| US FDA
ALLOWS SELENIUM/CANCER HEALTH CLAIMS
PRESS
RELEASE
FOR IMMEDIATE RELEASE:
2/21/03
WASHINGTON,
D.C.-On February 21, 2003, the Food and Drug
Administration authorized use of two health claims
that were the subject of a petition to FDA by
Wellness Lifestyles, Inc.(d/b/a American
Longevity) on the labels and in the labeling of
dietary supplements containing Selenium in daily
dose amounts of 400
micrograms or less:
(1) Selenium may reduce the
risk of certain cancers.
Some scientific evidence
suggests that consumption of selenium may reduce
the risk of certain forms of cancer. However, FDA
has determined that this evidence is limited and
not conclusive.
(2) Selenium may produce
anticarcinogenic effects in the body.
Some scientific evidence suggests that consumption
of selenium may produce anticarcinogenic effects
in the body. However, FDA has determined
that this evidence is limited and not
conclusive.
The announcement
follows FDA consideration of a health claim
petition filed by Wellness Lifestyles, Inc (d/b/a
American Longevity) that sought approval of the
cancer risk reduction and anticarcinogenic effect
claims (underlined above). The petition
contained substantial scientific evidence on those
nutrient-disease effects. Wellness Lifestyles,
Inc. has accepted the FDA's disclaimer language
(the text not underlined above) and the terms and
conditions for use of the qualified
claims.
The company intends to
place the claims and disclaimers on the labels and
in the labeling of its selenium-containing dietary
supplements.
A copy of the FDA
letter allowing use of the claim may be obtained
from Katie Bond at Emord & Associates
(202-466-6937).
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