In an article published on November 15, 2017, the Institute for Food Technologists (IFT) informed that the U.S. Food and Drug Administration (FDA) has published a draft guidance for industry on “Best practices for convening a GRAS panel.” The draft guidance was published in the U.S. Federal Register on November 16, 2016, and is open for comments until January 16, 2018 (regarding the provisions on collection of information) and May 15, 2018 (general). The “generally recognized as safe” (GRAS) provisions of the Federal Food, Drug, and Cosmetic Act allow chemical and food manufacturers to determine for themselves whether a substance is safe for use in human and animal food, based on “publicly available scientific information.” A GRAS substance “does not require pre-market review and approval by FDA as a food additive,” the IFT further explained. The GRAS provisions may also be applied to certain substances present in food contact materials (FCMs) that may become indirect additives to food.

The draft guidance presents FDA’s “current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel’s output (often called a “GRAS panel report”), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).” In addition, FDA published a guidance for industry regarding the regulatory framework for GRAS substances. FDA noted that both guidance documents contain “nonbinding recommendations.”

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IFT (November 15, 2017). “FDA announces draft guidance on best practices for convening a GRAS panel.

FDA (November 15, 2017). “Draft guidance for industry: Best practices for convening a GRAS panel.

FDA (November 15, 2017). “Guidance for industry: Regulatory framework for substances intended for use in human food or animal food on the basis of the generally recognized as safe (GRAS) provision of the federal food, drug, and cosmetic act.

Federal Register (November 16, 2017). “Best practices for convening a generally recognized as safe panel: Draft guidance for industry; availability.

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