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FDA issues consumer advisory warning on dietary supplement Jack3d

In many sets of statutes passed by legislature or regulations created by agencies, there are sometimes large sections devoted to definitions. Within that grouping of laws, certain words have specific meanings and only those meaning. They may also define the responsibilities and authority of an agency. Such is the case with an allegedly deadly workout supplement, that because of how the Food and Drug Administration's (FDA) authority is granted and how a dietary supplement is defined, the FDA has been limited in the actions it can take.

The dietary supplement is called Jack3d, and the ingredient 1,3 dimethylamylamine (DMAA) is potentially dangerous product and the FDA claims its use is illegal. However, the FDA lacks the legal authority to take DMAA off the market. Dietary supplements also are not subject to FDA pre-market approval, meaning they do not test these items before they are sold to consumers.

Last week the FDA issued a consumer advisory warning concerning the supplement and the industry trade organization also requested that manufacturers follow the advisory warning. The FDA attempted to stop production of supplement containing DMAA last year, but the producer of Jack3d said in response, "DMAA is a safe and lawful dietary ingredient." They argued it occurs naturally in a plant found in China, making it a natural substance, not a drug and therefore not requiring FDA approval.

DMAA acts like an amphetamine. Doctors have recognized the similarly between DMAA and a previously banned substance Ephedra which could cause heart attacks, strokes and death.

Nine countries, sports organizations and the military have banned it. The family of one young man who died after using the supplement is suing the manufacture in a product liability action alleging wrongful death. But the FDA can only warn against the use of the product.

Source: NBC News, "Deadly workout supplement? Jack3d outside FDA's reach," Janet Klein et al, April 11, 2013

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