October 25, 2017: Five Chinese Citizens and Four Chinese Companies Indicted in Scheme to Sell Mislabeled Dietary Supplements
Food and Drug Administration
U.S. Department of Justice Press Release
For Immediate Release
United States Department of Justice
Department of Justice
A Dallas, Texas, grand jury returned two indictments today against five Chinese citizens and four companies alleging fraud and other charges, the Justice Department announced. The charges relate to alleged sales of stimulants intended for inclusion in dietary supplements.
The indictments charge the defendants with participation in a scheme to produce and sell dietary supplements containing hidden synthetic stimulants, such as 2-amino-6-methylheptane (“DMHA”). The charges also involve alleged shipments of 1,3-dimethylamylamine (“DMAA”) and DMHA. DMAA, which is chemically similar to DMHA, has been linked to severe adverse events such as heart attacks and strokes.
The indictments allege that the defendants knew major American dietary supplement retailers would not carry supplements containing these stimulant ingredients. The indictments also allege the defendants agreed with a confidential government informant to either mislabel ingredients or otherwise help to hide the true nature of a proposed dietary supplement from retailers. None of the ingredients allegedly shipped during the undercover investigation were sold to consumers.
“It is unlawful for companies both outside and inside the United States to conceal questionable, dangerous, or illegal ingredients in dietary supplements sold to American consumers,” said Chad A. Readler, Acting Assistant Attorney General of the Department of Justice’s Civil Division. “These cases demonstrate the Department of Justice’s commitment to ensuring that dietary supplements are safe and accurately labeled.”
“U.S. consumers trust that their dietary supplements are safe and contain appropriate labeling. When unscrupulous producers add undeclared or misidentified ingredients to dietary supplements, there is no assurance that the product is safe for consumption,” said Catherine A. Hermsen, Acting Director, FDA Office of Criminal Investigations. “The FDA will continue to pursue and bring to justice those who participate in fraudulently marketing dietary supplements to the detriment of public health.”
The first indictment charges Genabolix USA Inc., a Nevada corporation; Shanghai Yongyi Bioltechnology Ltd., a Chinese corporation; Hu Chang Chun (a.k.a. James Hu), 44, of Shanghai, China, the principal of Genabolix; Gao Mei Fang (a.k.a. Amy Gao), 41, of Shanghai, China, the supply chain manager for Genabolix; and Zhang Xiao Dong (a.k.a. Mark Zhang), 31, of Shanghai, China, the sales manager for Genabolix, with mail fraud. The indictment also charges Genabolix, Shanghai Yongyi, Hu, and Gao with introducing misbranded food into interstate commerce. In addition, the indictment charges Genabolix, Yongyi, and Gao with obstruction of an agency proceeding and smuggling.
A second indictment charges Shanghai Waseta International Trade Co. Ltd., a Chinese corporation; Max Pharmatech Inc., a California corporation; Xu Jia Bao (a.k.a. Fred Xu), 48, of Shanghai, China, the principal of Shanghai Waseta; and Li Ting Ting (a.k.a. Sunny Lee), 37, of Shanghai, China, the overseas sales manager for Shanghai Waseta, with wire fraud and with introducing misbranded food into interstate commerce. The indictment also charges Shanghai Waseta with smuggling.
Gao Mei Fang, Zhang Xiao Dong, and Xu Jia Bao were arrested in late September at a dietary supplement trade show in Las Vegas and remain in custody. A date for trial before the federal district court in Dallas has not yet been set. The remaining individual defendants are not believed to be in the United States.
“Few things are more important than ensuring the safety of what we put into our bodies,” said U.S. Attorney John Parker for the Northern District of Texas. “Those who deliberately mislead us on this critical issue will be prosecuted to the fullest extent of our laws.”
An indictment is an accusation by a federal grand jury and is not evidence of guilt. The defendants should be presumed innocent unless and until proven guilty.
Upon conviction, the maximum statutory penalties for the individual defendants are 20 years’ imprisonment and a $250,000 fine for mail fraud or wire fraud; one year imprisonment and a $100,000 fine for the introduction of misbranded food into interstate commerce; three years’ imprisonment and a $250,000 fine for the introduction of misbranded food into interstate commerce with the intent to defraud or mislead; five years’ imprisonment and a $250,000 fine for obstruction of an agency proceeding; and 20 years’ imprisonment and a $250,000 fine for smuggling.
The FDA Office of Criminal Investigations-Dallas Division investigated the case. The case is being prosecuted by Assistant U.S. Attorneys Kathryn Rumsey and Errin Martin of the Northern District of Texas and Trial Attorneys David Sullivan and Patrick Runkle of the Justice Department’s Consumer Protection Branch.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Northern District of Texas, visit its website at https://www.justice.gov/usao-ndtx.
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