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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