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 Likely aided by their success, a raft of injectable “research” peptides that are not “intended” for human consumption are also sold online as wellness aids. These injectables are of dubious quality , produced by gray market compounding pharmacies (many of which are in China), promoted by social media influencers and figures such as Joe Rogan, and then injected by regular people who are “trying to get ahead of things like age, weight loss, muscular dystrophy”, said Chammout. However, evidence of safety and efficacy in humans, depending on the peptide, ranges from thin to nonexistent. New evidence casts doubt on RFK Jr testimony before Senate Read more “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 manufa