4 Highlights from FDA’s Supplemental Draft Guidance for the Intentional Adulteration Rule

The FDA just released the Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration. This third and final portion adds to the previously published  draft guidance with chapters covering food defense corrective actions, food defense verification, reanalysis, and recordkeeping. It also includes appendices on FDA’s mitigation strategies database and how businesses can determine Small and Very Small Businesses status under the IA rule.

4 Key Points You Should Know


Industry stakeholders are encouraged to review and comment to FDA by June 15, 2020 on things they agree or disagree with.
Comment online >


Understand if your business is categorized as very small or small in Appendix 3: Determination of Status as a Very Small Businesses or Small Businesses Under Part 121: Mitigation Strategies to Protect Food Against Intentional Adulteration.


Circumstances When an Improperly Implemented Mitigation Strategy May Be the Result of a Potential Intentional Adulteration Event. FDA has included information on what may be required if a facility suspects Intentional Adulteration has or may have occurred. This is included in Chapter 5, Section D. Within this section FDA states: “Intentional adulteration of food requires more than an opportunity for a contamination event. It also requires a person with intent to cause harm, attacking the food at the point where the mitigation strategy was not properly implemented at the time it was not properly implemented.”


More scenarios and examples for Food Defense Corrective Actions and Food Defense Verification Activities have been included.

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