Navigating U.S. Food Regulations: Safety and Enforcement

Navigating U.S. Food Regulations: Safety and Enforcement

This course is part of Personalized Nutrition, Policy, and Food Regulations Specialization

Instructor: Jessica Hartke

Access provided by ExxonMobil

4 modules

Gain insight into a topic and learn the fundamentals.

Intermediate level

Recommended experience

1 week to complete

at 10 hours a week

Flexible schedule

Learn at your own pace

4 modules

Gain insight into a topic and learn the fundamentals.

Intermediate level

Recommended experience

1 week to complete

at 10 hours a week

Flexible schedule

Learn at your own pace

What you'll learn

Discover how advocacy, industry, and government agencies interact to shape and enforce U.S. food regulations.
Understand U.S. nutrition policy, food assistance programs, and their impact on public health.
Explore food labeling, safety laws, and regulatory frameworks through expert-led frameworks and models.

Skills you'll gain

Details to know

Shareable certificate

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Assessments

6 assignments

Taught in English

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This course is part of the Personalized Nutrition, Policy, and Food Regulations Specialization

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There are 4 modules in this course

In today’s global food system, understanding how food regulations shape what we eat, how it’s labeled, and how it’s imported is more important than ever. Navigating U.S. Food Regulations: Safety and Enforcement is a dynamic 4-week Coursera course that explores the complex landscape of U.S. food laws, enforcement mechanisms, and the role of advocacy in shaping policy. From the Food Safety Modernization Act (FSMA) to the regulation of dietary supplements and infant formula, learners will gain a practical understanding of how food safety is maintained and how consumer protection is enforced. Led by instructor Dr. Jessica Hartke, you’ll explore how regulations evolve in response to public health needs and industry practices.

This course features insights from a distinguished team of experts, including food law scholar Bryan Endres, nutrition scientist Deshanie Rai, regulatory strategist Karleigh Bacon, and food policy specialists Robbie Burns and Nate Matusheski. You’ll also hear from guest lecturers who are leaders in advocacy and policy, offering firsthand accounts of how regulations are influenced and enforced. Whether you're a student, professional, or curious consumer, this course will equip you with the tools to critically evaluate food regulations and their impact on public health and industry. This course is part of the College of ACES suite of online programs. To learn more about online programs from the College of ACES and explore ways to apply your Coursera work toward a degree program at the University of Illinois, visit: https://aces.illinois.edu/online.

In the course orientation, you'll get to know the course, your classmates, and our learning environment, and gain the technical skills needed. Then, learn how advocacy groups influence food policy and regulation in the U.S. You will also learn how global organizations and U.S. agencies work together to ensure that imported foods meet safety and labeling standards. By the end of this module, you'll be able to explain how both domestic and international efforts help shape the food supply available to U.S. consumers.

What's included

9 videos5 readings2 assignments1 discussion prompt

9 videos Total 25 minutes

Course Introduction 2 minutes
Meet Your Instructor | Dr. Jessica Hartke 1 minute
Module 1 Overview 2 minutes
Instructor Bio | Robbie Burns, PhD 1 minute
Advocacy and Food Regulations in the U.S. 5 minutes
Influence of Global Policy Groups on U.S. Food Regulations 4 minutes
Introduction to U.S. Agencies that Regulate U.S. Food Imports 4 minutes
How Does the U.S. Ensure the Safety of Imported Foods? FSMA and FSVP: What Does It Mean? 4 minutes
Module 1 Summary 2 minutes

5 readings Total 90 minutes

Syllabus 10 minutes
Learn More About Flexible Pathways 10 minutes
Updating Your Profile 10 minutes
Food Safety Modernization Act (FSMA) 30 minutes
FDA Strategy for the Safety of Imported Food 30 minutes

2 assignments Total 60 minutes

Module 1 Quiz 30 minutes
Orientation Quiz 30 minutes

1 discussion prompt Total 10 minutes

Getting to Know Your Classmates 10 minutes

In this module, you will learn how the U.S. regulates special categories of foods, including medical foods, infant formula, and dietary supplements. These products serve unique roles in health and nutrition and are subject to specific rules for safety, labeling, and ingredient use. You’ll explore how key laws like the Infant Formula Act and the Dietary Supplement Health and Education Act (DSHEA) define these categories and guide FDA oversight. By the end of this module, you’ll be able to identify how each of these special foods is regulated and what makes them different from conventional foods.

What's included

8 videos2 readings1 assignment

8 videos Total 21 minutes

Module 2 Overview 2 minutes
Instructor Bio | Nate Matusheski, PhD 1 minute
Triggering Events: What Led to the Regulation of "Special Foods" in the U.S.? 3 minutes
Instructor Bio | Deshanie Rai, PhD, FACN 2 minutes
Medical Foods: What Are They and How Are They Regulated? 6 minutes
Infant Formula: Regulation of Products for Sole Source Nutrition 4 minutes
Yes, Dietary Supplements are Regulated by the FDA 3 minutes
Module 2 Summary 1 minute

2 readings Total 60 minutes

Infant Formula 30 minutes
FDA 101: Dietary Supplements 30 minutes

1 assignment Total 30 minutes

Module 2 Quiz 30 minutes

In this module, you will learn how food regulations are enforced in the U.S. through the work of key federal agencies like the FDA and USDA. You’ll explore the difference between labeling and advertising and understand why each is regulated differently. The module also covers enforcement tools such as recalls, withdrawals, safety alerts, and FDA warning letters. By the end of this module, you’ll be able to explain how enforcement actions help protect consumers and ensure companies follow food laws.

What's included

10 videos2 readings1 assignment

10 videos Total 19 minutes

Module 3 Overview 2 minutes
What Are the Main Enforcement Agencies? 3 minutes
Understanding the Difference Between Labeling and Advertising 2 minutes
How Are Advertising Regulations Enforced? 3 minutes
Case Study of Advertising Regulations Enforcement 2 minutes
Instructor Bio | Karleigh Bacon, PhD 1 minute
What Is the Difference Between a Recall, a Withdrawal, and a Safety Alert? 2 minutes
What is an FDA Warning Letter? 1 minute
How Can I Find Out About Recalls, Withdrawals, Safety Alerts, and Warning Letters? 1 minute
Module 3 Summary 1 minute

2 readings Total 60 minutes

Food Recalls: What You Need to Know 30 minutes
About Warning and Close-Out Letters 30 minutes

1 assignment Total 30 minutes

Module 3 Quiz 30 minutes

In this module, you will explore how food regulations are enforced through real-world examples and learn how consumers can take legal action when regulations fall short. You’ll examine case studies involving mislabeled or unsafe products and understand the role of private litigation and class-action lawsuits in protecting consumer rights. At the conclusion of this module, you will be ready to complete the final assessment for the course and earn your Coursera certificate!

What's included

7 videos6 readings2 assignments

7 videos Total 19 minutes

Module 4 Overview 2 minutes
Instructor Bio | Professor Bryan Endres 1 minute
Why Are Food Regulations Important? 3 minutes
How U.S. Food Regulations Are Enforced: Real-World Examples 5 minutes
Beyond Regulation: Consumer Initiatives 5 minutes
Module 4 Summary 1 minute
Course Wrap-up 2 minutes

6 readings Total 120 minutes

9th Circ. Clarifies What Consumers Must Read On Labels 30 minutes
Class Action Lawsuits: An Introduction 30 minutes
Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations 30 minutes
Congratulations! 10 minutes
Stack Your Course Certificate Toward Graduate Coursework 10 minutes
Getting Your Course Certificate 10 minutes