In the November 16, 2017, Federal Register, FDA announced the availability of a draft guidance for industry titled "Best Practices for Convening a GRAS Panel." This draft guidance document is intended for any person who convenes a panel of experts ("GRAS panel") to determine whether a substance may be used in food on the basis of the generally recognized as safe ("GRAS") provision of the Federal Food, Drug, and Cosmetic Act. A GRAS Panel is tasked with independently evaluating whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. The draft guidance provides FDA's current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise, to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's report (including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest), and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information). Comments are due May 15, 2018, except for the collection of information provisions in the draft guidance, which are due January 16, 2018.
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