FDA GLP-1 'Green List' Faces Shutdown Call Over Counterfeit API Risk

Dr. Michael C. Burgess, a physician and former chairman of the House Energy & Commerce Health Subcommittee, has publicly called on the FDA to shut down its GLP-1 "Green List" — the trust-based program granting preferential border treatment to select foreign manufacturers of active pharmaceutical ingredients (APIs) — warning that unapproved and counterfeit GLP-1 ingredients are reaching American consumers at scale.

What Happened

In a public appeal issued September 14, 2026, Burgess argued that the Green List's founding premise — lighter border scrutiny for companies the FDA has chosen to trust — has been broken by the evidence. FDA's own disclosures describe how Harbin Jixianglong Biotech, a Chinese API manufacturer placed on the list, obtained unapproved semaglutide API from a facility that was not on the list, relabeled it under its own name, altered manufacturing and retest records, and shipped it into U.S. commerce — conduct regulators said may have been an attempt to circumvent Import Alert 66-80.

Burgess proposes replacing firm-level trust with a transparent, shipment-specific system: admissibility decided by manufacturing origin, lot records, chain of custody, testing, and compliance history rather than the name on the paperwork.

Who Is Affected

• Patients and researchers sourcing semaglutide, tirzepatide, or retatrutide online, who may receive API of unknown potency or purity
• U.S. pharmaceutical manufacturers, undercut by ingredients that bypass FDA-quality production
• Compounders and telehealth sellers, now that courts have removed the shortage-era justification for compounded GLP-1s

Timeline

• February 2025 — A bipartisan coalition of state attorneys general warns the FDA that counterfeit GLP-1 products are entering the U.S. supply chain from China, Turkey, India, and other sources, and urges coordinated enforcement with Homeland Security and state pharmacy boards.
• August 2026 — FDA's revision of Import Alert 66-80 reports that of 48 sites evaluated for unapproved GLP-1 API production, 21 percent were noncompliant, and describes manufacturers that register, refuse FDA records requests, then quietly deregister.
• August 27, 2026 — The Fifth Circuit upholds FDA's determinations that the semaglutide and tirzepatide shortages ended, citing Novo Nordisk's capacity of roughly 5.8 million packages per month against about 520,000 compounded packages.
• September 14, 2026 — Burgess publishes his appeal, noting the Green List has since been extended to orforglipron API even though the shortage rationale that created it no longer applies.

What This Means for Researchers

The policy signal for the research community is blunt: a supplier's claimed status is not verification. Regulators found roughly one in five evaluated foreign GLP-1 API sites noncompliant, and the company named on import paperwork can differ from the facility that actually made the ingredient. If border authorities are moving from trust toward verifiable provenance, laboratories should apply the same standard — independent analytical testing, not supplier claims, is the only reliable signal of identity, purity, and fill weight.

How to Verify Your Peptides

• Follow our testing methodology overview and the comparison of HPLC versus LC-MS analysis
• Use compound-specific verification guides such as semaglutide purity and identity testing and tirzepatide HPLC verification
• Insist on lot-matched certificates of analysis and reject vendors who cannot produce them — see the testing FAQ

Safe Alternatives

FDA-approved GLP-1 therapies remain available through licensed pharmacies now that shortage-era compounding has wound down. Researchers can compare compounds on our semaglutide and tirzepatide reference pages, and review vetted suppliers in our vendor directory.

Sources

• Regulatory announcements (FDA Import Alert 66-80, August 2026)
• Industry reports and public policy analysis (September 2026)
• U.S. Court of Appeals for the Fifth Circuit, Outsourcing Facilities Association v. FDA (August 27, 2026)