----------------------------------------------------------- FDA NEWS RELEASE
FOR IMMEDIATE RELEASE March 20, 2009
Media Inquiries: Chris Kelly, 301-796-4676 Consumer Inquiries: 888-INFO-FDA
FDA Uncovers Additional Tainted Weight Loss Products Agency alerts consumers to the finding of new undeclared drug ingredients
The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.
The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes the following 72 products:
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“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”
On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products. The FDA will continue to update this list as warranted.
The products listed above, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products' labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:
sibutramine (an appetite suppressant available by prescription only and a controlled substance) fenproporex – a controlled substance not approved for marketing in the United States; fluoxetine – an antidepressant available by prescription only; bumetanide – a potent diuretic available by prescription only; furosemide – a potent diuretic available by prescription only; rimonabant – a drug not approved for marketing in the United States; cetilistat – an experimental obesity drug not approved for marketing in the United States; phenytoin – an anti-seizure medication available by prescription only; and phenolphthalein – a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.