People taking GLP-1 drugs deserve to know exactly what is being injected into their bodies.
A new Food and Drug Administration warning letter shows why they may not.
The FDA warned Harbin Jixianglong Biotech, a Chinese manufacturer tied to GLP-1 active pharmaceutical ingredients, over serious manufacturing and labeling violations. Most alarming, the company was placed on the agency’s GLP-1 API “Green List,” a designation meant to identify manufacturers meeting FDA standards, and then allegedly purchased semaglutide from facilities not on that list, relabeled it as its own, and shipped it toward the U.S. market, according to the FDA.
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That is not a clerical error. That is a direct threat to patients.
If the FDA’s findings are correct, a foreign company used the FDA’s own trusted designation to move GLP-1 ingredients of unknown origin into the American drug supply. Patients may believe they are receiving a safe, reliable medicine. Instead, they could be exposed to foreign substances with unknown sourcing, unknown handling, unknown quality controls, and unknown risks.
This raises a basic question: Why does this Green List even exist?
The FDA has already determined that the tirzepatide shortage was resolved in December 2024 and the semaglutide shortage was resolved in February 2025. The special shortage-driven rationale for mass production of copycat compounded GLP-1s is gone. So why is the FDA maintaining a pathway that appears to help foreign bulk-ingredient suppliers feed a market for unapproved GLP-1 products?
There is no defensible reason.
Worse, the Green List creates the very loophole it claims to close. As long as even one company is on the list, the market will migrate to that company. Foreign suppliers, brokers, distributors, and compounders all have an incentive to route product through the “approved” name. That makes the Green List less like a safety barrier and more like a magnet for regulatory gamesmanship.
The Harbin letter proves the point. According to the FDA, the company allegedly sourced semaglutide from non-Green List facilities, relabeled it, and used its own Green List status to move product. In plain English: Once the FDA gave one foreign supplier a green light, others could hide behind it.
That should end the experiment right now, period, full stop.
Compounded GLP-1 copycats are not FDA-approved. The FDA has said these drugs are not reviewed by the agency for safety, effectiveness, or quality before they reach patients. These are injectable medicines. Patients should not have to wonder whether the vial came from a verified manufacturer or from an opaque foreign supply chain disguised by a relabeled package.
The FDA deserves credit for catching this case. But catching it after the fact is not enough.
Regulators must find where this material went, which U.S. entities received it, and whether American patients were exposed. Congress should demand answers. And the FDA should shut down the GLP-1 Green List now.
Here’s the simple truth: The Green List is useless if the FDA cannot manage it. It is dangerous if foreign companies can exploit it. And it is indefensible when the underlying shortage is over.
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Medical innovation is saving lives. Unknown foreign GLP-1 ingredients put lives at risk.
The FDA should stop giving this market a green light.
Dr. Michael C. Burgess is a former representative from Texas, member of the GOP Doctors Caucus, and founder of the Healthcare Caucus.