September 2002 Legal Notes

American Longevity's petition is
supported by a substantial
amount of scientific evidence on
the role of selenium in the body.

Wellness Lifestyles, Inc. d/b/a American Longevity, makers of dietary supplements containing the antioxidant and essential trace element selenium, filed a health claim petition with the Food and Drug Administration (FDA) today asking the agency to approve the following two health claims for use on labels and in labeling of dietary supplements containing selenium:

Selenium may reduce the risk of certain cancers.

Selenium may produce anticarcinogenic effects in the body.

American Longevity's petition is supported by a substantial amount of scientific evidence on the role of selenium in the body. The petition is accompanied by a scientific report from Philip D. Whanger, Ph.D., Professor Emeritus at Oregon State University, a biochemist and nutritionist.

The FDA has 540 days within which to act on the petition. American Longevity has asked the FDA to approve the petition under its health claims review standard or, if the FDA chooses not to approve the petition, to allow use of the claims with disclaimers as required by the United States Court of Appeals' Pearson v. Shalala decision.