Fake Over-the-Counter Drug Manufacturer Convicted in U.S. Court

On January 29, 2011, two Chinese nationals 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.

According to court documents, 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, indicating that these fake drugs were also being imported into the United States from China and that they 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 websites, including online auction websites such as eBay. 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 non-narcotic controlled substance), reports the ICE.

On January 29, 2011, two Chinese nationals 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.

According to court documents, 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, indicating that these fake drugs were also being imported into the United States from China and that they 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 websites, including online auction websites such as eBay. 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 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 purported weight-loss-related drugs. Zhou himself admitted he was the manufacturer of the counterfeit Alli.

Zhou’s website, “www.2daydietshopping.com,” indicated that his 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.

Agents acting in an undercover capacity placed and paid for numerous orders for the 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 in depth 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 numerous consumer reports of adverse physical effects from taking Zhou’s fake medication, purchased from either the defendant’s web page or through a re-distributor. One consumer, an emergency room doctor, suffered a mild stroke after ingesting the fake 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 pleaded guilty.

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