The FDA has approved the GRAS notification of Lipogen’s PS (phosphatidylserine) patented product line. This is an important step that will facilitate the Israeli company’s expansion in the US, a spokesperson told just-food, and the first time that the FDA has approved a PS product line as safe for food fortification.
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Phosphatidylserine is primarily found in brain cells and is involved in numerous functions of neuronal activity. Clinical tests of Lipogen PS showed consumption brought significant memory and mental improvements.
“This is the first time that the FDA has approved a PS product as safe for food fortification,” said David Rutenberg, CEO at Lipogen. “Other PS ingredients available on the market are produced with bacterial enzymes while Lipogen PS production complies with non-bacterial enzymatic process. This “green-light” from FDA is a significant move for Lipogen as it aims our non-bacterial PS ingredient into the functional food and beverages marketplace.”
Lipogen is marketing its PS product, in both powder and liquid versions, internationally. The company said it used to fortify various products, including milk, yogurt products, breakfast cereals, biscuits and meal replacements.
Lipogen hopes that the FDA approval will boost sales within the food and beverage industry.
“The efficacy of PS has been recognised by the FDA which allows Qualified Health Claims (May 13, 2003). The GRAS affirmation of Lipogen PS as a functional food ingredient will greatly contribute to the fulfillment of consumer demand for mental functional supplements,” Rutenberg said.
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