FDA and Drug Safety

Sen. Tom Cotton, R‑Ark., has sent a formal letter to FDA Commissioner Martin Makary demanding an investigation into how far illegal and unregulated Chinese active pharmaceutical ingredients have penetrated the U.S. supply chain for compounded GLP‑1 weight‑loss drugs. Citing FDA and Customs and Border Protection data, Cotton notes that from September 2023 to January 2025 authorities intercepted 195 illegal API shipments, about 60 from China and Hong Kong, that were 'likely used' in compounded weight‑loss medications, and he points to estimates that up to 1.5 million Americans may now be using unregulated GLP‑1 compounds. His push comes on the heels of HHS’s referral of telehealth firm Hims & Hers to the Justice Department over a planned compounded semaglutide pill, and the FDA’s pledge to crack down on non‑FDA‑approved compounded GLP‑1 drugs that are being mass‑marketed as cheaper alternatives to Ozempic and Wegovy. Under pressure from federal regulators, Hims & Hers withdrew its Wegovy‑like pill last week, but Cotton is pressing for broader scrutiny of other compounders and telehealth outlets. The episode highlights mounting concern in Washington that the boom in online and compounded weight‑loss drugs has outpaced regulatory oversight, leaving patients exposed to unknown foreign ingredients and blurring the line between legitimate pharmacy compounding and industrial‑scale manufacturing.