Indiana Intellectual Property Law News
Eli Lilly and Company has reached a settlement with Totality Medispa, a South Carolina-based medical spa, after filing lawsuits in late 2023. The agreement requires Totality Medispa to pay a monetary amount and stop misleading consumers about selling Lilly’s popular, FDA-approved, diabetes and weight-loss treatments, tirzepatide, Mounjaro® or Zepbound®.
Eli Lilly is the only authorized supplier of FDA-approved tirzepatide medicines in the U.S. and does not provide tirzepatide’s active pharmaceutical ingredient (API) to any compounding pharmacies. Any product labeled as “tirzepatide” that is not sold by Lilly is not FDA-approved and could be dangerous.
Because Eli Lilly places patient safety at the forefront, the company has been alarmed by the dangers of Totality Medispa’s products being falsely marketed as FDA-approved tirzepatide, Mounjaro®, or Zepbound®. These counterfeit products have not been reviewed by the FDA or any global regulatory bodies, posing serious health risks to patients.
Investigations by Lilly found that some of Totality Medispa’s so-called compounded tirzepatide products contained harmful substances, impurities, and incorrect chemical structures. In one case, a product was merely sugar alcohol.
Under the settlement, Totality Medispa must:
- Ensure all compounded tirzepatide products comply with U.S. federal law.
- Report any adverse effects from its compounded tirzepatide to the FDA.
- Clearly state on its website and advertisements that “Compounded versions of tirzepatide are not FDA-approved, and neither the FDA nor any global regulatory agency has reviewed these products for safety, quality, or efficacy.”
- Stop suggesting its products are genuine, FDA-approved Lilly products.
- Cease using Lilly branding to promote its products.
Eli Lilly recognizes that solving this issue requires more than just their efforts. They urge state and federal regulators to take action against compounding pharmacies and counterfeiters who endanger patients by selling unsafe, misleading products. Lilly supports stronger regulatory measures to ensure that only safe, approved medications are available.