U.S. Marshals have seized tainted dietary supplements from Globe All Wellness, a Hollywood company, because Food and Drug Administration investigators found the materials contained a dangerous drug, the FDA said.
“Several of the seized products contain sibutramine hydrochloride . . . the active ingredient in the obesity drug Meridia,” the FDA said in a press release issued Thursday. “In December 2010, Meridia was withdrawn from the U.S. market after clinical data demonstrated that the drug increased the risk of heart attack and stroke.”
Globe All claims its products can lower blood pressure and cholesterol, the FDA release stated. Such drugs need FDA approval — which the products didn’t have.
“Companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research in a prepared statement. “With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking.”
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The FDA made inspections of the Hollywood company in October and February and concluded that the supplements “were not manufactured in accordance with the current good manufacturing practice requirements.”
The marshals seized products with the names SlimXtreme, SlimXtreme Gold, SlimPlus, SlimLee, GelSlim, SlimDrops and Colonew, according to the release.
In July 2011, the company issued a voluntary product recall of its product Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men.
Late Friday, a Globe All Wellness spokesman, who identified himself only as Ronny, said that his company had done nothing wrong and had been victimized by counterfeiters who put out bad products in his company’s name.