FDA announces draft guidance on best practices for convening a GRAS panel
The U.S. Food and Drug Administration (FDA) has issued for public comment a draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of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 Specifically, the draft guidance highlights best practices that will help parties interested in convening a GRAS panel:
Under the GRAS provision, established by the Federal Food, Drug, and Cosmetic Act, a substance that is GRAS does not require pre-market review and approval by FDA as a food additive. The GRAS provision requires that, for a substance to be GRAS, its safe use in food be widely recognized by qualified experts. This requirement applies to all GRAS conclusions. The draft guidance also emphasizes that using a GRAS panel does not necessarily mean that the GRAS criteria have been met. In summary, for a substance to be GRAS under the conditions of its intended use, two criteria must be met:
The FDA is also making available on its website a guidance document that highlights the GRAS regulatory framework and may be used as a reference of key resources for evaluating the safety of a substance under the conditions of its intended use. The guidance is also helpful in evaluating whether the available data and information satisfy the GRAS criteria.