FDA to discuss easing restrictions on peptides despite safety concerns

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. 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. …