Abstract

This chapters begins the substantive discussion of food regulation by looking at enforcement authority of the two primary food agencies in the U.S. By beginning with the enforcement authority later, subjects on prohibited acts will be placed in the context of risks and consequences. Introduction of the enforcement powers also enables instructors to test students using practical scenarios from Form 483s, Warning Letters, and Regulatory Control Actions. The discussion addresses the recent reorganization by the FDA. This chapter covers the full suite of enforcement actions available to the FDA and FSIS. It includes a detailed examination of constitutional and statutory defenses to inspections and enforcement actions.

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