Zivo Bioscience, a biotech/ag-tech R&D company focused on developing therapeutic, medicinal, and nutritional products derived from proprietary algal cultures, announced today that it has received an updated dossier from an independent scientific review panel reconfirming the “Generally Recognized As Safe” (GRAS) designation for its proprietary algal biomass. This designation allows Zivo’s algal biomass to be used as an ingredient in a defined range of foods and beverages for human consumption.
The GRAS designation, created by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act, is an important recognition that determines whether a food ingredient or additive has sufficient evidence of safety for consumption under intended conditions. The GRAS status assures manufacturers and marketers that they can safely integrate Zivo’s algal biomass ingredient into their food processing lines and products, including its nutritional information on product labels.
While Zivo’s algal biomass received the GRAS designation several years ago, the company’s commitment to innovation in cultivation, development, and downstream processing technologies prompted them to convene another independent scientific review panel. The objective was to renew and update the GRAS designation in preparation for a potential commercial product launch. This proactive step highlights Zivo Bioscience’s commitment to ensuring the safety and efficacy of its products.
John Payne, Chairman, CEO, and President of Zivo Bioscience, expressed his company’s dedication to advancing the cultivation and processing technologies associated with their algal biomass. He stated, “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.”
The updated GRAS review is based on Zivo’s commercial-scale cultivation processes and parameters, which more accurately reflect the 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. This exemption streamlines the regulatory process and paves the way for Zivo Bioscience to bring their algal biomass ingredient to market efficiently.
Zivo Bioscience is a research and development company with an intellectual property portfolio focused on 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. The company’s dedication to innovation and commitment to safety underscores its mission to develop high-quality, science-backed products.
Zivo Bioscience’s reconfirmation of the GRAS designation for its algal biomass is a significant milestone. With a focus on safety, innovation, and commercialization, the company will bring its algal-based products to market, potentially revolutionizing the field of biotech/ag-tech and offering new possibilities for therapeutic, medicinal, and nutritional applications derived from algal sources.
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