Staff Reports
Dr. Michael Burgess, the physician and former congressman advising RX Border Defense, raised a sharp alarm about the FDA’s so‑called “green list” at a recent policy event. He said the policy, meant to ease shortages of GLP‑1 drug ingredients, now lets foreign-made semaglutide and other APIs slide past safety checks. If you care about drug safety, patient protection, or common sense, this is the kind of regulatory shortcut that demands a wake‑up call.
Why the FDA “Green List” looks like a loophole
The green list was created after GLP‑1 shortages to let certain foreign manufacturers export active pharmaceutical ingredients (APIs) that the FDA had inspected or evaluated. Sounds sensible—until you remember regulators are human and bad actors are persistent. Burgess argues the policy amounts to “trust without verification.” In plain terms: the FDA puts a company on a list and then waives further checks at the border. That is an invitation for counterfeiters and sloppy supply chains to exploit an American market that is ravenous for weight‑loss drugs like Ozempic, Wegovy, Mounjaro and Zepbound.
A real‑world failure: mislabeled semaglutide from China
Burgess pointed to a concrete case that proves his worry is not paranoia. A Chinese firm, Harbin Jixianglong Biotech, was on the green list yet used semaglutide API made at a different, unlisted facility. They relabeled the product, altered testing records, and shipped it into the U.S. The contamination or fraud wasn’t caught before import; it was found after the fact. That is exactly the kind of bypass the green list was supposed to prevent but instead seems to enable.
Why Americans should care
GLP‑1 usage has exploded, with surveys showing a steep rise in Americans taking these drugs for weight loss. That means more people are exposed to whatever arrives in these shipments. When you mix huge consumer demand with regulatory shortcuts and foreign manufacturers heavily represented on the list—China figures prominently—you get a recipe for safer drugs becoming riskier. Patients deserve real verification, not bureaucratic optimism and hope that nobody will cheat the system.
Fix the policy: verify, inspect, and close loopholes
If the FDA wants to protect Americans, it should stop pretending a green list is a substitute for thorough inspections and better enforcement. “Trust, but verify” isn’t old‑timey rhetoric; it’s practical. Close the loopholes that let mislabeled or counterfeit APIs slip through, increase on‑site audits, require chain‑of‑custody proof for every batch, and demand transparency for overseas facilities. The choice is simple: tighten rules and keep patients safe, or keep the green list and hope nothing goes wrong. Congress and regulators should pick the safe option. America’s health shouldn’t be left to good intentions and blind trust.
