July 5, 2020

Volume X, Number 187

July 03, 2020

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FDA Provides Guidance Document on Reporting Human Food Establishments’ Temporary Closures or Significantly Reduced Production

On May 27, 2020, the U.S. Food and Drug Administration (FDA) released a guidance document 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.”  FDA issued this guidance to provide certain FDA-regulated food establishments (i.e., human food facilities and farms, but not restaurants and retail food establishments), with a convenient mechanism to voluntarily report if they have temporarily ceased or significantly reduced production, or if they are considering doing so.  FDA noted that this reporting mechanism may also be used to request assistance from the Agency regarding issues that may affect continuity of operations during the pandemic.

By way of background, facilities that manufacture/process, pack or hold food for consumption in the U.S. must register with FDA when initially beginning operations and then update that registration on a biennial basis and within 60 days of when certain changes in their operations occur.  FDA noted that rapid notification regarding certain FDA-regulated food establishments that are temporarily closing or reducing production will help FDA better understand the current status of the food supply and address challenges facing food producers to help support food production.

To address issues that may affect continuity of operations during the pandemic, FDA can provide information, such as relevant guidance, in areas including protecting worker safety, inability to access protective equipment for personnel, and supply chain imbalances.  In its guidance, FDA noted that it will work with other agencies, like the Centers for Disease Control and Prevention, Department of Homeland Security, Department of Agriculture, Occupational Safety and Health Administration, the Federal Emergency Management Agency, and State, local, tribal and territorial regulatory partners to provide the most up-to-date information.

This guidance is intended to remain in effect only for the duration of the public health emergency related to COVID-19.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 149


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...