United States Food Laws and Regulations

[FSC 811, Section 730]


WELCOME to the preview page for Food Regulation in the United States, FSC 811, Section 730.  This is a 3 credits, Internet-based, graduate or undergraduate level course offered by Michigan State University designed for anyone who must understand the legal and regulatory complexities of the regulation of food products in the United States including issues such as food and food safety regulation, regulatory compliance, HACCP, the regulation of genetic modifications, food additive regulation, food labeling, dietary supplements, the protection of the food supply, and the FDA Food Safety Modernization Act.
The Food and Drug Administration and the U.S. Department of Agriculture have primary jurisdiction over the regulation of meat and food products in the United States and the primary responsibility for the safety of these products.  That jurisdiction and responsibility is shared by up to nine (9) different federal agencies depending upon the source and nature of the product, the method of shipment, advertising, etc.  In this course, we will examine this fragmented system of food regulation in the United States generally and specifically with regard to issues of contemporary concern, such as food security, genetic modifications, dietary supplements, and food labeling. 

This course is one in our series of region-specific, Internet-based, food law courses that comprise our International Food Law Distance Education Certificate Program, sponsored by the Department of Food Science & Human Nutrition, College of Agriculture & Natural Resources, Online Master of Science in Food Safety Program, the Institute for Food Laws & Regulations at Michigan State University and the Michigan State University College of Law.

The lead instructor for this course is Neal D. Fortin, Director and Assistant Professor of the Institute for Food Laws & Regulations at Michigan State University.  The guest lecturers include attorneys, regulators and other food regulation experts from around the nation.  There is also a Course Manager, .(JavaScript must be enabled to view this email address), who will be your primary contact and who will be available to help with any and all concerns regarding this course.

Course Objectives:

The objectives of this course are to:

  • Familiarize you with the history and development of the laws and regulations which apply to foods and food products in the United States from production and distribution to retail sale.
  • Examine current issues in food regulation today, including food safety regulation and food security.
  • Familiarize you with the large variety of food law related resources available to you over the Internet.
  • Familiarize you with Internet navigation information on how to find specific regulations and to conduct food law research over the Internet using Lexis and other online legal databases.
  • Examine the major US food legislation, including the Food, Drug, and Cosmetics Act (FDCA), Food Additives Amendment, Dietary Supplement Health and Education Act (DSHEA), and the Food Safety Modernization Act (FSMA).
  • Familiarize you with the process of food and color additive approval in the US as well as nutritional labeling and health claims.
  • Enable you to recognize the critical role laws and regulation plays in protecting food safety.
  • Explore the intersection of food safety, science, and law. 

Course Design:

The course is taught in a series of sections or “Modules.”  Each module lasts one week and represents a specific issue or topic in US food regulation.  Each week a new module is uploaded.  Students have ten days to read the substantive materials, review the hyperlinked resources and complete the assignment.  Once uploaded, the Modules remain online throughout the duration of the course so you can always refer to it in case you miss a week or need to reference a particular topic.

Here is a sample Index of the Modules in this course.  The list of topics covered in any one semester is subject to change based upon interest and availability of instructors.

Module One

Welcome, Introdutions, Getting Started, Course Overview

Course basics, course navigation, student-instructor contacts, grading, attendance, and assignment submission.  Overview of the course. 

Module Two

An Introduction to Food Regulation in the United States

A short history of food regulation in the U.S., an introduction to the U.S. legal system, and an overview of government agency jurisdictions and authority.

Module Three


The basic requirements for food labeling: terminology, misbranding, identity, ingredients, allergens, warning statements, and packaging. 

Module Four

Nutritional Labeling and Health Claims

The requirements for nutritional labeling, nutrient level claims, and health claims on food plus an overview of the regulation of advertising. 

Module Five

Esthetic and Economic Adulteration

Key definitions, esthetic adulteration and sanitation, defect action levels, standards of identity, and economic adulteration. 

Module Six

The Regulation of Food Safety

Poisonous or deleterious substances, added and non-added substances, tolerances for necessary and unavoidable poisonous and deleterious substances.  Pesticide residues, risk assessment, environmental contaminants, tampering, carcinogens, the Delaney Clause, HACCP, and foodborne illness. 

Module Seven

Risk Control Plans and Produce Safety Standards - Provisions of the Food Safety Modernization Act (FSMA)


Module Eight

Food Additives and Irradiation

The regulation of the food additives and color additives, which includes regulation of irradiation of food. 

Module Nine

Genetically Engineered Foods

The policy, science, and regulation of foods produced through recombinant DNA techniques.

Module Ten

Dietary Supplements

An overview of the regulation of dietary supplements, which are regulated as a special subcategory of foods. 

Module Eleven

Module Twelve



Food Defense and Bioterrorism

Importation and Exportation of Food

These modules discuss the new emphasis on bioterrorism and food defense plus the regulation of U.S. food imports and exports, and agency enforcement authority, including the new import provisions of the Food Safety Modernization Act (FSMA), such as the foreign supplier verification program, the voluntary qualified importer program, mandatory import certification authority, and third-party auditor accreditation. 

Module Thirteen and
Module Fourteen

Federal Inspections and Enforcement

FDA and USDA-FSIS inspection authority, limits on government inspections, and planning for the inspection.  An overview of the enforcement tools of the FDA and USDA-FSIS with a focus on inspection powers, seizures, recalls, injunctions, and criminal penalties. 

Module Fifteen


Private Actions; State Enforcement
William Marler, Managing Partner in the law firm of Marler Clark

An overview of the civil liability for defective food products

State Enforcement and the Uniformity of Food Laws
Al Hafner & Neal D. Fortin

 A discussion of state government seizure power, injunctions, criminal liability, state enforcement, and private enforcement.

Final Examination

Course Evaluation

Course Finale
Neal Fortin and Mary Anne Verleger

Final Examination.  Final thoughts, course wrap up and student-instructor evaluations.


Your assignments will be due the following week and can be submitted by using the Course Assignment Drop Box file upload feature, course message, or as an email attachment.  Grades are posted electronically and are sent to you by email.  Class participation is mandatory and is accomplished by means of synchronous an asynchronous Internet communication technology, such as the written Discussion Forums.


You simply go online each week whenever it is convenient for you and a new module will be waiting.  Read the materials, explore the hyperlinked resources, complete the assignment, upload your assignment into the course assignment drop box, and with the click of a mouse, you are done for the week.

If you are looking for a convenient way to continue your education and are interested in or need information regarding the regulation of food and food products in the United States, this is the course for you.

Just click here [How to Enroll] to get started.  You will find a sample copy of the Application and instructions on how to enroll directly online.  Transcript submission is not required through the Lifelong Education program.  All materials will be provided through the course and there are no books required to be purchased.


How much time does this course take?  It should take an average of nine to twelve hours per week to complete a module including reading the substantive materials, reviewing the hyperlinked resources, and completing the assignment.

What if I’m called out of town for a week?  We understand the demands on working students.  The Module materials stay online for the duration of the course so you can always go back and complete a missed assignment.  Also, time extensions will be liberally granted; and if you give us a bit of notice, the course materials can be provided ahead of time by fax or e-mail attachment. 

How many courses must I complete to earn a certificate?  You must successfully complete twelve (12) credits by any combination of taking our three (3) credits full-semester courses or one (1) credit short courses and you will earn an International Food Laws Distance Education Certificate from Michigan State University, which evidences that you have successfully completed our program.  (We recommend taking only one course per semester if you are working.)

How long are the assignments?  Typically, not more than 1-3 pages but some will be shorter and some may be in the form of a case study or research assignment.

This course is offered fall and spring semesters.
For more information, see the semester course schedule