The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume 69 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients 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), and 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 websites 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 (CDER), 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, 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 U.S. 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.
 
Healthcare 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.

The American Herbal Products Association (AHPA), Silver Spring, MD, applauded FDA efforts. “AHPA’s mission to promote the responsible commerce of herbal products can only be accomplished when FDA and other government agencies actively enforce the law against outliers.” said AHPA President Michael McGuffin.

Steve Mister, president and CEO, Council for Responsible Nutrition (CRN), Washington, D.C., said, “It is unfortunate that some of these products have been marketed as dietary supplements. Under the law, what is in the dietary supplement bottle should be listed on the label and products that break the law have no business being on store shelves. CRN supports the agency’s decision to demand removal of these adulterated products from the market.

“It is particularly concerning that some of these weight loss products illegally contain pharmaceutical drugs, which can be especially dangerous and put consumers at risk,” he added. “Regardless of how it is marketed, if a weight loss product contains a drug ingredient, it is a drug under federal law. The new good manufacturing practices (GMPs) specific to dietary supplements, published in 2007, provide even more quality assurance throughout the entire manufacturing process to reduce the risk of accidental adulteration and cross-contamination, so that incidences like this are rare.”