Lilly files further legal actions against med-spas and wellness centers

Eli Lilly announced on June 20, 2024, that it filed additional lawsuits against med-spas and wellness centers accused of selling unapproved compounded products while falsely calling them Mounjaro or Zepbound, the company's FDA-approved tirzepatide medicines ^[1]. The filings came alongside an open letter from Lilly meant to inform patients, families, and health care providers about risks tied to counterfeit and compounded versions of its drugs ^[1].

Lilly says the defendants in these new suits misled consumers in three ways: by referring to their products as Mounjaro or Zepbound or as equivalent to them, by citing Lilly's clinical trial results in advertising in a way that suggested the compounded drugs were part of those trials, and by referencing FDA approval of Mounjaro and Zepbound as if the compounded versions were also FDA-approved ^[1]. These lawsuits follow an earlier round of cases Lilly filed in September and October 2023 ^[1].

Lilly also disclosed a settlement reached in May 2024 with Totality Medispa. That agreement required Totality to make a monetary payment and barred it from conduct that misled consumers into thinking it sold genuine Lilly products or an FDA-approved alternative ^[1]. Lilly said it has reached similar settlements with other med-spas and wellness centers over trademark infringement and false advertising ^[1].

In its open letter, Lilly said it has found compounded products advertised as tirzepatide with safety, sterility, and efficacy problems, including bacteria, high impurity levels, wrong coloring, or a chemical structure different from its approved drugs ^[1]. In at least one case, Lilly said, the product tested was nothing more than sugar alcohol ^[1]. The company also flagged that some online pharmacies are now advertising compounded pill or oral versions of tirzepatide, even though the FDA has only approved tirzepatide as an under-the-skin injection and no regulator has evaluated oral versions for safety or effectiveness ^[1].

Why it matters for patients

Patients who buy compounded products believing they are getting real Mounjaro or Zepbound may be getting something different, and in some cases something that could cause harm, according to Lilly's findings ^[1]. The company points to a broader pattern described by 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 or falsified versions to patients ^[1].

Compounded drugs can be legal in limited circumstances to meet specific patient needs, but the FDA has said they carry higher risk than FDA-approved drugs because they lack the same safety, quality, and efficacy protections, and that unnecessary use of them exposes patients to potentially serious health risks ^[1]. Lilly also reiterated that Mounjaro and Zepbound are approved only for adults to treat specific diseases, not for cosmetic weight loss or for use by anyone under 18 ^[1].

For patients trying to sort out what is a genuine, FDA-approved product versus a compounded or counterfeit one, these lawsuits and the open letter are Lilly's attempt to draw a public line between the two, though the sources do not say how patients can independently verify a product's authenticity before purchase.

What happens next

The sources do not specify a timeline for resolution of the newly filed lawsuits or name the specific med-spas and wellness centers targeted in this round of legal action ^[1]. It is also not yet known from these sources whether additional settlements beyond Totality Medispa will be disclosed, or how regulators like the FDA plan to respond to the reported sale of oral compounded tirzepatide products ^[1].