FDA to discuss easing restrictions on peptides despite safety concerns

Evidence of human safety and efficacy for various types of peptides, such as Semax and BPC-157, range from thin to nonexistent. Photograph: Iuliia Burmistrova/Getty Images View image in fullscreen Evidence of human safety and efficacy for various types of peptides, such as Semax and BPC-157, range from thin to nonexistent. Photograph: Iuliia Burmistrova/Getty Images FDA to discuss easing restrictions on peptides despite safety concerns Committee will meet in July to discuss peptides now sold in gray market despite limited evidence of safety and efficacy Advisers to the Food and Drug Administration (FDA) will soon hold a meeting about whether to ease restrictions on access to some research peptides, a group of drugs with a zealous following and thin evidence to support them. If restrictions are eased, US compounding pharmacies would be able to produce and fill prescriptions for Americans – a change that would effectively legalize a thriving gray market. “There are a lot of patients who are foaming at the mouth waiting for these peptides to get moved to Category 1” legal status, said Mohammed Chammout, a retail pharmacist in Michigan. Peptides are short-chain amino acids – a class of injectable drugs that includes both recent blockbusters, such as GLP-1 weight loss medications, and older drugs such as insulin. 16:00 The peptide boom: how the US got hooked on unregulated ‘miracle’ drugs | On the Ground However, evidence of safety and efficacy in humans, depending on the peptide, ranges from thin to nonexistent. “The ban is appropriate for these peptides that have no data and all sorts of concerns regarding safety,” said Dr Eric Topol, director and founder of the Scripps Research Translational Institute and author of Super Agers: An Evidence-Based Approach to Longevity. Topol has been a loud voice of caution against the untested drugs. The FDA’s pharmacy compounding advisory committee is scheduled to meet on 23-24 July and discuss seven peptides: BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax and Epitalon. There are three voting members, six vacancies and one non-voting member from the pharmaceutical industry. The FDA is not bound to follow the committee’s advice, but it usually does. Whether or not the ban is lifted, the drugs will not be “approved” by the FDA. Drug approval takes years, moving through phased clinical trials that grow from just a few hundred participants to thousands. These trials allow manufacturers to make specific and regulated health claims and provide doctors with guidelines about risks, side effects and who might be a viable candidate for the drug. When subjected to rigorous clinical trials, most drugs fail. Trials continue even after approval. For instance, Novo Nordisk is seeking to enroll 2,500 people for a study of how its brand-name GLP-1 medication, Wegovy, is being used in the real world. By contrast, consider BPC-157, one of the peptides the FDA advisory committee is scheduled to consider for ulcerative colitis. Sometimes called the “wolverine peptide”, BPC-157 is marketed as an injury recovery aid – and animal studies have been positive. However, the work was primarily conducted by one group of researchers in Croatia. “The amount of hype to evidence is just so skewed, it’s crazy,” Dr Flynn McGuire, who studied the research, told Stat and Undark in 2025. BPC-157, “should not be used by humans”, he added. Other consumer advocates, such as Public Citizen, have called on the agency to require full approval, not “a more lenient workaround”. The push for change comes after a 2023 decision by the Biden administration to ban compounding pharmacies from producing 19 research peptides due to safety concerns. At the time, the FDA cited risks of peptides, including everything from priapism – long-lasting, painful erections – to aiding the growth of tumors as reasons for the ban. The US health secretary, Robert F Kennedy Jr, recently characterized the Biden administration’s actions as “illegal” on The Joe Rogan Experience. The potential change appears to have put doctors largely at odds with the pharmacy compounding industry: at least one poll suggests 90% of physicians are worried about patients’ self-directed peptide use, while compounding pharmacies argue the change would give Americans a safer supply of drugs than what they are already using. “The honest answer is that the evidence base is still developing, which is true of many treatments that are now standard of care,” said Dr Anant Vinjamoori, chief medical officer of Hims. Through a spokesperson, Vinjamoori declined to identify a specific standard of care. Hims is part of Hims & Hers, which cheered the FDA’s decision to re-evaluate the drugs’ status. “What exists is largely preclinical, but preclinical evidence isn’t no evidence,” he added in an interview via email. Wall Street analysts estimate that telehealth peptide prescribing could reach $2.2bn per year, with Hims & Hers alone capturing as much as $440m if restrictions are eased. Hims & Hers acquired a US-based peptide facility in 2025. The company did not respond directly to a question about its expected share of the market. Critics further worry that the regulatory change is a fait accompli, no matter the lack of evidence. Kennedy said he is a “big fan” of peptides and has used them himself. As precedent, they point to Kennedy’s efforts to reduce the number of vaccines children receive. Kennedy fired all 17 members of a federal vaccine advisory committee and replaced them with ideological allies in June 2025. The panel then attempted to reduce the number of vaccines recommended for children, despite decades of positive safety and efficacy data. A court blocked the panel’s changes and the subject is still being litigated. “Whatever RFK is pushing for will somehow get done,” said Topol. Explore more on these topics US healthcare Pharmaceuticals industry Robert F Kennedy Jr Weight-loss drugs Drugs Health news Share Reuse this content