FDA Expands Nationwide Alert to Include 72 Tainted Weight Loss Supplements

The FDA has expanded a December 22, 2008, nationwide alert regarding tainted weight loss supplements to include 72 brands available online, in beauty salons and retail stores. The tainted products contain potentially harmful ingredients including a powerful diuretic, carcinogenic materials, anti-depressants and others. The threat of these chemicals is exacerbated by the fact that they are undeclared on the products' labels.

In the FDA's statement, consumers are urged to avoid these tainted supplements or, if they have already been consumed, users need to cease use and consult a physician. Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, explained in a release that "[The] 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 the recommended dosages."

The nationwide alert has been expanded from the initial release twice, once from twenty-two products to forty-four, and again from forty-four to seventy-two. A full list of tainted products is available at the FDA website, at the following address: 
http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm.

The alert includes the following list of harmful ingredients and their effects:
* sibutramine (an appetite suppressant available by prescription only and a controlled substance);
* 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. (FDA.gov)

These tainted supplements may cause several side effects including high blood pressure, seizures, tachycardia, palpitations, heart attack and stroke. Many of the drugs do not reveal their manufacturers on the label. According to the FDA, a majority of the products are manufactured in China. Other products on the list may have been manufactured in Brazil, Malaysia and Peru.

Many of the tainted products claim to be "dietary supplements," though they should have been sent for approval by the FDA. However, the regulation of dietary supplements does not follow the same strictures as conventional food or drugs. The Dietary Supplement Health and Education Act of 1994 sets down guidelines for the sale and manufacture of dietary supplements. Supplements must be ensured by the manufacturer as safe before sale, and the products do not need to be registered with the FDA.

The FDA reports that it is taking actions to have the tainted drugs removed from the market. The companies that manufacture these products are being investigated by the FDA; if necessary the FDA may take additional measures that could potentially include warning letters, seizure, injunction or criminal charges. The FDA claims that the products may even be recalled.

Dietary supplements and other products that are tainted with prescription drugs are a growing problem in the United States. Many of these products are able to dodge FDA oversight by marketing themselves as dietary supplements. Consumers are urged to consult a physician before the use of any supplement and should be wary of drugs claiming to be natural, "easy," or miraculous.

By Will Levine, and edited by Heather Kelley.