A Texas man was sentenced to one year in prison, reflecting the potential consequences of selling unapproved drugs falsely labeled as dietary supplements.
Elias Trevino Jr., 33, received his sentence six months after pleading guilty to possessing a controlled substance with the intent to distribute and one count of receiving a misbranded drug in interstate commerce. He was one of the owners of X2Zero, a retailer selling supplements online and through stores located in Corpus Christi, Texas.
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."
Trevino was ordered to serve three years of supervised release following completion of the prison term, according to a Nov. 20 news release from the U.S. Department of Justice (DOJ).
“Drugs labeled as natural dietary supplements that contain undeclared, dangerous ingredients present a serious risk to consumers’ health," Spencer E. Morrison of FDA’s Office of Criminal Investigations said in the news release. “We will continue to pursue and bring to justice criminals who endanger the public by offering and distributing such falsely labeled and dangerous drugs."
FDA determined a number of products sold as “herbal weight loss supplements" by Trevino’s business contained misbranded or unapproved foreign drugs, DOJ said in a May 15 press release, announcing Trevino’s guilty plea.
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 a co-owner, Vanessa Gonzales.
The products contained sibutramine and sildenafil, the active drug ingredient in Viagra, a prescription drug approved by FDA in 1998 to treat erectile dysfunction, the indictment alleged.
In 1997, FDA approved a prescription drug containing sibutramine under the trade name Meridia. But in October 2010, the agency requested the marketer—Abbott Laboratories—voluntarily withdraw the drug due to health risks associated with sibutramine, including an increased risk of death, heart attack and stroke. In December 2010, at the manufacturer’s request, FDA withdrew its approval of Meridia, and since then, the agency hasn’t approved a drug containing sibutramine for human use in the United States, DOJ said in its earlier press release.
Christina Woehr, a federal public defender who represented Trevino, did not immediately respond to a request for comment on her client’s sentence.
The case against Gonzales is still pending, said Angela Dodge, a public affairs officer with the U.S. Attorney's Office in the Southern District of Texas. Nathan Fugate, a lawyer representing Gonzales, did not immediately respond to a request for comment.
Over the years, FDA has identified many products labeled as dietary supplements but tainted with unapproved drugs that could harm consumers. The products are often marketed for body building, weight loss and sexual enhancement.
Such drug-laced products have smeared the reputation of a dietary supplement industry often characterized in the mainstream media as unregulated. Representatives from FDA recently stressed dietary supplements are regulated, and they distinguished the class of products from drugs.
In a webinar sponsored by FDA’s Division of Drug Information, Center for Drug Evaluation and Research (CDER) and Office of Communications, Capt. Jason Humbert, R.N., national health fraud coordinator in FDA’s Office of Regulatory Affairs, said “tainted supplements" is not the correct term for products adulterated with active pharmaceutical ingredients (APIs).
“These are not considered dietary supplements, but drugs pretending to be dietary supplements," he said, adding the practice of selling tainted products “defies logic."