FDA ALLOWS SELENIUM/CANCER HEALTH CLAIMS

02/21/03

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).

Emord & Associates, P.C.
Burke Professional Center
5282 Lyngate Court
Burke, Virginia 22015

1050 Seventeenth Street, N.W.
Suite 600
Washington, DC 20036

Phone: (202) 466-6937 ? Fax: (202) 466-6938
Web Site: www.emord.com
E-mail : jemord@emord.com