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Legally Speaking

FDA Warns About Tainted Weight Loss Pills

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09/01/2009 - Recently, the FDA issued a nationwide warning for consumers to stop using Hydroxycut, a popular nonprescription weight loss product, because of reports that it caused serious liver damage. Although the Hydroxycut warning received a lot of attention (perhaps because almost everyone had seen ads for it on television), a larger and potentially more serious health warning has gone largely unnoticed.

In December 2008, the FDA warned consumers to stop using no fewer than 28 different weight loss products that may be purchased without a prescription, because each of them contained one or more undeclared ingredients (ingredients that are in the pill but that are not listed on the label) that could cause any number of serious injuries. Since its initial warning, the FDA has done additional testing and has added another 41 tainted weight loss products that also contain undeclared and harmful ingredients. Many of these products advertise themselves as being "herbal" or "all natural," but nothing could be further from the truth.

Dangerous Ingredients

So what is in these weight loss pills and powders? All kinds of things, ranging from sibutramine (an illegal drug), to prescription drugs intended for purposes other than weight loss, to rimonabant (a drug not approved for use in the United States), and even chemicals that are suspected carcinogens. Needless to say, the FDA is advising consumers to stop taking the tainted drugs and to see a doctor if they suffer from any unusual symptoms.

Some of the health risks posed by the undeclared ingredients in these pills are very serious. For example, sibutramine (which has been found in several products) can cause high blood pressure, seizures, strokes, and heart attacks. Rimonabant, a prescription drug used in Europe, is linked to increased risk of depression and suicidal thoughts in users. Cetilistat, an anti obesity drug that is only now undergoing clinical trials, can cause organ rejection and gastrointestinal problems in certain people.

Other diet pills have been found to contain drugs (such as bumetanide, a diuretic, and fluoxetine, the active ingredient in Prozac) that are approved for use in the United States and that are proper with a prescription, but that can be dangerous to people who don't realize what they are taking. Finally, many of the pills contain things that are not drugs at all, but chemicals that should not be ingested, such as phenolphthalein, a carcinogen.


Many of the products subject to the FDA's warning are not made in the United States, and the FDA believes that a majority of them are made in China. It is suspected that these products also come from other places across the globe, including Brazil, Malaysia, and Peru.

The manufacturers of these pills are violating U.S. law, either because their products contain a prescription medication (in which case they cannot be sold without FDA approval) or because they are not actually exempt "dietary supplements." In many cases, the label information on these products is false and misleading.

The fact that these pills are coming from other countries presents a real problem: If a product is made in the United States, the FDA can order a recall (as with Hydroxycut), but if it comes from a foreign country, the FDA often lacks the practical ability to stop the drug's production. The size of the market is also a problem: With billions spent on weight loss pills every year, the FDA simply lacks the resources to test all pills to determine what is in them.

Because there are so many products, concerned consumers should check the FDA's website for product warnings and recall information, www.fda.gov, or call toll free at 1 888 INFO FDA (888 463 6332). And remember, the best way to lose weight is to eat less and exercise, which has the added benefit of not enticing you to spend money on a pill that might harm you.

How to Protect Yourself

•Check the FDA's website, www.fda.gov, to see if you are taking any of the products that contain undisclosed and dangerous ingredients. If you are, stop immediately.

•Consult a doctor before taking any diet pill or dietary supplement to treat obesity or lose weight.

•Be skeptical: Weight loss is not usually "easy," and if there were a "scientific breakthrough" or "miracle cure," you would have heard about it on the news. Be especially wary of anything touting a "secret ingredient."

•Remember that "all natural" is not the same thing as "safe."

•If you have any unusual symptoms or just don't feel right after taking a diet pill, see a doctor right away.

R. Michael Shickich is the founder of the Injury Law Firm located in Casper. The focus of his practice is personal injury and wrongful death cases.

The Wyoming State Bar does not certify any lawyer as a specialist or expert. Anyone considering a lawyer should independently investigate the lawyer's credentials and ability, and not rely upon advertisements or self-proclaimed expertise.

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