ZIVO’s GRAS Designation Reaffirmed for Proprietary Algal Biomass Product as a Human Food Ingredient
May 30 2023 - 8:45AM
Business Wire
Zivo Bioscience, Inc. (NASDAQ: ZIVO) (the “Company”), a
biotech/agtech R&D company engaged in the development of
therapeutic, medicinal and nutritional product candidates derived
from proprietary algal cultures, today announced it has received an
updated dossier from an independent scientific review panel
reconfirming the Company’s “Generally Recognized As Safe” (GRAS)
designation for its proprietary algal biomass to be marketed and
used as an ingredient in a defined range of foods and beverages for
human consumption.
GRAS is a designation created by the U.S. Food and Drug
Administration (FDA) under the Federal Food, Drug and Cosmetic Act
that determines if a food ingredient or additive has adequate
evidence of safety to be consumed under the conditions of intended
use. GRAS status conveys to manufacturers and marketers that they
are able to safely integrate ZIVO’s algal biomass ingredient into
food processing lines and products, and to include its nutritional
information on product labels.
“Our algal biomass received a GRAS designation several years
ago, yet our continued innovation in cultivation, development and
downstream processing technologies motivated us to convene another
independent scientific review panel to renew and update the
designation in anticipation of a potential commercial product
launch,” said John Payne, Chairman, Chief Executive Officer and
President of ZIVO Bioscience.
The present GRAS review is based on commercial-scale cultivation
processes and parameters, which better represent ZIVO’s planned
commercial product. The analysis concludes that ZIVO’s algal
biomass, as cultivated for commercial use, is exempt from the
premarket approval requirements of the FDA.
About ZIVO Bioscience
ZIVO Bioscience is a research and development company with an
intellectual property portfolio comprised of proprietary algal and
bacterial strains, biologically active molecules and complexes,
production techniques, cultivation techniques and patented or
patent pending inventions for applications in human and animal
health. Please visit www.zivobioscience.com for more
information.
Forward Looking Statements
Except for any historical information, the matters discussed in
this press release contain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Although ZIVO believes
that we have a reasonable basis for each forward-looking statement,
we caution you that these statements are based on a combination of
facts and factors currently known by us and our expectations of the
future, about which we cannot be certain. Our actual future results
may be materially different from what we expect due to factors
largely outside our control, including risks that our strategic
partnerships may not facilitate the commercialization or market
acceptance of our products; risks that our products may not be
ready for commercialization in a timely manner or at all; risks
that our products will not perform as expected based on results of
our pre-clinical and clinical trials; our ability to raise
additional funds; uncertainties inherent in the development process
of our products; changes in regulatory requirements or decisions of
regulatory authorities; the size and growth potential of the
markets for our products; the results of clinical trials, our
ability to protect our intellectual property rights and other
risks, uncertainties and assumptions, including those described
under the heading “Risk Factors” in our filings with the Securities
and Exchange Commission. These forward–looking statements speak
only as of the date of this press release and ZIVO undertakes no
obligation to revise or update any forward–looking statements for
any reason, even if new information becomes available in the
future.
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version on businesswire.com: https://www.businesswire.com/news/home/20230529005152/en/
ZIVO Bioscience, Inc. Keith Marchiando, Chief Financial
Officer (248) 452-9866 x130 kmarchiando@zivobioscience.com
LHA Investor Relations Tirth T. Patel (212) 201-6614
tpatel@lhai.com
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