On August 15 2025, the U.S. Food & Drug Administration (FDA) issued a Warning Letter to Platinum Biologics LLC for marketing umbilicalcordderived products including exosome products (NanoEx & Nano Xsomes) without approval. NDI warning letters fuel criticism of FDA enforcement approach The U.S. Food and Drug Administration is moving toward allowing compounding pharmacies to produce more than a dozen injectable peptides that were banned because of potentially significant safety risks, the New York Injectable Peptides: Out of the Back Alley and Into the Light? Berkley Lifesciences FDA to weigh easing limits on unproven peptides