The FDA’s GRAS proposal could strain capacity and create review bottlenecks

By John Herlihy, PhD

FDA’s proposed GRAS reforms would establish new review timelines while significantly increasing the number of notifications the agency receives. But meeting those timelines could prove challenging as FDA takes on a substantially larger workload without additional resources.

For food companies and ingredient developers, potential review delays could introduce uncertainty even though the proposal would continue to allow self-affirmed GRAS determinations.

This AgencyIQ analysis looks beyond the proposed requirements to examine FDA’s existing review capacity, where bottlenecks could emerge and what implementation challenges could mean for companies navigating the new system.

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