- The Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) that has existed nationwide since January 27, 2020 is set to expire at the end of the day on May 11, 2023. The end of the PHE will impact 72 guidance documents issued by FDA, including 10 food-related COVID-19 guidance documents issued by FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
- In a March 10, 2023 Constituent Update, FDA announced the status of CFSAN’s COVID-19 guidance documents to ensure a smooth transition after the PHE expires on May 11, 2023. Four guidance documents that were issued to provide temporary flexibility to the food industry to help support the food supply chain and meet consumer demand during the COVID-19 pandemic will no longer be in effect immediately when the PHE expires. These are:
- Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency;
- Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency;
- Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency; and
- 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 has identified an additional 3 food-related COVID-19 guidances that can be discontinued in connection with expiration of the COVID-19 PHE declaration but for which an extended wind-down period is appropriate to allow for an orderly transition. FDA is revising these guidance documents to continue in effect for 180 days after the COVID-19 PHE expires. These guidances, scheduled to no longer be in effect after November 7, 2023, are:
- Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency;
- Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines; and
- 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 intends to retain 3 food-related COVID-19 guidances, with appropriate changes, after expiration of the COVID-19 PHE declaration. FDA is revising these guidances to continue in effect for 180 Days after the PHE expires, during which time FDA plans to make further revisions. These are:
- Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic;
- Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency; and
- Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.
- An explanation of how the end of the PHE will impact all of FDA’s COVID-19-related guidances that have not already been withdrawn, including guidances for drug and biologic products, in addition to the food-related guidances noted above, is provided in a Federal Register notice published March 13, 2023. Although the changes to continue certain guidances for a brief period after the PHE declaration expires are being implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate.
The Daily Intake
Legal and Regulatory updates for the food and supplement industry