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FDA
ALLOWS SELENIUM/CANCER HEALTH CLAIMS
 PRESS
RELEASE
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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