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To put it mildly, the Food and Drug Administration (“FDA”) regulates dietary supplements much differently then their regulation of prescription and over the counter drug products. “Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements” Only after the supplement product reaches the consuming public does the FDA take any action, and only then when they have knowledge that the supplement is grossly unsafe.

It is this writer’s opinion that the FDA needs to become more involved in the regulation of supplements before they are issued to the consuming public. While this will no doubt be cumbersome, there is no question that supplement manufacturers have abused the lack of regulation to their advantage by making supplements available to the public before conducting any extensive research or studies to determine if the products they are putting out on the market are safe. Broad and ambiguous warning labels which seldom set forth a truthful presentation of the risks and benefits of a supplement fail to put the prospective purchaser on notice of the potential ramifications of consuming a supplement. Moreover, by lack of regulation supplement manufacturers are put in a position where it makes greater business sense for them to put a supplement on the market without going through the costly process of research and studies. Although regulation of supplements would prove costly to the FDA, the benefits of regulation will likely exceed the costs to society. One clear example of this is the supplement Ephedra
“Ephedra, also known as Ma-Huang, is the herbal form of ephedrine and is a central nervous system stimulant that behaves in the body much like an amphetamine. … [Ephedra] is used to help people lose weight, boost their energy levels and improve athletic performance. Ephedra is a natural herbal substance.”

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

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