November 15, 2017
The U.S. Food and Drug Administration today issued for public comment a draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of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 Specifically, the draft guidance highlights best practices that will help parties interested in convening a GRAS panel:
- identify GRAS panel members who have appropriate and balanced expertise;
- 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
- limit the data and information provided to a GRAS panel to publicly available information.
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 The draft guidance also emphasizes that using a GRAS panel does not necessarily mean that the GRAS criteria have been met.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 use of the substance must meet the same safety standard as a food additive: there must be a reasonable certainty of no harm under the conditions of its intended use; and
- the use of the substance must meet the general recognition standard: the intended use of the substance in food must be recognized as safe by qualified experts based on publicly available scientific information.
These criteria apply to all GRAS conclusions, not only to those GRAS conclusions that are based on an evaluation by a GRAS panel or to those GRAS conclusions that are submitted to FDA through FDA's GRAS notification program.
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.
- Federal Register Notice
- Draft Guidance for Industry: Best Practices for Convening a GRAS Panel
- Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food
- GRAS Final Rule
- Frequently Asked Questions about GRAS