Food Regulation

Featuring case studies and discussion questions, this textbook - with revisions addressing significant changes to US food law - offers accessible coverage appropriate to a wide audience of students and professionals.

• Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation

• Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s

• Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense

• Features case studies and discussion questions about application of law, policy questions, and emerging issues

Auteur
Neal Fortin, JD, is an attorney concentrating in food and drug law, food safety, food labeling, ingredient evaluation, biotechnology, and advertising. He is a Professor at Michigan State University, where he teaches courses in Food Regulation in the United States, Codex Alimentarius, and International Food Law. He is also an Adjunct Professor of Law at the Michigan State University College of Law, where he teaches Food and Drug Law. He is Director of the Institute for Food Laws and Regulations at Michigan State University (www.IFLR.msu.edu) and Director of the Masters' Program in Global Food Law at the Michigan State University College of Law.

Résumé

Featuring case studies and discussion questions, this textbook with revisions addressing significant changes to US food law offers accessible coverage appropriate to a wide audience of students and professionals.

• Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation
• Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s
• Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense
• Features case studies and discussion questions about application of law, policy questions, and emerging issues

Contenu

About The Author xxiii

Foreword xxv

Preface xxvii

Acknowledgments xxxi

Part I Introductory Chapters 1

1 Introduction to Food Regulation 3

1.1 Introduction 3

1.2 A Short History of Food Regulation in the United States 3

1.3 The U.S. Legal System 6

1.4 Agency Procedural Regulation 9

1.5 Agency Jurisdiction 14

1.6 Major Federal Laws 17

1.7 Informational Resources 19

2 What is Food? 21

2.1 Introduction to the Food, Drug, and Cosmetic Act 21

2.2 What Makes an Article a Food or a Drug? 23

2.3 The Central Role of Intended Use 25

2.4 Other Considerations 26

Part II Regulation of Labeling, Advertising, and Claims 29

3 Food Labeling 31

3.1 Introduction 31

3.2 Legal Authorities 32

3.3 Labeling Terminology 32

3.4 Affirmative Label Requirements 36

3.5 Misbranded Food: Prohibited Representations 45

3.6 Deceptive Packaging 52

3.7 Warning Statements 53

3.8 Allergens 55

3.9 Alcoholic Beverages 56

3.10 USDA FSIS 57

4 Nutritional Labeling and Nutrient Level claims 61

4.1 Introduction 61

4.2 The Nutrition Labeling and Education Act (NLEA) 65

4.3 The Nutrition Facts Panel 67

4.4 Trans Fats 70

4.5 NLEA and Restaurants 71

4.6 Menu and Vending Machine Labeling Requirements 73

4.7 Nutrient Content Claims (Nutrient Level Descriptors) 74

5 Health Claims 81

5.1 Background 81

5.2 Definitions 82

5.3 Health-Related Claims That Are Not Health Claims 83

5.4 Preapproved Health Claims (NLEA) 84

5.5 Authoritative Statements: FDA Modernization Act 87

5.6 Qualified Claims 88

5.7 Substantiation of Claims 99

5.8 Therapeutic and Related Disease Claims 105

6 Credence Claims and Conditional Labeling 107

6.1 Introduction 107

6.2 Country of Origin Labeling 107

6.3 Organic Foods 109

6.4 Natural Claims 110

6.5 Religious Certification Marks and Symbols 112

6.6 Geographic Indications 113

6.7 USDA Process Verified 114

6.8 Conditional Claims and Marks 114

7 Advertising and Other Regulation of Labeling 117

7.1 Introduction 117

7.2 Federal Trade Commission 117

7.3 Other Regulatory Considerations with Advertising 124

7.4 Competitor Challenges 125

Part III Regulation of the Composition of Food 127

8 Economic and Aesthetic Adulteration 129

8.1 Introduction 129

8.2 Food Standards: Regulation of Food Identity and Quality 130

8.3 Economic Adulteration 148

8.4 Sanitation and Aesthetic Adulteration 150

9 Regulation of Unintentional Poisonous or Deleterious Substances in Food 165

9.1 Introduction 165

9.2 Pesticide Residues 173

9.3 Environmental Contaminants 175

9.4 Specific Food Safety Rules 178

9.5 Science-Based, Risk-Control Plans 180

9.6 FSMA Hazard Analysis and Preventive Control (HARPC) Plans 188

9.7 Produce Safety Standards 189

9.7.1 Summary of the Produce Rule 190

9.8 Additional Food Safety Performance Standards 191

9.9 Reportable Food Registry 196

10 Regulation of the Safety of Intentional Components of Food: Food Additives, Food Colorings, and Irradiation 201

10.1 Introduction 201

10.2 Background 201

10.3 Food Additives 205 &...