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Dietary supplements and risks of injury or death – January 09, 2011

Last month in a letter directed to dietary supplement manufacturers, the U.S. Food and Drug Administration gave notice of a crackdown on what is believed to be the dangerous practice of marketing tainted products as dietary supplements.  According to FDA Commissioner Margaret A. Hamburg, M.D. “These tainted products can cause serious adverse effects, including strokes, organ failure, and death.”

By law, the manufacturer of a dietary supplements is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. However, the FDA is able to evaluate reports, and any other adverse event information reported directly to the FDA by healthcare providers or consumers, to identify early signals that a product may present safety risks to consumers. Once the dietary supplement has shown to be “unsafe,” the FDA can take action to restrict the product’s use or remove it from the marketplace.

Over the past few years, the FDA has given notice of almost 300 of these tainted supplements and received many injury complaints as a result of their usage. The problem arises when the supplement may use an active ingredient in a FDA approved drug or a closely related drug (an analog), or other compound, such as synthetic steroids that do not qualify as dietary supplements.

Of specific concern are the three most common areas of these illegal supplements:

Weight loss products which may contain sibutramine – recently withdrawn from the market in a drug named Merida, due to an increase risk of stroke or heart attacks. According to the FDA, dozens of weight loss products, including Slimming Beauty, Solo Slim and Slim-30 among others contain sibutramine or a drug closely related to sibutramine.

Body-building products which may contain cause acute liver damage or increase risk of heart attack, death or stroke due to the use of anabolic steroids or steroid analogs. Some of the products identified are Tren Xtreme, ArimaDex, and Clomed.

Sexual enhancement products containing the same active ingredients or an analog of the ingredient in approved drugs such as Viagr, Cialis and Levitra. Approved drugs are available only by prescription because they should not be used by people with certain medical conditions. Some of the products identified as violating federal law are Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee and others.

Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research noted that “the labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” but warned that “consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution and civil lawsuit.

If you feel you have been harmed by a tainted dietary supplement contact the Padberg Corrigan Law firm for a case review. We can be reached at any time at (314) 621-2900.

 

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