Lilly says trade judge ruled Customs should block imported knockoff tirzepatide
Seven sellers were found to violate federal law by misleading buyers about imported knockoff tirzepatide, and Lilly says the order covers anyone importing the products.
Eli Lilly said on December 23, 2024, that the judge in its U.S. International Trade Commission case ruled that U.S. Customs and Border Protection should block unlawful imports of knockoff tirzepatide [1]. Lilly called the decision a win for patients and said it rested on findings that sellers would likely mislead buyers about what they were getting [1].
Seven entities were found to have broken federal law, Lilly said. They are based in China, Spain, Texas, Florida and Iowa [1]. According to the company, the judge found their conduct was likely to deceive consumers about whether imported "tirzepatide" was genuine Lilly medicine, and that some made false claims that their products had been through clinical trials, had FDA approval, or contained tirzepatide at all [1]. Lilly said the ruling applies to anyone importing illicit knockoff tirzepatide and did not identify the seven by name [1].
"Most people have no idea that the knockoff compounded drugs they are taking may be coming from dangerous and illicit foreign sources," said Patrik Jonsson, executive vice president of Eli Lilly and president of Lilly Cardiometabolic Health and Lilly USA [1]. He said knockoff medicines, or the ingredients in them, are often made in unregistered plants abroad that no regulator has inspected [1]. Lilly said it has seized illegal shipments from China that were packaged to look like dog food, tea or face masks, or tucked inside a box of t-shirts [1].
What Lilly's own testing of knockoff tirzepatide has turned up includes bacteria, high endotoxin levels and high levels of impurities, the company said [1]. Potency was another problem. Almost half of the knockoff tirzepatide Lilly tested was weaker than its label claimed, and some held no tirzepatide at all, while others were stronger than represented, which Lilly said could lead a patient to overdose [1]. Lilly also cited an ABC report that bought semaglutide and tirzepatide online and found samples with none of the active ingredient and others at 250% of the advertised potency, plus a Tennessee Drug Task Force finding that counterfeit tirzepatide was sold to patients at med-spas [1].
Lilly pointed to a November FDA alert about tirzepatide from a licensed California compounder that the agency said used non-sterile ingredients and did nothing to sterilize them [1]. The FDA has repeatedly warned, according to the release, that compounded and counterfeit products can cause "serious and potentially life-threatening adverse health consequences including infections and sepsis" [1]. Lilly also noted that Australia banned compounded incretins this year, that regulators in South Africa, Brazil and Ireland have cautioned patients about unapproved versions, and that the American Diabetes Association issued guidance in December telling patients not to use compounded incretin products "due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness" [1].
Why it matters for patients
The order targets products crossing into the United States from abroad. Domestic compounding pharmacies are not addressed in Lilly's announcement [1]. Nothing in the release changes what a licensed U.S. pharmacy can dispense, and the company does not say what someone already using a compounded or imported product should do [1].
What the release does document is uncertainty about what is inside products sold outside the regulated supply chain. The problems described are not only about missing drug. They include doses well above what a label states and contamination the FDA links to infections and sepsis [1]. Compounded drugs and counterfeit drugs are separate categories, and the announcement does not keep them apart when it describes test results [1]. The release says nothing about cost, insurance coverage, or the legal status of compounded tirzepatide [1].
"The ITC order is an important step toward stopping bad actors who put patients at risk," Jonsson said, adding that Lilly will keep pursuing legal action and is urging state and federal regulators to act as well [1].
What happens next
Lilly did not say when Customs and Border Protection would begin enforcement, what penalties the seven entities face, or whether more cases are coming [1]. The release does not name the entities or the knockoff products beyond their locations [1].
Sources
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