Concerns Over FDA’s Green List for Pharmaceutical Ingredients
As a former congressman and medical professional, I feel compelled to raise awareness about a report advocating for the discontinuation of the current regulatory stance, particularly the “Green List.” This list offers preferential treatment to certain foreign firms deemed “trusted” for importing active pharmaceutical ingredients (APIs) into the U.S. The report argues that this trust-based approach is increasingly outdated and concerning.
People seeking genuine GLP-1 treatments are being disproportionately targeted by an underground market selling illicit and unapproved APIs, often sourced from places like China and other countries. These materials typically haven’t undergone thorough safety or quality evaluations by the FDA. It’s alarming; some of these unapproved products have been linked with contamination, undisclosed ingredients, and improper handling. They’re not just cheaper alternatives to legitimate medication.
Moreover, this parallel market undermines legitimate U.S. pharmaceutical manufacturing, which adheres to strict quality control and manufacturing standards. Misinformation in marketing intensifies this issue. It’s easy for consumers to confuse FDA-approved medications with their unapproved counterparts, thanks to the persuasive tactics used by websites and social media platforms.
In February 2025, a coalition of thirty-eight bipartisan attorneys general expressed concern to the FDA regarding this very issue. They sent a joint letter urging the agency to take action against those illegally profiting from the demand for FDA-approved GLP-1 products, while also sounding alarms about counterfeit drugs entering the U.S. supply chain from countries like China, Turkey, and India.
The attorneys general were clear about the dangers involved: these products could contain harmful contaminants or unknown substances. They also highlighted that online retailers have been selling GLP-1 active ingredients directly to consumers, often pushing them as convenient or affordable options, even if those ingredients come from unregulated sources. They urged the FDA to collaborate with various enforcement bodies to address this urgent issue before more consumers are put at risk.
Earlier this year, I raised alarms that the FDA’s Green List had shifted from being a protective measure to a potential liability.
The concerns were already growing; the FDA had revealed that a Chinese manufacturer listed on the Green List had acquired unapproved semaglutide from a facility outside the list, then repackaged it with misleading information before distribution in the U.S.
I previously argued that the FDA must shut down the Green List.
Since then, the rationale for such a move has only become more compelling.
For over thirty years, both as a physician and as a congressional member, I have observed the government grappling with its responsibility to ensure that Americans receive safe and effective medications. The rise of the illicit GLP-1 market now poses a significant test to that responsibility.
What frustrates me most is that the danger is very real now, not just a theoretical concern. Various stakeholders including the FDA, state regulators, and advocates have provided ample warnings. Yet the enforcement framework still permits unapproved foreign APIs to fill gaps that compliant manufacturers face.
Initially, the Green List was proposed as a mechanism to protect patients from dangerous unapproved APIs entering the U.S. from abroad. Companies that had their APIs evaluated by the FDA would be treated differently at the border, while other shipments would undergo closer inspection.
However, the Harbin case underscored a critical flaw in that system.
Trust in a company’s identity is not enough. Drug safety depends on the authenticity and integrity of the actual materials coming into the country, including their origin, handling, and testing records.
The situation with Harbin clearly demonstrated that the company on paper might not be the actual manufacturer of the active ingredient.
The FDA itself indicated this may have been an attempt to bypass the safeguards meant to protect American consumers.
This should have prompted a serious reevaluation of the entire system.
Instead, the Green List continues to operate.
What’s more troubling is that the public remains largely uninformed about most manufacturers who enjoy this Green List status. The FDA shares details on countries and specific products but keeps the names of companies receiving such preferential treatment confidential.
This lack of transparency makes independent oversight nearly impossible. Consumers cannot verify their suppliers, and regulators lack the information needed to determine if different Green List companies share common ownership or facilities. Congress and the public find it difficult to analyze the structures behind these companies.
This issue is particularly relevant given the involvement of numerous manufacturers from China.
Since my last warning, the FDA has revealed more troubling data—making it increasingly difficult to justify reliance on firm-level trust. In its latest update on Import Alert 66-80 from August 2026, the FDA stated that 21% of the 48 sites producing unapproved GLP-1 APIs were found noncompliant. Furthermore, some manufacturers attempted to register to supply GLP-1 ingredients but then refused to provide requested records, quickly deregistering thereafter.
Clearly, a model built on presumptive trust is inappropriate here.
The program has also expanded beyond the original justification related to shortages. The FDA has now extended Green List status to manufacturers of orforglipron APIs, even though they weren’t part of the earlier semaglutide shortages.
The legal context has become even clearer. A recent ruling from the U.S. Court of Appeals for the Fifth Circuit upheld the FDA’s view that shortages of Novo Nordisk’s semaglutide injections had concluded. The court emphasized that the agency considered a comprehensive array of data—production levels, inventory, and demand forecasts—rather than merely accepting a manufacturer’s claims.
This decision reinforces that the rationale for the Green List, based on past shortages, is now outdated. It has been scrutinized and upheld in federal court.
However, the unapproved GLP-1 ingredients are still infiltrating the market.
Notably, retatrutide hasn’t even been submitted for FDA approval yet, yet variations of it are already available to consumers without a thorough evaluation of their safety and efficacy.
At the same time, reports of adverse events linked with compounded GLP-1 products continue to rise, while traditional pharmacies don’t have the same strict reporting obligations as those producing FDA-approved medications. Consequently, the federal government lacks visibility into this unregulated market.
Although the FDA has issued warnings and alerts, the thirty-seven attorneys general called for more than just notifications—they urged the FDA to collaborate with Homeland Security to intercept counterfeit products, pursue illegal online sellers, and ramp up enforcement against illicit compounding pharmacies. Simply warning uncooperative sellers doesn’t deter them; some sellers operate under the belief that the rules don’t apply to them.
We’ve seen the consequences of regulatory failures before.
In 2012, contaminated drugs from the New England Compounding Center caused a fungal meningitis outbreak, infecting over 700 individuals and resulting in at least 64 fatalities. Congress had to intervene and rewrite federal compounding law in response.
We should address visible vulnerabilities before they lead to a similar tragedy.
My views on the Green List remain unchanged, but the volume of evidence supporting my stance has grown.
The objective shouldn’t be to shut out legitimate pharmaceutical production overseas or to eliminate valid patient-specific compounding.
The solution lies in halting the reliance on confidential firm status as a substitute for verified sourcing.
The FDA must eliminate the Green List exception for unapproved foreign GLP-1 APIs and institute a transparent, shipment-specific approach where admissibility is based on documented evidence regarding the actual material crossing the border.
This report outlines why this change is essential.
It explores the regulatory history that led us to this juncture, investigates the Harbin incident and its implications, reviews laboratory and adverse-event data, and illustrates how a lack of transparency in a trusted supplier system can be exploited in a global pharmaceutical context.
I raised these concerns before, and the evidence increasingly compels the FDA to take them seriously.
When it comes to medications that American patients rely on, trust should be built on verification rather than being a substitute for it.
