August 13, 2020

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FDA Releases Third and Final Installment of Intentional Adulteration Draft Guidance

On February 13, the FDA released a supplemental draft guidance to support compliance with the Intentional Adulteration (IA) rule under the Food Safety Modernization Act (FSMA). This draft is the third and last installment of the IA draft guidance.

FSMA’s final IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to the public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration. In the 2016 IA final rule, FDA identified four key activities that are most vulnerable to intentional adulteration: (1) bulk liquid receiving and loading, (2) liquid storage and handling, (3) secondary ingredient handling, and (4) mixing and similar activities.

The supplemental draft guidance adds to the draft guidance published in March 2019 with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. For example, the draft guidance explains the differences between food defense corrective actions and food safety corrective actions as well as the verification of mitigation strategies and the verification of preventive controls. It also includes appendices on FDA’s mitigation strategies database and how businesses can determine Small and Very Small Business status under the IA rule.

Stakeholders may submit comments on this IA draft guidance until June 15, 2020.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 50


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...