FOOD REGULATION FOOD REGULATION LAW, SCIENCE, POLICY, AND PRACTICE Neal D. Fortin, J.D. Professor and Director, Institute for Food Law & Regulations, Michigan State University Adjunct Professor of Law, Michigan State University College of Law A JOHN WILEY & SONS, INC., PUBLICATION Copyright © 2009 by Neal D. Fortin. All rights reserved. Published by John Wiley & Sons, Inc., Hoboken, New Jersey Published simultaneously in Canada No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (928) 750-8400, fax (978) 750-4470, or on the web at www.copyright.com. 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Food adulteration and inspection–United States. I. Title. KF3875.F67 2009 344.7304'232—dc22 2008021433 Printed in the United States of America 10 9 8 7 6 5 4 3 2 1 Dedicated to Katherine Fortin and Helen Fortin TABLE OF CONTENTS SUMMARY OF CONTENTS xxi PREFACE xxiii ACKNOWLEDGMENTS xxix 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 1.2.1 Why Do We Have Food Laws? 3 1.2.2 The 1906 Pure Food and Drug Act 5 1.2.3 Evolution of the Food Statutes 6 1.3 The U.S. Legal System 8 1.3.1 The Constitution 9 1.3.2 Statutes 9 1.3.3 Regulations 10 1.3.4 Case Law and Common Law 10 1.3.5 Federalism 11 1.4 Agency Procedural Regulation 13 1.4.1 The Administrative Procedure Act 14 1.4.2 Rulemaking 14 1.4.3 Adjudication 15 1.4.4 Judicial Review 16 1.4.5 Federal Advisory Committee Act (FACA) 16 1.4.6 Freedom of Information Act (FOIA) 17 1.4.7 Constitutional Limitations on Agency Power 17 1.5 Agency Jurisdiction 23 1.5.1 Food and Drug Administration 24 1.5.2 Centers for Disease Control and Prevention 24 1.5.3 USDA Food Safety and Inspection Service (FSIS) 25 1.5.4 U.S. Environmental Protection Agency 25 1.5.5 National Marine Fisheries Service (NMFS) 26 vii viii TABLE OF CONTENTS 1.5.6 Alcohol and Tobacco Tax and Trade Bureau (TTB) 26 1.5.7 U.S. Customs Service 26 1.5.8 U.S. Department of Justice 27 1.5.9 Federal Trade Commission 27 1.5.10 State and Local Governments 28 1.6 Major Federal Laws 29 1.6.1 The Statutes 29 1.6.2 Other Statutes 30 1.6.3 The Regulations 31 1.7 Informational Resources 32 1.7.1 Government Agencies 32 1.7.2 Associations and Trade Groups 32 1.7.3 Other Sources 32 Appendix 33 2. What Is a Food? 35 2.1 Introduction to the Food, Drug, and Cosmetic Act 35 2.1.1 Defi nitions 35 2.1.2 FDA’s Jurisdiction and the Defi nition of Food 38 2.1.3 Specifi c Food Classifi cations 39 2.2 What Makes an Article a Food or a Drug? 40 Nutrilabs, Inc. v. Schweiker 40 2.3 The Central Role of Intended Use 43 2.4 Other Considerations 44 2.4.1 Products Ordinarily Considered Foods 44 2.4.2 Products Intended to Be Processed into Food 45 2.4.3 Products No Longer Fit for Food 45 2.4.4 Packaging Materials 45 2.4.5 Evidence of Intended Use 46 PART II: REGULATION OF LABELING AND CLAIMS 47 3. Food Labeling 49 3.1 Introduction 49 3.2 Legal Authorities 50 3.3 Labeling Terminology 51 3.3.1 Label versus Labeling 52 3.3.2 The Scope of Labeling 53 Kordel v. United States 53 3.3.3 Labeling versus Food Advertising 56 3.3.4 The Internet and Labeling 57 TABLE OF CONTENTS ix 3.4 Affi rmative Label Requirements 59 3.4.1 Principle Display Panel (PDP) 59 3.4.2 Information Panel 59 3.4.3 Statement of Identity 60 Federation of Homemakers v. Butz 61 3.4.4 Net Quantity 65 3.4.5 Ingredient Labeling 67 3.4.6 Name and Address of the Responsible Party 70 3.4.7 Product Dates and Codes 71 3.5 Misbranded Food: Prohibited Representations 71 3.5.1 Section 403 on Misbranded Food 71 United States v. 95 Barrels of Alleged Apple Cider 74 3.5.2 False or Misleading as a Matter of Law 77 United States v. 432 Cartons Individually Wrapped Candy Lollipops 78 3.6 Deceptive Packaging 80 United States v. 174 Cases Delson Thin Mints 80 3.7 Warning Statements: Products Requiring Warning Labels 82 3.8 Allergens 85 3.9 Alcoholic Beverages 88 3.9.1 Wine Coolers versus Flavored Wine 89 3.9.2 A Double Standard 89 3.10 USDA 90 3.10.1 Labeling Approval 90 3.10.2 “Generic” Approvals (Labels without Prior Approval) 90 3.10.3 Safe Food-Handling Instructions 90 3.10.4 Additional Information Required 90 3.10.5 Record Keeping 91 3.11 Optional Label Information 91 3.11.1 Health Claims and Nutrient Level Claims 91 3.11.2 Grades 91 3.11.3 Trademarks and Copyrights 91 3.11.4 Religious Symbols 92 3.11.5 Universal Product Code 92 3.11.6 Organic 92 4. N utritional Labeling, Nutrient Level Claims, and Health Claims 93 4.1 Introduction 93 4.1.1 Nutrition and Public Health Expenditures 94 x TABLE OF CONTENTS 4.1.2 McFat Litigation 95 Pelman et al. v. McDonald’s Corp. 95 4.2 The Nutrition Labeling and Education Act (NLEA) 101 4.3 Nutrient Level Claims 103 4.3.1 Meals and Main Dishes 106 4.3.2 Standardized Foods 106 4.3.3 Healthy 106 4.4 Nutrition Panel Format 106 4.5 Trans Fats 111 4.5.1 Background on Trans Fat 112 4.5.2 Petition to Ban Hydrogenated Oil 112 4.5.3 Highlights of the Trans Fat Rule 113 4.6 Health Claims 113 4.6.1 General Well-Being Claims 114 4.6.2 Classical Nutrient-Defi ciency Disease and Nutrition 115 4.6.3 Structure-Function Claims 115 4.6.4 Pre-approved Health Claims (NLEA) 116 4.6.5 Authoritative Statements—FDA Modernization Act of 1997 124 4.6.6 Qualifi ed Claims—After Pearson v. Shalala 125 Pearson v. Shalala 127 4.6.7 Nutritional Claims Grading Proposed 138 4.6.8 Substantiation of Claims 139 4.7 NLEA and Restaurants 142 Public Citizen and CPSI v. Shalala 142 4.8 Advertising 145 4.8.1 Federal Trade Commission 145 4.8.2 Deceptive Advertising and Unfairness 146 4.8.3 Overview of Other Regulatory Aspects of Advertising 146 5. Economic and Aesthetic Adulteration 149 5.1 Introduction 149 5.2 Defi nitions 149 5.2.1 Food 149 5.2.2 Adulterated 150 5.2.3 Misbranded 151 5.3 Food Standards: Regulation of Food Identity and Quality 152 5.3.1 Historical Overview 153 5.3.2 FD&C Act § 401, Power to Set Food Standards of Identity 157 TABLE OF CONTENTS xi Corn Products Co. v. Dept. of HEW 161 Libby, McNeil & Libby v. United States 166 5.3.3 Current Issue 169 5.3.4 Penalties 169 5.3.5 Temporary Marketing Permits 169 5.4 Sanitation and Aesthetic Adulteration 170 U.S. v. 1,500 Cases . . . Tomato Paste 170 5.4.1 GMPs 173 5.4.2 Waiter, There’s a Fly in My Soup—FDA Defect Action Levels 174 5.4.3 The FDA Food Defect Level Handbook 175 5.4.4 Blending 179 5.4.5 De minimis Filth 179 United States v. 484 Bags, More or Less 179 United States v. Capital City Foods, Inc. 181 5.4.6 Decomposition 183 United States v. An Article of Food . . . 915 Cartons of Frog Legs 183 5.4.7 Insanitary Conditions 186 U.S. v. 1,200 Cans Pasteurized Whole Eggs by Frigid Food Products 187 5.4.8 Good Manufacturing Practices (GMPs) 189 United States v. Nova Scotia Food Products Corp. 189 5.4.9 Otherwise Unfi t for Food 194 PART III: FOOD SAFETY REGULATION 195 6. Food Safety Regulation 197 6.1 Introduction 197 6.1.1 Background—The Nature and Cost of Foodborne Illness 198 6.1.2 Poisonous and Deleterious Substances 200 6.1.3 Added Substances 201 United States v. Lexington Mill & Elevator Co. 232 U.S. 399 (1914) 201 6.1.4 Nonadded Substances 204 U.S. v. 1,231 Cases American Beauty Brand Oysters 204 6.1.5 Tolerances for Unavoidable or Necessary Poisonous and Deleterious Substances 208 Young v. Community Nutrition Institute et al. 209 6.2 Pesticide Residues 212 xii TABLE OF CONTENTS 6.2.1 FIFRA and EPA 213 6.2.2 FQPA and Risk Assessment 213 6.3 Environmental Contaminants 214 United States v. Anderson Seafoods, Inc. 215 6.4 Tampering: The Anti-tampering Act 220 6.5 Carcinogens: The Delaney Clause 221 Scott v. FDA 222 Public Citizen v. Young 225 6.6 HACCP 240 6.6.1 HACCP’s History 241 6.6.2 The Advantages of HACCP 241 6.6.3 The Nature and Cost of Foodborne Illness 242 Supreme Beef Processors, Inc. v. USDA 245 7 Food Additives, Food Colorings, Irradiation 253 7.1 Introduction 253 7.2 Background 253 7.3 Food Additives 260 7.3.1 The Food Additive Amendment of 1958 261 7.3.2 FD&C Act Defi nition 262 7.3.3 Additive Safety and Approval 264 7.3.4 Prior Sanctioned Substances 266 7.3.5 GRAS (Generally Recognized as Safe) 267 7.3.6 Proving GRAS Status 268 United States v. An Article of Food, Coco Rico, Inc. 268 7.3.7 Indirect Additives 272 Natick Paperboard Corp. v. Casper Weinberger and FDA 273 7.3.8 The FDA Modernization Act of 1997 (FDAMA) 277 7.3.9 MSG 278 7.3.10 Preservatives 283 7.3.11 Botanicals and Other Novel Ingredients 289 7.4 Color Additives 293 7.4.1 Color Additive Amendments 293 7.4.2 Provisional Listing 294 United States v. An Article of Food Consisting of 12 Barrels . . . Lumpfi sh Roe 302 7.5 Food Irradiation 306 7.5.1 Irradiation as a Food Additive under FD&C Act 306 7.5.2 Labeling 313 7.5.3 Agricultural Pests 314