News

The IPR Center Report

Partners in Action

Volume 1: No. 1 • November 2008

Operation Guardian Responds to Health and Safety Threats

In Spring 2007, pet owners in the U.S. were alarmed by headlines about animals dying of mysterious illnesses. It was not long before the Food and Drug Administration (FDA) targeted the pets’ food as the likely cause. Investigators traced the source of pet food to China and discovered it contained contaminated wheat gluten. The U.S. government looked for a comprehensive response to public health and safety threats that were the subject of recent recalls - food, toys, paint, counterfeit drugs, aircraft or automobile parts, and many other products.

In July 2007, President Bush established by Executive Order an Interagency Working Group on Import Safety. As a result of its participation in this working group, U.S. Immigration and Customs Enforcement (ICE) envisioned a long-term response called Operation Guardian (Guardian).

Guardian is a comprehensive enforcement initiative to combat the increasing importation of substandard, tainted, and counterfeit products that pose a health and safety risk to consumers. Guardian grew to include the expertise of fellow Department of Homeland Security component U.S. Customs and Border Protection, the FDA Office of Criminal Investigation, the Federal Bureau of Investigation, the U.S. Postal Inspection Service, the Department of Justice Computer Crimes & Intellectual Property Section, and the Consumer Product Safety Commission. The collaborative targeting and investigative efforts of Guardian member agencies have led to the seizure of commodities that include pharmaceuticals, circuit breakers, extension cords, surge protectors, steel components, honey, shrimp, Christmas lights, and toys. The combined seizures under this operation have exceeded $6 million.

The results are starting to show in the criminal courts as well:

• In February 2008, Randy Gonzales, a citizen of the Philippines, became the first foreign national extradited to the U.S. for conspiring to import and distribute counterfeit pharmaceutical drugs. He has pled guilty and is set to be sentenced on November 21, 2008.
• In July 2008, Kevin Xu was convicted by a federal jury in Houston of nine counts of conspiracy, trafficking in counterfeit pharmaceuticals, and introduction of misbranded and counterfeit pharmaceuticals into the United States. As a result of this investigation, there have been three Class 1 recalls of counterfeit Plavix, Casodex, and Zyprexa, in Europe, affecting in excess of $9 million of these drugs. Xu faces a maximum sentence of five years in prison and a $250,000 fine for the conspiracy charge. Each of the three misbranding counts carries a maximum sentence of three years imprisonment and a $10,000 fine. Each of the five trafficking charges carries a maximum punishment of 10 years in prison and a $2 million fine. Xu is scheduled to be sentenced in Fall 2008.
• In August 2008, Saifoulaye Diallo, Habib Bah, Mabass Inc., and Vidtape Inc. pled guilty in the Eastern District of New York to trafficking in counterfeit goods, specifically counterfeit toothpaste. Both Diallo and Habib face up to 10 years in prison and up to $2 million dollars in fines. The companies may be fined up to $15 million. Sentencing is tentatively scheduled for January 2009.

These cases illustrate the positive impact the Guardian initiative is having on combating emerging threats that pose health and safety risks to U.S. consumers.