The U.S. Department of Justice (DOJ) announced a guilty plea in a Texas case involving a misbranded drug and a controlled substance. Vanessa Gonzales of Corpus Christi is the second individual to plead guilty in this case. Elias Trevino, Jr. entered his plea on May 15, 2017, and received a twelve-month sentence in November 2017. Both Gonzales and Trevino were owners of X2Zero, a store that sold dietary supplements online and in stores in the Corpus Christi-area.
The U.S. Food and Drug Administration (FDA) found that a number of products sold by X2Zero labeled as “herbal weight loss” products contained sibutramine, a drug originally approved for the management of obesity in 1997. In October 2010, the FDA recommended against the continued use of sibutramine because of potential cardiovascular risks associated with the drug. The FDA sent a warning letter to Gonzales and Trevino in December 2016 that listed seven products sold by X2Zero that contained unlisted pharmaceutical ingredients such as sibutramine and sildenafil.
Like Trevino, Gonzales admitted before the judge that she knowingly sold supplements that were misbranded or contained unapproved foreign drugs. Both said that the drugs they purchased were manufactured in China. Sentencing for Gonzales has been scheduled for September 17, 2018. She faces up to six years in prison and fines up to $350,000. This case is the result of the FDA’s Office of Criminal Investigations. Assistant U.S. Attorney Robert D. Thorpe Jr.prosecuted both cases.