(2 cr.) This course examines the legal and policy issues associated with the Food and Drug Administration's regulation of foods and dietary supplements and tobacco products. The class reviews the statutory provisions of the Federal Food, Drug, and Cosmetic Act, as well as the governing case law, implementing regulations, and administrative actions that govern the development/formulation, product positioning and approval/clearance, and labeling/marketing of these products. The course also covers food safety issues, focusing on the Food Safety Modernization Act of 2011 and FDA's rules on restaurant menu and vending machine labeling. The course also includes some coverage of the U.S. Department of Agriculture, its authority over meat and poultry products, and its regulation of organic programs under the Organic Foods Production Act. Students receive a comprehensive overview of the historical background and current state of FDA, and explore FDA's expanding authority over novel technologies, enforcement and inspection powers, and post-marketing surveillance to address safety concerns. (2 or 3 credits dependent on instructor)


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