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Topics and Cases - Nutritional and Dietary Supplements

Nutritional and dietary supplements are meant to provide vitamin and nutritional support for the consumer. They are designed to replace or add to the effectiveness of existing foods and nutrients, or support other bodily systems and functions.

One issue with these supplements is they are not always made with what they say they are nor are they manufactured in a controlled, regulated environment. Often times what the product proposes to do for the consumer is completely unfounded or is an outright falsehood. If you or a loved one is taking nutritional or dietary supplements, please read on for facts about the products and the litigation surrounding them.

Facts about Nutritional and Dietary Supplements:

• Dietary supplements are not regulated through the same approval process and drugs and medical devices. Dietary supplements are regulated through an entirely diferent regulatory scheme. In many instances, manufacturers are not required to obtain approval from the FDA before putting a product on the market.
• Manufacturers in many instances are not required to conduct clinical trials or provide safety information to FDA.
• In 1994, the Dietary Supplement and Health Education Act of 1994 (DSHEA), came into law. This Act places the responsibility of regulation, quality control, and standardization with the manufacturer to test for purity contamination as well as duty to provide adequate warnings. In only limited circumstances is more required by the FDA, and the FDA does not take action until long after reports of injury or other harms.
• The FDA has been investigating supplements in order to discover whether or not they include ingredients that are deemed to be FDA-approved drugs. The areas in which the FDA found the highest rate of products marketed as dietary supplements but containing hidden ingredients include products for weight loss, sexual enhancement, and body building. This includes a recall of more than 70 products marketed for sexual enhancement, 40 products marketed for weight loss and more than 80 products marketed for body building.

Litigation News:

• In 2004, the FDA banned the use of ephedra, which was used in many weight loss supplements. Many lawsuits followed, and were consolidated in an MDL in New York.
• Many people who have taken supplements containing kava kava have brought lawsuits after severe and complete liver failure, in some cases requiring liver transplants.