FDA Allows Qualified Selenium, PS Health Claims

WASHINGTON--The Food and Drug Administration (FDA) authorized four health claims, with appropriate disclaimers, that were the subject of petitions to the agency. Emord & Associates served as counsel for the petitioners, who sought to use label claims concerning phosphatidylserine (PS) and selenium.

The first two claims, authorized Feb. 21, involve selenium and cancer. Wellness Lifestyles Inc. filed the claims, and has accepted the disclaimer language, terms and conditions for use. The claims, with FDA's disclaimer language (in italics), read as follows:

* "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."

* "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 second two claims, authorized Feb. 24, regard PS and cognitive dysfunction. Kyl Smith, D.C., filed the claims, and intends to authorize placement of the claims and disclaimers on the labeling of products he licenses. The claims, with FDA's disclaimer language (in italics), read as follows:

* "Phosphatidylserine (PS) may reduce the risk of cognitive dysfunction in the elderly. Very limited and preliminary scientific research suggests that PS may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is very little scientific evidence supporting this claim."

* "Phosphatidylserine (PS) may reduce the risk of dementia in the elderly. Very limited and preliminary scientific research suggests that PS may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim."