Key facts
- Eli Lilly has filed six lawsuits against U.S. companies for allegedly selling black-market versions of its experimental obesity drug retatrutide.
- The lawsuits target businesses including compounding pharmacies, medical spas, and online sellers.
- Retatrutide is currently in Phase 3 clinical trials and has not been approved by any regulators.
- The U.S. Food and Drug Administration has stated that sales of unapproved GLP-1 products are illegal.
- Lilly has referred more than 200 individuals and entities to various regulatory and law enforcement agencies.
- U.S. Customs and Border Protection intercepted over 31,000 units of illicit GLP-1 drugs in fiscal year 2025.
Eli Lilly has initiated legal action by filing six lawsuits against U.S. companies accused of illegally selling black-market versions of its experimental obesity drug, retatrutide. The drugmaker stated that these businesses, including compounding pharmacies, medical spas, and online sellers, marketed the unapproved compound to consumers despite it remaining under clinical development.
Retatrutide is currently undergoing Phase 3 clinical trials for obesity, type 2 diabetes, and related conditions, with no regulatory approval granted for human use. The U.S. Food and Drug Administration has previously declared that the sale and compounding of retatrutide and other unapproved GLP-1 products are illegal.
Eli Lilly's Chief Medical Officer, Dr. David Hyman, emphasized the risks associated with these unverified products, stating, "What is being sold on the black market is not a medicine – it is entirely unverified, unapproved and not worth the risk." The company noted that demand for weight-loss treatments has fostered a market for products claiming to contain such drugs, often sourced from unregulated manufacturers.
In addition to the lawsuits, Lilly has reported referring over 200 individuals and entities to various regulatory bodies, including the FDA, the U.S. Justice Department, state attorneys general, law enforcement, and professional licensing boards. The company also urged social media platforms, e-commerce sites, payment processors, shipping firms, and regulators to implement stronger measures against sellers of unapproved retatrutide.
Data from U.S. Customs and Border Protection revealed significant interceptions of illicit GLP-1 drugs. During fiscal year 2025, the agency intercepted over 690 shipments, totaling more than 31,000 units. In July alone, these figures more than doubled, with over 1,400 seizures and nearly 90,000 vials intercepted. Dr. Max Denning of Eli Lilly highlighted the substantial risks consumers face when using these unverified products.