FDA Withdraws COVID-Era FSMA Guidance

The U.S. Food and Drug Administration (FDA) is withdrawing the following two temporary guidances, originally published during the COVID-19 public health emergency, regarding human and animal foods that involve onsite visits under the Food Safety Modernization Act (FSMA): 

• Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19 
• Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 

In these two documents, the agency issued guidance on onsite auditing and observations requirements to assist firms responding to the COVID-19 pandemic and help ensure continued food safety and availability during this time.  

COVID no longer causes travel to be impracticable to any significant extent, said FDA. The agency said the temporary guidances “are no longer relevant or needed.” The withdrawals will be effective June 16.  

Guidance Background.

When the U.S. COVID-19 public health emergency declaration ended in May 2023, the FDA recognized certain firms might still be impacted by COVID-19 travel restrictions and advisories. Accordingly, in July 2023, the FDA reissued two temporary COVID-era FSMA guidances for certain regulatory requirements involving onsite activities. 

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, and onsite monitoring activities and duration of already-issued certifications for the Accredited Third-Party Certification Program.