COVID-19 Update: FDA Issues Guidance on Voluntary Reporting of Temporary Closures or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During COVID-19 Public Health Emergency

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On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public health emergency. The agency’s guidance document is entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency” (“Guidance”). The Guidance details a mechanism by which human food facilities and farms may voluntarily notify FDA of temporary closures and significant reductions in operations, or to request a dialogue with FDA on issues related to continuing or restarting their operations during the COVID-19 pandemic. This Guidance does not apply to restaurant and retail food establishments or to animal food operations.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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