BOULDER, Colorado — Not far from the majestic Rocky Mountains lies an ordinary suburban neighborhood with tree-lined streets and modest light gray homes.
This is not the place you would imagine an investigation into the black market Ozempic would begin. But it happened.
A CNBC investigation into counterfeit weight loss drugs uncovers an international illegal market where criminals brazenly modify drugs and ship genuine products from overseas. This is what is called drug trafficking and violates federal law.
The operation primarily involves counterfeit or illegal versions of Novo Nordisk’s diabetes drug Ozempic and obesity drug Wegoby, as well as Eli Lilly’s Mounjaro and Zepbound. All four drugs belong to a very popular class of weight loss drugs known as GLP-1. As the demand for treatment skyrockets, criminal schemes are emerging to capitalize on that demand.
CNBC bought the drug, sold as Ozempic, from a company called Laver Beauty, whose website and corporate documents list an address in a quiet residential area of Boulder. The drug costs $219 for a one-month supply, a fraction of the US retail price of Ozempic, which costs $968 for a one-month supply.
The Boulder homeowners said they received mail and a 1099 IRS tax form addressed to Laver Beauty, but claim they have no connection to the company.
The medical supplies CNBC purchased were shipped via DHL from an office building in Shijiazhuang, China, about a four-hour drive from Beijing. The package arrived at CNBC headquarters in Englewood Cliffs, New Jersey, in a plain cardboard box with no refrigeration, except for two melted ice packs. Ozempic is supposed to be kept refrigerated. The authentic-looking drug packaging contained Chinese characters and the Novo Nordisk logo.
Novo Nordisk said in an email that the drug “appears to be a repurposed product manufactured and distributed for the Chinese market in late 2023 and early 2024, and is therefore unauthorized or unapproved for the U.S. market.” ” he said. ”
The company added that “sterility cannot be verified, which may increase the risk of infection for patients using counterfeit products.”
Law enforcement officials told CNBC that the Ozempic received from China is part of a larger ongoing federal investigation into Ozempic packages being shipped to the United States.
Laver Beauty did not respond to CNBC’s request for comment, but a person identifying themselves as a company representative told CNBC in a WhatsApp chat: “All of our products are authentic. We don’t sell fakes.” The person confirmed to CNBC that the products purchased were intended for the Chinese market.
The representative also messaged that the Boulder address was “the former address of our U.S. warehouse.” The day after CNBC inquired about the Boulder address, it was removed from the company’s website.
counterfeit medicine
The Ozempic that CNBC purchased is considered an illegal diversion drug. A separate, related and growing problem is the rise in counterfeit medicines, or counterfeit products disguised as genuine.
Last year in the UK, authorities seized hundreds of counterfeit Ozempic pens (insulin pens relabeled as Ozempic).
“Demand is increasing and, as is often the case in situations like this, criminals are trying to fill the unbalanced gap between supply and demand for a particular product, making it difficult to find genuine counterfeits of Ozempic products. It’s now available online,” said Andy Mooring, deputy director of criminal enforcement at the UK Medicines and Healthcare products Regulatory Agency.
Andy Moring, deputy director of criminal enforcement at the UK Medicines and Healthcare products Regulatory Agency, holds up a real and fake Ozempic pen.
CNBC
Mohring spoke to CNBC from the warehouse outside London where the counterfeit goods are stored. In 2023, a total of 869 counterfeit Ozempic pens were seized.
Counterfeit weight loss pills pose serious health risks, according to drug companies and federal authorities. In some cases, they can be fatal to the person using them.
Eli Lilly, the maker of Mounjaro and Zepbound, said it is actively fighting counterfeit products.
“We have a very sophisticated and rigorous system for testing drugs before they are approved for use in patients,” said Dr. Daniel Skovronsky, Eli Lilly’s chief scientific officer. In fact, (counterfeit products) are not getting through the system at all.” He is also the president of Lilly Research Institute.
Dr. Daniel Skovronski, Eli Lilly’s chief scientific officer and director of Lilly Laboratories, shows samples of real and fake Munjaro.
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He showed CNBC an elaborate fake labeled as Mounjaro, but contained an entirely different drug: a type 2 diabetes drug that does not cause weight loss.
“It looks like Mounjaro to everyone in the world, and it comes in a box labeled Mounjaro,” he said. “And there’s also a pen that says Mounjaro. But it’s not Mounjaro at all.”
Counterfeiters are already trying to get their hands on the company’s weight-loss drug Letaltortide, which isn’t even on the market yet. CNBC discovered it is being sold online.
“We are testing it today in a phase 3 clinical trial. We don’t know yet, but we hope to have results next year. Then we will know,” Skovronksi said.
Asked about sites selling what they claim is letaltortide, Skovronksi said, “Oh, that’s crazy…Even real letaltortide is not ready for use in patients outside of clinical trials.”
Increase in port seizures
Counterfeit and diversions of Ozempic and other obesity drugs are common in the vast international mail facility on the grounds of New York City’s John F. Kennedy International Airport. More than 60,000 counterfeit and illegal products were seized at the facility last year.
Ozempic, Wigovy and other weight loss drugs seized at JFK International Mail Facility.
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“Unfortunately, I’m not surprised by these new types of drugs that we’re seeing, whether it’s weight loss drugs or other drugs,” said the port overseeing U.S. Customs and Border Protection (CBP) at JFK Airport. Director Sal Ingrassia said: he told CNBC. “Through this facility they will be diverted, counterfeited and transported illegally.”
Since January 1, CBP has made more than 198 seizures of the drug labeled Ozempic, according to CBP. Nine medicines labeled ‘Wegovy’ and one labeled ‘Mounjaro’ were also seized.
CBP’s seizure data does not specify how much of the drug was genuine and diverted to the United States, or whether it was counterfeit.
Sal Ingrassia is the port director for U.S. Customs and Border Protection at JFK.
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CNBC showed Ingrassia the Ozempic the company purchased from Laver Beauty, and although the package lacked the necessary refrigeration, the shipment clearly “disrupted the legal supply chain,” he said. said.
“For me, this is something that if we find out, we will stop and take action. This is a dangerous product,” he said.
Ingrassia said he expects the number of seizures of weight loss products to be double this year compared to last year.
And what happens to the seized items? Ingrassia said that because injection pens are classified as medical devices, U.S. Customs is not allowed to destroy them unless they are part of an active investigation by the FDA. It is then sent back to the foreign supplier.
Crackdown on illegal sites
Ingrassia said most of the repurposed products are ordered online or via social media.
“The people who are ordering these products are primarily individuals, looking for deals online, and obviously taking a big risk by doing so. We are also seeing that,” he said.
The pharmaceutical industry has partnered with cybersecurity firm Brandshield to go after sellers of counterfeit and illegally diverted medicines.
BrandShield CEO Yoav Keren told CNBC that the company has flagged and ultimately shut down various sites, including Facebook and TikTok accounts that were impersonating GLP-1 manufacturers and selling versions of the drug. .
Spokespeople for Meta and TikTok, parent companies of Facebook and Instagram, said their platforms do not allow the sale of prescription drugs and that the companies are taking steps to remove such listings.
“This is a challenge that spans platforms, industries, and communities, which is why we are working with law enforcement, regulators, and private industry to combat this issue,” a Meta spokesperson said in an email to CNBC. We continue to invest resources and work on further improvements.” Our enforcement of this type of content. ”
Kellen said 250 sites identified by BrandShield as related to fake weight loss products were removed last year, eight times more than in 2022.
“It’s kind of whack-a-mole, but we’re chasing them. We’re chasing them, this is our technology, we find them very quickly,” he said. Ta.
Connection with Türkiye
Counterfeit Ozempic has been reported in 15 countries, according to the World Health Organization, which issued a global alert in June warning of the health risks of purchasing counterfeit products.
For the US government, that’s a big problem.
“We’re seeing a huge influx of repurposed drugs from Europe and South America,” said Nicole Johnson, national program manager for the Intellectual Property Rights Coordination Center, which fights counterfeit products. “But when it comes to counterfeits, a lot of what we’re seeing in the U.S. right now is just reusing old Ozempic pens, so you can actually take the original packaging out and fill it with saline.”
Nicole Johnson is a national program manager at the Intellectual Property Rights Coordination Center.
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Mr Johnson said the countries with the highest numbers of counterfeit and repurposed drugs were India, China, the UK, Mexico and Turkey. In Turkey, she says, government-subsidized medicines are fueling the counterfeit drug market.
Istanbul is known for the beauty of the Bosphorus, surrounded by stunning palaces and mosques. But it’s also one of the hubs of the lucrative counterfeit drug trade, according to U.S. authorities who track counterfeit medicines.
“What criminals usually do is find something they can exploit to make more money. So medicines were bought up and sold all over the world. Things that were supposed to help people were misused. “There are,” Johnson said.
Last fall, Turkish national police carried out raids across Istanbul as part of an international crackdown.
Maziar Mike Doosdar, executive vice president of international operations at Novo Nordisk, agreed that Turkey has become a hotspot for pharmaceutical crime.
Magial Mike Doostdahl is executive vice president of international operations at Novo Nordisk, based in Zurich.
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Counterfeiters are acquiring sophisticated packaging equipment that is “comparable to the original company’s equipment,” Dusdahl said.
“They source their equipment from pretty much the same places that we and our competitors source their equipment, so the packaging looks very similar to the original product,” he said. Ta.
“There are more online channels promoting these products…and selling them through online channels is actually prohibited in Turkey,” said Direnc Bada, an Istanbul-based lawyer who represents a major pharmaceutical company in Turkey. “It has been done,” he pointed out.
Direnc Bada is a lawyer representing Turkish pharmaceutical companies.
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FDA warnings, complaints
In the United States, the FDA announced in a December alert that it had seized “thousands of counterfeit units” of Ozempic in “the legitimate U.S. supply chain.”
Asked about the status of the investigation into counterfeit Ozempic, an FDA spokesperson said there were no updates to the original warning.
The risks when purchasing counterfeit medicines can be high. Considering the delicate nature of the formulation and the specific transport requirements of medicines, consumption of illegal versions can pose a risk to human health.
“It’s one thing to counterfeit a luxury bag, it’s quite another to counterfeit medicine,” Dusdahl said.
Reports of problems with weight loss drugs containing semaglutide, the active ingredient in Ozempic, or tirzepatide, the active ingredient in Munjaro, have skyrocketed since 2019.
“This is a very serious problem for us as a pharmaceutical company, as an industry, because patient safety is our license to operate, and you’re toying with people’s safety,” Dusdahl said. he said.
“There are no good counterfeit products,” he says.
—CNBC’s Eunice Yun and Paige Tortorelli contributed to this report.
