paper in 2025 finding that compounded GLP-1s were linked to higher rates of adverse effects than non-compounded products between 2018 and 2024, including more abdominal pain, diarrhea, and nausea. Reporting of prescribing and preparation errors were also higher for compounded medications, the paper found. Safdar says he knows of several instances when people had serious health problems after taking compounded medications. He worries that people will think that these peptides have robust clinical evidence behind them as a result of being added to the list. “Allowing peptides to be compounded removes incentives to go through FDA's rigorous drug approval process,” said Dr. Peter Lurie, a former FDA associate commissioner and the president of the Center for Science in the Public Interest, during his testimony at the meeting. “Any company that aspires to prove the safety and effectiveness of a peptide will turn away from them, knowing that compounders will simply be able to sell them without ever needing to generate safety and effectiveness evidence.”Indeed, Lurie continued, financial analysts are predicting a $2.2 billion telehealth marketing opportunity if these seven peptides are approved for compounding. Him & Hers stock rose more than 10% after the BPC-157 vote.