Inspections, Compliance, Enforcement, and Criminal Investigations

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

   

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Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release

 

 

For Immediate Release
June 18, 2018

United States Department of Justice

Southern District of Texas

CORPUS CHRISTI, Texas - A 35-year-old Corpus Christi woman has pleaded guilty to one count of possessing a controlled substance with the intent to distribute and one count of receiving a misbranded drug in interstate commerce, announced U.S. Attorney Ryan K. Patrick.

 

Vanesa Gonzales was one of the owners of X2Zero, a store selling dietary supplements online and through stores located in Corpus Christi. 

 

In 1997, the Food and Drug Administration (FDA) approved a prescription drug containing sibutramine under the trade name “Meridia” for the management of obesity. In October 2010, the FDA requested Meridia’s marketer to withdraw the drug from the United States market due to the health risks associated with sibutramine, including an increased risk of heart attack, stroke and death. On Dec. 21, 2010, at the manufacturer’s request, FDA withdrew its approval of Meridia. Since its removal, no drug containing sibutramine has been approved for human use in the United States.

 

The FDA found a number of the products X2Zero sold as “herbal weight loss supplements” to contain misbranded or unapproved foreign drugs.

 

At today’s hearing before Senior U.S. District Judge John D. Rainey, Gonzales admitted she knowingly possessed and sold diet drugs containing sibutramine. She acknowledged she imported the drugs from China and sold them through both the X2Zero store in Corpus Christi and on the internet in violation of the federal Food, Drug and Cosmetic Act.

 

Sentencing has been set for Sep. 17, 2018, at 5:00 p.m. At that time, Gonzales faces up to six years in federal prison and fines of up to $350,000. She has been and will remain in custody pending that hearing.  

 

The FDA-Office of Criminal Investigations conducted the investigation. Assistant U.S. Attorney Robert D. Thorpe Jr.is prosecuting the case.

 

Topic(s): 

Prescription Drugs

Health Care Fraud

 

Component(s): 

USAO - Texas, Southern

 

 

 

Page Last Updated: 06/20/2018
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