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FDA Releases Draft Guidance On Best Practices For Convening A GRAS Panel

The US Food and Drug Administration (FDA) this week issued for public comment a draft guidance document on best practices to follow when convening a panel of experts to evaluate whether a substance is generally recognized as safe (GRAS) under the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.

The draft guidance document is intended for and directed to: those proponents who intend to consider the opinion of a GRAS panel in reaching a conclusion that the intended use of a substance in human food or animal food is GRAS; those persons who assemble a GRAS panel and provide the framework for its deliberations; and/or those persons who are interested in FDA’s views and recommendations on best practices for convening a GRAS panel.

Convening a GRAS panel and relying on the GRAS panel as a proxy for the larger scientific community knowledgeable about the safety of substances directly or indirectly added to food is one mechanism that proponents have used to support a proponent’s conclusion that the safety of a substance under the conditions of its intended use in human food or animal food is generally recognized, the guidance explained.

The draft guidance highlights best practices that will help parties interested in convening a GRAS panel: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.

In August 2016, FDA issued a final rule establishing a GRAS notification procedure That final rule completed a rulemaking that the agency initiated through a proposed rule in 1997 and a notice reopening the comment period for the proposed rule to update comments and to solicit comment on specific issues in late 2010.

During the interim period between the proposed rule and the final rule, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) filed and responded to more than 600 GRAS notices for substances intended for use in human food and the agency’s Center for Veterinary Medicine (CVM) filed and responded to 18 GRAS notices for substances intended for use in animal food.

Thus, although FDA’s experience with GRAS notices submitted under the framework of the GRAS notification procedure began with the effective date of the final rule (Oct. 17, 2016), the agency noted that it has “substantial experience” with GRAS notices filed during the interim pilot program before that date.

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 intended for any person who intends to market a food substance on the basis of a conclusion that the substance is GRAS under the conditions of its intended use, including a manufacturer of the food substance, a manufacturer of a food product containing the food substance, and a distributor...

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