FDA Announces Draft Guidance on Best Practices for Convening a GRAS Panel

The U.S. Food and Drug Administration today issued for public comment a draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use. Specifically, the draft guidance highlights best practices that will help parties interested in convening a GRAS panel:

  1. identify GRAS panel members who have appropriate and balanced expertise;
  2. 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
  3. limit the data and information provided to a GRAS panel to publicly available information.

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