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August 17, 2016, Covington Alert
This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through regulation, the voluntary notification program that has been running as an interim pilot for nearly two decades. It also modernizes the regulations in a few key respects, sweeping out obsolete provisions about a GRAS petition process that is no longer used and replacing them with a description of the voluntary GRAS notification procedure already familiar to the food industry.
August 24, 2016, Law360
May 16, 2016, Covington Alert
Last week, FDA finalized its guidance for industry about medical foods, which it issued in draft form in August 2013. This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety ...
April 7, 2016, Covington Alert
Yesterday, FDA published in the Federal Register its final rule establishing sanitary transportation requirements for both human and animal food. The rule is intended to ensure that food transportation practices do not create food safety risks. FDA provides a flexible, risk-based approach that largely aims to allow the transportation industry to continue to use ...