No Regulation of Dietary Supplements by FDA
By on January 6, 2011 at 10:05 am

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While watching TV with a couple friends late one night over break, an ad for the popular energy drink, 5-Hour Energy, came on.  At the end of the commercial one of my friends inquired what the side effects of the drink might be, to which the other responded, “I don’t know, but it must have been approved by the FDA.”  I dug deeper to discover the FDA does not regulate “dietary supplements” such as 5-Hour Energy and that it is up to the companies who develop such products to ensure their safety.  My concern is not so much the health effects of 5-Hour Energy, but of the lack of awareness that these products are not regulated.

The FDA defines a dietary supplement as a product taken by mouth which contains a “dietary ingredient” such as a vitamin, mineral, herb or botanical, or amino acid. To this day, this classification of products is assumed to be safe and required little regulation. Furthermore, the FDA has lacked the resources to support a division to monitor them.  Over time the dietary supplement market has grow substantially with the addition of energy drinks like 5-Hour Energy as well as other boosters with increasing concentrations of vitamins and minerals, raising the question of their long term side effects.  Studies have shown that when consumed in regular amounts as recommended on the bottle, the negative side effects are minimal, if any.  The most noticeable is a niacin flush, a reddening and heating of the skin due to an over intake of B3 vitamin (mentioned on every bottle). Other more harmful side effects such as neuropathy, a neurological impact that generates pain and numbness of extremities, and hypervitaminosis can occur when the vitamins with 5 Hour Energy are taken in excess.  While these side effects are more serious, they have rarely been observed and do not justify calling the product unsafe.

Despite its relative harmlessness, the lack of awareness that 5-Hour Energy and other dietary supplements are not regulated generates a casual attitude towards the consumption of powerful concoctions of dietary ingredients that have a large impact on the human body, positive or not.  This and increased consumption, combined with the feeling, as expressed by my friend above, that if a product makes it to the shelf it is safe, leads me to believe more attention should be brought to the fact that dietary supplements are not regulated by the FDA.

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