FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires

Constituent Update

March 10, 2023

Today the U.S. Food and Drug Administration (FDA) issued a Federal Register notice to explain how the end of the Public Health Emergency (PHE) will impact the agency’s COVID-19 guidance documents. On January 30, President Biden announced that the PHE would expire on May 11, 2023. During the PHE, the agency issued guidance documents to help address the circumstances of the PHE and COVID-19. Most of these guidances state that they are intended to remain in effect only for the duration of the declared COVID-19 PHE.

The Center for Food Safety and Applied Nutrition issued 10 guidance documents to provide temporary flexibility to the food industry to help support the food supply chain and meet consumer demand during the pandemic. 

The FDA is providing this information to all impacted stakeholders to ensure a smooth transition. 

Docket Number	Guidance Title	Status
FDA-2020-D-1139	Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency	This guidance will no longer be in effect when the COVID-19 PHE expires.
FDA-2020-D-1139	Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency	This guidance will no longer be in effect when the COVID-19 PHE expires.
FDA-2020-D-1139	Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency	This guidance will no longer be in effect when the COVID-19 PHE expires.
FDA-2020-D-1139	Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency	This guidance will no longer be in effect when the COVID-19 PHE expires.
FDA-2020-D-1139	Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency	FDA is revising to continue in effect for 180 days after the COVID-19 PHE expires.  After November 7, 2023, this guidance will no longer be in effect.
FDA-2020-D-1139	Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines	FDA is revising to continue in effect for 180 days after the COVID-19 PHE expires. After November 7, 2023, this guidance will no longer be in effect.
FDA-2020-D-1386	Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption	FDA is revising to continue in effect for 180 days after the COVID-19 PHE expires. After November 7, 2023, this guidance will no longer be in effect.
FDA-2020-D-1139	Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic	FDA is revising to continue in effect for 180 Days after the PHE expires, during which time the FDA plans to make further revisions.
FDA-2020-D-1108	Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency	FDA is revising to continue in effect for 180 Days after the PHE expires, during which time the FDA plans to make further revisions.
FDA-2020-D-1304	Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency	FDA is revising to continue in effect for 180 Days after the PHE expires, during which time the FDA plans to make further revisions.