FDA Updates Duration of Enforcement Discretion Policies in Two COVID-19 Era FSMA Guidances
Constituent Update
July 13, 2023
Today, the U.S. Food and Drug Administration is re-issuing two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).
Although the PHE ended in the United States on May 11, 2023, the FDA recognizes that certain international firms might still be impacted by COVID-19 travel restrictions and advisories. Therefore, the FDA has revised the two guidances to extend the enforcement discretion policies issued during the PHE relative to supplier onsite audits for the 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), when certain circumstances are met.
The enforcement discretion policies described in the revised guidances 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, remain unchanged. The FDA anticipates that when the guidances are no longer needed, the FDA will publicly announce the withdrawal of the guidances.
Additional Information:
- FDA Issues Temporary COVID-19 Policy for Receiving Facilities and Importers in Meeting FSMA Supplier Verification Onsite Audit Requirements
- FDA Issues Temporary Policy for Certain Requirements under the Accredited Third-Party Certification Program During COVID-19 Public Health Emergency