FDA extends comment period for the intentional adulteration rule draft guidance

The U.S. Food and Drug Administration (FDA) is extending the comment period for the third installment of the draft guidance designed to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule under the FDA Food Safety Modernization Act (FSMA).

The agency released the third installment of the draft guidance in February 2020. Since that time, the agency has received a request for an extension to allow stakeholders enough time to provide comprehensive feedback. The comment period will be extended until Aug. 14, 2020.

This last installment of the IA rule draft guidance adds to the previously published revised draft guidance. Chapters in the previous installment cover topics focusing on food defense corrective actions, food defense verification, reanalysis of food defense plans, and recordkeeping; it also includes appendices on FDA’s online Mitigation Strategies Database and how a business can determine if it is a small or very small business under the rule.