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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 This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety requirements. This alert provides a brief background about the legal framework for medical foods and a high-level summary of the guidance, and highlights key differences between the draft guidance and final guidance.
August 25, 2016
Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...
August 24, 2016, Law360
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 ...