Warning March 2009 : Undeclared Drug Ingredients
FDA expanded 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 72 products.
Product list : http://www.fda.gov/bbs/topics/NEWS/2009/NEW01977.html
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:
- 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.
The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.
The Spirit Dog
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