Food Regulation – Law, Science, Policy, and Practice 2e

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.

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