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."
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