Press Announcements > FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online

Press Announcements > FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide.

The action occurred as part of the Eighth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the Internet.

As part of this year’s international effort – Operation Pangea VIII – the FDA sent Warning Letters to the operators of nearly 400 websites offering unapproved or misbranded prescription medicines to U.S. patients and to nine firms distributing unapproved or uncleared medical devices online. FDA inspectors, in collaboration with other federal agencies, screened and seized illegal drug products and medical devices received through International Mail Facilities (IMFs) in Chicago, Miami and New York during the IIWA. These screenings resulted in 814 parcels being detained and referred to appropriate FDA offices for follow up. Parcels found in violation of the Federal Food, Drug and Cosmetic Act will be refused entry into the country.

To learn more, please visit: Pangea VIII.