On January 11, 2023, FDA released its final guidance on foreign supplier verification program (FSVP) requirements for importers of food for humans and animals. This session will provide an overview of the laws and regulations relative to food imports in the U.S, as well as an analysis of the core elements and notable changes reflected in FDA’s final guidance on FSVPs.

• Overview of laws and regulations relative to food imports in the U.S.
• Understanding how the FDA USDA and other US regulatory bodies monitor food import/export activity outside the US
• Analyzing the requirements of the Final FSVP Rule, as well as FDA’s 2018 guidance intended to help importers develop and implement an FSVP
• Examining FDA’s recent Final Guidance on FSVPs, including clarification on issues such as:
  • The FSVP “importer” definition and the scope of FDA’s FSVP requirements;
  • FDA’s enforcement discretion policies;
  • FSVP compliance, approval, and verification requirements;
  • FSVP documentation and audit procedures;
  • Requirements regarding hazard analysis, hazard reports, and controls for identified hazards
  • FSVP requirements for importers of dietary supplements
• Identifying circumstance under which a foreign supplier verification program is required and when it is not