Totality MediSpa, created in 2018 and located out of Charleston, South Carolina, has been selling counterfeit versions of Eli Lillly’s diabetes drug, Mounjaro, and its new weight loss treatment, Zepbound.
Totality MediSpa used Lilly branding on their compounded versions of the drugs. From using this branding, Totality was claiming that their products were FDA-approved and had undergone the critical clinical testing stages.
These counterfeit products had in fact not been reviewed by the FDA or any global regulatory agency for their safety, efficacy, or quality, creating a huge health safety issue for those who participated in using these medications or treatments.
The counterfeits, after analysis, contained high levels of bacteria, high impurity levels, and even sugar alcohol (Financial Express 2024).
Eli Lilly filed lawsuits against ten medical spas in September and October of 2023 regarding the counterfeit, non-FDA approved versions of Lilly’s Ozempic-like drug Mounjaro.
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The key component involved in these counterfeit options is a drug named tirzepatide. Once compounded, it acts very similarly to Mounjaro by lowering blood sugar levels and increasing insulin production in the body to suppress appetite (Palmer 2023).
Although created through these MediSpas, it lacks the clinical testing and safety features that FDA and other regulatory agencies provide as a stamp of approval for consumers.
The ten MediSpas caught with counterfeits were found in seven different states in the US including South Carolina, Texas, Utah, Minnesota, Arizona, Florida, and Georgia (Schimelpfening 2023).
The lawsuits were filed on the justification of trademark infringement, false advertising, unfair competition, and unfair trade practices.
As a result, Totality Spa entered a settlement offer with Lilly which included an undisclosed monetary payment in addition to the compliance of terminating the use of Lilly’s trademark names while advertising products.
In addition, they must distribute only compounded tirzepatide produced legally according to the federal law and report any adverse events to the FDA (Loftus 2024).
The market for weight loss drugs has changed in terms of who the target audience for these medications are. Originally serving diabetic patients, these weight loss drugs are becoming the new fad for celebrities and people looking to drop pounds quickly.
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As new customers enter the market, demand for weight loss drugs have skyrocketed while supply has stayed the same.
Those who are medically prescribed to the medication as a way of diabetes therapy have experienced obstacles regarding minimal supply.
Attempting to solve this problem while simultaneously finding a way to capitalize on their solution, MediSpas have taken advantage of their ironically hungry and eager customer profile and the overcrowded market to fast-track a weight loss drug of their own with the credibility and name brand of Eli Lilly.
$12.5 billion is the amount of sales Novo Nordick’s Ozempic and Wegovy experienced in their first nine months in 2023 (Saul 2023).
Local MediSpas are looking to get a cut of the profits by capitalizing on the marketable opportunity and huge increase in demand.
As Lilly lawsuits settle and their stock price continues to rise past the $787 a share as it was on May 14th, the date of the Totality MediSpa settlement, along with less non-FDA approved Ozempic-like drugs are available in the market, it will be interesting to see how the market reacts to this continued supply and demand issue.
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