The FDA, in partnership with international regulatory and law enforcement agencies, took action in June against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The effort, led by INTERPOL, was part of Operation Pangea IX.
George Karavetsos, director of the FDA’s Office of Criminal Investigations, said, “preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers’ health. Operation Pangea IX demonstrates the FDA’s continuing commitment to stand united with our international partners to protect consumers in the United States and throughout the world from criminals who put profit above the health and safety of consumers.”
The action ran from May 31 to June 7, 2016. Extensive inspections were conducted at International Mail Facilities (IMFs) with the U.S. Customers and border Protection. Formal complaints were sent to domain registrars asking for the suspension of the 4,402 websites.
One hundred ten of those websites sell the chemical 2,4-Dinitrophenol (DNP) as a weight loss product. DNP is used as a dye, wood preserver, and herbicide and has never been approved by the FDA for human consumption, let alone as a prescription drug. In fact, a guilty plea from Adam Alden of Bakersfield, California was received on May 9, 2016 for introducing an unapproved drug that was made with that product into interstate commerce. A Rhode Island customer who bought DNP over the internet from Alden and other sources died in October 2013 as a result of ingesting DNP.
In addition, the FDA sent warning letters to operators of 53 websites that illegally offered unapproved and misbranded prescription drug products for sale. FDA screened and seized illegal drug products received through IMFs in San Francisco, Chicago, and New York. They detained 797 parcels which will be destroyed if found to contain unapproved drugs.
U.S. consumers purchased unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, along with other health conditions. Consumers should always be cautious when buying prescription drugs online. And consumers are vulnerable to credit card fraud, identity theft, and computer viruses from these illegal compound pharmacies. You can report suspected criminal activity at the FDA Criminal Investigations web site.
