Cincinnati CBP Intercepts Over $407,000 in Unapproved Pharmaceuticals and Medical Devices

Cincinnati, OH – U.S. Customs and Border Protection (CBP) officers in Cincinnati, in conjunction with special agents from the U.S. Food and Drug Administration (FDA) Office of Criminal Investigation and officers from the FDA Office of Import Operations Consumer Safety, recently concluded an operation that successfully intercepted a significant quantity of unapproved pharmaceutical and medical products. The enforcement action, which took place in late October, targeted high-risk, FDA-regulated ophthalmology products and misbranded prescription pharmaceuticals, including items intended for orthopedic injections, rheumatology infusions, cosmetic applications, and oncology treatments, all destined for distribution within the United States.

The operation resulted in the seizure of 398 shipments containing a total of 8,521 pairs of undeclared or misdeclared contact lenses. Additionally, 50 other shipments were seized, which contained misbranded or misdeclared FDA-regulated drugs or medical devices. These included items such as GLP1 medications, Botox, dermal fillers, skin care products, and various other substances and powders prohibited by the FDA. The total estimated Manufacturer’s Suggested Retail Price for these intercepted pharmaceuticals, had they been legally imported, would have amounted to $407,784. The seized items were found to be destined for various locations across the United States.

The interception of these products highlights the risks associated with counterfeit and unapproved medical goods entering the consumer market. Counterfeit items can contain harmful substances and pose a direct threat to public health. The agency noted that counterfeiters often exploit high-demand products, leading to the infiltration of imitation goods into online marketplaces, which presents a substantial risk to American consumers.

While many individuals may purchase contact lenses for non-medical purposes such as costume accessories, the FDA classifies all contact lenses as medical devices. Their sale and distribution legally require a valid prescription from a licensed optometrist, and they are not permitted to be sold over the counter. Consumers who suspect that a vendor is illegally selling contact lenses or other medical products are encouraged to report such activities to the FDA.

Furthermore, imported pharmaceuticals must adhere to the FDA’s stringent standards for quality, safety, and effectiveness. Many online pharmacies operate in violation of these U.S. pharmacy standards, creating significant health risks for consumers. Individuals purchasing medications from unfamiliar online sources may unknowingly receive products of inferior quality, containing unknown ingredients, or exhibiting unusual side effects, potentially leading to a lack of therapeutic effectiveness.

This recent operation builds upon previous interagency efforts that have led to numerous seizures of infringing and harmful items, creating opportunities for enhanced enforcement actions. Products that do not comply with FDA regulations can indeed cause significant harm to the public. In a comparable operation during fiscal year 2025, 146 shipments were seized, and an additional 38 were denied entry due to unapproved contact lenses and other FDA-regulated items.

Article by Mel Anara, based upon information from U.S. Customs and Border Protection

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