December 20, 2022
Today, the U.S. Food and Drug Administration (FDA) 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.
For a substance to be generally recognized as safe (GRAS) under the conditions of its intended use, the publicly available data and information must show it meets the safety standard for a food additive. Additionally, there must be common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the intended conditions of use.
Under the GRAS provision established by the Federal Food, Drug, and Cosmetic Act, the use of a substance that is GRAS does not require pre-market approval by the FDA as a food additive. In most cases, a well-supported GRAS conclusion will not need evaluation by a GRAS panel as evidence of general acceptance. For example, peer-reviewed primary safety studies or secondary reviews of primary literature may provide evidence of general acceptance. However, the final guidance includes information on the value of a GRAS panel in providing evidence, in specific circumstances, to support the “general acceptance” aspect of the eligibility criteria for GRAS status through scientific procedures.
In finalizing this guidance, the FDA considered comments on the draft guidance issued in November 2017.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.
For questions about the final guidance as it relates to substances used in human food, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1200.
For questions about the final guidance as it relates to substances used in animal food, contact the Center for Veterinary Medicine (CVM) at 240-402-7002.
For More Information:
- Federal Register Notice
- Final 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