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Vitamin shop co-owner sold misbranded or foreign drugs not approved by FDA

Posted at 2:01 AM, Jun 19, 2018
and last updated 2018-06-27 12:27:03-04

CORPUS CHRISTI – A Corpus Christi woman admits to U.S. court that she knowingly possessed and sold diet drugs containing sibutramine.

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.

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

Another co-owner, Elias Trevino, pleaded guilty to similar charges in November.

The vitamin store was found to have been selling a number of misbranded or unapproved foreign drugs for weight loss.

She faces up to six years in federal prison and fines up to $350,000.  

Read more:  Local vitamin shop owner sentenced for misbranded drugs, controlled substance