Phosphatidylserine Data Limited To Dementia Mitigation Not Prevention – FDA
This article was originally published in The Tan Sheet
Executive Summary
All the data submitted to FDA in support of a health claim linking phosphatidylserine to prevention of dementia or cognitive dysfunction examine the ingredient's ability to mitigate the conditions in a diseased population, not on reducing risk in the general population, the agency said in a May 13 letter
You may also be interested in...
Brain Gain: Supplements And Nutraceuticals Expand Cognitive Health Science
The next generation of substances to slow cognitive decline and perhaps even prevent Alzheimer's disease may take a test run through the dietary supplement and nutraceutical markets
GRAS phosphatidylserine
GCI Nutrients Liposerine is the only phosphatidylserine currently Generally Recognized as Safe-affirmed by FDA, according to the Burlingame, Calif.-based firm. The agency deemed Liposerine suitable for use in a number of food products, including ready-to-eat breakfast cereals, yogurt, tofu, chocolates and beverages, in a July 20 GRAS notice. In May 2003, FDA approved a qualified health claim for phosphatidylserine and a reduced risk of cognitive dysfunction in the elderly (1"The Tan Sheet" May 19, 2003, p. 15). The ingredient firm foresees Liposerine in products targeting the aging baby-boomer market, but also in memory-loss products for school-aged children, according to a spokesperson for the firm. Liposerine is available as a 20% phosphatidylserine powder, a 35% phosphatidylserine powder and a 20% phosphatidylserine liquid. The branded ingredient also is suitable for use in dietary supplements, and Nu Skin, which markets supplements under the Pharmanex brand, was "intrigued" by the product, the spokesperson said. Liposerine is not the only branded phosphatidylserine; Cargill acquired the Leci-PS branded phosphatidylserine when it bought Degussa's food ingredients business in March (2"The Tan Sheet" April 3, 2006, p. 8)...
Selenium Cancer Risk Reduction Qualified Claims To Be Allowed By FDA
Health claims linking selenium supplements with reducing cancer risk will be permitted by FDA through its "enforcement discretion," according to the agency