Food Regulation Handbook from C.H.I.P.S.

Food Regulation
Law, Science, Policy, and Practice
by Neal D. Fortin, JD

Food Regulation: Law, Science, Policy, and Practice provides an in-depth guide to the federal statutes, regulations, and regulatory agencies involved in food regulation.

After an introduction to U. S. food and drug regulation, it covers current food regulations, inspection and enforcement, international law, the Internet, and ethics.

Throughout the book, the focus in on the federal law, but state and international regulation is also addressed. All of the key topics in food regulation are covered:

  • Introduction to food regulation and food definition
  • Regulation of labeling and claims
  • Food safety regulation
  • Specialized food regulation
  • Inspection and enforcement
  • International food law and ethics


Introductory Chapters

  1. Introduction to Food Regulation in the United States. A short history of food and drug regulation in the United States. An overview of government agency jurisdictions and authority over food
  2. What is a Food? Introduction to the Food, Drug, and Cosmetic Act (FD&C Act). What makes an article a food, a drug, a device, or a product outside the scope of the Act?

Regulation of Labeling and Claims

  1. Labeling and Misbranding. The basic requirements of food labeling, misbranding, legal authorities, labeling terminology, affirmative label requirements, prohibited representations, deceptive packaging, warning statements, allergens
  2. Nutritional Claims and Health Claims. The requirements for nutritional labeling and health claims on food plus an overview of the regulation of advertising. The Nutritional Labeling and Education Act (NLEA)
  3. Esthetic and Economic Adulteration. Key definitions, adulteration, food (unfit for food, packaging materials), esthetic adulteration, defect action levels, GMPs, standards of identity, and economic adulteration

Food Safety Regulation

  1. Food Safety. Poisonous or deleterious substances, pesticides, the Delaney Clause, the Food Quality Protection Act (FQPA), foodborne illnesses, HACCP, and tampering law. Current issues in foodborne illness, such as mad cow disease
  2. Food Additives, Color Additives, and Irradiation. The regulation of food additives, color additives, and irradiation

Specialized Food Regulation

  1. Dietary Supplements. The regulation of this special class of food, which is regulated neither as conventional food nor as food additives. Dietary Supplement Health & Education Act of 1994 (DSHEA), ephedrine; "street drug alternatives," and dietary supplement ads on the Internet
  2. Biotechnology and Genetically Engineered Organisms. The regulation biotechnology, genetically modified foods, and cloning
  3. Food Terrorism. A look at food security and the federal government’s new bioterrorism powers
  4. Importation and Exportation. The regulation of U.S. food imports and exports, including harmonization of domestic and foreign trade restrictions, and agency enforcement authority

Inspection and Enforcement

  1. Federal Enforcement. An overview of the enforcement tools of the FDA and USDA-FSIS with a focus on seizures, recalls, and penalties
  2. Inspections. An overview of the FDA and state inspections, and Fourth Amendment, and practical issues
  3. State Laws and Their Relationship to Federal Laws. A discussion of state enforcement, the state food and drug laws, and federal pre-emption
  4. Private Actions. Private causes of actions and their regulatory role

General Chapters

  1. International Food Law. The implications of international trade, international treaties, and the Codex Alimentarius
  2. Ethics. Discussion of ethical issues in food law and in government regulation

Table of Abbreviations
Table of Cases

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Food Regulation
Law, Science, Policy, and Practice
by Neal D. Fortin, JD

2009 • 677 pages • $124.00 + shipping

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