FDA Uncovers Additional Tainted Weight Loss Products

yoyo scaleAgency alerts consumers to the finding of new undeclared drug ingredients

WASHINGTON (RPRN) 03/23/09-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:

2 Day Diet

Fatloss Slimming

Slim 3 in 1 M18 Royal Diet

2 Day Diet Slim Advance

GMP

Slim 3 in 1 Slim Formula

2x Powerful Slimming

Herbal Xenicol

Slim Burn

3 Day Diet

Imelda Fat Reducer

Slim Express 4 in 1

3 Days Fit

Imelda Perfect Slim

Slim Express 360

3x Slimming Power

JM Fat Reducer

Slim Fast*

5x Imelda Perfect Slimming

Lida DaiDaihua

Slim Tech

7 Day Herbal Slim

Meili

Slim Up

7 Days Diet

Meizitang

Slim Waist Formula

7 Diet

Miaozi MeiMaoQianZiJiaoNang

Slim Waistline

7 Diet Day/Night Formula

Miaozi Slim Capsules

Slimbionic

8 Factor Diet

Natural Model

Sliminate

Eight Factor Diet

Perfect Slim

Slimming Formula

21 Double Slim

Perfect Slim 5x

Somotrim

24 Hours Diet

Perfect Slim Up

Starcaps

999 Fitness Essence

Phyto Shape

Super Fat Burner

BioEmagrecim

Powerful Slim

Superslim

Body Creator

ProSlim Plus

Super Slimming

Body Shaping

Reduce Weihgt

Trim 2 Plus

Body Slimming

Royal Slimming Formula

Triple Slim

Cosmo Slim

Sana Plus

Venom Hyperdrive 3.0

Extrim Plus

Slim 3 in 1

Waist Strength Formula

Extrim Plus 24 Hour Reburn

Slim 3 in 1 Extra Slim Formula

Xsvelten

Fasting Diet

Slim 3 in 1 Extra Slim Waist Formula

Zhen de Shou

* This product should not be confused with the line of meal replacement and related products that are 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 which appears 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.

“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:

* 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 FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. The FDA also encourages 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. 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.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch,
5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 800- FDA-0178
* Phone: 800- FDA-1088

Information on these products for consumers and health care professionals can be found at: http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

To learn more about the FDA’s initiative against unapproved drugs see the FDA’s Compliance Policy Guide at: http://www.fda.gov/cder/Guidance/6911fnl.htm.

For drug safety information, see: FDA’s Drug Safety Initiative.