Lilly settles with med spa over misleading tirzepatide claims

Eli Lilly said on May 14, 2024 that it reached a settlement with a medical spa it had sued over compounded tirzepatide, the active ingredient in its diabetes drug Mounjaro and its weight-loss drug Zepbound ^[1][2]. The agreement requires Totality Medispa to make a monetary payment and bars conduct that Lilly said misled consumers into believing the spa sold FDA-approved Lilly products ^[1][2].

The payment amount was not disclosed in Lilly's announcement ^[1]. Under the agreement, Totality must obtain and distribute compounded tirzepatide only from sources that comply with U.S. federal law, report any patient adverse events to the FDA, and display this statement on its website and all advertisements: "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" ^[1]. The spa also must stop using Lilly branding to promote its products and must not suggest its products are genuine, FDA-approved Lilly medicines ^[1][2].

Lilly filed the lawsuits that led to the settlement in September and October 2023 ^[1]. The company said it found products marketed as compounded tirzepatide that contained bacteria, high impurity levels, different chemical structures, and different colors than Mounjaro or Zepbound — and that in at least one case, "the product was nothing more than sugar alcohol" ^[1]. In March 2024, Lilly said it had found bacteria and high impurity levels in products claiming to be compounded versions of tirzepatide ^[2].

Lilly said it is the only lawful supplier of FDA-approved tirzepatide medicines in the United States and does not sell or provide tirzepatide active pharmaceutical ingredient to compounding pharmacies ^[1]. "Patients taking a product referred to only as 'tirzepatide' are not taking an FDA-approved product," the company said ^[1].

Reuters reported that compounded drugs are custom-made medicines based on the same ingredients as branded versions, are often cheaper, and are subject to less regulatory scrutiny ^[2]. Novo Nordisk, which makes the semaglutide drugs Ozempic and Wegovy, sued compounding pharmacies after finding their products impure by as much as 33% ^[2].

Why it matters for patients

Products advertised as compounded tirzepatide are not FDA-approved, and Lilly says neither the FDA nor any global regulatory agency has reviewed them for safety, quality, or efficacy ^[1]. The FDA has said compounded drugs pose a higher risk to patients than FDA-approved drugs and that unnecessary use exposes patients to potentially serious health risks ^[3]. Lilly has said counterfeit products may contain no medicine, the wrong medicine, incorrect dosages, or multiple medicines mixed together, and are advertised online, on social media, or at certain med spas ^[3].

Tirzepatide is approved in the U.S. only as an injection under the skin; the FDA has not approved pill or other oral versions of tirzepatide, and no regulator has evaluated their safety or effectiveness ^[3]. Lilly also says Mounjaro and Zepbound are approved only for adults with serious diseases and are not intended for cosmetic weight loss or for people under 18 ^[3].

The settlement applies to one medical spa. No product recalls tied to the agreement were reported ^[1].

What happens next

In a June 20, 2024 update, Lilly said it published an open letter to patients and filed additional legal actions against med spas, wellness centers, and other entities selling unapproved compounded products containing what they claim is tirzepatide ^[3]. Lilly said it has entered similar settlements with other med spas and wellness centers that it accused of infringing its trademarks and falsely advertising their products ^[3]. The dates and payment amounts for those settlements have not been disclosed ^[1][3].

Lilly said it supports state and federal regulators taking action to deter and punish compounding pharmacies and counterfeiters ^[1][2]. The company did not specify what further regulatory steps, if any, it expects ^[1].