Eli Lilly Reaches Settlement with Totality MediSpa Over Sale of Compounded Mounjaro and Zepbound

Eli Lilly announced it has reached a settlement with a medical spa selling counterfeit versions of the company’s blockbuster tirzepatide GLP-1 drugs Mounjaro and Zepbound.

In a news release, Lilly said following a series of lawsuits it filed in September and October 2023, the company has “entered into a settlement agreement requiring defendant Totality Medispa to make a monetary payment and prohibiting Totality from engaging in certain conduct.”

The monetary payment that Charleston, South Carolina-based Totality Medispa will have to make is undisclosed.

Lilly said the settlement will put a stop to Totality from misleading consumers into believing that it’s selling US Food and Drug Administration (FDA)-approved Mounjaro or Zepbound, that its compounded products have been evaluated in clinical tests or that its compounded medicines have been proven safe and effective to achieve certain clinical results.

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

Totality must also include a disclaimer on its websites and all advertisements that states “Compounded versions of tirzepatide are not FDA-approved, and neither the FDA nor any global regulatory agency has reviewed these products for safety, quality or efficacy.” The med spa has agreed to this requirement.

The spa can obtain and distribute compounded tirzepatide products on the condition that they are produced in compliance with US federal law.

Any adverse events linked to Totality’s compounded tirzepatide must be reported to the FDA.

Related: Compounded Versions of Mounjaro Being Sold at Pharmacies and Spas Prompt Lawsuits

“Patient safety is Lilly’s highest priority. Lilly is deeply concerned that products fraudulently claimed by compounding pharmacies or counterfeiters to be FDA-approved tirzepatide, Mounjaro or Zepbound may expose patients to serious health risks,” said Lilly.

Given concerns about safety, the company said no unsafe products should be on the market, especially given that neither the FDA nor any global regulatory agency has reviewed the compounded products for safety, quality or efficacy.

Lilly said it discovered some products claiming to be compounded tirzepatide medicines that contained bacteria, high impurity levels, different chemical structures and different colors than Mounjaro or Zepbound. “In at least one instance, the product was nothing more than sugar alcohol,” said Lilly.

In addition to Totality, Lilly is suing seven other companies, which include medical spas and compounding pharmacies, for selling compounded versions of Mounjaro and illegally using Lilly branding to pass them off as the real thing.

Fellow GLP-1 maker over companies selling compounded versions of its semaglutide products, Ozempic and Wegovy, and using fraudulent marketing. In February, Novo reached settlements with a medical spa and a weight loss clinic in Florida selling Ozempic dupes.

Given the relentless high demand for the drugs, both Novo and Lilly’s GLP-1 products remain on the FDA’s Drug Shortages list since the end of 2022.

The FDA updated the list in April, stating that most doses of Zepbound have “limited availability” due to a “demand increase for the drug.” Only the lowest dose of Zepbound is currently available, and the FDA expects the limited availability to continue through to the end of the second quarter, which is into at least June.

Ozempic and Mounjaro are approved for the treatment of type 2 diabetes but have been prescribed for off-label use for weight loss, which has sparked controversy, especially given the shortages. Wegovy and Zepbound are approved for weight loss in conjunction with diet and exercise for people with overweight or obesity.

Regarding the settlement with Totality, Lilly said, “While this agreement is an important step forward, this is not a problem that Lilly can solve alone.” It implored state and federal regulators to take action and “punish compounding pharmacies, counterfeiters and others who put patients at risk by selling unsafe products claiming to be tirzepatide.”

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