Shengyang Zhou, aka “Tom”, age 31, of Kunming, Yunnan, China, has entered a guilty plea to charges of trafficking in counterfeit versions of the pharmaceutical weight loss drug known as Alli. 

Zhou entered the plea before U.S. District Judge Philip B. Brimmer.  He is scheduled to be sentenced on May 6, 2011.  A co-defendant, Qingming Hu, age 61 of Plano, Texas, pled guilty to distributing Sibutramine, a Schedule IV non-narcotic controlled substance.  Hu is scheduled to be sentenced on April 28, 2011.

According to court documents, over the course of December 2008 through March of 2009, the U.S. Food and Drug Administration (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 warned 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). 

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 GlaxoSmithKlein. 

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.

Sold online 

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.

During the course of the investigation, law enforcement agents identified Zhou as the trafficker and importer into the United States of these counterfeit and unapproved purported weight loss related drugs.  Zhou also identified himself as the manufacturer of the counterfeit Alli.

Zhou’s website,www.2daydietshopping.comindicated 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 unapproved product featured in FDA public alerts was shipped to Hu for re-distribution to United States customers.

Undercover agents placed numerous orders for the counterfeit and illegal diet pills.  In turn, money was wired to bank accounts.  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. 

During that meeting the undercover agents told Zhou that they had access to a private customs broker who would be willing to import the counterfeit Alli into the United States through air cargo shipments that would be mis-described. 

As the investigation continued undercover agents and Zhou agreed to meet in Hawaii to discuss increasing the order for counterfeit Alli.  At that meeting Zhou provided proof that he was capable of producing large quantities of Alli, and that he had cured certain imperfections.  At the end of the meeting agents handed Zhou cash to complete the Alli order transaction.  At that point, Zhou was arrested.

A number of consumers reported feeling an assortment of adverse physical effects from taking the counterfeit Alli that they had purchased from the defendant’s web page or through a re-distributor.  One consumer, an emergency room doctor, suffered a mild stroke after ingesting the counterfeit Alli.

Zhou faces a maximum penalty of ten 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.