Best Practices for Convening a GRAS Panel; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Best Practices for Convening a GRAS Panel." This guidance document is intended for any person who is responsible for a conclusion that 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 (FD&C Act) when that person convenes a panel of experts ("GRAS panel") to independently evaluate 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. This guidance provides our 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 output (often called a "GRAS panel 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).