BIRMINGHAM, AL – U.S. Customs and Border Protection (CBP) officers assigned to the Port of Birmingham discovered nearly 500 unregistered non-contact and infrared thermometers originating in Malaysia and China. If genuine, the thermometers would have a combined MSRP of $21,400.
Although the thermometers included U.S. Food and Drug Administration (FDA) markings on the packaging and devices, they were seized because the shipping company was not registered with the FDA at the time of importation. All medical devices imported into the United States must meet the FDA’s regulatory requirements, which include pre-market notification to the FDA under section 510(k) of the Food, Drug and Cosmetic Act. Goods that do not meet FDA requirements may be seized and prevented from entering U.S. commerce.
“CBP officers and agriculture specialists in the Port of Birmingham remain vigilant even during the COVID-19 pandemic,” said David Pond, CBP Birmingham Port Director. “Keeping these types of unregulated medical devices out of the United States is a top priority for CBP.”
So far this calendar year, CBP has seized more than 107,000 illegitimate COVID-19 test kits, more than 11,000 doses of FDA-prohibited chloroquine, and more than 750,000 counterfeit masks. Of these, the New Orleans Field Office has seized 3,461 test kits, 297,014 unauthorized masks, and nearly 30 shipments of unregulated COVID-19 related medication.
FDA and CBP have an agreement for the cooperative enforcement of the Food, Drug, and Cosmetic Act, Section 801, Title 21 U.S.C. 381. The FDA is responsible for regulating medical devices used to diagnose, prevent and treat COVID-19, such as diagnostic tests, ventilators, and personal protective equipment (PPE) -- including surgical masks, face shields, respirators, gowns, and gloves. FDA industry guidance on thermometers can be found on the Enforcement Policy for Clinical Electronic Thermometers website. For more information, click visit the Coronavirus (COVID-19) and Medical Devices website.
CBP has established an educational initiative to raise consumer awareness and conscientiousness about the consequences and dangers that are often associated with the purchase of counterfeit and pirated goods. Information about the Truth Behind Counterfeits public awareness campaign can be found at www.cbp.gov/fakegoodsrealdangers.
IPR violations can also be reported to the National Intellectual Property Rights Coordination Center at https://www.iprcenter.gov/referral/ or by telephone at 1-866-IPR-2060.