The U.S. Food and Drug Administration (FDA) is withdrawing two COVID-19 pandemic-era temporary guidances regarding human and animal foods that involve onsite visits under the FDA Food Safety Modernization Act (FSMA). Specifically:

• “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19” (read here)
• “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19” (read here).

In these documents, FDA issued guidance about onsite auditing and observation requirements to assist firms responding to the COVID-19 pandemic and help ensure continued food safety and availability during the pandemic. When certain circumstances were present—including, but not limited to, when COVID-19 travel restrictions prevented onsite visits—the temporary guidances addressed supplier onsite activities for the FSMA Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs rule. These temporary guidances also addressed onsite monitoring activities and the duration of already-issued certifications for the Accredited Third-Party Certification Program.  

As COVID-19 no longer significantly impacts travel, FDA believes the temporary guidances are no longer relevant. To ensure that industry is not surprised by the change in policy, the withdrawals will go into effect on June 16, 2026.