Lilly settles with a med spa selling knockoff tirzepatide

Eli Lilly announced on May 14, 2024, that it had reached a settlement with Totality Medispa, a med spa accused of misleading customers into thinking it sold Lilly's FDA-approved drugs Mounjaro and Zepbound, both brand names for tirzepatide ^[1][2]. Under the deal, Totality Medispa must make a monetary payment to Lilly and stop using Lilly's branding in its marketing ^[1][2].

The settlement followed lawsuits Lilly filed in September and October 2023 against multiple med spas and compounding pharmacies ^[1][2]. Lilly says it is the only lawful supplier of FDA-approved tirzepatide medicines in the United States and does not sell tirzepatide active pharmaceutical ingredient to any compounding pharmacy ^[1]. That means, according to Lilly, that any product sold simply as "tirzepatide" is not an FDA-approved product ^[1].

As part of the agreement, Totality Medispa is required to only obtain and distribute compounded tirzepatide made in compliance with federal law, report any adverse events to the FDA, and post a disclaimer on its website and ads stating that compounded tirzepatide is not FDA-approved and has not been reviewed by the FDA or any global regulator for safety, quality, or efficacy ^[1]. The company also must stop suggesting its products are genuine, FDA-approved Lilly medicines ^[1].

Lilly said this settlement was one of several similar agreements reached with other med spas and wellness centers that had used Lilly's trademarks or made false advertising claims ^[3]. In March 2024, Lilly said it had found bacteria and high impurity levels in products marketed as compounded tirzepatide; in at least one case, Lilly said the product tested was nothing more than sugar alcohol, with no active drug at all ^[1][2]. Novo Nordisk, which makes the semaglutide drugs Ozempic and Wegovy, has pursued a similar legal campaign; last year it sued a compounding pharmacy in Florida after finding a version of compounded Wegovy that was up to 33% impure ^[2].

Compounded drugs are custom-made versions of a medicine's active ingredients, often sold at lower prices, but they are not FDA-approved and face far less regulatory scrutiny than brand-name drugs ^[2]. Lilly has stated it does not believe it can solve the counterfeit and compounding problem alone, and it is calling on state and federal regulators to take further action against pharmacies and sellers that put patients at risk ^[1].

Why it matters for patients

For people using or considering tirzepatide, this settlement is a signal that some products marketed under that name at med spas or wellness centers may not be safe or genuine. Lilly has said some compounded products it tested contained bacteria, had different colors than real Mounjaro or Zepbound, had a different chemical structure, or contained no active drug at all ^[1][3]. The company has also said no regulator has evaluated the safety or effectiveness of pill or oral versions of tirzepatide being advertised by some online pharmacies, since FDA has approved only injectable tirzepatide ^[3].

Patients cannot assume that a product labeled tirzepatide, Mounjaro, or Zepbound at a med spa is the same as Lilly's FDA-approved medicine. Lilly says it is the only lawful source of FDA-approved tirzepatide products in the U.S. and does not supply the active ingredient to compounders ^[1]. The company has also reiterated that Mounjaro and Zepbound are approved only for adults with specific medical conditions, not for general cosmetic weight loss or for people under 18 ^[3].

What happens next

Lilly said it entered into similar settlements with other med spas and wellness centers beyond Totality Medispa, though the sources do not name all of them ^[3]. On June 20, 2024, Lilly filed additional legal actions against med spas, wellness centers, and other entities and published an open letter warning patients and providers about counterfeit and unsafe compounded tirzepatide products ^[3]. It is not yet known from these sources whether further settlements or new enforcement actions from federal or state regulators have followed since then.