February 18, 2019

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FDA Issues First Draft Guidance Document on Intentional Adulteration

  • As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food Safety Modernization Act (FSMA).  These rules are intended to guard against the deliberate adulteration of food by employees.

  • The 94-page guidance provides an overview of key aspects of the regulations (found at 21 C.F.R. Part 121), including preparing a Food Defense Plan (Chapter 1), conducting a vulnerability assessment (Chapter 2), mitigation strategies (Chapter 3), and food defense monitoring (Chapter 4).  It also offers a number of worksheets to assist businesses in complying with the new rules, which become effective for most businesses on July 26, 2019.

  • The second installment is expected to provide more detailed guidance on methods to identify a facility’s most vulnerable points, and the third installment will address corrective actions, verification, reanalysis, and record keeping.  These guidance documents are expected later in 2018.  Commissioner Scott Gottlieb believes that the guidance addresses stakeholder concerns regarding the practicality of the rules and the need for flexibility when conducting vulnerability assessments, but it remains to be seen whether industry agrees.

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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...