CINCINNATI– In early to mid-October, Cincinnati Customs and Border Protection conducted a special operation focused on unapproved and counterfeit contact lenses and other high-risk regulated commodities imported into the United States. The purpose of this enhanced enforcement was to identify and intercept Food and Drug Administration (FDA) ophthalmology products and misbranded prescription pharmaceuticals and injectable cosmetics. 
Officers found more than 12,100 pairs of undeclared or misdeclared decorative contact lenses, 2,800 capsules of ampicillin, and 198 syringes of counterfeit dermal fillers, Botox, and Dysport. The prohibited items originated from multiple countries, including China, Poland, Germany, Thailand, Hong Kong, and South Korea, and were destined to addresses across the United States. The cumulative Manufacturer’s Suggested Retail Price (MSRP) for the prohibited items was $216,856 had they been legally imported.
“Consumers should understand the dangers associated with unapproved medical devices and unregulated medicines and cosmetics,” said Cincinnati Port Director Richard Gillespie. “Not only is their health and safety is put at risk, but trade in these illegitimate goods funds criminal enterprises and other criminal activities. Our officers work hard every day to prevent these dangerous and illegal shipments from making its way to the hands of our citizens.”
“The FDA shares the concerns raised by CBP and works closely with them to address the public health threat posed by contaminated contact lenses being imported into the US,” said Dan Solis, Assistant Commissioner for Import Operations. “Our strong relationship with CBP enables the kind of collaborative work necessary to best apply each agency’s authority and enforcement tools and prevent unapproved medical devices from further distribution within the US. More details on contact lenses may also be found within the FDA Web Page – https://www.fda.gov/medical-devices/contact-lenses/decorative-contact-lenses-halloween-and-more”
Decorative contact lenses are commonly used as accessories for Halloween costumes and the performing arts, but the FDA emphasizes that all contact lenses are medical devices that require a valid prescription from a licensed optometrist, and are not legally sold over-the-counter. If consumers suspect a vendor is illegally selling contacts or other medical products, they can report it to the FDA.
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