U.S – The U.S. Food and Drug Administration (FDA) has released a final guidance document titled, “Best Practices for Convening a GRAS Panel” which offers information to individuals putting together an expert GRAS panel. 

In most cases, general recognition of safety can be supported without convening a generally recognized as safe (GRAS) GRAS panel.

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.

The Federal Food, Drug, and Cosmetic Act’s GRAS provision states that a substance’s use as a food additive does not require FDA premarket approval.

A robust GRAS conclusion will typically not require assessment by a GRAS panel as proof of general acceptance.

For instance, primary safety studies that have undergone peer review or secondary analyses of original literature may show that a concept is generally accepted.

However, information on the importance of a GRAS panel in providing proof to support the “general acceptance” portion of the requirements for GRAS designation through scientific methods is included in the final guidance.

FDA took into account feedback on the draft guidance released in November 2017 when drafting the final version.

The final guidance outlines best practices to assist individuals considering convening a GRAS panel and defines the distinction between a GRAS panel and an FDA advisory committee.

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.

It also states how to identify GRAS panel members who have appropriate and balanced expertise, and how to limit the data and information provided to a GRAS panel to publicly available information.

In addition, the guidance spells out 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 a conflict of interest.

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 regulator is welcoming the general public to send either electronic or written comments on the final advice.

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