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FDA Evaluation of GRAS Notices and FCNs Resumes

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The U.S. Food and Drug Administration (FDA) has informed those who submitted generally recognized as safe (GRAS) notices and food contact notifications (FCNs) prior to the recent government shutdown that it resumed evaluating them on January 28, 2019. FDA suspended evaluations of GRAS notices and FCNs beginning December 22, 2018, when the shutdown began.

Specifically referring to its evaluation of GRAS notices, FDA stated “our 180-day date for pending GRAS notices will be adjusted to reflect the thirty-seven days that our evaluation was suspended.” For more information on the GRAS program see the article, The Final GRAS Regulation: Putting the Voluntary Notification Procedure in Place.

FDA issued similar notices to notifiers of pending FCNs, announcing an adjustment of the statutory timeframe for the FCN review period due to the shutdown.  Under FDA’s FCN system, once the Agency accepts an FCN, if FDA does not object to the FCN in writing within 120 days, the submitter and its customers may rely on the clearance described in the FCN in marketing their products. For more background on the FCN process, see the article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?

Those who have submitted GRAS Notices or FCNs should keep in mind that the possibility remains for another shutdown if a long-term agreement on funding is not reached by February 15, 2019.