After Eli Lilly sued several companies that were allegedly selling unauthorized versions of its tirzepatide products, the drugmaker has successfully cracked down on one of them.
The GLP-1 maker came to an agreement with Charleston, South Carolina-based Totality MediSpa, forcing the med spa to stop “misleading consumers into believing” that it’s selling FDA-approved Mounjaro and Zepbound, according to a Lilly statement.
The spa will pay an undisclosed amount of money and take several “corrective actions," Lilly added.
For one, the spa will only distribute compounded tirzepatide products that are “produced in compliance with U.S. federal law” and report to the FDA any adverse events resulting from their use.
The settlement also requires Totality to not make any statements suggesting that it sells genuine Lilly products and stop its use of Lilly branding in its product promotions.
The med spa agreed to display on its website and advertisements that “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.”
Totality’s website does not currently mention tirzepatide or any of the brand name products, but the company’s Instagram account does include a link to a Zepbound savings card that leads to Lilly’s coverage site.
However, the med spa’s website does offer “semaglutide (Ozempic) injection” on its list of weight-loss options, linking directly to Ozempic maker Novo Nordisk’s product website.
Novo, too, has sued several med spas and other sellers of knockoff semaglutide drugs and settled with two in February.
Lilly previously warned against fake copycats of its popular drugs, emphasizing the potential health risks of products that haven’t been vetted by a regulatory agency.
The Indiapolis-based drugmaker said it has discovered products claiming to be compounded tirzepatide that contain bacteria, high impurity levels and different chemical structures and colors. On one occasion, a fake version contained nothing but sugar alcohol, the company said.
The latest settlement marks an “important step forward,” but “this is not a problem that Lilly can solve alone,” the company said in a statement. The company went on to laud state and federal regulators for taking action to “deter and punish” compounding pharmacies and counterfeiters that sell unsafe knockoffs.
Lilly previously filed at least eight lawsuits over GLP-1 copycats, targeting med spas and compounding pharmacies across the country for their alleged unlawful marketing tactics.
Meanwhile, all but one of Lilly's Mounjaro and Zepbound dose strengths are expected to be in "limited availability" through the second quarter, according to the FDA's shortage database.