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
9.8 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
11.2 The Statutory Definition 244
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
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
12.7 Labeling 293
12.8 The Right To Know 301
12.9 Genetic Contamination 311
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
21.4 International Trade Disputes 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
