FDA Releases Draft Guidance for Intentional Adulteration Rule

June 19, 2018

Today, the FDA released the first of three installments of a draft guidance document designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). The remaining two installments are expected to come out later this year.

The first compliance date for the largest facilities arrives in July 2019.

This first part of the draft guidance includes chapters on:

  • The components of the food defense plan;

  • How to conduct vulnerability assessments using the key activity type method;

  • How to identify and implement mitigation strategies; and

Food defense monitoring requirements. To further assist and engage stakeholders, FDA will announce plans to hold a public meeting on the draft guidance when the second installment is released later this year. All three parts will be available for public comment upon release.