Experimental peptides have become darlings among influencers, chiropractors, and doctors focused on longevity, antiaging, or \u201cbody optimization,\u201d even though the FDA hasn\u2019t approved them for safety or effectiveness. Health secretary Robert F. Kennedy Jr. and other leaders of the Make America Healthy Again movement have pushed to make unproven peptides more accessible \u2014 and they\u2019ve gained traction.<\/p>\n
On Oct. 14, a temporary \u201caccess policy<\/a>\u201d appeared on a White House docket, proposing to allow licensed pharmacies to make and sell certain unapproved peptides to people. Scientists at the FDA had advised against the measure at a meeting in July<\/a>, warning that the drugs hadn\u2019t been adequately vetted in clinical trials.<\/p>\n A panel that advises the FDA disagreed, however, voting to loosen restrictions. Many of the panel members are new appointees with financial stakes<\/a> in the peptide industry. In an email, Department of Health and Human Services spokesperson Emily Hilliard said that every committee member satisfies the FDA\u2019s ethics requirements.<\/p>\n \u201cI voted \u2018yes\u2019 for patient safety, the greater good, and medical freedom,\u201d Haleem Mohammed, one of the new committee members, said at the FDA meeting<\/a>. He\u2019s the chief medical officer of a men\u2019s clinic that sells peptides, Gameday Men\u2019s Health.<\/p>\n To make good decisions, consumers need to rely on accurate information, but much of the hype around peptides is misleading. KFF Health News flags four misleading phrases commonly used by those promoting peptides \u2014 and one truth.<\/p>\n Red Flag: Peptides aren\u2019t drugs.<\/strong><\/p>\n Gary Brecka, a co-chair of the MAHA Action committee, says peptides aren\u2019t drugs in this episode<\/a> of his podcast. He talks about using them to \u201chelp regulate cortisol, improve circulation, all kinds of things.\u201d When peptides are used to treat, prevent, or cure conditions, or to affect the body\u2019s function, they are, by definition<\/a>, drugs.<\/p>\n \u201cPeptide\u201d is a general term for substances that are smaller than proteins but made of the same building blocks. Humans make many peptides, including insulin. Insulin is a drug when people inject it to regulate blood sugar.<\/p>\n \u201cMost of the drugs we have had some antecedent in nature,\u201d said Jacob Sherkow, a professor of law specializing in biotechnology at the University of Illinois Urbana-Champaign. \u201cHeroin is natural. No one in their right mind would call it not a drug.\u201d<\/p>\n Brecka did not respond to requests for comment, but Chris Woodward, a public relations representative for him, said in an email that the health issues discussed on Brecka\u2019s podcast do not constitute medical advice.<\/p>\n Red Flag: Peptides are safe because they\u2019re natural.<\/strong><\/p>\n Peptide promoters have suggested<\/a> that peptides are safe because they\u2019re natural. This clip of Brecka\u2019s discussion with Brigham Buhler, a co-author of The Peptide Revolution <\/em>and owner of a compounding pharmacy<\/a> that sells peptides, is an example. Some influencers go further, saying that peptides are safe because they\u2019re made by the human body. Buhler did not respond to requests for comment.<\/p>\n It\u2019s murky territory. One of the most popular experimental peptides, BPC-157, was developed by Croatian scientists who isolated what they called \u201cbody protective compound\u201d from gastric juices in the stomach lining. However, researchers have been unable to find a trace of BPC in the human genome, meaning it\u2019s not made by humans, said Katrin Svensson, a peptide scientist at Stanford University. Researchers in Taiwan suggest the peptide is produced by stomach microbes, according to Undark magazine<\/a>.<\/p>\n Even if BPC-157 and other peptides exist in nature, Svensson said, \u201cnatural things can be toxic.\u201d People have died from taking too much insulin<\/a>, for example. And drugs considered safe can still make people feel ill. To learn about safety, and whether the benefits of a drug offset the side effects, researchers conduct placebo-controlled trials. These reveal problems that might not be obvious in the short term, such as liver damage, as well as underlying conditions that could turn minor issues into something serious.<\/p>\n The FDA is considering lowering restrictions on BPC-157 and five other experimental peptides that have not undergone high-quality clinical trials and are not FDA-approved. \u201cI am excited about peptides too,\u201d said Svensson, whose lab studies several peptides that she hopes to develop into drugs. \u201cBut,\u201d she added, \u201cyou need to show they\u2019re not harmful.\u201d<\/p>\n Red Flag: These peptides treat illnesses and heal injuries.<\/strong><\/p>\n Kris Wusterhausen, one of the new appointees to the FDA advisory panel, has said<\/a> that the experimental peptide BPC-157 \u201ccan reduce [acid] reflux disease\u201d and treat \u201cneurologic disorders.\u201d He\u2019s the founder of an antiaging company that sells the peptide<\/a> and advertises<\/a> \u201cclinically guided peptide treatments.\u201d He did not respond to requests for comment.<\/p>\n Such claims are common among peptide promoters who say that various experimental peptides treat muscle injuries, covid, inflammatory bowel disease, and more. But vanishingly few clinical trials have been conducted.<\/p>\n A summary of a small clinical trial testing BPC-157 as a treatment for inflammatory bowel disease was published in 2005, but it lacked critical details about how the study was conducted. FDA scientists who reviewed the summary<\/a> called it \u201cinadequate.\u201d<\/p>\n Another small study<\/a> concluded that BPC-157 relieved knee pain for 14 of the 16 patients involved, but it lacked a control group, meaning the participants might have felt better because of other factors, or their pain simply resolved over time.<\/p>\n In a 2025 review of research<\/a> on BPC-157 as a treatment for musculoskeletal injuries, researchers warned that it should be \u201capproached with caution\u201d because of a lack of evidence. Flynn McGuire, a physical rehabilitation doctor at the University of Utah and an author of the review, said anecdotes about people having miraculous recoveries are even less reliable.<\/p>\n He has told patients he won\u2019t prescribe BPC-157 until quality studies are conducted. \u201cPeople want new things quickly,\u201d he said, \u201cbut medicine and science just don\u2019t work fast.\u201d<\/p>\n Peptide enthusiasts also tout laboratory studies, such as a particular peptide stimulating blood vessel growth. Such research is critical, but it doesn\u2019t speak to safety, efficacy, or off-target effects in people, like fueling cancerous growths. Human biology is complicated, which is why most substances that show promise in early experiments fail in clinical trials.<\/p>\n Red Flag: Peptides can\u2019t be patented<\/strong>.<\/p>\n Before taking the helm of the Department of Health and Human Services, Robert F. Kennedy Jr. posted about peptides<\/a> on X. (Screen grab of X)<\/p>\n A few months before Kennedy took charge at HHS, he suggested<\/a> on the social media platform X that the FDA hindered access to peptides and other alternative therapies because they couldn\u2019t be patented. It\u2019s a common misconception about peptides: In an analysis of Reddit posts<\/a> about the drugs, researchers found many posts suggesting that mainstream medicine has sidelined peptides because pharmaceutical companies cannot patent the substances and therefore can\u2019t turn a profit.<\/p>\n Yet hundreds of peptide patents are listed in the U.S. Patent and Trademark Office database. A patent on an early formulation of BPC-157 is for sale<\/a>.<\/p>\n \u201cOne cannot obtain a patent on the natural thing itself,\u201d Sherkow said, \u201cbut if you slightly modify it, link it to something that allows me to inject it, formulate it to be more stable, all of that stuff is patentable and is being patented.\u201d<\/p>\n Peptide patents can be lucrative. Pharmaceutical companies are suing one another over patents surrounding GLP-1 peptides, the basis of Ozempic and other such weight loss drugs. The market for those medicines is projected to reach $190 billion<\/a> within the next decade, according to the investment bank Morgan Stanley.<\/p>\n So why haven\u2019t pharmaceutical companies invested in clinical trials on popular peptides? Clinical trials cost millions of dollars, so companies first must be convinced the drugs look promising enough for FDA approval, as well as have an edge over current medications.<\/p>\n Companies conduct experiments before investing big bucks. They may have done so for certain peptides and been discouraged by the results, Svensson said.<\/p>\n Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors backed out of funding trials on a peptide he helped discover, MOTS-c, because they worried its use overlapped with GLP-1 medications. \u201cInvestors felt we couldn\u2019t compete with that,\u201d he said.<\/p>\n Kennedy\u2019s push to make experimental peptides more accessible might make clinical trials even more unlikely, researchers say, because compounding pharmacies wouldn\u2019t need FDA approval to sell the drugs for human use.<\/p>\n In a letter to the FDA, the pharmaceutical trade organization PhRMA advised against easing restrictions on unapproved peptides, saying it would \u201cerode incentives for manufacturers to undertake the substantial time and cost required for FDA approval.\u201d<\/p>\n True: Americans aren\u2019t as healthy as they could be.<\/strong><\/p>\n Kennedy and other leaders of the MAHA movement are right when they say<\/a> the U.S. spends more on healthcare<\/a> per person than any other nation and ranks below all other wealthy nations in life expectancy<\/a>. They also rightly note the high cost of treatment. Six in 10 U.S. adults said they worried about affording prescription drugs in a recent KFF poll<\/a>, with 4 in 10 saying they\u2019ve skipped doses or taken other measures because of the price.<\/p>\n Researchers have outlined policies to lower healthcare costs and improve public health, such as limiting drug monopolies<\/a> and improving access to healthy food<\/a>. What\u2019s not on the list: skipping clinical trials to sell unproven treatments that could harm people.<\/p>\n KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/em><\/p>\n This article<\/a> first appeared on KFF Health News<\/a> and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License<\/a>.<\/p>","protected":false},"excerpt":{"rendered":" Experimental peptides have become darlings among influencers, chiropractors, and doctors focused on longevity, antiaging, or \u201cbody optimization,\u201d even though the FDA hasn\u2019t approved them for safety or effectiveness. Health secretary Robert F. 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