Dr. Kyl Smith files phosphatidylserine health claim petition with the FDA - Brief Article

Townsend Letter for Doctors and Patients,  July, 2002  

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Kyl Smith, DC, filed a health claim petition with the Food and Drug Administration in April asking the agency to approve the following two health claims for use on labels and in labeling of dietary supplements that contain phosphatidylserine:

* The consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly.

* The consumption of phosphatidylserine may reduce the risk of dementia in the elderly.

This is the first time a party has filed a health claim petition for reduction in the risk of diseases of the brain.

Dr. Smith's petition is supported by a substantial amount of scientific evidence on the role of phosphatidylserine, a compound commonly found in the healthy human brain that can be isolated from soya and egg yolks among other food sources. The petition is accompanied by a scientific report from Michael John Glade, PhD, FACN, CNS, former Senior Scientist of the American Medical Association.

FDA has 540 days within which to act on the petition. Dr. Smith has asked the FDA to approve the petition under its health claims review standard or, if 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.

COPYRIGHT 2002 The Townsend Letter Group
COPYRIGHT 2002 Gale Group