On Monday, Eli Lilly announced it has filed lawsuits against three medical spas and online sellers for offering products that falsely claim to include tirzepatide, the active ingredient in its well-known weight-loss medication, Zepbound, which also includes some dissolvable tablets.

The new legal actions target Pivotal Peptides, MangoRx, and Genesis Lifestyle Medicine of Nevada, marking the first instances of legal measures against counterfeit tirzepatide since the U.S. Food and Drug Administration (FDA) removed the drug from its list of medications experiencing shortages earlier this month.

Lilly clarified that these lawsuits were initiated independently of tirzepatide’s previous status on the shortage list, meaning they could have been filed regardless of any supply issues.

Pivotal Peptides asserts it provides research-grade tirzepatide, while MangoRx markets a compounded version, both easily accessible online. The medical spa Genesis is reported to sell and administer compounded forms of the medication, as per the lawsuits.

Lilly accused Pivotal Peptides of marketing products that claim to contain tirzepatide directly to consumers without requiring a medical prescription, despite claiming the products are for research purposes.

The lawsuits were lodged in both federal and state courts in Indiana, Texas, and Washington, with allegations of false advertising and promotion against the defendants. Lilly stated that it had previously sent a “cease and desist” letter to Pivotal Peptides prior to filing the lawsuits.

“Lilly is pursuing these legal actions to safeguard American consumers from potential health risks,” noted a company spokesperson, emphasizing that the defendants were making misleading claims regarding the safety and effectiveness of their products, along with misrepresenting clinical data.

The Indianapolis-based pharmaceutical company has already taken legal action against over two dozen medical spas, wellness centers, and compounding pharmacies selling products that claim to include tirzepatide, which is also recognized for treating type 2 diabetes under the brand name Mounjaro.

In its recent filings, Lilly reported that MangoRx was offering an oral formulation of tirzepatide branded as Trim, despite the absence of any studies validating the safety and efficacy of that formulation. Currently, the FDA has only sanctioned tirzepatide for injection use.

After Lilly’s “cease and desist” letter, Pivotal Peptides reportedly updated its website to indicate it was undergoing maintenance and shifted its sales approach to include email, social media, and word of mouth tactics, as outlined in Lilly’s lawsuit.

Lilly claims that Genesis offers compounded tirzepatide combined with vitamin B12, asserting that such combinations are “untested, unproven, and pose unwarranted risks to consumers.”

Lilly is seeking court orders to prevent these vendors from selling their products that falsely claim to contain tirzepatide, in addition to unspecified damages.

Earlier this month, a court filing indicated that the FDA agreed to reconsider a previous ruling that prohibited drug compounders from offering their versions of Eli Lilly’s highly sought weight loss and diabetes treatments.

The agency mentioned in a court document that it would permit compounding pharmacies and facilities to continue supplying these drugs while it investigates the potential shortage of their active ingredient. Generally, compounded formulations of medications tend to be more affordable for patients compared to their brand-name counterparts.

This decision was a reaction to a lawsuit filed by the Outsourcing Facilities Association, representing the compounding industry. Following the FDA’s announcement on Friday to reassess its earlier decision, U.S. District Judge Mark Pittman in Fort Worth, Texas, temporarily paused the lawsuit.