LawFuel.com – US Attorney Newswire
JOINT INTERNATIONAL UNDERCOVER INVESTIGATION BY FOOD AND DRUG ADMINISTRATION OFFICE OF CRIMINAL INVESTIGATIONS, U.S. IMMIGRATION AND CUSTOMS ENFORCEMENT, AND U.S. POSTAL INSPECTION SERVICE DISRUPTS COUNTERFEIT DRUG MANUFACTURING OPERATION
DENVER – Sengyang Zhou, aka “Tom,” a 30-year old Chinese national from Kunming, Yunnan, China, was charged by Criminal Complaint, which resulted in his arrest without incident on Tuesday, March 23, 2010, in Hawaii for illegally importing counterfeit weight loss medication. Zhou traveled from China to Hawaii intending to meet with persons interested in distributing his counterfeit weight loss pills in the United States. Zhou’s arrest was the culmination of an extensive joint federal law enforcement operation by Food and Drug Administration Office of Criminal Investigations (FDA OCI), U.S. Immigration and Customs Enforcement (ICE), and the U.S. Postal Inspection Service (USPIS). Following his arrest, Zhou appeared before a federal magistrate judge in Honolulu, Hawaii for initial proceedings on the Criminal Complaint pending against him. He waived his rights to further proceedings in the District of Hawaii and will be transported in U.S. Marshal custody to the District of Colorado, where further proceedings will be conducted in the case. The government has moved that Zhou be detained without bond pending the completion of the prosecution of this case.
A second defendant, Qingming Hu, age 60, was arrested without incident in Plano, Texas, also on Tuesday, March 23, 2010, for participating in and aiding this illegal scheme. Following her arrest, Hu appeared before a federal magistrate judge in the Eastern District of Texas. She waived her right to a preliminary hearing in the Eastern District of Texas and agreed to make an appearance in Denver, Colorado on April 7, 2010 to face charges pending against her. She was then released on bond.
According to the affidavit in support of the Criminal Complaint, during the course of 2008, 2009, and 2010, the FDA issued a series of alerts on its website concerning tainted weight loss pills and counterfeit drugs. Initial alerts focused on “Superslim,” “2 Day Diet,” and Meitzitang, among other purported weight loss products believed to having been imported from China and being marketed as dietary supplements or nutritional products. The FDA stated in these initial alerts that the items posed a very serious health risk to consumers, because, based on analysis, they were found to be drugs that contained undeclared active pharmaceutical ingredients, including Sibutramine (a controlled substance), antidepressants, potent diuretics available only by prescription, and drugs not approved in the United States.
The ingredient Sibutramine, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. In later alerts, FDA warned the public about counterfeit versions of the brand name drug Alli, a popular over the counter weight loss drug manufactured by Glaxo-Smith Klein. The alerts indicated that these counterfeit drugs were also being imported into the United States from China and did not contain the proper active pharmaceutical ingredient for the authentic product but instead contained dangerous levels of Sibutramine. The counterfeit versions of Alli were being sold in the United States, among other ways, through internet auction websites.
During the course of the investigation, law enforcement agents identified Zhou as the alleged trafficker and importer into the United States of these counterfeit and unapproved purported weight loss related drugs. According to the complaint affidavits, Zhou also identified himself as the manufacturer of the counterfeit Alli. Zhou allegedly engaged in these activities primarily through the operation of an internet website and internet postings placed on one or more business to business websites that solicited orders from customers in the United States and elsewhere. The defendant also communicated with customers and potential customers via Yahoo email accounts.
Agents acting in an undercover capacity placed numerous orders for the counterfeit and illegal diet pills. In turn, money was wired to one of three bank accounts in the United States, or to Zhou’s girlfriend in China. At one point, two agents flew to a third country in an undercover capacity to meet with Zhou. At that meeting they discussed in depth Zhou’s manufacturing capabilities. Zhou identified himself as the manufacturer of the counterfeit Alli and promised to fix defects in the counterfeit versions of the Alli he had previously shipped, defects that had been noted by the FDA in its public alerts.
The affidavit in support of the criminal complaint filed against Zhou identifies at least one victim of Zhou’s crime. A man who had been taking an authentic version of Alli found a cheaper version of the product being sold over the internet. The victim ordered the pills, which were allegedly counterfeit produced by Zhou. As a result, the victim took the pills and started to feel ill, exhibiting a significant adverse reaction, including symptoms associated with heart palpitations, numbness within his left arm, severe anxiety, enormous eye pressure/headaches, profuse sweating and chills. He thought he was having a heart attack like episode, thinking his life was in jeopardy. The victim handed investigative agents the bottle he purchased over the internet, which was tested at FDA’s Forensic Chemistry Center. The pills contained Sibutramine and were determined to be fake versions of Alli. Agents were able to tie the pill purchase to Zhou.
Zhou’s website, “www.2daydietshopping.com” indicated that his business operated a United States branch out of Plano, Texas. Agents determined through investigation that the branch was operated by Qing Ming Hu, a naturalized United States citizen born in China. Some of the product shipped to Hu for redistribution to United States customers included “2 Day Diet” and “Super Slim,” items that were listed among the illegal, unapproved drugs by the FDA in its public alerts.
As part of the coordinated arrests of Zhou and Hu, federal agents executed a search warrant on the Plano, Texas residence that served as Zhou’s United States branch. Agents also served seizure warrants to freeze funds in four bank accounts in the United States that Zhou had established to collect funds from his illegal drug sales.
“The Food and Drug Administration will work together with other government entities to aggressively target those individuals who put the public’s health at risk by selling counterfeit drugs,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “International borders and the perceived anonymity of the Internet will not deter FDA from investigating violations of the law. I commend the U.S. Attorney’s Office in Colorado and all agencies involved in this case for their tireless effort to protect the public health.”
“An important mission of ICE is to enhance public safety by ensuring that counterfeit pharmaceuticals don’t enter the stream of commerce and then into the hands of customers,” said John Morton, Department of Homeland Security Assistant Secretary for U.S. Immigration and Customs Enforcement (ICE). “With the outstanding teamwork among our law enforcement partners, our ICE agents have used our unique customs expertise and law enforcement authorities to quickly put an end to dangerous diet pills being sold to unsuspecting consumers.”
“This arrest is evidence that no matter where you are, be it in the United States or abroad, if you use the U.S. Mail to endanger the American public, we will find you,” said Shawn Tiller, Inspector-in-Charge of the Denver Division of the U.S. Postal Inspection Service. “We will continue to use our resources to protect the American public and ensure the integrity of the U.S. Mail. This case is another great example of federal law enforcement agencies partnering together to keep America safe.”
Zhou is charged with introduction and delivery for introduction into interstate commerce of unapproved new drugs, which carries a penalty of not more than 3 years imprisonment and up to a $250,000 fine; the importation of pharmaceutical drugs contrary to law, which carries a penalty of not more than 20 years in federal prison, and up to a $250,000 fine; the importation and distribution of schedule IV, non-narcotic controlled substances, which carries a penalty of not more than 5 years imprisonment and up to a $250,000 fine; and trafficking in counterfeit goods, which carries a penalty of not more than 10 years in federal prison and up to a $250,000 fine.
Hu is also charged with introduction and delivery into interstate commerce of unapproved new drugs, as well as with distribution of a Schedule IV non-narcotic controlled substance, an offense which carries a penalty of not more than 3 years imprisonment and up to a $250,000 fine.
This case is being investigated by the Food and Drug Administration Office of Criminal Investigations (FDA OCI), U.S. Immigration and Customs Enforcement (ICE), and the U.S. Postal Inspection Service (USPIS).
The case is being prosecuted by Assistant U.S. Attorney Ken Harmon.
The Criminal Complaint is a probable cause charging document. Anyone accused of committing a federal felony crime has a Constitutional right to be indicted by a federal grand jury.
The charges contained in the Criminal Complaint are allegations, and the defendants are presumed innocent unless and until proven guilty.
United States Attorney’s Office Press Releases are also on the Internet
SENGYANG ZHOU INVESTIGATION
AGENCY FACT SHEET
Food and Drug Administration (FDA)
The FDA is the federal agency responsible for administering federal statutes and regulations aimed at protecting the health and safety of United States citizens and residents by ensuring, among other things, that drugs are safe and effective for their intended uses before they may be offered and sold in the United States. One of the primary statutes that the FDA enforces is the Federal Food, Drug, and Cosmetic Act, which is designed, among other things, to ensure that drugs sold for human use are safe and effective and bear labeling that contains true and accurate information.
FDA Alerts Regarding these weight loss pills
December 22, 2008: FDA Warns Consumers about Tainted Weight Loss Pills http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116998.htm
March 20, 2009: FDA Uncovers Additional Tainted Weight Loss Products http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149547.htm
Q & A’s on Tainted Weight Loss Products http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm136187.htm
January 18, 2010: FDA Warns Consumers about Counterfeit Alli http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm
January 25, 2010: Counterfeit Alli Release http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm198557.htm
U.S. Immigration and Customs Enforcement (ICE)
U.S. Immigration and Customs Enforcement (ICE) is the largest investigative agency within the Department of Homeland Security, responsible for investigating trade and immigration violations. Part of ICE’s responsibilities is to ensure that Customs-related laws are enforced in order to ensure products that are being imported into the United States are not being imported contrary to law.
U.S. Postal Inspection Service (USPIS)
The mission of the United States Postal Inspection Service is to protect the U.S. Postal Service, secure the nation’s mail system and ensure public trust in the mail. Postal Inspectors are federal law enforcement officers who conduct criminal investigations and prepare them for court. They also work in concert with other agencies on investigations where the U.S. Mail is one aspect of a target’s criminal conduct.
Spokesman, Public Affairs Officer
U.S. Department of Justice
United States Attorney’s Office, District of Colorado
303-454-0243 direct; 303-489-2047 cell phone