CINCINNATI–-In late October, Cincinnati U.S. Customs and Border Protection officers, U.S. Food and Drug Administration Office of Criminal Investigation special agents and FDA Office of Import Operations Consumer Safety officers conducted an operation focused on intercepting high-risk, FDA- regulated ophthalmology products and misbranded prescription pharmaceuticals such as orthopedic injections, rheumatology infusions, cosmetic devices, and oncology drugs destined to locations in the United States. CBP and FDA officers seized a total of 398 shipments containing a total of 8,521 pairs of undeclared or misdeclared contact lenses.
Officers also seized 50 other shipments containing misbranded or misdeclared FDA-regulated drugs or medical devices, such as GLP1 medications, Botox, dermal fillers, skin care products, and several other FDA-prohibited substances and powders. All these shipments were destined to addresses across the entire United States. The cumulative Manufacturer’s Suggested Retail Price for the prohibited pharmaceuticals was $407,784 had they been legally imported. “Counterfeit products, such as these items, can contain toxic substances that can impact the public’s health,” said Director of Field Operations LaFonda Sutton-Burke, Chicago Field Office. “Counterfeiters have no moral compass and will counterfeit just about anything to make a buck.
We have encountered counterfeit makeup, perfumes, toys, clothing, electronics, machinery parts – basically, anything in demand, we’ve seen it. The movement of these goods into online marketplaces pose a significant risk to the American consumer.” Although most people buy contact lenses to be used as accessories for Halloween costumes and the performing arts, the FDA emphasizes 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. Additionally, imported pharmaceuticals must meet FDA’s standards for quality, safety, and effectiveness. Unfortunately, many online pharmacies are not compliant with U.S. pharmacy standards. This poses health risks to consumers who purchase what they believe is a genuine product at a much lower cost. The product the consumer receives may be inferior.
Risks posed by using medications from unfamiliar sources include unknown ingredients, unusual side effects, and lack of effectiveness of the product. Previous interagency operations have generated a significant number of seizures of infringing items and producing opportunities for additional enforcement. Items not conforming to FDA regulations can be of significant harm to the public.
During a similar operation in fiscal year 2025, 146 shipments were seized and another 38 were denied entry for unapproved contact lenses and other FDA-regulated items.
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