FDA Temporary Flexibilities for Food Industry End as COVID-19 Public Health Emergency Expires

With the COVID-19 pandemic’s classification as a Public Health Emergency comes to an end, temporary flexibilities granted by the U.S. Food and Drug Administration (FDA) to aid the food industry through the pandemic are set to expire. The COVID-19 public health emergency will officially end on May 11, 2023 in the U.S., and FDA has provided a Federal Register notice detailing the 10 relevant policies and their expiration dates.

On April 14, 2023, FDA also issued a guidance for industry, titled, Transition from 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. The guidance is intended for qualified exempt farms subject to the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule). Exempt farms are subject to modified Produce Safety Rule requirements. The guidance document communicates FDA’s current thinking on how, when the COVID-19 Public Health Emergency expires, qualified exempt farms may transition away from those temporary policies (listed below) and back to the qualified exemption eligibility criteria as established in the Produce Safety Rule.

Temporary Policies and Expirations

The following policies will expire on May 11, 2023:

• 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
• Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.

The following policies are being revised by FDA and will continue to be in effect until November 7, 2023, which is 180 days after the Public Health Emergency expires:

• Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency
• 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
• 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
• Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.

Finally, one policy—Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency—will expire on November 7, 2023.