FDA Issues 'No Questions' Letter to Polyphenolics Supporting its GRAS Notification For Beverage Use

MegaNatural® Gold Grape Seed Extract and MegaNatural® GSKE Grape Pomace Extract the first in their category to receive “no questions” letter

MADERA, CA -The Food and Drug Administration's Office of Food Additive Safety (“FDA”) has notified Polyphenolics, a division of Canandaigua Wine Company, Inc., that it currently has no questions regarding the conclusion, reached earlier by Polyphenolics, that MegaNatural® Gold Grape Seed Extract and MegaNatural® GSKE Grape Pomace Extract are Generally Regarded as Safe (“GRAS”) for use in fruit juices and fruit flavored beverages.

MegaNatural® Gold is the first grape seed extract to achieve this status. The “no questions” letter comes after the FDA's review of Polyphenolics' self-affirmation study to determine that these products are GRAS. The MegaNatural® Gold products are purified, concentrated phenolic/flavonoid compounds.

MegaNatural® Gold Grape Seed Extract and MegaNatural® GSKE Grape Pomace Extract (formerly called grape skin extract) are GRAS for use in fruit juices, fruit flavored beverages, fruit flavored beverage mixes and carbonated fruit flavored beverages at a concentration of up to 210 PPM (alone or in combination).

These products have gained wide acceptance in dietary supplements for their antioxidant properties, as they are synergistic with vitamins C and E and will give double the antioxidant capacity when used in combination with either of these vitamins, according to a study by Dr. Joe Vinson, University of Scranton, Scranton, PA.

“The FDA's letter, based on our own GRAS determination, affirms the acceptability of using MegaNatural® Gold Grape Seed Extract and GSKE Grape Pomace Extract in the fruit beverage segment,” said Anil Shrikhande, President, Polyphenolics, Inc. “It is a giant step toward expanding the availability of these two products beyond the realm of nutraceuticals and into the mass marketplace.”

Polyphenolics is a leading manufacturer of ingredients for the nutritional and beverage industries. Its extracts are produced in Canandaigua Wine Company, Inc.'s California wineries from unfermented grapes, using a patented, solvent-free, water extraction process. For more information call (574) 243-9825 or visit www.polyphenolics.com

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