Under the GRAS provision established by the Federal Food, Drug, and Cosmetic Act, the use of a substance that is GRAS does not require premarket approval by 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In finalizing the guidance, FDA considered comments on the draft guidance issued in November 2017.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 the 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 should be submitted to: the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.