Food regulation law, science, policy, and practice, 2nd edition

FOOD REGULATION FOOD REGULATION Law, Science, Policy, and Practice Second Edition NEAL D FORTIN Copyright  2017 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, (978) 750-8400, fax (978) 750-4470, or on the web at www.copyright.com Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permission Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose No warranty may be created or extended by sales representatives or written sales materials The advice and strategies contained herein may not be suitable for your situation You should consult with a professional where appropriate Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at (800) 762-2974, outside the United States at (317) 572-3993 or fax (317) 572-4002 Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products, visit our web site at www.wiley.com Library of Congress Cataloging-in-Publication Data: Names: Fortin, Neal D., author Title: Food regulation : law, science, policy, and practice / Neal D Fortin Description: Second edition | Hoboken : Wiley, 2017 | Includes index Identifiers: LCCN 2016031565| ISBN 9781118964477 (hardback) | ISBN 9781118964491 (epub) Subjects: LCSH: Food law and legislation–United States | Food industry and trade–Safety regulations–United States | Food adulteration and inspection–United States | BISAC: TECHNOLOGY & ENGINEERING / Food Science | SOCIAL SCIENCE / Agriculture & Food | LAW / Agricultural Classification: LCC KF3875 F67 2017 | DDC 344.7304/232–dc23 LC record available at https://lccn.loc.gov/2016031565 Printed in the United States of America 10 Dedicated to Katherine Fortin and Helen Fortin TABLE OF CONTENTS ABOUT THE AUTHOR FOREWORD xxiii xxv PREFACE xxvii ACKNOWLEDGMENTS xxxi PART I INTRODUCTORY CHAPTERS Introduction to Food Regulation 1.1 Introduction 1.2 A Short History of Food Regulation in the United States 1.2.1 Why Do We Have Food Laws? 1.2.2 The 1906 Pure Food and Drug Act 1.2.3 Evolution of the Food Statutes 1.3 The U.S Legal System 1.3.1 The Constitution 1.3.2 Statutes 1.3.3 Regulations 1.3.4 Case Law and Common Law 1.3.5 Federalism 1.4 Agency Procedural Regulation 1.4.1 The Administrative Procedure Act 1.4.2 Rulemaking 1.4.3 Adjudication 1.4.4 Judicial Review 1.4.5 Federal Advisory Committee Act (FACA) 1.4.6 Freedom of Information Act (FOIA) 1.4.7 Constitutional Limitations on Agency Power 1.5 Agency Jurisdiction 1.5.1 Food and Drug Administration 3 3 7 7 9 10 10 10 11 11 14 14 vii viii TABLE OF CONTENTS 1.6 1.7 1.5.2 Centers for Disease Control and Prevention (CDC) 1.5.3 USDA Food Safety and Inspection Service (FSIS) 1.5.4 U.S Environmental Protection Agency (EPA) 1.5.5 National Marine Fisheries Service (NMFS) 1.5.6 Alcohol and Tobacco Tax and Trade Bureau (TTB) 1.5.7 U.S Customs and Border Protection (CBP) 1.5.8 U.S Department of Justice (DOJ) 1.5.9 Federal Trade Commission (FTC) 1.5.10 State and Local Governments Major Federal Laws 1.6.1 The Main Statutes 1.6.2 Other Statutes 1.6.3 The Regulations Informational Resources 1.7.1 Government Agencies 1.7.2 Associations and Trade Groups 1.7.3 Other Sources What is Food? 2.1 Introduction to the Food, Drug, and Cosmetic Act 2.1.1 Definitions 2.1.2 FDA’s Jurisdiction and the Definition of Food 2.1.3 Specific Food Classifications Meat, Poultry, and Eggs Water 2.2 What Makes an Article a Food or a Drug? Nutrilab, Inc v Schweiker 2.3 The Central Role of Intended Use 2.4 Other Considerations 2.4.1 Products Ordinarily Considered Foods 2.4.2 Products Intended to Be Processed into Food 2.4.3 Products No Longer Fit for Food 2.4.4 Packaging Materials 2.4.5 Evidence of Intended Use PART II REGULATION OF LABELING, ADVERTISING, AND CLAIMS Food Labeling 3.1 Introduction 3.2 Legal Authorities 3.3 Labeling Terminology 3.3.1 Label versus Labeling 3.3.2 The Scope of Labeling Kordel v United States 3.3.3 Labeling versus Food Advertising 3.3.4 The Internet and Labeling 3.4 Affirmative Label Requirements 3.4.1 Label Terms 3.4.2 Statement of Identity Name of the Food Prominence Standardized Foods Undefined Foods—Common or Usual Name 15 15 15 16 16 16 16 16 17 17 17 18 18 19 19 19 19 21 21 21 23 23 23 23 23 24 25 26 26 26 26 26 26 29 31 31 32 32 33 33 33 35 35 36 36 36 36 37 37 37 TABLE OF CONTENTS Forms of a Food Fanciful Names Federation of Homemakers v Butz What’s in a Name? Lean Finely Textured Beef A.K.A “Pink Slime” Artificially Flavored Imitation Beverages Containing Juice When Is Peach Juice Apple Juice? 3.4.3 Net Quantity 3.4.4 Ingredient Declaration Ingredient Labeling: What’s in a Food? Specialized Ingredient Labeling Requirements Incidental Additives and Processing Aids 3.4.5 Name and Address of the Responsible Party 3.4.6 Labeling Special Circumstances 3.5 Misbranded Food: Prohibited Representations 3.5.1 Sec 403 Misbranded Federal Food, Drug, and Cosmetic Act Misbranded Food FD&C Act § 201(n) United States v 95 Barrels Alleged Apple Cider United States v 432 Cartons Individually Wrapped Candy Lollipops Misleading to Whom? U.S v Manischewitz Diet Thins 3.6 Deceptive Packaging United States v 174 Cases Delson Thin Mints 3.7 Warning Statements 3.7.1 Product Requiring Warning Statements 3.8 Allergens 3.9 Alcoholic Beverages 3.10 USDA FSIS 3.10.1 Labeling Approval 3.10.2 “Generic” Approvals (Labels Without Prior Approval) 3.10.3 Safe Food Handling Instructions Raw Meat and Poultry 3.10.4 Additional Information Required 3.10.5 Record Keeping 37 37 38 49 50 50 52 52 53 53 55 56 57 58 58 58 59 59 Nutritional Labeling and Nutrient Level claims 4.1 Introduction McF at Litigation Pelman ex rel v McDonald’s Corp 4.2 The Nutrition Labeling and Education Act (NLEA) Good Reading for Good Eating 4.3 The Nutrition Facts Panel 4.3.1 Daily Value (DV) 4.3.2 Nutrition Facts Format 4.3.3 Serving Sizes 4.3.4 Declaration of Serving Size Common Household Measures 4.3.5 Specific Exemptions to Nutrition Facts Labeling Small Businesses 4.4 Trans Fats 61 61 62 62 65 66 67 67 67 68 69 69 69 69 70 39 40 40 40 41 41 42 42 43 44 45 45 45 45 46 46 47 47 ix x TABLE OF CONTENTS 4.4.1 Background on Trans Fat 4.4.2 Petition to Ban Hydrogenated Oil 4.4.3 The Trans Fat Labeling Rule 4.4.4 Partially Hydrogenated Oil De-GRASed NLEA and Restaurants Public Citizen and CSPI v Shalala Menu and Vending Machine Labeling Requirements 4.6.1 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 4.6.2 Calorie Labeling of Articles of Food in Vending Machines 4.6.3 State and Local Preemption 4.6.4 Voluntary Election Covered by the Law Nutrient Content Claims (Nutrient Level Descriptors) 4.7.1 Definition 4.7.2 Express versus Implied Claims 4.7.3 Core Nutrient Level Descriptors 4.7.4 Meals and Main Dishes 4.7.5 Modifications of Standardized Foods 4.7.6 Disclosure Statements 4.7.7 Exemptions 4.7.8 New Nutrient Content Claim Approvals 70 70 70 71 71 71 73 Health Claims 5.1 Background 5.2 Definitions 5.2.1 The Categories of Health Claims 5.3 Health-Related Claims That Are Not Health Claims 5.3.1 General Well-Being Claims 5.3.2 Structure–Function Claims 5.3.3 Dietary Guidance 5.3.4 Nutrient Content Claims 5.4 Preapproved Health Claims (NLEA) 5.4.1 Calcium and Osteoporosis 5.4.2 Dietary Fat and Cancer 5.4.3 Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease 5.4.4 Sodium and Hypertension (High Blood Pressure) 5.4.5 Fiber-Containing Grain Products, Fruits, and Vegetables and Cancer 5.4.6 Fruits, Vegetables, and Grain Products that Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease 5.4.7 Fruits and Vegetables and Cancer 5.4.8 Folate and Neural Tube Birth Defects 5.4.9 Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries (Cavities) 5.4.10 Dietary Soluble Fiber, Such As That Found in Whole Oats and Psyllium Seed Husk, and Coronary Heart Disease 5.4.11 Soy Protein and Coronary Heart Disease 5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols 5.5 Authoritative Statements: FDA Modernization Act 5.6 Qualified Claims 5.6.1 Commercial Speech Central Hudson Gas & Electric v Public Service Commission of New York 81 81 82 82 83 83 83 83 83 84 84 84 4.5 4.6 4.7 73 74 74 74 74 75 75 75 77 77 78 78 78 84 85 85 85 85 86 86 86 87 87 87 88 88 88 496 ETHICS the American public in the integrity of the federal government ∗∗∗∗∗ • National Institutes of Health: https://ethics.od.nih.gov/ • Interagency Ethics Council: www.iecjournal.org • Bar Associations • Office of Government Ethics: www2.oge.gov/web/oge.nsf • Office of Special Counsel: https://osc.gov/ • Department of Justice: https://www.justice.gov/jmd/ departmental-ethics-office • Department of Agriculture: www.ethics.usda.gov/ State bar associations typically offer a wide variety of resources on legal ethics Typically, members may contact an ethics help line to receive an informal, advisory opinion from a staff attorney regarding an ethics issue pertaining to the inquirer’s prospective conduct GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS Form 483 for Report of Inspectional Observations ARS Agricultural Research Service (USDA) ATF Bureau of Alcohol, Tobacco, Firearms, and Explosives, U.S Department of Justice AAFCO Association of American Feed Control Officials ATPA American Technology Pre-Eminence Act of 1991 ABI/ACS U.S Customs and Border Protection’s Automated Broker Interface of the Automated Commercial System B 483 A Acidified food (AF) A low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85 ADI Acceptable Daily Intake AF Acidified food AFDO Association of Food and Drug Officials ALJ Administrative Law Judge Amicus curiae Someone not a party to the lawsuit who petitions the court to submit a brief on the case Often shortened to “amicus.” Latin for “friend of the court.” AMS Agricultural Marketing Service (USDA) AMS/TMD Agricultural Marketing Service, Transportation and Marketing Division of the USDA ANPR Advance Notice of Proposed Rulemaking APA Administrative Procedures Act APHIS Animal and Plant Health Inspection Service (USDA) BATF Bureau of Alcohol, Tobacco, and Firearms in the U.S Department of Treasury In 2002 the Homeland Security Act transferred BATF to the Department of Justice In 2003 the functions of BATF were split into two agencies The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) was transferred to the Department of Justice, and the Alcohol and Tobacco Tax and Trade Bureau (TTB) remained with the Department of Treasury BPA Bisphenol A BCP Bureau of Consumer Protection, Federal Trade Commission (FTC) Biotechnology In common use refers to techniques used to modify the deoxyribonucleic acid (DNA) or the genetic material of an organism to achieve a desired trait Biotechnology is also the shorthand term for an aggregation of scientific developments that include everything from stem cells applications and cloning to genetically engineered foods Food Regulation: Law, Science, Policy, and Practice, Second Edition Neal D Fortin  2017 Neal D Fortin Published 2017 by John Wiley & Sons, Inc 497 498 GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS BNF Biotechnology Notification BSE Bovine spongiform encephalopathy BST Bovine somatotropin, also abbreviated as bST and BGH (bovine growth hormone) database of Cumulative Estimated Daily Intakes (CEDIs) and Acceptable Daily Intakes (ADIs) Cf Compare In legal citations it direct attention to contrasting, analogous, or explanatory material Abbreviation of Latin “confer.” C CFC Chlorofluorocarbon CAC CFIA Canadian Food Inspection Agency CFP Conference for Food Protection CHD Coronary heart disease CFCs Chlorofluorocarbons CFR Code of Federal Regulations CPB U.S Customs and Border Protection CFSAN Center for Food Safety and Applied Nutrition, Food and Drug Administration C-TPAT Customs-Trade Partnership Against Terrorism is the U.S Customs and Border Protection in a partnership with importers to develop and adopt measures that add security but not have a chilling effect on trade The partnership establishes supply chain security criteria for members to meet and in return provides incentives and benefits like expedited import processing cGMPs Current good manufacturing practices Coal tar color Is a vernacular term for certified colors, which are synthetic colors that used to be derived from coal tar but now are usually derived from petroleum Codex Codex Alimentarius COLA Certificate of label approval issued by TTB for alcoholic beverages COOL Country-of-origin labeling CSREES Cooperative State Research, Education and Extension Services (USDA) in existence since 1994 was replaced with the National Institute of Food and Agriculture (NIFA), U.S Department of Agriculture (USDA) through the Food, Conservation, and Energy Act of 2008 Customs See CBP CVM Center for Veterinary Medicine, FDA Bt CARVER+Shock Cause of Action Bacillus thuringiensis Codex Alimentarius Commission, a joint body of the Food and Agriculture Organization and World Health Organization A risk assessment tool, CARVER, where the acronym stands for six attributes that are used to evaluate targets for an attack Criticality: What impact would an attack have on public health and the economy? Accessibility: How easily can a terrorist access a target? Recuperability: How well could a system recover from an attack? Vulnerability: How easily could an attack be accomplished? Effect: What would be the direct loss from an attack, as measured by loss in production? Recognizability: How easily could a terrorist identify a target? The CARVER tool evaluates a seventh attribute—the psychological impacts of an attack or shock attributes of a target For example, the psychological impact tends to be greater if there is a large number of deaths involved or if the target has historical or cultural significance The facts and legal grounds sufficient to bring a court action to enforce the law For example, a cause of action for misbranding under section 403(a)(1) of the Food, Drug, and Cosmetic Act requires facts of false or misleading labeling CBP U.S Customs and Border Patrol in the Department of Homeland Security CCFAC Codex Committee on Food Additives and Contaminants CCFICS Codex Committee on Food Import and Export Certification and Inspection Systems CCFL Codex Committee on Food Labeling CCP Critical control point D CDC Centers for Disease Control and Prevention De minimis CEDI Cumulative estimated dietary intake CEDI/ADI Database For a large number of food contact substances, CFSAN maintains a Latin meaning about minimal things It is often short for the legal maxim, “De minimis non curat lex” or The law does not concern itself with trifles GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS 499 DHHS U.S Department of Health and Human Services FALCPA Food Allergen Labeling and Consumer Protection Act DOJ Department of Justice FAP Food Additive Petition DOT Department of Transportation FAS Foreign Agriculture Service, USDA DRI Daily Reference Intake FASEB DRV Daily Reference Value DUNS Data Universal Numbering System is a system developed by Dun & Bradstreet, which assigns a unique identifying number, referred to as a “DUNS number” or “D-U-N-S number,” to a single business entity and location FDA uses the DUNS numbers for reference on establishment location DUNS numbers are used by many organizations worldwide Federation of American Societies for Experimental Biology, which is a nonprofit umbrella organization of U.S scientific societies in biological and medical research FCN Food Contact Notification FCS Food Contact Substance, Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food FDA Food and Drug Administration, of the U.S Department of the Health and Human Services FDAMA Food and Drug Administration Modernization Act of 1997 FDCA Federal Food, Drug, and Cosmetic Act, also FFDCA and FD&C Act FD&C Act Federal Food, Drug, and Cosmetic Act FERN Food Emergency Response Network (FERN) is a network coordinated by the FDA and USDA to integrate the nation’s food testing laboratories FERN coordinates the testing activities of federal, state, and local laboratories FIFRA Federal Insecticide, Fungicide and Rodenticide Act FMIA Federal Meat Inspection Act FOIA Freedom of Information Act FoodNet Foodborne Diseases Active Surveillance Network, which was established in 1995 as a collaborative program among CDC, ten state health departments, USDA FSIS, and FDA FoodNet conducts surveillance for infections caused by specific pathogenic microorganisms for approximately 15 percent of the United States population The objectives of FoodNet are to determine the burden of foodborne illness in the United States; monitor trends in specific foodborne illness over time; attribute foodborne illness to specific foods and settings; and disseminate information that can lead to improvements in public health DSHEA Dietary Supplements Health and Education Act of 1994 DV Daily Value E EA Environmental Assessment EAFUS “Everything Added to Food in the United States” database, which is an informational database maintained by CFSAN under an ongoing program known as the Priority-based Assessment of Food Additives (PAFA) and which contains information about the more than 3000 substances EIS Environmental Impact Statement EC European Community EDI Estimated daily intake EEC European Economic Community EIR Establishment Inspection Report EMEA European Union Medicines Agency EPA Environmental Protection Agency EPIA Egg Products Inspection Act EU European Union EUP Experimental use permit issued by the EPA F FAO Food and Agriculture Organization (United Nations) FACA Federal Advisory Committee Act FAIRS Food and Agricultural Imports Regulations and Standards (FAIRS), which are reports issued by the FAS of USDA 500 GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS adequately shown to be safe under the conditions of its intended use Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive Information that supports the GRAS determination musts be publicly available and generally accepted by the scientific community and should be the same quantity and quality of information that would support the safety of a food additive practice and the development of interventions to reduce the burden of foodborne FONSI Finding of No Significant Impact (National Environmental Policy Act) FPLA Fair Packaging and Labeling Act FQPA Food Quality Protection Act of 1996 FR Federal Register (also Fed Reg.) FSIS Food Safety and Inspection Service, U.S Department of Agriculture (USDA) FSVP Foreign Supplier Verification Program FTC Federal Trade Commission FTCA Federal Trade Commission Act G GAIN Global Agriculture Information Network (GAIN) of the USDA FAS, which publishes import and export guides GAO General Accounting Office GAP Good agricultural practice GATT General Agreement of Trade and Tariffs GE Genetic Engineering, which refers to genetic modification through use of recombinant deoxyribonucleic acid (rDNA) techniques, or gene splicing, to give desired traits Genetically engineered foods are also called biotech, bioengineered, and genetically modified GRASE Generally Recognized As Safe And Effective GRNs Generally Recognized as Safe Notifications H HACCP Hazard Analysis Critical Control Point HARPC Hazard Analysis and Risk-Based Preventive Controls—the Food Safety Modernization Act § 103 amended the FD&C Act by adding § 418 [21 U.S.C 350 g], which requires that most food facilities implement a written HARPC plan GEMS Global Environment Monitoring System, World Health Organization (WHO) GAO General Accounting Office HFCS High Fructose Corn Syrup Genome The complete set of genetic material of an organism HHS GEO Genetically Engineered Organisms (genetically engineered through use of rDNA techniques); a synonym for GMO U.S Department of Health and Human Services (sometime written as DHHS), the parent department for FDA, CDC, and others agencies I GI Geographical indications IFA Infant Formula Act GIPSA Grain Inspection, Packers, and Stockyards Administration (USDA) In rem GM Genetically Modified, a synonym for GE An action involving the status of a thing (property) The Latin means “against [the] thing” GMOs Genetically Modified Organisms (genetically modified through use of rDNA techniques) Inter alia Among other things (Latin) INAD Investigational New Animal Drug IOM Investigations Operations Manual GMPs Good Manufacturing Practices IOM GPO Government Printing Office GRAS Generally Recognized As Safe, which means generally recognized, among qualified experts, as having been Institute of Medicine, which is a division of the National Academies of Sciences, Engineering, and Medicine (see also NAS) IP Information Panel GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS J JECFA Joint (FAO/WHO) Expert Committee on Food Additives JIFSAN Joint Institute for Food Safety and Nutrition L LACF Low-acid canned foods LFTB Lean finely textured beef, or LFTB, is a defatted beef product developed in 1991 Beef trimmings are heated then processed by centrifuge action to separate off the fat The lean beef extracted is treated with ammonium gas (anhydrous ammonia) to kill bacteria LFTB gained the nickname of “pick slime.” Lm Listeria monocytogenes LMOs Living modified organisms Low-acid canned food (LACF) A food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7 Nanotechnology The National Nanotechnology Initiative Program defines nanotechnology as “the understanding and control of matter at dimensions between approximately and 100 nanometers, where unique phenomena enable novel applications.” NAFTA North American Free Trade Agreement NARB National Advertising Review Board, FTC NARMS National Antimicrobial Resistance Monitoring System NAS National Academy of Sciences (now the National Academies of Sciences, Engineering, and Medicine) The academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions related to science, technology, and medicine The Academies operate under an 1863 congressional charter of the National Academy of Sciences, signed by President Abraham Lincoln The National Academy of Sciences eventually expanded to include the National Research Council (NRC) in 1916, the National Academy of Engineering in 1964, and the National Academy of Medicine, which was established in 1970 as the Institute of Medicine (IOM) NCIE National Center for Import and Export, Veterinary Services, USDA NCIMS National Conference on Interstate Milk Shipments NCWM National Conference on Weights and Measures NDA New drug application NDI New dietary ingredient NDRMMP National Drug Residue Milk Monitoring Program NEPA National Environmental Policy Act NGO Nongovernment organization NIFA National Institute of Food and Agriculture of USDA, which provides funding for programs that advance agriculture-related sciences NIH National Institutes of Health NIST National Institute of Standards and Technology NLEA Nutrition Labeling and Education Act of 1990 M MAVs Maximum allowable variations MOU Memorandum of understanding MRA Mutual recognition agreement MRL Maximum residue limit N NACMCF National Advisory Committee on Microbiological Criteria for Foods provides recommendations to both the U.S Secretary of Agriculture Secretary and the Secretary of Health and Human Services (HHS), the department, which oversees the U.S Food and Drug Administration NACMCF focused on the microbiological criteria by which the safety and wholesomeness of food can be assessed The committee membership consists of scientists from academia, industry, other organizations, and federal and state government as well as one individual affiliated with a consumer group NADA New animal drug application NAD National Advertising Division, Council of Better Business Bureaus 501 502 GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS NMFS National Marine Fisheries Service, NOAA, Dept of Commerce NOAA National Oceanic and Atmospheric Administration NOAEL No observable adverse effect level NOEL No Observed Effect level NOIE Notice of Intended Enforcement Action NOOH Notice of opportunity for hearing NOP National Organic Program, which was established to implement the Organic Foods Production Act of 1990 NOSB National Organic Standards Board is a USDA advisory board established to help develop the organic standards NPRM Notice of proposed rulemaking NRC National Research Council which is a division of the National Academies of Sciences, Engineering, and Medicine (see also NAS) NRTE Not ready-to-eat NSIP National Seafood Inspection Program PCBs Polychlorinated Biphenyls PCQI Preventive Controls Qualified Individual, who is someone who has successfully completed training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system as specified by FSMA rules The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more PCQIs 21 C.F.R § 117.126(a)(2) The PCQI is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review 21 C F.R § 117.160(b)(1) PDP Principal Display Panel Phenotype The set of observable characteristics of an individual resulting from the interaction of its genome with the environment PHS Public Health Service of DHHS OASIS Operational and Administrative System for Import Support, FDA PIPs Plant-Incorporated Protectants PKU Phenylketonuria OCI Office of Criminal Investigations, FDA PMN Premarket notification ODS Office of Dietary Supplements, NIH PMO Pasteurized Milk Ordinance OFAS Office of Food Additive Safety, CFSAN PNSI Prior Notice System Interface at FDA OFPA Organic Foods Production Act of 1990, which was Title XXI of the 1990 Farm Bill, mandated the establishing of national standards for the production and handling of foods labeled as “organic.” p.o.e.m.s Polyoxyethylene monostearates ppb Parts per billion (1 μg/kg) PPIA Poultry Products Inspection Act ppm Parts per million (1 mg/kg) Prima facie On first appearance but subject to further evidence or information Prop 65 Proposition 65, which is the California Safe Drinking Water and Toxic Enforcement Act of 1986, that among other requirements mandates warning labels for substances officially listed by California as having a in 100,000 chance of causing cancer or birth defects or other reproductive harm PUFI Packed under federal inspection, which is an official mark of NMFS PulseNet PulseNet is a collaborative program for the surveillance and detection of foodborne illness that is coordinated by the CDC, with laboratory participants from state health departments, local health departments, and federal agencies Using pulsed-field gel electrophoresis O OIG Office of the Inspector General, DHHS OMB Office of Management and Budget OSHA Occupational Safety Hazard Administration OTC Over-the-counter P PAFA Priority-based Assessment of Food Additive database, which serves as CFSAN’s institutional memory for the toxicological effects of food ingredients known to be used in the United States PAFA contains administrative, chemical, and toxicological information on over 2,000 substances directly added to food, including substances regulated by the FDA as a direct food additive, secondary direct food additive, color additive, GRAS, and prior-sanctioned substance GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS (PFGE), PulseNet participating laboratories perform molecular subtyping (often called “fingerprinting”) of foodborne disease causing bacteria The patterns are then submitted electronically to the PulseNet database, which allows for the rapid comparison of patterns and facilitates identification of common source outbreaks PulseNet allows for the collection and analysis of state and local epidemiological surveillance data for the identification of outbreaks that may otherwise go unnoticed Q QCPs Quality Control Programs SPS Sanitary and Phytosanitary Agreement, WTO SSA Significant scientific agreement SSOPs Sanitation Standard Operating Procedures STOP Safe Tables Our Priority T TAP Technical Advisory Panel, which is a panel of experts convened by the National Organic Standards Board (NOSB) to evaluate scientific data on materials being considered for the organic National List TBT Technical Barriers to Trade Agreement, WTO TOR Threshold of regulation exemption from food additive regulation, which is available for a substance used in a food contact article if the use in question has been shown to meet the requirements in 21 CFR 170.39 TRIPS The World Trade Organization 1995 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) TRO Temporary restraining order TTB Alcohol and Tobacco Tax and Trade Bureau, U.S Department of Treasury TSE Transmissible spongiform encephalopathy R RACC Reference amounts customarily consumed rBST Recombinant bovine somatotropin, also abbreviated as rbST and rBGH (recombinant bovine growth hormone) RDA Recommended Daily Allowance RDI Reference Daily Intake rDNA Recombinant deoxyribonucleic acid Redbook FDA guidelines for development of safety tests Redbook II The toxicological principles for the safety assessment of direct food additives and color additives used in food REE The Research, Education and Economics mission area of the USDA RfD Reference dose, which is the estimated amount of the chemical a person could be exposed to on a daily basis throughout the person’s lifetime with no appreciable risk of harm RgD Regulatory dose, which is the RfD after modification by risk management RFR Reportable Food Registry RTE Ready-to-eat 503 U UPC Uniform Product Code USC United States Code U.S Customs Service In 2003 most of the functions of the Customs Service were moved from the Department of Treasure to the U.S Customs and Border Patrol in the Department of Homeland Security USDA United States Department of Agriculture USP United States Pharmacopeia USPTO United States Patent and Trademark Office V VQIP S Voluntary Qualified Importer Program (FD&C Act § 806) SAHCODHA Serious adverse health consequences or death to humans or animals W SCOGS Select Committee on GRAS Substances WHO World Health Organization SDWA Safe Drinking Water Act WIC SE Salmonella enteritidis Special Supplemental Food Program for Women, Infants and Children SOPs Standard operating procedures WTO World Trade Organization TABLE OF CASES 119 Cases “New Dextra Brand Fortified Cane Sugar”, United States v., 142 1,200 Cans Pasteurized Whole Eggs by Frigid Food Products, United States v., 157, 159 1,231 Cases American Beauty Brand Oysters, United States v., 169 1,500 Cases Tomato Paste, United States v., 151 174 Cases Delson Thin Mints, United States v., 51, 52 24 Bottles “Sterling Vinegar & Honey, United States v., 34 24 Cases, More or Less [Herring Roe], United States v., 163 298 Cases, etc., Ski Slide Brand Asparagus, etc., United States v., 163, 164 40 Cases “Pinocchio Brand Blended Oil”, United States v., 8, 364 432 Cartons Individually Wrapped Candy Lollipops, United States v., 49 45/194 Kg Drums of Pure Vegetable Oil, 209 484 Bags, More or Less, United States v., 152, 155 62 Cases of Jam v United States, 145 Barrels Spray Dried Whole Eggs, United States v., 363 76,552 Pounds of Frog Legs, United States v., 329, 335 88 Cases Bireley’s Orange Beverage, U.S v., 49, 51 95 Barrels Alleged Apple Cider, United States v., 47, 49, 311 Alliance for Bio-Integrity v Shalala, 294, 295, 305 American Frozen Food v Mathews, 150 American Public Health Assoc v Butz, 187, 194 An Article of Food 915 Cartons of Frog Legs, United States v., 157 An Article of Food, Coco Rico, Inc., United States v., 222 An Article of Food 12 Barrels Lumpfish Roe, United States v., 235 An Article Sudden Change, United States v., 51 Anderson Seafoods, Inc., United States v., 175 Armour & Co v Ball, 413, 421 Articles of Food Consisting of Pottery, United States v., 228 Berger v United States, 159 Berlex Laboratories, Inc v FDA, 458 Blommer Chocolate Co v Bongards Creameries, Inc., 440 Brunetto Cheese Mfg Corp v Celebrezze, 139 Calvert Cliffs Coordinating Committee v U.S Atomic Energy Commission, 469 Capital City Foods, Inc., United States v., 156 Carolene Products Co v United States, 136, 148 Center For Food Safety v Hamburg, 465 Central Hudson Gas & Electric v Public Service Commis­ sion of New York, 88, 270, 303 Certified Grocers Co-Op, United States v., 159 Chocolate Manufacturers Assn of U.S v Block, 449 Colonnade Catering Corp v United States, 391, 398–400 Columbia Cheese Co v McNutt, 137 Corn Products Co v Dept of HEW, 140 Daubert v Merrill Dow 305, 306 Food Regulation: Law, Science, Policy, and Practice, Second Edition Neal D Fortin  2017 Neal D Fortin Published 2017 by John Wiley & Sons, Inc 505 506 TABLE OF CASES Environmental Defense Fund, Inc v Matthews, 470 Ewig Bros Co., United States v., 175 Federal Security Administrator v Quaker Oats Co., 144 Federation of Homemakers v Butz, 38, 448 Florida ex rel Broward Co v Eli Lilly & Co., 445 Florida Lime and Avocado Growers, Inc v Paul, 413 Gardner v Michigan, 376 Geertson Seed Farms v Johann, 287, 472 H.B Gregory Co., United States v., 159 Hanly v Kleindiest, 472 Hawai’i Floriculture & Nursery Association v County of Hawaii, 289 Heckler v Chaney, 363, 397, 461, 465 Hillsborough Co v Automated Medical Labs, Inc., 413, 415 International Dairy Foods Association v Amestoy, 301 International Dairy Foods Association v Boggs, 304 Jackson v Nestle-Beich, Inc., 435, 436 Jamieson-McKames Pharmaceuticals, Inc., United States v., 388 Jones v Rath Packing Co., 418 Kordel v United States, 33 Lexington Mill & Elevator Co., United States v., 167, 362 Libby, McNeil & Libby v United States, 143 Lujan v Defenders of Wildlife, 126, 426 Manischewitz Diet Thins, United States v., 50 McIlwain v Hayes, 232, 467 McKinnis v Kellogg USA, 49 Merrell Dow Pharmaceuticals, Inc v Thompson, 445 Mexicali Rose v Superior Court, 433, 438 Millet, Pit and Seed Co., Inc v United States, 167 Milnot Co v Richardson, 147 Minnesota v Barber, 421 Monsanto v Kennedy, 212 Monsanto Co v Geertson Seed Farms, 288 Natick Paperboard Corp v Casper Weinberger and FDA, 26, 225, 228 Natural Resources Defense Council et al v FDA, 350, 351, 353 North American Cold Storage Co v City of Chicago et al., 374 Nova Scotia Food Products Corp., United States v., 161, 186, 187, 453 Nutrilabs, Inc v Schweiker, 23, 24, 265 Orthopedic Equipment Co v Eutsler, 439 Pacific Trading Co v Wilson & Co., Inc., 446 Park, United States v., 378 Pearson v Shalala, 87, 90, 270 Pelman et al v McDonald’s Corp., 62 Pharmanex v Shalala, 254 POM Wonderful LLC v Coca-Cola Co., 52, 426 Porteous v St Ann’s Café & Deli, 434 Public Citizen and CSPI v Shalala, 71 Public Citizen v Heckler, 464 Public Citizen v Young, 214 Reduction Company v Sanitary Works, 374 Robert Ito Farm, Inc v County of Maui, 288 Sanders, United States v., 364 Schollenberger v Pennsylvania, 421 Scott v FDA, 210, 218 Shoultz v Monfort of Colorado, Inc., 446 Sierra Club v U.S Army Corps of Engineers, 477 Sullivan, United States v., 362, 364 Supreme Beef Processors, Inc v USDA, 183, 187, 188, 407 Syncor International Corporation v Shalala, 456 Ten Cartons of Ener-B Nasal Gel, United States v., 246 Ten Cases, More Or Less, Bred Spred, 130 Texas Food Industry et al v Mike Espy et al., 187 Thirteen Crates of Frozen Eggs, United States v., 159 Thriftimart, Inc., United States v., 391 Two Plastic Drums Black Currant Oil, United States v., 208 Undetermined Quantities of Articles of Drug, United States v., 272 United States v _ (see opposing party) Vermont Yankee Nuclear Power Corp v Natural Resources Defense Council, 448 Werbel v Pepsico, Inc., 49 Whitaker v Thompson, 266 Young v Community Nutrition Institute et al., 171, 461 INDEX acidified food, 153, 178, 330, 395 action levels, see defect action levels additives approval process, 206, 208 botanicals, 22, 120, 230–231, 245, 262 colors, see color additives definition, 202, 205–206 FDA Modernization Act of 1997 (FDAMA), 227 Food Additive Amendment of 1958, 205–206 generally, 201, 203 generally recognized as safe (GRAS), 220–222 incidental additives, 44, 55–56, 226 indirect additives, 224–231 MSG, 43, 230 preservatives, 230 prior-sanctioned substances, 220 sulfites, 9, 44, 57, 65, 204, 230 Administrative Procedures Act (APA), 9–10, 90, 351, 449, 458 adulteration aesthetic adulteration, 150 blending, 153, 155 decomposition, 130, 157 definition, 129 economic 148–150 filth, 129 insanitary conditions, 129, 159–161 otherwise unfit for food, 163–164 adverse event reporting, 197, 270–271, 395, 396 adverse publicity, see enforcement, adverse publicity advertising, 34, 35, 47, 57, 58, 117–126 dietary supplements, 117–123, 273 Lanham Act actions, 52, 112, 125–126, 425–431 aflatoxin, 155, 172, 175, 215, 282, 339, 465 Alcohol and Tobacco Tax and Trade Bureau (TTB), 14, 16, 56–57, 117, 124–125, 208, 327, 333 imports, 335 alcoholic beverages, jurisdiction, 16, 56–57 allergens, 44, 55–56, 188, 228, 279, 280, 284–285, 292, 293, 297, 305 androstenedione, see dietary supplements Animal and Plant Health Inspection Service (USDA-APHIS), 238, 278, 286, 288, 311, 317, 325 327, 332, 472, 475 animal food, 334, 339–358, 466 diversion of adulterated food, 150–155, 373 antibiotics, 5, 23, 110, 114, 192, 245, 345–357, 461 antibiotic claims, see USDA process verified artificial coloring, see color additives American Association of Feed Control Officials (AAFCO), 342, 343, 344 artificial, 40, 43, 46, 49, 50, 110–111, 204, 233, 234, 304, 452 Baytril, see enrofloxacin beef hormones, 114, 339, 344, 345, 485–486 beer, 57, 222, 489 non-malt, 57 Better Business Bureau, see National Advertising Division Bioterrorism Act, 322, 327, 328, 329, 335 bioterrorism, see food terrorism black currant oil, 208–209 blending, 153, 155, 364, 464 botanicals, 22, 230, 245–246, 262, 272 bovine growth hormone, see bovine somatotropin bovine somatotropin (BST), 291, 301, 302–305, 344–345 bovine spongiform encephalopathy (BSE), 357–358, 487 bottled water, GMPs, 153, 178 bottled water, jurisdiction, 14, 23 breach of express warranty, 433 of implied warranty, 432 BSE, see bovine spongiform encephalopathy Food Regulation: Law, Science, Policy, and Practice, Second Edition Neal D Fortin  2017 Neal D Fortin Published 2017 by John Wiley & Sons, Inc 507 508 INDEX caffeine, 24, 27, 124, 177, 221, 224, 228, 230, 252, 271, 276 California Proposition 65, see Proposition 65 carcinogens, aflatoxins, see aflatoxin Carcinogens, Delaney Clause, 6, 18, 54, 203–204, 215–219, 229, 231, 258, 340, 489–490 CARVER+Shock, 323 caseinate, 44, 147 cease and desist letters, 125 Centers for Disease Control and Prevention (CDC), 15, 87, 96, 319, 345 certified colors, see color additives, certified chewing gum, 21, 23, 25, 68, 159, 224 Children’s Advertising Review Unit (CARU), 125–126 cholesterol claims, 71, 75–77 daily reference value, 67 labeling, 68, 74 civil liability, see private actions civil penalties, 124, 371–372 claims authoritative statement, see Health claims dietary guidance, 83 disease related, see Health claims general well-being, 82 NLEA, see Health claims nutrient content, 74–77 qualified, see Health claims structure-function, 82 substantiation, 99–105, 107, 118–123, 125, 265, 297–298 cloning, 277, 313–315, 342 Clostridium botulinum, 161, 178, 186, 369, 453 Codex Alimentarius, 16, 114, 181, 279, 292, 341, 482–483, 486 color additives, artificial 43, 46, 110–111, 233, 234, 418, 452 certified, 231 provisional listing, 232 coloring, animal feed, 234 colors, Southampton, see Southampton colors comfrey, 220, 271 common law, Conference for Food Protection (CFP), 342, 411 confidentiality, 320, 468, 495 consent decree, see, enforcement, consent decree contaminants, see defect action levels contempt action, 376 copyright, 115 country-of-origin labeling, 108 credence claims, 107 criminal liability, 378 Customs and Border Protection (CBP), 16, 326, 332, 371, 383 cyber letters, 368 daily value (DV), 67–68, 76, 78, 79, 86, 262 debarment, see enforcement deceptive packaging, 52–53 deceptive trade practices, see Unfair trade practices decomposition, see adulteration, decomposition defect action level, blending, 155–156 defect action levels, 153–155 Delaney Clause, see Carcinogens, Delaney Clause Department of Justice (DOJ), see U.S Department of Justice De minimis filth, 155–157, 218 denial of import entry, 371 destruction of products without a hearing, 374 detention, see Enforcement, detention dietary guidance, see claims, dietary guidance dietary supplements adulteration, 259– 260 androstenedione, 271 approval and safety, 257–259 aristolochic acid, 271 claim substantiation, 99–105, 265 definition, 243–253 ephedra, 270–271 generally, 243 good manufacturing practices (GMPs), 261 health claims, 81–105, 264–270 labels, 262–264 new dietary ingredients (NDI), 258 problem supplements, 270–271 disguised administrative rule, 460 drug, definition, 21–23 drug residue, 345 due process, 9–10, 12–14, 19, 147, 326, 373 economic adulteration, see Adulteration, economic Egg Products Inspection Act, 18 eggs, jurisdiction, 15 egg safety rules, 180 enforcement adverse publicity, 382 civil actions, 376–377 civil penalties, 371–372 consent decree, 372 criminal actions, 377–382 debarment, 370 detention, 370–371 discretion, 363 FSIS inspection-related powers, 372 import detentions, 370–371 injunctions, 374 interstate commerce, 363–364 jurisdiction, 363–366 publicity, 382 recalls, 368–370 role of DOJ, 363 seizure, see enforcement, detention suspension of inspection, 406 USDA generally, 406 warning letters, 366–368 withdrawal of inspection, 406 withdrawal of product approvals, 372 enrichment, see fortification enrofloxacin (Baytril), 346, 461 environmental assessment, 284, 292–293, 306, 307, 469–479 environmental contaminants, 175–178 INDEX environmental impact statement, 471–478 Environmental Protection Agency (EPA), 173–174, 289–290, 317, 326, 333 ephedra, see dietary supplements ethics, generally, 493–498 European Union food issues with US, 485 GE-derived foods, 488–489 generally, 485 expiration date, 45, 261 export certificates, 336 exemption, 334 generally, 334 import for, 335 false or misleading as a matter of law, 49 Farm Bill, 107–109, 337 FDA Modernization Act of 1997 (FDAMA), 61, 75, 78, 82, 87, 88, 227, 264, 303 FDAMA claims, see Health claims, authoritative statement health claims FDA inspectional observations, see Form 483 Federal Advisory Committee Act (FACA), 10–11 Federal Communications Commission (FCC), 124 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 173 genetically engineered food, 288–289 Federal Meat Inspection Act, 17, 23, 362, 404, 410 Federal Trade Commission (FTC), 14, 16, 32, 35, 52, 112, 117–124 federalism, 7–9 feed, see animal food First Amendment, 12, 88–97, 112, 267–275, 303, 304, 310 flavoring, 40, 43, 46, 55, 56, 64, 110–112, 150, flavor enhancer, 43–44, 230 FOIA, see, Freedom of Information Act food additives, see additives Food Contact Notification, 227 food defense, 317–323 food facility registration, see registration food grades, 115 Food Quality Protection Act (FQPA), 18, 174 food standards, generally, 130 temporary marketing permits, 145 food tampering, see tampering food terrorism economic and trade effects, 319 generally, 318–321 preventive controls, 188, 322–323 Salmonella-tainted election, 319–320 social and political implications, 319 threat, 318– 319 food, definition, 21 foodborne illness, burden,165 Form 402–404, 481 fortification, 142, 202, 231, 265, 489–490 Freedom of Information Act (FOIA), 9, 11, 366, 468–469 Freedom of Information Act, reverse FOIA, 468 generally recognized as safe, see GRAS 509 genetically engineered animals, 291–292 genetically engineered foods, 277–290 EPA’s role, 289 FDA Policy, 283 food safety, 280 labeling, 293–312 right to know, 301–312 USDA’s role, 286–289 genetically modified foods, see genetically engineered Foods geographical indications, 113–114 grades, see Food grades GRAS (Generally Recognized as Safe), 220–222, 233 HACCP, 181–187 Halal, see labeling, halal hard look doctrine, 477, HARPC, 188–189 health claims authoritative statement (FDAMA), 78, 82, 87 classical nutrient-deficiency disease and nutrition, 264 dietary guidance, 83 disease related, 105 general well-being, 83 NLEA, 84–87 qualified, 88–98 high fructose corn syrup (HFCS), 44–45, 112, 221 hydrogenated oil, 70–71, 141, 224 hydrolysates, 43–44, 53, 86 imitation, 40, 130, 134, 137, 139, 145–147 imports additional forms for certain foods, 328 basic import procedure, 326-327 denial of entry, 371 enforcement, 333 food facility registration, 322, 328 generally, 326 prior notice, 328 USDA’s Import System, 333 Voluntary Qualified Importer Program, 330 in vitro meat, see meat indirect additives, see additives, Indirect insanitary conditions, 10, 159–162, 171, 184–187, 367, 378, 380, 395, 404, 407, 455 inspection constitutional limits, 385 frequency, 387–388 FSIS generally, 406 FSIS Records Access, 410 generally, 386 notice, 396, 398, 402 photographs, 395 planning, 401 –404 record access under the bioterrorism act, 393 risk-based, 387 samples, 404 warrantless, 388 international food law, 481–490 510 INDEX international trade agreements, 483 Internet, webpages as labeling, 35–36 interstate commerce, 365 interstate commerce, unreasonable burden, 421 irradiation, agricultural pests, 238 Irradiation, food additive under FD&C Act, 236–237 irradiation, generally, 236 irradiation, labeling, 238 jurisdiction, restaurants, 366 justice, see U.S Department of Justice Konjac, 164 kosher, see labeling, kosher labeling affirmative requirements, 31, 36 alcoholic beverages, 56 allergens, 55 halal, 113 information panel, 36 ingredients, 42 kosher, 113 menu, 73–74 natural, see natural nutrition panel, 67 organic, see organic principle display panel (PDP), 36 quantity, 41 responsible party, 45 sell-by or use-by dates and codes, 45 statement of identity, 36 terminology, 32 USDA “generic” approvals, 58 USDA labeling approval, 58 USDA safe food-handling instructions, 58 vending machine, 73 warning statements, 53–54 webpages as labeling, 35 wine coolers versus flavored wine, 57 Lanham Act, 51, 52, 112, 117, 125, 126, 425–433 LFTB, 39–40 LibertyLink rice, 311 Listeria monocytogenes, 170, 191, 406 mad cow disease, see bovine spongiform encephalopathy (BSE) market withdrawal, 370 McFat litigation, 62 meat, in vitro, 313 mechanically tenderized meat, 58 melamine, 6, 197, 343 mercury, 175–178, 411 medical food, 70, 253 menu labeling, see labeling, menu metric, 41–42, 66, 69 misbranded food, prohibited representations, 45–52 misbranded, definition, 45 moisture loss, 42 MSG, 43, 230 nanotechnology, 312–313 natural claims, 110–112 National Advertising Division (NAD), 112, 117, 125–126 National Conference on Interstate Milk Shipments (NCIMS), 344 National Marine Fisheries Service (NMFS), 16, 328, 336 National Oceanic and Atmospheric Administration (NOAA), 334 National Antimicrobial Resistance Monitoring System (NARMS), 346 National Shellfish Sanitation Program (NSSP), 410 negligence, see private actions National Environmental Policy Act, 284, 292, 293, 311, 469, 475, 478 new dietary ingredient (NDI), see dietary supplement, new dietary ingredient nutrient content claims, see claims, nutrient content Nutrition Labeling and Education Act (NLEA), 41, 61, 65, 66, 71, 82, 83, 427–429 Open Meetings Act, 469 organic, 109–110, 111, 175, 288–289, 293, 298, 304, 311, 472, 474, 476 organoleptic evidence, 160 otherwise unfit for food, see adulteration, otherwise unfit for food packaging, deceptive, see deceptive packaging packaging, food additive definition, 203, 205–207 packaging, indirect additive, 204, 224–225 Pasteurized Milk Ordinance (PMO), 410 performance standards, 191–192 pesticide residues, 173–174, 175 photographs, see inspections pink slime, see LFTB Poisonous and deleterious substances, added substances, 167 generally, 168 nonadded substances, 175 tolerances, 171 Poultry Products Inspection Act (PPIA), 18, 362, 372, 373, 374, 404, 410, 413 precautionary principle, 486, 487, 488, 489–490 preemption, see states and private actions Prescription Drug Marketing Act of 1987, 422 preservatives, 4, 46, 110, 202, 204, 230 prior notice, 322, 327–328, 331 prior sanctioned substance, see additives, prior-sanctioned substances private actions False Claims Act, 444 foreign-natural test versus reasonable expectation, 433–434 generally, 425 hot coffee case, 431 negligence per se, 439 negligence, 433–434 no private cause of action under the FD&C Act, 445 preemption of tort claims, 443 products liability, 431–432 processed verified, see USDA process verified produce safety standards, 189–191 INDEX products liability, see private actions, products liability prohibited acts, 363 Proposition 65 (California), 410 preservatives, 4, 111, 202, 205, 230 pre-emption of tort claims, see private actions Proxmire Amendment, 250 puffery, 49, 98 Pure Food and Drug Act of 1906, 4–5, 18, 47 qualified claims, see claims, qualified Qui tam, see private actions, False Claims Act ractopamine, 114 rBST, see bovine somatotropin recalls, 6, 15, 18, 31, 101, 179, 196–198, 290, 368–370, 383 records access, 393–394, 406 recordkeeping, 59, 178, 181, 182, 189–191, 298, 323, 393–394 recombinant DNA (rDNA), 110, 112, 277 reconditioning, 329, 333, 335, 373 reference daily intake (RDI), 67, 76, 87 refusal to permit access, 394 registration, food facility, 322 registration, suspension, 371 Regulatory Control Action, 372 religious symbols, 112–113 Reportable Food Registry (RFR), 196–199 restaurants, jurisdiction, 409–410 reverse FOIA, see Freedom of Information Act, reverse FOIA risk assessment, FQPA, 174 risk-based inspections, see inspections risk categorization, 387–388 rulemaking, 9–10, 448 saccharin, 54, 132, 210, 224 safe food handling instructions, 58–59 scurvy, see health claims, classical nutrient-deficiency disease and nutrition seizures, see enforcement, detention Shiga-toxin producing E coli, 192–196 significant scientific agreement, 87, 90–97, 99, 264 Sorghum beer, 57 Southampton colors, 233–234 SPS, see WTO Standardized foods, 37, 77–78, 131–139 StarLink corn, 290 states destruction of products without a hearing, 412 federal laws delegating authority to the states, 422 federal preemption of states, 412–413 inspection and enforcement powers, 412 role generally, 362, 409 steroid hormone, see hormone street drug alternatives, 272 strict liability, 377–381 511 strict liability in tort, see private actions structure-function claims, see claims, structure-function substantiation, see claim substantiation, sulfanilamide, suspension, see Registration suspension, and Enforcement, suspension of inspection tampering Anti-tampering Act, 318 pesticide poisoning, 320 Tariff Act of 1930, 36, 107–108, 326, 333 TBT, see WTO temporary marketing permit, see food standards, temporary marketing permits terrorism, see Food terrorism, 318–321 threshold of regulation, 202, 227–229 tolerances, 153, 171–172, 216, 333, 448 traceability, 300, 393, 488 traceback, see traceability trade groups, 19, 196, 238 trademarks, 114, 115, 426 trans fats, 70–71 transparency, 40, 280, 286, 301, 447 TRIPS, 113 unfair trade practices, 125, 431 Universal Product Code (UPC), 115 unsanitary conditions, see insanitary conditions USDA food grades, see food grades labeling, see labeling, USDA labeling major enforcement powers, 405 process verified, 114, 300 U.S Department of Justice, 16, 317, 363, 498 U.S Postal Service, 17, 124 untitled correspondence, 368 vending machine labeling, see labeling, vending machine Vitamin-Mineral Amendment, see Proxmire Amendment Voluntary Qualified Importer Program, see imports warranty claims, see private actions warning letters, 368 warning statements, products requiring warning labels, 53–54 warrantless inspections, see inspections wine, 14, 57 cooler, 57 withdrawal of inspection, 372 withdrawal of product approval, 372 withholding action, 372, 405 World Trade Organization (WTO), agreement on Technical Barriers to Trade (TBT), 109, 482, 484 Sanitary and Phytosanitary Agreement (SPS), 484, 485, 487 ... Misbranded 130 8.2 Food Standards: Regulation of Food Identity and Quality 130 8.2.1 Historical Overview 130 The Main Food Standards of Identity 131 What Are the Requirements Regarding Food Standards?... LCSH: Food law and legislation–United States | Food industry and trade–Safety regulations–United States | Food adulteration and inspection–United States | BISAC: TECHNOLOGY & ENGINEERING / Food. .. FIFRA and EPA 9.2.2 FQPA and Risk Assessment 9.3 Environmental Contaminants United States v Anderson Seafoods, Inc 9.4 Specific Food Safety Rules 9.4.1 Low-Acid Canned Food and Acidified Food 9.4.2