Deadly Over-The-Counter Fake Drugs Distributed to Americans

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On January 29, 2011, Shengyang Zhou, a Chinese national, and Qingming Hu, a naturalized US citizen, pled guilty to trafficking in over-the-counter weight-loss medications, including manufacture and distribution, in the United States, announced the U.S. Immigration and Customs Enforcement Office (ICE), culminating a two year undercover investigation.  These pills were distributed to Americans and many reported adverse physical effects after taking them, including one report of a patient suffering a stroke.

Who: U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI), the Food and Drug Administration's Office of Criminal Investigations (FDA OCI), and the U.S. Postal Inspection Service.

When: January 28th, 2011; counterfeit drugs manufactured, imported and sold by Mr. Zhou and Ms. Hu from 2008 through 2010.

Where: Plano, Texas USA.

How: Sting operation conducted in concert by the ICE, HIS, FDA-OCI, and USPS.

According to documents presented in court, between December 2008 and March 2009, the FDA issued a series of alerts concerning tainted weight loss pills and counterfeit versions of the brand-name drug "Alli," a popular over-the-counter weight-loss drug. It was indicated that these fake drugs were also being imported into the United States from China and that they did not contain any of the genuine pharmaceutical ingredient for the “Alli”, but instead contained dangerous levels of Sibutramine. The counterfeit versions of Alli were being sold in the United States, via several channels including through internet websites and online auction websites such as eBay. The FDA in their alerts had warned consumers that the items posed a very serious health risk because they were found via analysis to be drugs that contained undeclared active pharmaceutical ingredients, such as Sibutramine (a non-narcotic controlled substance), reports the ICE.

Law enforcement agents identified Shengyang Zhou, aka "Tom," 31, of Kunming, Yunnan, China as the trafficker and importer into the United States of these counterfeit and unapproved so-called weight-loss drugs. Zhou has admitted he was the manufacturer of the counterfeit Alli.

The website, "www.2daydietshopping.com," indicated that Zhou’s business operated a U.S. branch out of Plano, Texas. Agents determined through investigation that the branch was operated by Qing Ming Hu, 61 of Plano, Texas, a naturalized U.S. citizen born in China. Some of the unapproved product featured in FDA public alerts was shipped to Hu for re-distribution to U.S. customers.

Undercover agents placed and paid for several orders for over-the-counter counterfeit and illegal diet pills from Zhou's website, "www.2daydietshopping.com," ostensibly operated out of Plano, Texas. Eventually, two agents flew to a third country in an undercover capacity to meet with Zhou and discussed the details of Zhou's manufacturing capabilities. Zhou identified himself as the manufacturer of the counterfeit Alli, promising 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.

There were many reports from consumers of adverse physical effects from taking medication purchased either directly from the defendant's web page or from a re-distributor. One consumer, an emergency room doctor, suffered a mild stroke after ingesting the counterfeit weight-loss drug.

Zhou faces a maximum penalty of 10 years imprisonment, a $250,000 fine, and restitution for the counterfeit goods offense to which he has pled guilty.

Hu faces maximum penalty of five years imprisonment and a $250,000 fine for the distribution offense to which she has pled guilty.

"Americans must have confidence that drugs introduced into and distributed throughout the United States are genuine, FDA-compliant products," said Patrick J. Holland, special agent in charge of the FDA Office of Criminal Investigations. "The FDA will aggressively pursue all foreign and domestic perpetrators of illegal drug distribution schemes who threaten the public's health by selling counterfeit drugs."

Related sources:

" Chinese National and Chinese American Convicted of Importing Counterfeit Weight-loss Drugs ,"US Immigrations and Customs Enforcement News Release. January 28th 2011.