Customs and Border Protection (CBP) and Food and Drug Administration (FDA) joint operation seizes over $3.5 million worth of fake medications at Cincinnati port.

Customs and Border Protection (CBP) and Food and Drug Administration (FDA) joint operation seizes over $3.5 million worth of fake medications at Cincinnati port.

In a significant joint operation, U.S. Customs and Border Protection (CBP) and the U.S. Food and Drug Administration (FDA) have seized a staggering 54,843 counterfeit products, with a combined value of over $3.53 million if legitimate. The operation, which took place at the Port of Cincinnati, targeted questionable shipments being imported into the U.S.

The seized shipments contained a variety of unapproved FDA drugs, including counterfeit injectables and pills. Among the counterfeit pharmaceuticals were FDA-approved drugs like Ozempic, Semaglutide, Retatrutide, and Tirzepatide injections, as well as 16,740 injectables of counterfeit pre-filled medicated pens.

The health risks associated with illicit products are concerning due to the unknown ingredients, which may not be safe when purchased from unapproved sources online. Consumers are, therefore, advised to purchase pharmaceuticals from reputable sources to minimize these risks.

The FDA offers guidance for the legitimate import of human drugs into the United States, requiring that they comply fully with the same standards as domestically produced drugs, including labeling, registration, and product listing requirements. The FDA's comprehensive "Entry Review" process ensures that products offered for import are electronically reviewed for compliance and admissibility.

The operation also resulted in the discovery of various other medications, such as Botox, Juvéderm, dermal fillers, erectile dysfunction medication, contact lenses, and other FDA-prohibited items. Purchasing regulated cosmetics and pharmaceuticals online can potentially pose serious health risks to consumers.

In addition to the FDA, CBP partners with other agencies during operations to enforce regulations. Properly trained and licensed medical professionals should administer medications to ensure safety, and consumers should always ensure that medications are administered by such professionals.

The FDA is also proposing changes to improve supply chain transparency, including requiring drug labels to disclose detailed information on the manufacturers of active pharmaceutical ingredients and finished products. This move is aimed at enhancing traceability and ensuring the safety of the nation's drug supply.

The FDA provides administrative guidances specifically addressing the importation of FDA-approved prescription drugs and biological products. Potential enforcement actions, including debarring individuals or firms from importing drugs, are also in place to ensure compliance with FDA laws and regulations.

In light of this operation, it is clear that the partnership between CBP and FDA is crucial in protecting the nation's drug supply. Consumers are urged to be vigilant and purchase pharmaceuticals from reputable sources to safeguard their health.

[1] FDA (2021). Importing Pharmaceuticals. https://www.fda.gov/drugs/import-programs/importing-pharmaceuticals

[2] FDA (2021). Proposed Rule for Supply Chain Transparency. https://www.fda.gov/news-events/public-health-focus/fda-proposes-rule-require-drug-companies-disclose-information-manufacturers-active-pharmaceutical

[3] FDA (2021). FDA's Import Programs. https://www.fda.gov/about-fda/office-food-drug-and-cosmetic-regulation/fda-import-programs

[4] FDA (2021). Enforcement Actions. https://www.fda.gov/about-fda/enforcement-activities-and-recalls/enforcement-actions

[5] FDA (2021). Guidance for Industry: Importation of FDA-Approved Prescription Drugs and Biological Products. https://www.fda.gov/media/121749/download

1. The seized counterfeit products at the Port of Cincinnati, in addition to questionable medications, included other FDA-prohibited items such as Botox, Juvéderm, dermal fillers, erectile dysfunction medication, and contact lenses, highlighting the need for consumer vigilance in purchasing regulated cosmetics and pharmaceuticals.
2. To enhance the safety of the nation's drug supply, the FDA is proposing changes to improve supply chain transparency. These changes include requiring drug labels to disclose detailed information on the manufacturers of active pharmaceutical ingredients and finished products.
3. In light of the joint operation between CBP and FDA, the FDA provides administrative guidelines specifically addressing the importation of FDA-approved prescription drugs and biological products. Potential enforcement actions, such as debarring individuals or firms from importing drugs, are in place to ensure compliance with FDA laws and regulations.

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