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84<br />

Dietary Supplements and the Law<br />

Well over 50% of the US population take some type of dietary supplements.<br />

Sales of vitamins, minerals, herbs, meal supplements, sports-<strong>nutrition</strong><br />

supplements, and <strong>special</strong>ty supplements were in excess of $22 billion<br />

in 2006. To understand why dietary supplement use is a concern, one<br />

must appreciate the history. In 1994 the Dietary Supplement Health and<br />

Education Act (DSHEA) was passed by Congress for several reasons:<br />

• Limit impediments to marketing and promoting dietary supplements.<br />

• Provide for wide availability of supplements to consumers.<br />

• Enhance information available to consumers.<br />

The passing of DSHEA gave the Food and Drug Administration (FDA)<br />

regulatory control over dietary supplements, and the law required that the<br />

label of a dietary supplement provide the name and quantity of each ingredient.<br />

However, it is incumbent upon the manufacturer to provide the information<br />

and the innocent consumer assumes that information on labels is<br />

truthful and not misleading. This is, more than often, not the case. ConsumerLab.com,<br />

a product-certification company, conducted a survey of nearly<br />

1,000 supplements and found that one in four had quality problems.<br />

The FDA also regulates whether new ingredients can enter the marketplace<br />

or existing ones should be removed for safety reasons. However, federal<br />

rules requiring makers of dietary supplements to test all their ingredients<br />

were not part of DSHEA. The FDA also regulates what claims may (or<br />

may not) be made, but they do not monitor claims. The regulations within<br />

DSHEA contain many gaps. Some of the concerns include:<br />

• The responsibility of ensuring that products are properly labeled lies<br />

with the manufacturer.<br />

• Supplement ingredients sold in the United States before October 15,<br />

1994 are presumed to be safe and are therefore not subject to review<br />

by the FDA for safety.<br />

• The responsibility of providing evidence of safety lies with the manufacturer.<br />

Purity is a concern:<br />

Supplements may be<br />

contaminated with<br />

heavy metals and even<br />

prescription medications.<br />

• The FDA has to prove that a product is not safe if it is already on the market.<br />

• Government resources to check dietary supplement quality are limited.<br />

In June, 2007, FDA imposed new regulations, which had been mandated<br />

by DSHEA. The FDA established regulations that dietary supplements<br />

must be produced in a quality manner, do not contain contaminants<br />

or impurities, and are accurately labeled. Supplement manufacturers will<br />

now be required to test all of the ingredients in their products to make sure<br />

they are neither adulterated nor contaminated.<br />

Click for more information on this new ruling.

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