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Dietary Supplements - College Paper

Dietary Supplements


Some manufacturers are marketing supplements that have substances and effects similar to drugs. The FDA is attempting to impose drug status on these supplements and is being challenged in the courts by supplement manufacturers. In this article, I examine the legal debate surrounding the definition and regulation of substances - whether as a drug or a dietary supplement. First, I outline some key differences in the regulation of drugs and supplements and examine the two provisions of DSHEA that blur the distinction. Second, I describe recent attempts by the FDA to clarify the guidelines for defining supplements and their associated health claims, as well as court actions challenging these ...

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new drug testing, a new drug application review, and postmarketing surveillance research. Conversely, product testing is not required for any supplement with ingredients that have been present in the food supply prior to October 15, 1994, or that have a history of use or other safety evidence in labeled conditions.
Many supplements were not required to submit evidence because the ingredients were found in food or had been used safely prior to the passage of DSHEA. For those supplements that do not meet these requirements, evidence of safety must be submitted to the FDA 75 days prior to market release. However, this safety information, which could include any citation to a published article may be of questionable quality potentially biased study conducted by the manufacturer, an in vitro rather than human. As a result, the FDA has been put in a policing. Furthermore, DSHEA has made market removal of unsafe supplements more difficult for the FDA.
To be a dietary supplement adulterated ...

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Dietary Supplements. (2008, March 9). Retrieved April 24, 2024, from http://www.essayworld.com/essays/Dietary-Supplements/80247
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"Dietary Supplements." Essayworld.com. March 9, 2008. Accessed April 24, 2024. http://www.essayworld.com/essays/Dietary-Supplements/80247.
"Dietary Supplements." Essayworld.com. March 9, 2008. Accessed April 24, 2024. http://www.essayworld.com/essays/Dietary-Supplements/80247.
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PAPER DETAILS
Added: 3/9/2008 12:50:50 AM
Category: Health & Medicine
Type: Premium Paper
Words: 463
Pages: 2

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