Customs and Border Protection (CBP) and Food and Drug Administration (FDA) collaborate to seize over $3.5 million worth of counterfeit drugs at Cincinnati port.
The United States Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) have joined forces to combat the illegal importation of pharmaceuticals, seizing a significant number of counterfeit products in a recent operation at the Port of Cincinnati.
The operation resulted in the seizure of 54,843 counterfeit products, with a combined value of over $3.53 million. Among the seized items were hundreds of boxes containing possible counterfeit and unapproved medications, including Ozempic, Semaglutide, Retatrutide, and Tirzepatide injections. A total of 16,740 injectables of counterfeit pre-filled medicated pens were also seized.
The FDA's guidance for legitimately importing human drugs into the United States requires that all FDA-regulated products offered for import comply with the same standards as domestic products. The FDA reviews these imports through an initial electronic “Entry Review” process to determine admissibility and may refuse entry of any product violating FDA laws and regulations.
Key points from the FDA's import guidance include compliance with FDA standards, the Nationalized Entry Review Program (NER), accurate data submission, cooperation with CBP, consumer advice, and proposals for enhanced FDA authority and supply chain transparency. The NER, effective August 4, 2025, centralizes import reviews nationally to improve the detection and interdiction of dangerous products, including risky or counterfeit drugs.
Importers must provide complete and valid information about their products and suppliers to facilitate FDA review. CBP enforces FDA restrictions at ports of entry, seizing unapproved or counterfeit drugs and working closely with the FDA. Consumers are advised to purchase pharmaceuticals only from reputable sources and to ensure medications are administered by properly trained and licensed medical professionals.
The pharmaceuticals originated in many different countries, with the most coming from Hong Kong, China, Colombia, and Korea. The seized shipments had final destinations to 40 of the 50 states, including Washington D.C., with most shipments heading to Texas, Florida, Georgia, Colorado, California, and New York.
It is essential to note that there is no guarantee the ingredients are safe when purchasing from unapproved sources online. The health risks of illicit products are concerning due to the unknown ingredients. The FDA provides guidance on how human drugs can be legitimately imported into the United States, and CBP recommends consumers follow these guidelines to ensure their safety.
The FDA, in collaboration with CBP, is urging consumers in Cincinnati and across the nation to be cautious when purchasing health-and-wellness products, particularly injection medications like Ozempic, Semaglutide, Retatrutide, and Tirzepatide, as the seizure of counterfeit and unapproved versions has increased. With the upcoming implementation of the Nationalized Entry Review Program (NER) on August 4, 2025, the government aims to enhance health safety by centralizing import reviews and improving the detection of dangerous products.
%20and%20Food%20and%20Drug%20Administration%20(FDA)%20collaborate%20to%20seize%20over%20%243.5%20million%20worth%20of%20counterfeit%20drugs%20at%20Cincinnati%20port.){kind=link}