Feds Seize Supplements from Global All Wellness
February 19, 2013
HOLLYWOOD, Fla.U.S. Marshals last week seized dietary supplements from Global All Wellness, LLC over safety concerns that the products contain an undisclosed active pharmaceutical ingredient.
The products contain sibutramine, an active ingredient in an obesity drug (Meridia) that was removed from the market more than two years ago after clinical data established the product increased the risk of heart attack and stroke, according to FDA.
Global All Wellness, based in Hollywood, Fla., also made disease-based claims that its products can lower blood pressure and cholesterol, rendering them unapproved drugs, the agency noted.
"Companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk," Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a statement. "With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking."
FDA seized various lots of SlimXtreme, SlimXtreme Gold, SlimPlus, SlimLee, GelSlim,SlimDrops and Colonew.
INSIDER late Tuesday could not immediately reach Eran Hamami, the owner of Global All Wellness. An answering service representative for the company said a message for him could not be left.
About a year ago, FDA sent a warning letter to Hamami, advising the company that its products contained undeclared pharmaceutical ingredients and were unapproved drugs.
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