The first tip came into West Tennessee law enforcement about two months ago: A resident in the area was selling cheap versions of Ozempic and other weight loss drugs.
According to officials with the West Tennessee Drug Task Force, the tipster believed the products couldn’t be legitimate due to their unusually low prices: A 10-milligram vial of semaglutide, the active ingredient in Ozempic and Wegovy, sold for about $100, for example, and a 15 mg vial costs $140. The brand-name versions, from drugmaker Novo Nordisk, sell for around $1,000 for a month’s supply.
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Last week, officials said they raided Emily Arnold’s home in Medina, Tennessee, and found more than 300 vials of counterfeit versions of semaglutide, tirzepatide — the ingredient in the weight loss drug Zepbound and the diabetes drug Mounjaro — along with other drugs used for weight loss. Syringes, alcohol preps, mailers and other materials were also confiscated.
Officials learned that she allegedly had also been supplying the drugs to two med spa clinics in the state. Some people who used the counterfeit drugs reported rashes and other pain from the injections, officials said.
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“We stumbled into one room that was set up, sort of like a lab,” said Johnie Carter, the director of the West Tennessee Drug Task Force. “We even found three packages that were already packaged up and ready to go.”
“It was very shocking,” he added.
Officials said Arnold, 41, has been charged with four felonies and a misdemeanor, including impersonating a licensed professional. She will plead not guilty, her attorney said.
As highly effective but pricey weight loss drugs gain popularity in the U.S., experts and public health officials warn that low-cost counterfeit versions are becoming increasingly common.
Counterfeit versions of Wegovy or Zepbound are different from compounded weight loss drugs. Compounding is a legitimate practice that’s monitored by the Food and Drug Administration. Compounded medications are essentially copies made by a licensed pharmacist and usually prescribed by a doctor.
The FDA is allowing pharmacies to dispense compounded versions of semaglutide and tirzepatide until shortages of the brand-name drugs are fully resolved. In October, the FDA said compounding pharmacies can continue making their own versions after a compounding trade group sued the agency, saying the drugs were still in shortage. Compounded versions of the drugs tend to cost less and are popular at online pharmacies and med spas.
Counterfeits, on the other hand, aren’t licensed. They are manufactured and packaged to look like legitimate brand-name medications, but often contain little to none of the actual drug.
Shabbir Safdar, the executive director of the Partnership for Safe Medicines, an advocacy group that tracks counterfeit drugs, said fake GLP-1 medications are “the No. 1 fraud issue” that group is seeing in the U.S. and other parts of the world right now.
“It has exploded,” Safdar said. “I’ve never seen the quantity of fraud and crime that is happening in this space right now in anything for years. The criminals have been as active as the market excitement about the medicines are.”
The packaging of the counterfeit weight loss drugs can “appear like a perfect look-alike” to the brand-name versions, Safdar said. At the same time, he said, they could contain wrong or harmful ingredients, or contain too little, too much or no active ingredient at all.
West Tennessee law enforcement officials said that testing by Eli Lilly, the maker of Mounjaro and Zepbound, after the raid revealed that one of the samples sold by Arnold was nothing more than water, which could be dangerous if not properly sterilized.
“No one will be bothered if you’re hurt,” Safdar said. “They just want your money.”
The proliferation of counterfeit drugs
The FDA is aware of and investigating reports of counterfeit weight loss drugs being illegally marketed in the U.S., an agency spokesperson said in a statement.
“We vigilantly monitor the internet for fraudulent or unapproved products and have issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide,” the spokesperson said.
If needed, the spokesperson added, the FDA’s Office of Criminal Investigations will work with federal law enforcement officials to carry on seizures, injunctions and criminal prosecutions. Last year, the FDA announced that officials had seized thousands of units of counterfeit Ozempic found in the U.S. drug supply chain, but noted that some may still be available for purchase.
An Eli Lilly spokesperson said in a statement that the company was pleased that regulators in Tennessee took action to “stop one of the bad actors selling knockoff tirzepatide.” Lilly has obtained shipments from China claiming to be tirzepatide that are packaged as dog food, tea and facial masks or hidden inside of a box of T-shirts, the spokesperson said.
“The proliferation of counterfeit and other unsafe, unapproved tirzepatide knockoffs is dangerous and needs to be stopped,” the spokesperson said.
Novo Nordisk said it’s fighting counterfeit products and pursuing litigation against groups that sell counterfeit drugs.
“Producing counterfeit products and inserting them into the legitimate U.S. supply chain is an illegal activity and puts patients at considerable risk,” a Novo Nordisk spokesperson said in a statement.
The risks of counterfeit drugs
Using a counterfeit medication can lead to dangerous complications, said Dr. Daniela Hurtado Andrade, an endocrinologist at the Mayo Clinic in Jacksonville, Florida.
“You never know what they are mixing them with,” said Andrade, who spoke generally about the dangers of counterfeit drugs. “There is the potential risk that they are mixed with electrolytes, which for example, can put a person at risk of having cardiac arrhythmias.”
With counterfeit drugs, there’s no way to know they’re following health regulations.
“If you are putting a contaminated substance under your skin, you can certainly be at risk of developing infections,” she said. “These are infections that are local, but then you could have certain complications of local infections that can become systemic infections.”
Who is most at risk of counterfeit drugs?
Anyone who buys a GLP-1 drug without a prescription could be at risk of getting a counterfeit version.
The most vulnerable are people without adequate health care coverage or without prescription drug benefits, or who feel stigmatized by their weight and don’t want to see a doctor, Timothy Mackey, a professor of global health at the University of California, San Diego, said.
The nature of the weight loss drugs — large amounts of people qualify for them and their high cost — make the problem even more challenging to control, said Mackay, who studies counterfeit drugs.
“This situation is a bit different than prior counterfeit medicine incidents, as arguably so many people are at risk,” he said. “And consumers believe that they should be readily available, conveniently.”
Safdar, of the Partnership for Safe Medicines, said the best way people can protect themselves is to always get the brand-name product through a prescription from a doctor.
He acknowledged that other people may not qualify for the drug’s indicated use and will seek alternatives.
“I’ve seen people say, ‘I got it because I was trying to lose that last 10 pounds,’” Safdar said. “People are finding telehealth providers who will write that prescription and then dabbling in the market. None of that is safe.”
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