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 |
