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FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

  • In the March 28, 2018 FDA Voice blog  Dr. Gottlieb provided background and insight on the Intentional Adulteration rule.

  • The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing the burden of foodborne illness by requiring that producers, importers and distributors of food take systematic steps to prevent contamination. Congress passed FSMA with a view of the unique risks posed by a global food supply. Six of FDA’s seven “foundational rules” for FSMA focus on the safe production, storage, and transport of human and animal food by addressing conventional food safety hazards.  But a different reality shapes the seventh rule on intentional adulteration. This provision seeks to prevent acts of terrorism meant to harm and kill many people.  For more background see the Daily Intake blog posts here and here.

  • Extensive analysis shows that some of the most significant risks are posed by an attack perpetrated by someone who has legitimate access to a facility.  Though unlikely, such adulteration is a legitimate concern.  For example, there was a recent report of a foiled terror plot in the United Kingdom that involved an employee at a food manufacturing plant who had been investigating ways to poison supermarket-ready foods.

  • FDA intends to issue a guidance well in advance of the 2019 compliance date.  The guidance will publish in three installments, the first coming in the near future.

    • The first installment will include a simple, cost-effective way to identify the most vulnerable parts of the production process. It will detail numerous ways to guard against deliberate contamination, including some existing and cost-effective measures, as well as additional ways to monitor the operation to make sure that protections are working.

    • The second installment will include guidance on an additional, detailed, and flexible method to identify a facility’s most vulnerable points.

    • The third installment will focus on corrective actions, verifying that the system is working, how to reanalyze the plan and its parts, and record keeping.

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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...

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