End of Public Health Emergency Winds Down FDA Flexibility

While COVID may linger unendingly as an endemic disease, its categorization as a Public Health Emergency (PHE) officially ends in the U.S. on May 11, 2023. And with that comes the expiration of a number of FDA guidance documents that provided temporary flexibility for certain food industry activities to help address the circumstances of the PHE and COVID-19. Four of the guidances will expire on May 11, while FDA is providing a 180-day extension (until November 7) for six others.

With five of the guidances related to labeling, it is critical that food establishments throughout the supply chain ensure you are in compliance. To facilitate the distribution of food during the COVID-19 pandemic:

• Food manufacturers that have packaged foods on hand that are labeled for use in restaurants, FDA temporarily allowed the sale of packaged food lacking a Nutrition Facts label and the sale of that packaged food by restaurants, provided that the food does not have any nutrition claims and contains other required information on the label. Expires May 11, 2023.
• FDA temporarily allowed retail food establishments to sell shell eggs in cartons or flats without labels, provided certain circumstances are present. Expires May 11, 2023.
• While encouraging chain restaurants and similar retail food establishments to comply with menu labeling requirements, FDA temporarily allowed flexibility in their meeting of menu labeling requirements under section 403(q)(5)(H) of the FD&C Act (21 U.S.C. 343(q)(5)(H)) and under 21 CFR 101.11. Expires November 7, 2023.
• Understanding the difficulties of relabeling formulation changes during the supply and worker shortages of the pandemic, FDA provided temporary labeling flexibilities for minor formulation changes under specific circumstances. Expires November 7, 2023.
• FDA temporarily allowed flexibility in vending machine food labeling relevant to the FD&C Act which requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from the machines. Expires November 7, 2023.

In addition to these temporary labeling flexibilities, a number of other temporary allowances are expiring, including allowing egg producers who only sold eggs to facilities for further processing to sell to the table egg market, provided certain circumstances are present; flexibility in the eligibility criteria for the qualified exemption from FSMA’s Produce Rule; relaxing of PC/FSVP onsite supplier audit requirements; voluntary closure/reduced production reporting; flexibility in accredited 3rd party audits and certifications; and guidance for refrigerated food transport vehicles and storage units used for the temporary preservation of human remains. 

With the public health emergency having lasted more than three years (January 31, 2020–May 11, 2023), it is likely that at least some of the procedures that food establishments implemented during that time have become standard practice, with some workers and managers not even realizing that they were only provided as temporary allowances. As such, it is critical that food safety and quality assurance teams take a look at practices that were changed during the pandemic, determine if any were implemented under the temporary PHE guidances, and take any needed corrective action to ensure full compliance with standard regulation.

With the number of temporary flexibilities made for labeling, this should be a priority area of concern, both for assessment of supplied goods as well as internal formulation changes and menu/vending machine labeling. In some cases, food establishments have six months to conduct assessments and ensure accurate labels, but for both packaged foods for restaurant and shell eggs in carton or flats, less than a month remains for compliance.