Illegal weight-loss ingredients are 'flooding into US'

Illegal versions of GLP-1 agonist ingredients for medicines like Novo Nordisk's Wegovy and Eli Lilly's Zepbound are entering the US despite laws prohibiting their importation, according to an industry report.

An investigation led by the Partnership for Safe Medicines (PSM) claims that the active pharmaceutical ingredients (APIs) for Wegovy and Zepbound – respectively semaglutide and tirzepatide - are being imported into the US from several countries, including China and India, for use by compounding pharmacies.

Under US law, a brandname drug on the FDA shortage list can be made available by compounding pharmacies, even if still under patent protection. However, it is illegal for compounders to use ingredients that are not made in FDA-registered facilities, and PSM's analysis (PDF) found that some of them are using APIs from "unauthorised foreign sources."

The organisation's investigation looked at records of shipments into the US maintained by Customs and Border Protection (CBP) and compared them to lists of legitimate, FDA-registered establishments that have listed a semaglutide or tirzepatide product.

After studying 2,465 shipments from September 2023 to January 2025, PSM identified 239 problematic shipments of semaglutide or tirzepatide that were from unregistered entities with no semaglutide or tirzepatide products listed with the FDA. The FDA stopped just 44 of these shipments, with the remainder "likely used in knockoff products sold to unsuspecting Americans."

Using APIs of uncertain is particularly problematic when they are destined to be used in injectables, with potentially serious consequences if, for example, they were not sterile.

While some shipments were identified as ingredients for use in drug compounding, others used more vague descriptions, such as 'non-sterile liquid', which could suggest some effort to evade scrutiny.

"Use of compounded versions of GLP-1 medications has surged, with telehealth companies and compounding pharmacies aggressively marketing them to consumers," said Shabbir Safdar, executive director of PSM, which recently complained to the FDA about an ad run by telehealth firm Hims & Hers during the Super Bowl, which failed to mention that the semaglutide it offers is compounded and not FDA-approved and also omitted side effect information.

"Consumers remain largely unaware that, unlike prescription medicines, these knockoffs are not FDA-approved and they’re not generics," he added. "Our report reveals these knockoff GLP-1s may contain active ingredients from unregulated, overseas manufacturers that are not suitable for human use."

The era of compounding of semaglutide and tirzepatide should be heading to an end in the coming weeks, as the FDA has taken the two drugs off the shortages list.

However, those decisions have been challenged in the courts by the Outsourcing Facilities Association (OFA), an industry body representing compounders, and Texas-based company FarmaKeio Superior Custom Compounding.

The PSM report is calling on the FDA to make more strenuous efforts to refuse entry to APIs that may be illegal, add the rogue manufacturers identified in its analysis to its Import Alert list so future shipments are flagged for close scrutiny, and prioritise inspections of compounders that attempt to import GLP-1 APIs from unregistered facilities.