Florida And Louisiana Residents Charged In Multi-State Scheme To Distribute Illegal And Mislabelled Diet Pills
BATON ROUGE, LA - United States Attorney Walt Green announced today actions taken in connection with a federal criminal investigation into an alleged multi-state scheme to illegally distribute diet pills containing sibutramine, a Schedule IV controlled substance, which were falsely labeled and marketed as “all natural” dietary supplements.
A federal grand jury indictment, originally filed on July 29, 2015, was unsealed today. The indictment charges Darlene V. Krueger, age 53, of Destrehan, Louisiana, with conspiring to distribute and possess with the intent to distribute sibutramine, distributing sibutramine, and introducing misbranded drugs into interstate commerce.
The indictment alleges that sibutramine was the active pharmaceutical ingredient in Meridia, a prescription weight loss drug removed from the market in 2010 following studies that showed significantly increased risk of strokes and heart attacks. According to the indictment, since the removal of Meridia, no drug containing sibutramine has been approved for use in humans in the United States.
The indictment alleges further that, between 2009 through 2014, Krueger conspired with John Wesley Hoag, age 51, of Ft. Lauderdale, Florida, to sell purportedly “all natural” dietary supplements under various names, such as “Slim Forte Slimming Capsules,” “Slim Forte Double Power Slimming Capsules,” “Slim-Vie Slimming Capsules,” and “Slim-Vie Double Power Slimming Capsules,” which they knew contained sibutramine, to customers throughout the United States. According to the indictment, even after learning that the diet pills contained sibutramine and had potentially serious side effects, Krueger continued to distribute the diet pills and disseminate false and misleading information about the safety and efficacy of her products.
On July 29, 2015, Hoag pled guilty before U.S. District Judge John W. deGravelles to a Bill of Information charging him with conspiring with Krueger to distribute and possess with the intent to distribute sibutramine and introducing misbranded drugs into interstate commerce. During the guilty plea hearing, Hoag admitted to unlawfully importing the diet pills from manufacturers based in China and then distributing the diet pills to his distributors, including Krueger, and consumers.
As a result of their respective roles, Krueger and Hoag face significant incarceration, fines, restitution, forfeiture of proceeds, and supervised release following imprisonment.
U.S. Attorney Green stated: “This important prosecution is a reminder that drug trafficking conspiracies come in all shapes and sizes, and can involve a wide variety of illegal substances, none of which we will tolerate. When individuals knowingly sell potentially dangerous misbranded drugs to unsuspecting consumers, my office will work diligently with our law enforcement partners to protect public health by identifying the illegal products and dismantling the illegal distribution networks.”
“Consumers are put at serious risk when they are unknowingly exposed to undeclared active pharmaceutical ingredients in products falsely labeled as natural dietary supplements,” said Robert J. West, Acting Special Agent-in-Charge, Miami Field Office, FDA Office of Criminal Investigations. “Our office will continue to defend the public’s health by ensuring that dietary supplements are accurately labeled, and do not contain dangerous undeclared active pharmaceutical ingredients.”
This ongoing investigation is being handled by the FDA’s Office of Criminal Investigations. The matter is being prosecuted by Assistant United States Attorneys Cam T. Le and Paul L. Pugliese.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA. For more information regarding dietary supplements and to report adverse events, please visit the FDA’s website at http://www.fda.gov/Food/DietarySupplements/.
NOTE: An indictment is an accusation by the Grand Jury. A defendant is presumed innocent until and unless adjudicated guilty at trial or through a guilty plea.