GRAS Panel Identified, GRAS Manuscript in Process
The Burdock Group, an FDA compliance consulting firm contracted by ZIVO in August of 2016, has identified and engaged the scientists who will form the independent GRAS panel to review ZIVO safety and efficacy data compiled over the last two years. Simultaneously, Burdock Group scientific and compliance consultants are drafting the formal GRAS manuscript, which forms the basis for safety and efficacy claims. Once completed, the full report will be submitted to the FDA in an effort to obtain a "No Objection" letter. ZIVO will be able to market its algal biomass products once the GRAS panel has affirmed the findings in the GRAS manuscript. The FDA "No Objection" letter is expected to follow 75 days later.
Concurrently, ZIVO has entered into its final phase of product stability testing, the results of which will be incorporated into the GRAS compliance documentation. The product stability testing was also affected by the availability of algal biomass due to hot weather at the Synthetic Genomics (SGI) grow facility in southern California's Imperial Valley. Another set of delays was created when the lab managed by the Burdock Group was not able to accurately assess product stability, and a restart of the stability study was required in late 2017.