Agency 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®â€. 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.â€
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.
