to include updated information.

FDA News

FOR IMMEDIATE RELEASE
December 22, 2008
Media
Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA

FDA Expands Warning to Consumers About Tainted Weight Loss Pills

List increases from 28 to 69 products; Agency seeking
recalls

The U.S. Food and Drug Administration is expanding its nationwide alert to
consumers about tainted weight loss pills that contain undeclared, active pharmaceutical
ingredients. On December 22, 2008, FDA warned consumers not to purchase or
consume 28 different products marketed for weight loss. Since that time, FDA
analysis has identified 41 more tainted weight loss products that may put consumers’ health
at risk.
The tainted weight loss products are:

Fatloss Slimming
2 Day Diet
3x Slimming Power

Japan Lingzhi 24 Hours Diet
5x Imelda Perfect Slimming
3 Day Diet

7 Day Herbal Slim
8 Factor Diet
7 Diet Day/Night Formula

999 Fitness Essence
Extrim Plus
GMP

Imelda Perfect Slim
Lida DaiDaihua
Miaozi Slim Capsules

Perfect Slim
Perfect Slim 5x
Phyto Shape

ProSlim Plus
Royal Slimming Formula
Slim 3 in 1

Slim Express 360
Slimtech
Somotrim

Superslim
TripleSlim
Zhen de Shou

Venom Hyperdrive 3.0
Starcaps
Slim Waistline

Slim Waist Formula
Slim Up
Sliminate

Slim Fast
2x Powerful Slimming
Slim Express 4 in 1

Reduce Weihgt
Super Fat Burner
Super Slimming

Sana Plus
Trim 2 Plus
Powerful Slim

Waist Strength Formula
Slimming Formula
Perfect Slim Up

Slim Burn
Slim 3 in 1 Slim Formula
Slim 3 in 1 M18 Royal Diet

Slim 3 in 1 Extra Slim Waist Formula
Slim 3 in 1 Extra Slim Formula
Natural Model

2 Day Diet Slim Advance
Miaozi MeiMiaoQianZiJiaoNang
Meizitang

Meili
JM Fat Reducer
Imelda Fat Reducer

7 Days Diet
Extrim Plus 24 Hour Reburn
Fasting Diet

Cosmo Slim
Body Slimming
Body Shaping

Body Creator
BioEmagrecin
3 Days Fit

21 Double Slim
Eight Factor Diet
7 Diet

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers’ health at risk.
These weight loss products, some of which are marketed as “dietary
supplements,” are promoted and sold on various Web sites and in some
retail stores. Some of the products claim to be “natural” or to
contain only “herbal” ingredients, but actually contain potentially
harmful ingredients not listed on the product labels or in promotional advertisements.
These products have not been approved by the FDA, are illegal and may be potentially
harmful to unsuspecting consumers.
The FDA advises consumers who have used any of these products to stop taking
them and consult their healthcare professional immediately. The FDA encourages
consumers to seek guidance from a healthcare professional before purchasing
weight loss 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 their maximum recommended dosages,” said
Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers
have no way of knowing that these products contain powerful drugs that could
cause serious health consequences. Therefore FDA is taking this action to protect
the health of the American public.”
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 health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.
Rimonabant, another ingredient found in these products, was evaluated, but
not approved by the FDA for marketing in the United States. The drug, which
is approved in Europe, has been associated with increased risk of depression
and suicidal thoughts and has been linked to five deaths and 720 adverse reactions
in Europe over the last two years.

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 for consumers can be found at:
http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm
To learn more about FDA’s initiative against unapproved drugs read FDA’s
Compliance Policy Guide here: http://www.fda.gov/cder/Guidance/6911fnl.htm.
For drug safety information, read: FDA’s
Drug Safety Initiative

source

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