Accokeek Man Pleads Guilty To Drug Misbranding

Greenbelt, Maryland – Jonathan Gonzales, age 50, of Accokeek, Maryland, pleaded guilty today to introducing misbranded drugs into interstate commerce with the intent to defraud or mislead.  The charges stem from a scheme to sell mislabeled drugs via the Internet.

The guilty plea was announced by United States Attorney for the District of Maryland Robert K. Hur and Special Agent in Charge Mark S. McCormack of the Food and Drug Administration, Office of Criminal Investigations – Metro Washington Field Office.

According to his plea agreement, beginning in 2009, Gonzales began selling products marketed as dietary supplements through eBay and his personal website, helptomakelifebetter.com.  Gonzales received these products from sources in China.

In 2013, the Food and Drug Administration (FDA) began to investigate Gonzales for multiple products and found that some of the products contained active pharmaceutical ingredients, in particular sibutramine and/or phenolphthalein. Sibutramine is a Schedule IV controlled substance and the active ingredient in Meridia, a prescription drug produced by Abbott and approved by the FDA in 1997 to treat obesity.  Abbott voluntarily stopped marketing Meridia at the request of the FDA after clinical data indicated an increased risk of cardiovascular adverse events, including heart attacks and strokes.  Phenolphthalein was an ingredient in some over-the-counter laxatives until 1999, when the FDA reclassified the drug as not generally recognized as safe and effective.

Upon discovery of the two drugs, the FDA sent Gonzales an e-mail with the results of their analyses of Gonzales’s products and noting that it was Gonzales’s responsibility under federal law to ensure that the products he distributed did not contain any undeclared and potentially harmful ingredients.  The FDA also explained the dangers of the drugs and his responsibilities to follow Federal law.  Gonzales responded to the e-mail, acknowledging that he would remove any products for sale that may be harmful.

Gonzales told the FDA employee that only a few product listings remained and that he would sell those products and would not replace them.  Gonzales also told the FDA that he had told his distributors in China that he would not be ordering any more products from them.  He asked FDA personnel to contact him if they found any issues with his website. However, Gonzales continued to market and sell the products he had promised not to sell.

Federal law enforcement officers searched Gonzales’s home pursuant to a warrant on January 14, 2016.  A substantial amount of misbranded products were found in the home, seized, and tested.  The misbranded products contained sildenafil (the active ingredient in Viagra), sibutramine and phenolphthalein.

Gonzales faces a maximum sentence of three years in prison.  U.S. District Judge Paula Xinis has scheduled sentencing for September 10, 2018 at 2:30 p.m.

United States Attorney Robert K. Hur commended the FDA for their work in the investigation.  Mr. Hur thanked Assistant U.S. Attorney Kelly Hayes and Special Assistant U.S. Attorney John Pelletierri, who are prosecuting the case.

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