A store owner has admitted to knowingly selling diet drugs as dietary supplements and faces up to six years in federal prison and fines of up to US$350,000, the U.S. Department of Justice (DOJ) announced this week.
Vanessa Gonzales, of Corpus Christi, Texas, 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, DOJ revealed in a news release. She was one of the owners of a business (X2Zero) selling dietary supplements online and through stores in Corpus Christi.
“The FDA found a number of the products X2Zero sold as ‘herbal weight loss supplements’ to contain misbranded or unapproved foreign drugs,” DOJ stated.
During a June 18 court hearing, “Gonzales admitted she knowingly possessed and sold diet drugs containing sibutramine,” DOJ added in the news release. “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” federal law.
In 1997, FDA approved a prescription drug containing sibutramine under the trade name Meridia to treat obesity. However, FDA withdrew its approval of the medicine in late 2010 at the manufacturer’s request, following concerns that sibutramine posed an increased risk of death, heart attack and stroke.
Gonzales, 35, is scheduled to be sentenced on Sept. 17, 2018. Nathan Fugate, a lawyer representing her, did not immediately respond to an emailed request for comment.
In 2017, a co-defendant in the case, Elias Trevino Jr., was sentenced to one year in prison. While handing down the sentence, Senior U.S. District Judge John D. Rainey reportedly described Trevino’s behavior as “egregious conduct that I can’t ignore."
The misbranded drugs were sold under such names as “Bella Vi INSANE AMP’D," “Zeal DynamiZm" and “Vivacious Natural Eruption," according to an indictment against Trevino and Gonzales.
“Drugs labeled as natural dietary supplements that contain undeclared, dangerous ingredients present a serious risk to consumers’ health," Spencer Morrison of FDA’s Office of Criminal Investigations said in a Nov. 20, 2017 news release, announcing the sentence against Trevino. “We will continue to pursue and bring to justice criminals who endanger the public by offering and distributing such falsely labeled and dangerous drugs."