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.