Customs and Border Protection (CBP), in conjunction with the Food and Drug Administration (FDA), halted the importation of over $3.5 million worth of counterfeit prescription drugs at Cincinnati port.
In a significant move to protect public health, U.S. Customs and Border Protection (CBP) and the U.S. Food and Drug Administration (FDA) have jointly seized a vast quantity of unapproved and counterfeit drugs during an operation at the Port of Cincinnati.
The operation uncovered a wide range of pharmaceuticals, including counterfeit injectables and pills, originating from various countries. Hong Kong, China, Colombia, and Korea were among the top sources of these illicit products. The seizure encompassed 54,843 counterfeit products, with a combined value of over $3.53 million if they were legitimate.
Among the seized shipments were counterfeit Ozempic, a FDA-approved drug for type 2 diabetes, but not for weight loss treatment. Other medications intercepted included Botox, Juvéderm, dermal fillers, erectile dysfunction medication, contact lenses, and other FDA-prohibited items. CBP officers also seized a total of 16,740 injectables of counterfeit pre-filled medicated pens.
The health risks associated with these illicit products are concerning due to the unknown ingredients. CBP advises consumers to purchase pharmaceuticals from reputable sources and to ensure they are administered by properly trained and licensed medical professionals.
CBP enforces laws for partner agencies, including the FDA, and targets and inspects questionable shipments being imported into the U.S. The FDA provides guidance on how human drugs can be legitimately imported into the United States, with imported drug products requiring FDA approval or meeting FDA standards for safety, efficacy, and labeling. Personal importation exceptions may apply under limited circumstances, such as when the product is not commercially available domestically for a serious health condition, the quantity is small (normally up to 90 days’ supply), and there is no unreasonable risk.
Importers, including commercial entities, must comply with FDA rules such as the Foreign Supplier Verification Program (FSVP) to verify foreign suppliers and ensure compliance with U.S. standards. Failure to do so can result in penalties including product detention, refusal, or destruction. The FDA has enhanced its import oversight with programs like the Nationalized Entry Review to detect unsafe imports more efficiently nationwide.
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. CBP completes enforcement action when necessary to protect the public from harmful and counterfeit products.
In summary, legitimate importation requires FDA clearance or an allowable personal import exception, compliance with U.S. laws, proper documentation, and importers’ verification of foreign product safety and regulatory adherence. Unauthorized or unapproved drug imports are subject to seizure or refusal. Consumers are strongly advised to purchase pharmaceuticals from reputable sources to avoid potential health risks.
In the wake of the seizure at the Port of Cincinnati, concerns about counterfeit drugs extend to sports-related substances, as counterfeit pre-filled medicated pens, potentially including performance-enhancing drugs, were among the seized items. Consumers in Cincinnati and other cities, such as Houston, Atlanta, Denver, Los Angeles, and New York, should be vigilant when purchasing pharmaceuticals, including sports-related medications, to ensure they are from reputable sources to protect their health.
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