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FDA Expands Warning on Tainted Weight Loss Products

Mar 23, 2009 | Parker Waichman LLP

The U.S. Food and Drug Administration (FDA) just announced that it 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—as well as new, undeclared active pharmaceutical ingredients—fenproporex, fluoxetine, furosemide, and cetilistat in this warning.

The FDA explained that on December 22, 2008 it warned consumers not to purchase or consume 28 different products marketed for weight loss and that on January 8, 2009 it expanded that list to include 41 additional tainted products.  The list now includes 72 tainted products.
Some of these tainted products are marketed as dietary supplements, some are promoted and sold on various Websites, and some are sold in retail stores and beauty salons.  Also, some 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 and/or furosemide, are potent diuretics available by prescription only; rimonabant, a drug not approved for marketing in the U.S.; cetilistat, an experimental obesity drug not approved for marketing in the U.S.; phenytoin, an anti-seizure medication available by prescription only; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent not approved for marketing in the U.S.

Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine.  These higher levels of sibutramine can increase the incidence and severity of these health risks.  Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

The current list now includes the following products:
    2 Day Diet
    2 Day Diet Slim Advance
    2x Powerful Slimming
    3 Day Diet
    3 Days Fit
    3x Slimming Power
    5x Imelda Perfect Slimming
    7 Day Herbal Slim
    7 Days Diet
    7 Diet
    7 Diet Day/Night Formula
    8 Factor Diet
    Eight Factor Diet
    21 Double Slim
    24 Hours Diet
     999 Fitness Essence
    BioEmagrecim
    Body Creator
    Body Shaping
    Body Slimming
    Cosmo Slim
    Extrim Plus
    Extrim Plus 24 Hour Reburn
    Fasting Diet
    Fatloss Slimming
    GMP
    Herbal Xenicol
    Imelda Fat Reducer
    Imelda Perfect Slim
    JM Fat Reducer
    Lida DaiDaihua
    Meili
    Meizitang
    Miaozi MeiMaoQianZiJiaoNang
    Miaozi Slim Capsules
    Natural Model
    Perfect Slim
    Perfect Slim 5x
    Perfect Slim Up
    Phyto Shape
    Powerful Slim
    ProSlim Plus
    Reduce Weihgt
    Royal Slimming Formula
    Sana Plus
    Slim 3 in 1
    Slim 3 in 1 Extra Slim Formula
    Slim 3 in 1 Extra Slim Waist Formula
    Slim 3 in 1 M18 Royal Diet
    Slim 3 in 1 Slim Formula
    Slim Burn
    Slim Express 4 in 1
    Slim Express 360
    Slim Fast*
    Slim Tech
    Slim Up
    Slim Waist Formula
    Slim Waistline
    Slimbionic
    Sliminate
    Slimming Formula
    Somotrim
    Starcaps
    Super Fat Burner
    Superslim
    Super Slimming
    Trim 2 Plus
    Triple Slim
    Venom Hyperdrive 3.0
    Waist Strength Formula
    Xsvelten
    Zhen de Shou
* The FDA notes that the Slim Fast product on this list is not to be confused with the line of meal replacement and related products marketed as conventional foods under the brand name “Slim-Fast®.”  The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products.

According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “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.  Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”

The FDA said that it has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls; however, based on its inspections and the companies’ inadequate responses to recall requests, it may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The FDA is advising consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately and is also urging consumers to seek guidance from a health care professional before purchasing weight loss products.  The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke.

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