FDA Grants GRAS Status to Enzymotec's PS
Meiri-Benedek: 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.
10/01/08 Israeli biotech company Enzymotec has announced that it had received "No Questions" from the US-FDA for its GRAS notification on Sharp-PS (Phosphatidylserine) product .
Enzymotec expects to publish results of three human clinical trials made on PS in the next few months.
PS, is a common dietary supplement used to improve memory, concentration and other cognitive capabilities, especially for the aged population.
"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," says, Mrs. Iris Meiri-Benedek, Enzymotec regulatory affairs manager. "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," concludes Mrs. Meiri-Benedek.
Enzymotec develops and produces novel, lipid-based health ingredients for dietary supplements and functional foods. The company's leading products are:, SharpPS and SharpPS GOLD for cognitive performance improvement of seniors, CardiaBeat offering a broad health effect to reduce CVD risks and InFat for balanced nutrition in infant formula.
