Greater than the Sum of Its Parts: FDA Releases Supplemental Draft Completing its Draft Guidance Regarding Protecting Food Against Intentional AdulterationFDA’s recently released Supplemental Draft Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration:  Guidance for Industry” serves as a substantial supplement to the lengthy Revised Draft Guidance that FDA issued in March 2019 which shares the same title.[1]  Once finalized, these guidance documents will together serve to help covered companies comply with FDA regulations that require companies to have and implement a “food defense plan” (FDP) as a safeguard against intentional food adulteration risks.[2]

These FDA regulations implement provisions of the Federal Food, Drug and Cosmetic Act that result from the FDA Food Safety Modernization Act amendments. For businesses other than small and very small businesses, the compliance date for these regulations was July 26, 2019, but FDA has announced that it will not start routine inspections until March 2020.

FDA specifically describes the purpose of this guidance as helping covered entities develop and implement an FDP. The Revised Draft Guidance and Supplemental Draft Guidance together offer nine chapters, each addressing a specific consideration for developing an FDP. The following identifies the chapters introduced in both the Revised Draft Guidance and Supplemental Draft Guidance:

Revised Draft Guidance Supplemental Draft Guidance
Chapter 1: The Food Defense Plan Chapter 5: Mitigation Strategies Management Components: Food Defense Corrective Actions
Chapter 2: Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable Process Steps Chapter 6: Mitigation Strategies Management Components: Food Defense Verification
Chapter 3: Mitigation Strategies for Actionable Process Steps Chapter 7: Reanalysis
Chapter 4: Mitigation Strategies Management Components: Food Defense Monitoring Chapter 9: Records
Chapter 8: Education, Training, or Experience

The Revised Draft Guidance and Supplemental Draft Guidance also include appendices that offer worksheets and assessments to aid covered entities with compliance efforts.

Interested parties have until June 15, 2020 to submit comments on this final round of guidance to ensure FDA will consider

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[1] Revised Draft Guidance. “Mitigation Strategies to Protect Food Against Intentional Adulteration:  Guidance For Industry” (March 2019)(revising and superseding draft guidance issued in June 2018), available at https://www.fda.gov/media/113684/download.

[2] 21 C.F.R. Part 121 (“Mitigation Strategies to Protect Food Against Intentional Adulteration”); Final Rule.  81 Fed. Reg. 34166 (May 27, 2016).