A prescribed dietary supplement is intended to supply nutrients
(vitamins, minerals, fatty acids or amino acids) that are missing or
not consumed in sufficient quantity in a person's diet. This may
include herbal supplements which have a history of claims that they
cure or prevent certain diseases. The medical utility and regulatory
status of dietary supplements is controversial.
The FDA regulates dietary
supplements as foods, and not as drugs. The FDA does not pre-approve
dietary supplements on their safety and efficacy, unlike drugs.
If a dietary supplement claims in any way to cure, mitigate, or treat a
disease, it would be considered to be an unauthorized new drug and in
violation of the applicable regulations and statutes. As the FDA states
it in a response to this question in a FAQ:
Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its
label or in labeling* as a treatment, prevention or cure for a specific
disease or condition would be considered an unapproved--and thus
illegal--drug. To maintain the product's status as a dietary
supplement, the label and labeling must be consistent with the
provisions in the Dietary Supplement Health and Education Act (DSHEA)
of 1994.
*Labeling
refers to the label as well as accompanying material that is used by a
manufacturer to promote and market a specific product.
Tags: dietary supplements
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Last update: 2007-09-17 23:41
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Revision: 1.0
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