This week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule. The draft, “Mitigation Strategies to Protect Food Against Intentional Adulteration”, includes chapters that address food defense corrective actions and verification, reanalysis and recordkeeping. It also includes appendices on FDA’s Mitigation Strategies Database, along with how business can assess their status as a small or very small business.
This is the third and final installment of the draft guidance for the IA rule.
The FDA is still on schedule to begin routine intentional adulteration inspections next month.