Enforcement Discretion Policies in FSMA Guidances Extended

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FDA Extends Enforcement Discretion Policies in FSMA Guidances Involving Onsite Visits Abroad Due to the Ongoing, International Impact of COVID-19

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Monday, July 17, 2023

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We previously reported on the status of the 10 food-related Coronavirus Disease 2019 (COVID-19) guidance documents that were issued by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) under the Public Health Emergency (PHE) that existed nationwide from January 27, 2020 until it expired on May 11, 2023. FDA announced that three of these COVID-19 guidance documents would be retained for 180 Days after the expiration of the PHE (i.e., until November 7, 2023), unless superseded by a revised final guidance before that date.

On July 13, 2023, FDA announced it is re-issuing two of the three temporary guidances that were retained after the expiration of the COVID-19 PHE declaration to extend the enforcement discretion policies relative to supplier onsite audits for the FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs rule, and onsite monitoring activities and duration of already-issued certifications for the Accredited Third-Party Certification Program (TPP). Specifically, recognizing that certain international firms might still be impacted by COVID-19 travel restrictions and advisories, FDA has revised the Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 and Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19, without any policy changes, to indefinitely extend the effective dates for these guidances.

FDA anticipates that when the guidances are no longer needed, it will publicly announce the withdrawal of the guidances. FDA’s Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic, which had also been retained after the expiration of the COVID-19 PHE in the U.S., is still set to expire on November 7, 2023, unless superseded by a revised final guidance before that date.