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.

The Differences Between Synthetic and Natural Nutritional Supplements

As online dieticians, we always establish the first things first: whole foods. The majority of your nutrition should come from sources of whole grains and fresh fruits and vegetables, followed by lean protein and healthy fats. Then, to compensate for the deficiencies in our diet, or damage caused by toxins and free radicals in our body, we need to add multivitamins and anti-oxidants. Some supplements may help ensure that you get adequate amounts of essential nutrients or help promote optimal health and performance if you do not consume a variety of foods in proper amounts. Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may even have unwanted effects. Then there is this question: Which are better, "synthetic" or food-based "natural" dietary supplements? The proper nutritional program is essential to an effective online diet plan.

As with most research, both sides are supported and rebutted. Currently, the definition of "natural" in foods and dietary supplements has not been established by the government. Therefore, the interpretation can vary greatly. There is a common misconception that "natural" vitamins and minerals are extracted from plants in their pure form and as such are superior to "synthetic" vitamins and minerals, which are made in a laboratory. This can be misleading because it is not possible to extract pure vitamins from plants without considerable amounts of chemical processing. Also, the biological activity of a compound has nothing to do with its source, but is determined by its chemical structure. So really, whether the chemical originates from a leafy plant or a test tube, it is the same compound.

Some vitamin and antioxidant compounds can be efficiently synthesized in factories to produce products that are identical in chemical form to those found in nature and that are pure and fully safe. Some synthetic vitamins are preferentially absorbed over food sources and vice versa.

Folic Acid, for example, is preferentially absorbed and utilized over natural food folates that must go through several conversion processes to be utilized as folic acid.

Vitamin E, a fat-soluble vitamin, exists in eight different forms. Each form has its own biological activity, which is the measure of potency or functional use in the body. Alpha-tocopherol is the name of the most active from of vitamin E in humans. It is also a powerful biological antioxidant. Vitamin E in supplements is usually sold as alpha-tocopheryl acetate, a form that protects its ability to function as an antioxidant, and is sometimes derived from soy. The synthetic form is labeled "D, L" while the natural from is labeled "D." The synthetic form is only half as active as the natural form.

There are no known differences in the biological activity of natural and synthetic L-ascorbic acid (vitamin C). As reported by the Linus Pauling Institute, a study in 68 male nonsmokers found that ascorbic acid consumed as cooked broccoli, orange juice, orange slices, and synthetic ascorbic acid tablets are equally bioavailable, as measured by plasma ascorbic acid.

Most important: since the FDA doesn't regulate nutritional supplements, look for ones that offer purity, safety, effectiveness, bioavailability, and whether natural or synthetic, ones that are best absorbed and utilized by the body. Such standards may be upheld when a product has a GMP (good manufacturing practice) seal on it, is potency guaranteed and may also be reviewed by the following organizations:

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