Table of Contents
About the Authors xi
Preface xvii
Acknowledgments xxi
Foreword xxiii
Chapter 1 Regulation of Food Formulation, Manufacturing, Labeling, and Advertising: A Primer, Farm to Fork Ricardo Carvajal 1
Introduction 1
Federal Agencies That Regulate Food 3
FDA 3
U.S. Department of Agriculture 4
Alcohol and Tobacco Tax and Trade Bureau 4
U.S. Environmental Protection Agency 5
Federal Trade Commission 5
Food Formulation 5
Food Additive Approval 6
"Generally Recognized as Safe" Exception 6
Dietary Supplements 9
Food Manufacture: Ensuring Safety 10
Labeling and Advertising 18
Mandatory Labeling Requirements 19
Voluntary Labeling Requirements 19
Concluding Thoughts 22
Chapter 2 Food Litigation: An Emerging Field Tommy Tobin 23
Food and Civil Litigation 23
Rise of Food Litigation 24
Types of Cases 27
Conclusion 35
Chapter 3 Reasoning with the Reasonable Consumer Standard in Food Litigation Charles C. Sipos Carrie Akinaka Tommy Tobin 37
Introduction 37
Doctrinal Origins 38
Rise of Food Litigation 40
What Is the Reasonable Consumer Defense and When Does It Come into Play? 42
Ongoing Debates in Reasonable Consumer Jurisprudence 45
The Reasonable Consumer Standard Is an Objective Test 46
Just How Sophisticated is the Reasonable Consumer? 46
Courts Rely on a Number of Factors in Determining Reasonableness 47
Conclusion 52
Chapter 4 Food Safety James F. Neale Benjamin P. Abel 53
Introduction to the Regulatory Framework 53
The Major Food Regulators at the Federal Level 54
USDA 54
FDA 57
Inspections 60
Prohibited Acts 62
Allergens 65
Preventive Controls and Countermeasures 66
Chapter 5 Food Recalls James F. Neale Benjamin P. Abel 73
Governmental Agencies Responsible for Food Product Recalls 73
Regulators Governing Food Product Recalls 74
Recall Types 75
Company-Initiated Recalls 75
Government-Initiated Recalls 76
Manufacturer's Failure or Refusal to Initiate Voluntary Recall 76
Recall Classifications 78
Class I Recalls 78
Class II Recalls 79
Class III Recalls 79
Product Withdrawals 79
Recall Plan and Team 80
Conducting a Recall 82
The Recall's Scope 84
Recall Communications 85
Status Reports 86
Regulator Site Inspection Contemporaneous with Recall 86
Admissibility of Recall in Subsequent Litigation 89
Effectiveness Checks 91
Termination 92
Chapter 6 Federal Nutrition Programs Roger R. Szemraj Stewart Fried 93
Overview 93
SNAP 93
Child Nutrition Programs 97
How Children Qualify for Free and Reduced-Price Meals 99
What Meals May Be Served 101
Buy American Requirement 102
State Administrative Expenses 102
COVID-19 Activities 102
Summer Food Service Program 103
CACFP 103
Eligibility 103
Reimbursement Rates 104
Special Supplemental Nutrition Program for Women, Infants, and Children 105
The Food Package 106
Where WIC Benefits Can Be Redeemed 106
The Emergency Food Assistance Program 106
What Foods Are Available 107
What Operating Assistance Is Available 107
Who Is an Eligible Recipient? 107
COVID-19 Response 107
Commodity Supplemental Food Program 108
USDA Foods 108
Dietary Guidelines for Americans 109
Process 110
Importance of the Guidelines to Nutrition Programs 110
Opportunities for Involvement 110
Chapter 7 Practicing International Food Law: Considerations for Counsel Charles F. Woodhouse 113
Is There Such a Thing as "International Food Law"? 113
Getting Started in International Food Law: Education 115
The Truly "International" Food Regulatory System 116
The "Work" of a U.S. "International Food Lawyer" 117
How to Train to Become an "International" Food Attorney 119
Focus Areas 120
Discussion of Packaging and Food Contact Materials 120
Allergen Labeling 121
Pesticide and Biocide Residual Levels 123
Food Labeling-International Trade 123
Food Safety Documentation 123
Recalls and Recall Management 123
Specific Issues in European Union Food Law Research 124
Conclusion 125
Chapter 8 Blockchain in the Food Industry Darin Detwiler 127
Introduction 127
A "New Era of Smarter Food Safety" 128
Food Safety History 129
The "Five Pillars" of the Food System 131
Food Safety 131
Food Quality 132
Food Authenticity 132
Food Defense 133
Food Security 134
Blockchain and the Greater Technology Ecosystem 135
The Food Technology Ecosystem 135
Blockchain 137
Conclusion 140
Chapter 9 Food Law and the Pandemic: Securing the Food System Lawrence Reichman Tommy Tobin 143
COVID-19 from the Federal Agency Perspective 143
Mitigating Disruptions to the Food Supply Chain 147
Food Work Environments 150
Addressing Food Insecurity 155
What Is Ahead 157
Chapter 10 Intellectual Property Anne W. Glazer 159
Introduction 159
Patent 161
The Patent Definition 161
On-Sale Bar 162
Utility Patents 163
Design Patents 163
The Effect of a Patent 164
Patent Infringement Remedies 164
Trade Secret 164
Keeping Trade Secrets Secret 165
The Trade Secret Definition 165
Misappropriation 167
Remedies 167
NDAs 168
Employees Coming and Going 169
Trademark 170
A Word about Domain Names 171
State Law, Federal Law 171
The Trademark Definition 173
Trademark Spectrum of Distinctiveness 174
Trademark Selection and Clearance 176
The Likelihood of Confusion 176
Trademark Registration 178
Trademark Infringement Remedies 179
Copyright 179
The Copyright Definition 180
Copyright Registration 180
Copyright Ownership 181
Copyright Fair Use 182
Copyright infringement and Remedies 182
Exhaustion and First-Sale Doctrines 183
Table of Cases 185
Index 191