Table of Contents

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

10.4 Prior Sanctioned Substances 220

10.5 GRAS (Generally Recognized As Safe) 220

10.6 Indirect Additives 224

10.7 Some Controversial Food Additives and Substances 228

10.8 Color Additives 231

10.9 Food Irradiation 236

Part IV Specialized Food Regulation 241

11 Dietary Supplements 243

11.1 Introduction 243

11.3 Approval & Safety 257

11.4 Enforcement 260

11.5 Good Manufacturing Practices (GMPS) 261

11.6 Labels 262

11.7 Health Claims 264

11.8 Problem Supplements 270

11.9 Street Drug Alternatives 272

12 Genetic Engineering and Other Biotechnology 277

Part A. Regulation of production 277

12.1 Introduction 277

12.2 Background 278

12.3 FDA’S Regulatory Review of New Plant Varieties 283

12.4 USDA APHIS Role 286

12.5 EPAS Role—The Safety of Pesticides In Bioengineered Plants 289

12.6 Regulation of Genetically Engineered Animals 291

Part B. Labeling 293

12.7 Labeling 293

Part C. Disputed cases 301

12.8 The Right to Know 301

12.9 Genetic Contamination 311

Part D. Other biotechnology 312

12.10 Nanotechnology 312

12.11 in Vitro Meat 313

12.12 Cloning 313

13 Food Defense 317

13.1 Introduction 317

13.2 The Anti-Tampering Act 318

13.3 Food Terrorism 318

13.4 The Bioterrorism Act and FDA’s New Powers 321

13.5 FSMA Food Defense Mandates 322

13.6 Conclusions 323

14 Importation and Exportation 325

14.1 Introduction 325

14.2 The Major Federal Agencies 326

14.3 The FDA Import Process 326

14.4 The Food Safety Modernization Act—A New Paradigm For Importers 329

14.5 USDA’s Import System 331

14.6 Other Import Controls 332

14.7 Challenges Facing Import Regulation 334

14.8 Export 334

15 Animal Food 339

15.1 Introduction 339

15.2 Animal Feed Regulation 339

15.3 Drugs For Animals Raised For Food 344

15.4 BSE (Mad Cow Disease) 357

Part V Inspection and Enforcement 359

16 Federal Enforcement 361

16.1 Introduction 361

16.2 Statutory Authorities 362

16.3 Enforcement Jurisdiction 363

16.4 Administrative Enforcement 366

16.5 FDA Civil Court Actions 373

16.6 Criminal Actions 377

16.7 Other Remedies and Concerns 382

17 Inspections 385

17.1 Introduction 385

17.2 Constitutional Limits 385

17.3 Statutory Power For Inspections 386

17.4 Inspection Frequency 387

17.5 The Warrantless Inspection Exception 388

17.6 Consent to Inspect 391

17.7 Scope of FDA Inspection Authority 392

17.8 Refusal to Permit Access 393

17.9 Planning For The Inspection 401

17.10 FSIS Inspection Authority 404

18 State Laws and Their Relationship to Federal Laws 409

18.1 Introduction 409

18.2 State Inspection and Enforcement Powers 412

18.3 Federal Preemption of States 412

18.4 Federal Laws Delegating Authority to The States 422

Part VI General Chapters 423

19 Private Actions 425

19.1 Introduction 425

19.2 Competitor Lawsuits 425

19.3 Products Liability 431

19.4 The False Claims Act 444

19.5 No Private Cause of Action Under The Fd&C Act 445

20 Administrative Law and Food Regulation 447

20.1 Introduction 447

20.2 Rulemaking—The Power to Legislate 447

20.3 The Power to Adjudicate 461

20.4 Executive Control of The Agencies 461

20.5 Administrative Discretion 461

20.6 Public Access to Agency Information 468

20.7 Environmental Assessment 469

21 International Food Law 481

21.1 Introduction 481

21.2 International Food Standards 481

21.3 Foreign Regulatory Systems 485

22 Ethics 491

22.1 Professionalism and Ethics 491

22.2 Ethical Practice Pointers 492

22.3 Attorney Rules of Ethics 493

22.4 Criminal Statutes Related to Ethics 495

22.5 Resources 495

Glossary of Abbreviations and Specialized Terms 497

Table of Cases 505

Index 507

About the Author

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.