Illegal Ozempic shipments enter the US through e-commerce sales

The problem is that people may try to get Ozempic and related drugs at a lower price by purchasing 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 drugs and cosmetic products that pose a risk to consumers.

Last week, Vanity Fair reported that thousands of counterfeit Ozempic pens were delivered to a New York warehouse in 2023, and the FDA is investigating. Producer Novo Nordisk has admitted that organized crime is increasingly involved in the production and distribution of fake versions. The publication reported that the fake Ozempic is shipped via U.S. Postal Service International Mail to New York JFK Airport, with 60% of the shipments coming from China. One shipment detected by CBP contained 10,000 units of the counterfeit drug Ozempic.

Ozempic is approved as a prescription drug for the treatment of type 2 diabetes. Doses are administered using a pen-type pen to control high blood sugar levels. The FDA also approved a drug containing a higher dose of Ozempic’s active ingredient, called semaglutide, for the treatment of obesity, under the brand name Wegovy. These drugs have become popular for their weight-loss effects, and people are looking for doctors to prescribe them for off-label use or buying them online.

FDA is concerned about potentially counterfeit, misbranded, or unapproved products containing semaglutide or similarly named ingredients. As the FDA recently warned, some combination forms of semaglutide may not contain the same active ingredient as approved versions of the type 2 diabetes and weight loss drug.

“Due to the increased demand for this product, the FDA is aware of individuals smuggling these drugs into the country. Prescription drugs smuggled out of the United States, especially injectable products that are supposed to be sterile, can pose serious health risks to those who use them. The drugs have not undergone appropriate import processes and may contain unknown or unsafe ingredients,” said Dan Solis, FDA deputy commissioner for import operations.

Very few online pharmacies meet American pharmaceutical standards. Consumers take risks when purchasing medications because they may contain unknown ingredients, cause unusual side effects or be ineffective, CBP added.

The agency handles 4 million low-value items a day at postal and express facilities, as well as sea and land ports throughout the country. Specialists use manifest data provided by carriers to identify shipments coming from different destinations and determine which ones to select for closer inspection. Teams of dogs walk the conveyor belts, and non-invasive X-ray machines are also tools for detecting pharmaceuticals such as fentanyl and Ozempic, cash, weapons and other smuggled materials. The reality is that, according to security experts, there are more counterfeit drugs in the international postal system than authorities can detect.

Bansbach said smugglers could divert shipments from Colombia to DHL Express air services if CBP becomes aware of the operation. “That’s what we’re looking for: Will they change their tactics or try to hide it a little better?” he said.

Customs and Border Protection recently stepped up inspections of parcels at airports and requested more detailed data from customs agents to make its operations more effective on de minimis shipments, especially from China. Large online retailers in China such as Temu, Shein and Alibaba have benefited from the carve-out of Section 321 in the U.S. Tariff Code, which exempts single direct-to-consumer shipments under $800 from duties and taxes. The resulting cross-border parcel attack strained CBP’s monitoring capabilities, making it easier for bad actors to use the Postal and Parcel Services to ship illicit products into the country.

Under a voluntary pilot program initiated four years ago, customs agents can electronically submit shipment data through the U.S. Customs Trade Processing Portal if they declare themselves as an importer of record. A key advantage of this Type 86 entry procedure is that it also covers goods under the import jurisdiction of other agencies, such as the FDA, that require additional data elements. In exchange for faster processing, applicants must submit more data, including the 10-digit harmonized tariff code.

CBP recently suspended a half-dozen customs agents from the program for unspecified regulatory violations. Seko Logistics was quickly conditionally reinstated and took legal action against the agency, asking for details of the alleged violations and full restoration of its import processing benefits.

Click here to see more FreightWaves/American Freight Forwarders stories by Eric Kulisch.

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