FDA OK with Enzymotec’s PS GRAS Status

MIGDAL HAEMEQ, Israel— Enzymotec received a "no questions" response from the U.S. FDA for its GRAS (generally recognized as safe) notification for its Sharp-PS™ phosphatidylserine ingredient. Enzymotec expects to publish the results of three human clinical trials using phosphatidylserine (PS) to address cognitive function in the next few months.

“We believe that PS can expand into functional foods in the near future and a GRAS determination was the first step to enable that. We have already tested its applicability into chocolate bars and dairy applications with great feedback on taste and texture," said Iris Meiri-Benedek, regulatory affairs manager, Enzymotec. "What makes this product  unique is the fact that it is GRAS for use in its active dosages that  will allow functional food manufacturers to introduce an efficacious level of PS in their finished products, thus extending their flexibility and the message  they will eventually be able to make for their products.”

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