The U.S. Food and Drug Administration (FDA) has issued a final guidance titled Best Practices for Convening a GRAS Panel. Although in most cases general recognition of safety can be supported without convening a GRAS panel, this guidance provides information to those assembling a panel of experts (“GRAS panel”) to evaluate whether there is general acceptance among the scientific community that the publicly available scientific data and information demonstrate that a substance is safe under the conditions of its intended use in human or animal food.
In finalizing this guidance, the FDA considered comments on the draft guidance issued in November 2017. The final guidance clarifies the difference between a GRAS panel and an FDA advisory committee, and highlights best practices to help those interested in convening a GRAS panel, including:
Identifying GRAS panel members who have appropriate and balanced expertise.
Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
Limiting the data and information provided to a GRAS panel to publicly available information.
Clarifying best practices for convening a GRAS panel helps promote a consistent, science-based approach to evaluating the safety of substances added to human or animal food.
The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to Regulations.gov with the docket number: FDA-2017-D-0085. Written comments should be identified with the docket number: FDA-2017-D-0085 and the title of the guidance document and submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.