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*ÂüÁ¶1 ³ì½ÊÀÚ»ó¾Æ ȨÆäÀÌÁö
 
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FDA ÀÎÁõÀÚ·á.. 

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*ÂüÁ¶ 4

FDA Allows Qualified Antioxidant/Cancer Health Claim
Posted on: 04/01/2003

WASHINGTON--The Food and Drug Administration (FDA) authorized
a new health claim, with appropriate disclaimer language, that was the
subject of a petition to the agency. Emord & Associates served as
counsel for the petitioners, who sought to use a health claim linking
intake of antioxidant vitamins and a reduced risk of certain kinds of
cancer.

FDA's final order follows a decision issued in December 2002 by the
U.S. District Court for the District of Columbia. In the case, Whitaker
et al v. Thompson et al, the court determined FDA could not suppress
the health claim on first amendment grounds; the FDA appealed the
decision, but withdrew its appeal March 28.

The claim reads: "Consumption of antioxidant vitamins may reduce the
risk of certain kinds of cancer." As ordered by the court, FDA
reviewed disclaimer language suggested by the court and submitted by
other parties. FDA offered three disclaimers to run with the claim.

* Some scientific evidence suggests that consumption of antioxidant
vitamins may reduce the risk of certain forms of cancer. However, FDA
has determined that this evidence is limited and not conclusive.

* Some scientific evidence suggests that consumption of antioxidant
vitamins may reduce the risk of certain forms of cancer. However, FDA
does not endorse this claim because this evidence is limited and not
conclusive.

* FDA has determined that although some scientific evidence suggests
that consumption of antioxidant vitamins may reduce the risk of certain
forms of cancer, this evidence is limited and not conclusive.

In the notice to Emord, Christine L. Taylor, Ph.D., director of the Office
of Nutritional Products, Labeling and Dietary Supplements at FDA's
Center for Food Safety and Applied Nutrition (CFSAN) said the agency
would exercise enforcement discretion with respect to antioxidant
dietary supplements containing vitamin E and/or vitamin C that meet
two criteria: the products must use one of the FDA disclaimers and
recommended intake must not exceed the Tolerable Upper Intake Level
(established by the Institute of Medicine) of 2,000 mg/d of vitamin C
and 1,000 mg/d of supplemental alpha-tocopherol
..................................................