Lilly sues med-spas and wellness centers over compounded tirzepatide

Eli Lilly and Company filed its first round of lawsuits over compounded tirzepatide products in September and October 2023, suing med-spas, wellness centers and other sellers that advertised compounded drugs as Mounjaro, as Zepbound, or as FDA-approved tirzepatide ^[1]. Lilly described those earlier cases in a June 20, 2024 news release that announced a further round of legal actions and an open letter to patients about counterfeit and compounded versions of its medicines ^[1].

In the June 2024 cases, Lilly alleges that the defendants did three things: referred to their products as Mounjaro or Zepbound, or as the same as those drugs; used results from Lilly's clinical trials in their advertising, leading consumers to believe the compounded drugs were part of Lilly's trials; and cited FDA approvals for Mounjaro and Zepbound as if the compounded products were themselves FDA-approved ^[1]. Lilly also says it identified safety problems with the defendants' products ^[1].

Lilly's open letter states that counterfeit products advertised online, through social media or at certain med-spas "may contain no medicine, the wrong medicine, incorrect dosages, or multiple medicines mixed together," and that they "are never safe to use" ^[1]. The release cites the National Association of Boards of Pharmacy, which said illegal actors are taking advantage of high demand and short supply of incretin medications to sell substandard and falsified versions of these products ^[1].

On compounding, Lilly notes that compounded products may be legal in limited circumstances to address specific patient needs, but they are not FDA-approved and lack the same safety, quality and efficacy protections as FDA-approved medicines ^[1]. According to the release, 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 ^[1].

Lilly says it found compounded drugs advertised as tirzepatide with safety, sterility and efficacy problems. Some, it says, contained bacteria, high impurity levels, a pink color instead of colorless, or a completely different chemical structure than Lilly's approved medicines; in at least one instance, the company says, the product was nothing more than sugar alcohol ^[1]. The release also says some online pharmacies advertise compounded pill or oral versions of "tirzepatide," while FDA has approved tirzepatide only as an injection under the skin, and no regulator has evaluated the safety or effectiveness of pill or oral versions ^[1].

Lilly says Mounjaro and Zepbound are approved only for adults to treat serious diseases, and are not intended for cosmetic weight loss or for people under 18 ^[1].

In May 2024, Lilly entered a settlement with Totality Medispa that required a monetary payment and prohibited certain conduct that misled consumers into believing the business sold Lilly's Mounjaro or Zepbound, or an FDA-approved alternative ^[1]. Lilly says it reached similar settlements with other med-spas and wellness centers that had infringed its trademarks and falsely advertised their products ^[1]. The release does not disclose the amount of the Totality payment or the terms of the other settlements, and it does not report how the September and October 2023 cases were resolved ^[1].

Why it matters for patients

The lawsuits turn on how products are named and marketed, not only on what is in them. If a clinic, website or social media ad calls a product Mounjaro, Zepbound or "FDA-approved tirzepatide," that wording is what Lilly is challenging in these cases ^[1].

A compounded product that contains tirzepatide is not the same regulatory product as Mounjaro or Zepbound, which are the only tirzepatide medicines FDA has approved ^[1]. Lilly says it found sterility, impurity and identity problems in some compounded drugs sold as tirzepatide, including one case where the product was sugar alcohol ^[1]. Oral versions sold as "tirzepatide" have not been evaluated by any regulator for safety or effectiveness, according to the release ^[1].

The release does not say compounded tirzepatide is always illegal. Lilly states that compounding may be legal in limited circumstances to address specific patient needs, while FDA has said compounded drugs carry higher risk than approved drugs ^[1]. Lilly is the maker of Mounjaro and Zepbound and has a commercial interest in the outcome of this campaign; the allegations described here come from Lilly's release and its filings as characterized there ^[1].

What happens next

The June 20, 2024 release announced the new legal actions on that date, but does not list the defendants in those cases or set a schedule for them ^[1]. No hearing dates, rulings or additional settlement terms have been disclosed in the release ^[1]. Lilly says the lawsuits are part of a continuing effort to address patient safety concerns about products marketed as its medicines ^[1].