Regulatory Leadership in Food Law

Course Code: FSC 820

Credits: 3 credits

In the modern regulatory state, the attorney or regulatory affairs manager is looked to for counseling on more than just the meaning of black letter law, but also for guidance and leadership in dealing with agencies, particularly in adverse or high-stakes situations. This course provides students with an introduction to regulatory affairs as these issues apply to the regulation of food.

Among other concepts, this course covers: the nature of the regulatory process; the role of regulatory affairs; the practical application of regulatory affairs; tools and strategies; the nature of assessing and communicating risk; quality controls and management; compliance; and judicial review of agency decisions. All reading assignments will be available as downloads within the modules or via the provided URLs. The course syllabus is subject to change each semester but generally covers the following topics:

  • Introduction to regulatory affairs
  • How different agencies and countries regulate food labeling
  • Legal issues surrounding food labeling
  • The intersection of science and law
  • Regulation of food additives and chemicals used in the food industry
  • Regulation of genetically engineered products
  • Working with government officials in the US and internationally
  • Registration in USA
  • International registration and submissions to governments
  • Staying current with changing laws, regulations and processes
  • Assessing risk
  • How to manage risk communication
  • Effectively presenting information within an organization
  • Quality control and management
  • FDA Office of Regulatory Affairs (ORA)
  • Compliance
  • Judicial review of agency decisions

This course is offered in the spring semester. 

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