FDA’s GRAS rule is here, with mandatory notification, streamlined reporting – and some exemptions

By Jared Rothstein

FDA has proposed significant reforms to its GRAS regulations, including mandatory notification for GRAS conclusions, a streamlined reporting pathway for certain substances already in the food supply and exemptions from some requirements.

But the proposal is more nuanced than an end to self-affirmed GRAS. Its provisions raise important questions about notification, postmarket oversight, implementation and how companies should prepare if the rule is finalized.

This AgencyIQ analysis goes beyond the headline to examine what the proposal would change, what it would leave intact and the regulatory and compliance implications food companies should be watching.

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