Indianapolis-based Eli Lilly has filed lawsuits against four compounding companies—Mochi Health, Fella Health and Delilah, Henry Meds, and Willow Health Services—accusing them of selling unapproved products containing tirzepatide, a key ingredient in Lilly's Mounjaro and Zepbound weight-loss and diabetes drugs. The lawsuits were filed in the U.S. District Courts of California. Lilly's complaint against Fella Health and Delilah alleges a conspiracy with doctor groups to sell untested weight-loss drugs, misleading consumers about the safety and efficacy of their products. Lilly emphasizes that only its FDA-approved Mounjaro and Zepbound are tested and safe, with no evidence supporting the oral form of tirzepatide or combinations with additives like glycine or l-arginine. The FDA also notes that compounded drugs are not FDA-approved, which means their safety, effectiveness, and quality are not verified.
Lilly's lawsuit against Mochi Health claims that the company is part of an enterprise making and selling unapproved weight-loss drugs, putting patients at risk and diverting them from proven medicines. Mochi Health, however, defended its practices, stating that its licensed physicians determine the best treatments for patients in compliance with FDA guidance. The lawsuits against Willow Health and Henry Meds follow similar claims of deceptive marketing of unapproved, unsafe drugs. Earlier this month, Lilly also took legal action against over two dozen medical spas, wellness centers, and pharmacies selling products falsely claiming to contain tirzepatide.
In other news, Eli Lilly has formed partnerships to improve access to its FDA-approved weight-loss medications. Recently, Noom collaborated with Lilly's pharmacy provider, Gifthealth, to offer Zepbound to members with a doctor’s prescription. Similarly, Teladoc Health partnered with Gifthealth to streamline access to Zepbound for members in its Comprehensive Weight Care Program. Meanwhile, direct-to-consumer company Hims & Hers faced criticism for a Super Bowl commercial promoting compounded weight-loss medications, which sparked controversy with its portrayal of the weight-loss industry.