Eli Lilly files six more lawsuits over compounded tirzepatide sold by med spas
Lilly says it is the only lawful supplier of FDA-approved tirzepatide and does not know where med spas get the ingredient for compounded products marketed as Mounjaro or Zepbound.
Eli Lilly filed six new lawsuits in late June 2024 against medical spas and wellness centers around the country, alleging they sold compounded products containing tirzepatide while misleading customers into believing those products were approved by the Food and Drug Administration [1]. The cases were filed in courts in Ohio, Texas, Hawaii and the District of Columbia [1].
The new complaints resemble claims Lilly brought against Totality Medispa in the fall of 2023, when the company alleged the spa misled consumers into believing it was selling FDA-approved compounded Mounjaro or Zepbound, that its compounded medicines had been clinically tested, and that they were safe [1]. In May 2024, a month before the new filings, Lilly and Totality Medispa reached a settlement [1]. Under that agreement, the spa was required to make a monetary payment and to take several corrective steps: stop using Lilly branding, stop making statements suggesting its products were genuine, obtain and distribute only compounded tirzepatide produced in compliance with U.S. law, report any adverse events from compounded tirzepatide to the FDA, and post a warning on its website and ads that compounded tirzepatide is not FDA-approved [1].
Tirzepatide is the active ingredient in Mounjaro and Zepbound, and Lilly is the only lawful supplier of the FDA-approved versions of the drug [1]. In an open letter dated June 20, 2024, the company said Mounjaro and Zepbound are not for cosmetic weight loss, are intended to treat diabetes and obesity, and must be prescribed by a health care practitioner [1]. Lilly also said neither product is approved for patients under 18 and expressed concern that social media posts and ads were inappropriately targeting people under 18 [1].
The letter stated that Lilly does not supply tirzepatide to compounding pharmacies, medical spas, wellness centers or online retailers, and that the company does not know where those entities obtain tirzepatide [1]. Lilly said compounded drugs carry a higher risk than FDA-approved medications and cited sterility concerns and safety issues including bacteria, different chemical structures, high impurity levels and lack of active ingredients [1]. The company also published a visual guide for identifying authentic Mounjaro and Zepbound products [1]. The article notes that public demand for GLP-1 drugs has outpaced available supply, a gap that has led medical spas to offer compounded versions passed off as the genuine product [1].
Why it matters for patients
Only Mounjaro and Zepbound are FDA-approved tirzepatide medicines, according to Lilly, and compounded tirzepatide is not FDA-approved [1]. That distinction matters for anyone comparing what a med spa or wellness center offers with what a pharmacy dispenses.
Lilly states that it does not supply tirzepatide to compounding pharmacies, medical spas, wellness centers or online retailers and does not know where they get the ingredient [1]. In practical terms, that means the manufacturer does not stand behind the source of a compounded product sold through those channels.
The company's stated concerns about compounded drugs include sterility problems and possible issues such as bacteria, different chemical structures, high impurity levels and missing active ingredients [1]. The settlement with Totality Medispa shows one remedy Lilly has sought: a warning posted on websites and ads stating that compounded tirzepatide is not FDA-approved [1].
Mounjaro and Zepbound are not approved for anyone under 18 and are not intended for cosmetic weight loss, per the open letter [1].
Several key details have not been disclosed in the reporting: the six new suits do not name the spas and wellness centers involved, no outcome has been reported for any of them, and no information has been reported on whether patients were harmed in those cases [1].
What happens next
No court dates, hearings or rulings in the six June 2024 cases have been reported [1]. The only resolved matter described is the Totality Medispa settlement reached in May 2024 [1]. The commentary anticipates more cases while demand for GLP-1 drugs stays high, and notes Lilly's particular concern that social media is used to advertise or sell counterfeit drugs and that illegal online pharmacies will try to profit from that demand [1].
Sources
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