CINCINNATI—Throughout the last week of April, Cincinnati U.S. Customs and Border Protection (CBP) officers and U.S. Food and Drug Administration (FDA) Office of Criminal Investigation special agents and FDA consumer safety officers conducted a collaborative blitz, Special Operation Safe Passage, targeting high risk FDA-regulated products such as COVID-19 medications and test kits, prescription medications, beauty products, medical devices, and other items that violate FDA laws and could prove dangerous or ineffective.
CBP and FDA officers found hundreds of shipments containing prohibited and counterfeit cosmetics, injectable treatments, dermal fillers, retroviral and cancer treatment drugs, human growth hormones, fat reduction machines, and other regulated drugs and devices such as:
- Botox and Dysport
- Liporase, Radiesse, and EPTQ Lidocaine
- Viagra and Cialis
- COVID-19 test kits
- Unapproved body sculpting machines, liposuction machines, and other fat reduction machines
The illegal products originated from countries all over Asia and Europe and were headed to addresses throughout the United States. In total, officers seized or denied entry to 318 shipments. The cumulative value for all the prohibited products was over $1.23 million had the products been genuine and approved by the FDA.
“CBP is focused on protecting American citizens from misbranded, counterfeit, or unapproved drugs, cosmetics, and medical devices by disrupting the importation of these illegal and potentially harmful products and removing them from our supply chain,” said Cincinnati Port Director Richard Gillespie. “Our officers and specialists enforce hundreds of laws for many partner agencies and are committed to ensuring the health and safety of American citizens.”
E-commerce growth and rapid shipping logistics has allowed more and more consumers to purchase medications and treatments from online vendors for what appears to be a cheaper price for the same product sold behind the prescription counter. However, unlike FDA-sanctioned drugs and medical equipment sold by known companies, online platforms and third-party sellers offer products made in unregulated facilities with unknown quality controls and unknown ingredients.
“FDA is committed to protecting U.S. consumers from deceptive, unapproved medical products, whether produced domestically or abroad,” said Judy McMeekin, Pharm.D., associate commissioner for regulatory affairs. “We will continue to work with our federal partners to apprehend and bring to justice those who attempt to put the health of Americans at risk.”
CBP provides basic import information about admissibility requirements and the clearance process for e-commerce goods and encourages buyers to confirm that their purchases and the importation of those purchases comply with any state and federal import regulations.