Description
Updated edition of a practical text on food regulatory law
Featuring case studies, expert insights, and compliance strategies, Food Regulation provides an in-depth overview of food regulation, from federal and state laws, international regulations, and the latest developments in biotechnology and traceability, all the way to ethics and private actions. The book includes practical scenarios, discussion questions, and problem exercises to enhance reader understanding.
Making complex statutes and regulations accessible to non-lawyers, this revised edition features new rules for labeling bioengineered food, plant-based meat and dairy replacements, CBD in food, cell-cultured meat, and gene-edited food, as well as new health claims, FDA inspection protocols, and food traceability rules.
Written by a practicing attorney and professor, Food Regulation explores topics including:
- Agency procedural regulation, covering the Administrative Procedure Act, rulemaking, agency adjudication, judicial review, the Federal Advisory Committee Act (FACA), and the Freedom of Information Act (FOIA)
- Food labeling, covering legal authorities, labeling terminology, affirmative label requirements, prohibited representations and misbranded food, deceptive packaging, and warning statements
- Credence claims and conditional labeling, covering country of origin labeling, organic foods, natural claims, religious certification marks and symbols, and geographic indications
- Dietary supplements, covering approval and safety, enforcement, good manufacturing practices (GMPs), labels, health claims, and problem supplements such as ephedra
- Importation and exportation, covering programs, authoritative bodies, and provisions
Containing the most up-to-date information on the subject, the new edition of Food Regulation is a valuable resource for anyone involved in food regulation, from students to corporate counsels in fields including law, food science, and public health.
Table of Contents
Foreword xxiii
About the Author xxv
Preface xxvii
Acknowledgments xxxi
Part I Introductory Chapters 1
1 Introduction to Food Regulation in the United States 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 18
1.7 Informational Resources 20
2 What is Food? 23
2.1 Introduction to the Food, Drug, and Cosmetic Act 23
2.2 What Makes an Article a Food or a Drug? 25
2.3 The Central Role of Intended Use 27
2.4 Other Considerations 27
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 54
3.7 Warning Statements 56
3.8 Allergens 57
3.9 Alcohol Beverages 61
3.10 Usda Fsis 63
4 Nutritional Labeling and Nutrient Level Claims 65
4.1 Introduction 65
4.2 The Nutrition Labeling and Education ACT 66
4.3 The Nutrition Facts Panel 66
4.4 Trans Fats 72
4.5 NLEA and Restaurants 73
4.6 Menu and Vending Machine Labeling Requirements 74
4.7 Products Regulated by USDA- FSIS 76
4.8 Nutrient Content Claims (Nutrient Level Descriptors) 77
4.9 FDA's Fortification Policy 83
4.10 McFat Litigation 84
5 Health Claims 89
5.1 Background 89
5.2 Definitions 90
5.3 Health- Related Claims That are Not Regulated as Health Claims 91
5.4 Approved Health Claims (or NLEA Claims) 92
5.5 Authoritative Statements—FDA Modernization Act 95
5.6 Qualified Claims 96
5.7 Substantiation of Claims 108
5.8 Medical Foods 114
5.9 Therapeutic and Related Disease Claims 115
6 Credence Claims and Conditional Labeling 117
6.1 Introduction 117
6.2 Country of Origin Labeling 117
6.3 Organic Foods 119
6.4 Natural Claims 120
6.5 Religious Certification Marks and Symbols 122
6.6 Geographic Indications 123
6.7 USDA Process Verified 124
6.8 Conditional Claims and Marks 125
7 Overview of the Regulation of Advertising 127
7.1 Introduction 127
7.2 Federal Trade Commission 127
7.3 Other Regulatory Considerations With Advertising 136
7.4 Competitor Challenges 136
Part III Regulation of the Composition of Food 139
8 Economic and Esthetic Adulteration 141
8.1 Introduction 141
8.2 Food Standards: Regulation of Food Identity and Quality 142
8.3 Economic Adulteration 156
8.4 Sanitation and Esthetic Adulteration 158
9 Regulation of Unintentional Poisonous or Deleterious Substances in Food 175
9.1 Introduction 175
9.2 Pesticide Residues 183
9.3 Environmental Contaminants 186
9.4 Science-Based, Risk- Control Plans 189
9.5 FSMA Hazard Analysis and Preventive Control (HARPC) Plans 200
9.6 Produce Safety Standards 202
9.7 FSMA Performance Standards 205
9.8 The Food Traceability Rule 205
9.9 Specific Food Process Control Rules 206
9.10 Reportable Food Registry 209
10 Regulation of the Safety of Intentional Components of Food: Food Additives, Food Colorings, and Irradiation 213
10.1 Introduction 213
10.2 The History of the Food Additives Amendment of 1958 213
10.3 Background 214
10.4 Food Additives 216
10.5 Prior-Sanctioned Substances 231
10.6 GRAS (Generally Recognized as Safe) 231
10.7 Indirect Additives 237
10.8 Some Controversial Food Additives and Substances 242
10.9 Color Additives 244
10.10 Food Irradiation 249
Part IV Specialized Food Regulation 253
11 Dietary Supplements 255
11.1 Introduction 255
11.2 The Statutory Definition 256
11.3 Approval and Safety 267
11.4 Enforcement 272
11.5 Good Manufacturing Practices (GMPS) 273
11.6 Labels 274
11.7 Health Claims 276
11.8 Advertising 282
11.9 Problem Supplements 283
11.10 Street Drug Alternatives 285
12 Genetic Engineering and Other Biotechnology 291
12.1 Introduction 291
12.2 Background 292
12.3 FDA's Regulatory Review of New Plant Varieties 293
12.4 USDA APHIS' Role 297
12.5 EPA'S Role—The Safety of Pesticides in Bioengineered Plants 301
12.6 Regulation of Genetically Engineered Animals 303
12.7 The Adequacy of Regulation of GMO Safety 306
12.8 Labeling 309
12.9 GMO Free Labeling 318
12.10 The Right To Know 319
12.11 Genetic Contamination 328
12.12 Nanotechnology 329
12.13 In Vitro Meat 330
12.14 Cloning 331
13 Food Defense 335
13.1 Introduction 335
13.2 The Anti- Tampering Act 336
13.3 Food Terrorism 336
13.4 The Bioterrorism Act and FDA's New Powers 339
13.5 FSMA Food Defense Mandates 340
13.6 Conclusions 341
14 Importation and Exportation 343
14.1 Introduction 343
14.2 The Major Federal Agencies 343
14.3 The FDA Import Process 344
14.4 The Food Safety Modernization Act—A New Paradigm for Importers 347
14.5 USDA's Import System 350
14.6 Other Import Controls 352
14.7 Challenges Facing Import Regulation 353
14.8 Export 354
15 Animal Food 357
15.1 Introduction 357
15.2 Animal Feed Regulation 357
15.3 Drugs For Animals Raised for Food 362
15.4 BSE (Mad Cow Disease) 375
Part V Inspection and Enforcement 377
16 Inspections 379
16.1 Introduction 379
16.2 Food Facility Registration 379
16.3 Constitutional Limits 380
16.4 Statutory Power for Inspections 383
16.5 Inspection Frequency 383
16.6 The Warrantless Inspection Exception 385
16.7 Consent to Inspect 387
16.8 Scope of FDA Inspection Authority 388
16.9 Refusal to Permit Access 391
16.10 Planning for the Inspection 398
16.11 FSIS Inspection Authority 401
17 Federal Enforcement 405
17.1 Introduction 405
17.2 Statutory Authorities 407
17.3 Enforcement Jurisdiction 407
17.4 Administrative Actions 410
17.5 FDA Civil Court Actions 418
17.6 Criminal Prosecution 424
17.7 Other Remedies and Concerns 429
18 State Laws and Their Relationship to Federal Laws 433
18.1 Introduction 433
18.2 State Inspection and Enforcement Powers 435
18.3 Federal Pre- Emption of States 436
18.4 Federal Laws Delegating Authority to the States 445
18.4.1 Prescription Drug Marketing Act of 1987 445
18.4.2 Nutritional Labeling and Education Act of 1990 (NLEA) 445
19 Private Actions 447
19.1 Introduction 447
19.2 Competitor Lawsuits 447
19.3 Products Liability 453
19.4 The False Claims Act 466
19.5 No Private Cause of Action Under the FD&C Act 466
Part VI General Chapters 469
20 Administrative Law and Food Regulation 471
20.1 Introduction 471
20.2 Rulemaking—The Power to Legislate 471
20.3 The Power to Adjudicate 484
20.4 Executive Control of the Agencies 485
20.5 Administrative Discretion 485
20.6 Judicial Deference to Agency Interpretations of the Law 491
20.7 Public Access to Agency Information 493
20.8 Environmental Assessment 494
21 International Food Law 505
21.1 Introduction 505
21.2 International Food Standards 505
21.3 Foreign Regulatory Systems 510
21.4 International Trade Disputes 511
22 Ethics 517
22.1 Professionalism and Ethics 517
22.2 Ethical Practice Pointers 518
22.3 Attorney Rules of Ethics 519
22.4 Criminal Statutes Related to Ethics 521
22.5 Resources 521
Glossary of Abbreviations and Specialized Terms 523
Table of Cases 531
Index 535
