U.S. authorities say they have begun seizing illegal parcel shipments of the popular weight-loss drug Ozempic at ports of entry as smugglers take advantage of programs that expedite duty-free entry of small-dollar imports.
Ozempic joins a soaring number of illegal medications, including synthetic drugs like fentanyl, entering the United States through e-commerce sales channels.
Customs and Border Protection officers have confiscated 11 Ozempic-related shipments this year since February at DHL Express’ main sortation hub at Cincinnati/Northern Kentucky International Airport, the agency announced last week. All the shipments originated in Colombia and were destined for New York, Massachusetts and Texas. Most shipments held more than 100 pre-filled injection pens, with a combined value of $887,000 for comparable legitimate products.
The seizures represent the first time CBP inspectors in the central United States have seen contraband Ozempic, said Steven Bansbach, a spokesman for the Chicago field office, which has jurisdiction in parts of 12 states. Officers in May also seized a small number of Ozempic parcels at Chicago O’Hare International Airport, he added. All the entries were classified as de minimis shipments, meaning their declared value of $800 or less made them exempt from import duties and filing a formal import declaration.
The concern is that people may be trying to buy Ozempic and related drugs at a lower cost by buying them from sources outside the country that are not regulated by the Food and Drug Administration. CBP works closely with the FDA to identify illicit medications and beauty products that pose a risk to consumers.
Vanity Fair reported last week that thousands of counterfeit Ozempic pens were delivered in 2023 to a warehouse in New York and that the FDA is investigating. Manufacturer Novo Nordisk acknowledged that organized crime is increasingly involved in producing and distributing counterfeit versions. The publication reported that fake Ozempic is being shipped through the U.S. Postal Service’s international mail facility at JFK airport in New York and 60% of it originates in China. One shipment detected by CBP contained 10,000 units of counterfeit Ozempic.
Ozempic is approved as a prescription drug to treat Type 2 diabetes. Doses are administered with a pen injector to control high blood sugar levels. The FDA has also approved a drug with a higher dose of the active ingredient in Ozempic, called semaglutide, to treat obesity, under the brand name Wegovy. The drugs have become popular for their weight-loss effects, with people seeking out physicians who will prescribe them for off-label use or buying them online.
The FDA is concerned about potentially counterfeit, misbranded or unapproved products containing semaglutide or similarly named ingredients. Certain compounded forms of semaglutide may not contain the same active ingredient as the approved versions for Type 2 diabetes and weight loss, the FDA recently warned.
“With the increased demand for this product, FDA is aware of individuals smuggling these drugs into the country. Prescription drugs that are smuggled from outside the U.S., particularly injectable products that should be sterile, can present a serious health risk to those who use them. The drugs have not undergone the proper import processes and may contain unknown or dangerous ingredients,” said Dan Solis, FDA assistant commissioner for import operations.
Very few online pharmacies are compliant with U.S. pharmacy standards. Consumers are taking a chance buying medications because they may include unknown ingredients, have unusual side effects or lack effectiveness, CBP added.
The agency processes 4 million low-value shipments per day at mail and express air facilities, as well as sea and land ports, around the country. Specialists use manifest data supplied by carriers to identify incoming shipments from various destinations and determine which ones to target for closer review. Canine teams walk along conveyor belts, and nonintrusive X-ray machines also are tools for detecting pharmaceuticals such as fentanyl and Ozempic, cash, weapons, and other contraband materials. The reality is there are more counterfeit pharmaceuticals in the international mail system than authorities can detect, according to security experts.
Bansbach said smugglers could change their shipping pattern from Colombia utilizing DHL Express air service as CBP gets wise to the operation. “That’s what we’re on the lookout for: Are they going to switch their tactics or try to conceal it a little bit better?” he said.
Customs and Border Protection has recently ramped up parcel inspections at airports and required more detailed data from customs brokers to enhance its targeting of de minimis shipments, especially from China. Large e-tailers in China, such as Temu, Shein and Alibaba, have taken advantage of the Section 321 carve-out in the U.S. tariff code, which exempts single direct-to-consumer shipments under $800 from duties and taxes.The resulting onslaught of cross-border parcels has taxed CBP’s monitoring capabilities, making it easier for bad actors to use postal and parcel shipping to ship illicit products into the country.
Under a voluntary pilot program initiated four years ago, customs brokers can electronically transmit shipment data through the U.S. customs trade processing portal if they declare themselves as the importer of record. A key benefit of this Entry Type 86 procedure is that it also covers goods that fall under the import jurisdiction of other agencies, such as the FDA, which require extra data elements. In exchange for faster processing, filers must submit more data, including a 10-digit harmonized tariff code.
CBP recently suspended a half-dozen customs brokers from the program for unspecified compliance violations. Seko Logistics was quickly reinstated on a conditional basis and has taken legal action against the agency seeking details about alleged transgressions and full restoration of import processing benefits.
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