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Import Report Finds 200,000 Units of Unapproved Retatrutide Crossing the US Border

Three-dimensional structure render: Cryo-EM structure of the retatrutide-bound human GLP-1R-Gs complex
Structure: RCSB PDB entry 8YW3 (CC0 1.0 public domain). Rendering: RCSB PDB.

A new freight fraud report from Partnership for Safe Medicines says a single shipment of retatrutide declared 222,930 pieces at the US pharmaceutical border in May and June 2026. Retatrutide is still in clinical trials with Eli Lilly and has not been approved by the FDA.

Retatrutide is an investigational weight-loss compound in the same commercial slipstream as semaglutide and tirzepatide. PSM states there is currently no legitimate commercial supply chain for patients to obtain it, so anything sold outside authorized trials is coming from the black market.

The numbers behind the shipments

PSM reviewed 167 peptide shipments and 1,792 shipments tied to antidiabetics, semaglutide and tirzepatide, using FDA import records, ITACS manifest data and FDA registration databases. Among the peptide shipments, 23% originated from facilities identified as illegitimate manufacturers while only 4% were refused entry; for the antidiabetic group the figures were 12% and 1.5%.

Eight retatrutide shipments were identified in the pipeline. PSM points to recent CBS News reporting documenting patient harm associated with chemicals claiming to be the unapproved drug.

Addresses that are not factories

The detail that does the most work in this report is the manufacturer addresses. Four shipments came from entities identified as "retalabs," with one listed address tracing back to a bookstore and postal offices in the Netherlands, and two listed an address associated with a Shoppers Drug Mart location.

That is the kind of finding that makes the compliance argument for you. A manifest naming a shopping center as a drug manufacturer is not a subtle signal, and it still cleared.

The PCAC vote complication

In July 2026 the FDA's Pharmaceutical Compounding Advisory Committee voted to recommend adding six of seven peptides to the 503A Bulk Drug Substance List, against the recommendation of FDA scientists. The compounds considered were BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax and Epitalon, with GHK-Cu, Dihexa acetate and Melanotan II due in February 2027.

PSM executive director Shabbir Imber Safdar has warned the vote could be read by patients as FDA approval or endorsement, which it is not. PSM says it identified 17 shipments involving PCAC peptides, roughly 10% of those reviewed, and that none were refused despite being unregistered and listed plainly on the manifest.

The custom peptide loophole

Of the 167 peptide shipments, 74 were labeled simply as "peptide" or "custom peptide" in ITACS. PSM says those descriptions reveal nothing about contents, manufacturer or intended use, and for the first time in over a year it is changing its recommendation to say such shipments should face extra scrutiny or be rejected.

Where enforcement goes next

PSM's short-term asks are inspection of shipments with an invalid FEI number and continued monitoring of green list facilities, with authority to destroy violative shipments in the medium term. The unresolved question is jurisdictional: CBP can currently act on trademark and controlled substance violations, not Food, Drug, and Cosmetic Act violations, and PSM wants that changed.

Source: RSS.app — Peptides bundle. Read the original.

Filed under: supply, glp-1

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