TY - BOOK AU - Fortin,Neal D. TI - Food regulation: law, science, policy, and practice SN - 9781118964477 (hardback) AV - KF3875 .F67 2017 U1 - 344.7304/232 23 PY - 2017/// CY - Hoboken PB - Wiley KW - Food law and legislation KW - United States KW - Food industry and trade KW - Safety regulations KW - Food adulteration and inspection KW - TECHNOLOGY & ENGINEERING / Food Science KW - SOCIAL SCIENCE / Agriculture & Food KW - LAW / Agricultural N1 - Includes bibliographical references and index; About The Author xxiii Foreword Preface Acknowledgments Part I Introductory Chapters 1 Introduction to Food Regulation 1.1 Introduction; 1.2 A Short History of Food Regulation in the United States; 1.3 The U.S. Legal System; 1.4 Agency Procedural Regulation; 1.5 Agency Jurisdiction; 1.6 Major Federal Laws; 1.7 Informational Resources 2 What is Food? 2.1 Introduction to the Food, Drug, and Cosmetic Act; 2.2 What Makes an Article a Food or a Drug? 2.3 The Central Role of Intended Use; 2.4 Other Considerations Part II Regulation of Labeling, Advertising, and Claims 3 Food Labeling 3.1 Introduction; 3.2 Legal Authorities; 3.3 Labeling Terminology; 3.4 Affirmative Label Requirements; 3.5 Misbranded Food: Prohibited Representations; 3.6 Deceptive Packaging; 3.7 Warning Statements; 3.8 Allergens; 3.9 Alcoholic Beverages; 3.10 USDA FSIS 4 Nutritional Labeling and Nutrient Level claims 4.1 Introduction; 4.2 The Nutrition Labeling and Education Act (NLEA); 4.3 The Nutrition Facts Panel; 4.4 Trans Fats; 4.5 NLEA and Restaurants; 4.6 Menu and Vending Machine Labeling Requirements; 4.7 Nutrient Content Claims (Nutrient Level Descriptors) 5 Health Claims 5.1 Background; 5.2 Definitions; 5.3 Health-Related Claims That Are Not Health Claims; 5.4 Preapproved Health Claims (NLEA); 5.5 Authoritative Statements: FDA Modernization Act; 5.6 Qualified Claims; 5.7 Substantiation of Claims; 5.8 Therapeutic and Related Disease Claims; 6 Credence Claims and Conditional Labeling 6.1 Introduction; 6.2 Country of Origin Labeling; 6.3 Organic Foods; 6.4 Natural Claims; 6.5 Religious Certification Marks and Symbols; 6.6 Geographic Indications; 6.7 USDA Process Verified; 6.8 Conditional Claims and Marks 7 Advertising and Other Regulation of Labeling 7.1 Introduction; 7.2 Federal Trade Commission; 7.3 Other Regulatory Considerations with Advertising; 7.4 Competitor Challenges Part III Regulation of the Composition of Food 8 Economic and Aesthetic Adulteration 8.1 Introduction; 8.2 Food Standards: Regulation of Food Identity and Quality; 8.3 Economic Adulteration; 8.4 Sanitation and Aesthetic Adulteration 9 Regulation of Unintentional Poisonous or Deleterious Substances in Food 165 9.1 Introduction; 9.2 Pesticide Residues; 9.3 Environmental Contaminants; 9.4 Specific Food Safety Rules; 9.5 Science-Based, Risk-Control Plans; 9.6 FSMA Hazard Analysis and Preventive Control (HARPC) Plans; 9.7 Produce Safety Standards; 9.7.1 Summary of the Produce Rule; 9.8 Additional Food Safety Performance Standards; 9.9 Reportable Food Registry 10 Regulation of the Safety of Intentional Components of Food: Food Additives, Food Colorings, and Irradiation 10.1 Introduction; 10.2 Background; 10.3 Food Additives; 10.4 Prior Sanctioned Substances; 10.5 GRAS (Generally Recognized As Safe); 10.6 Indirect Additives; 10.7 Some Controversial Food Additives and Substances; 10.8 Color Additives; 10.9 Food Irradiation Part IV Specialized Food Regulation 11 Dietary Supplements 11.1 Introduction; 11.3 Approval & Safety; 11.4 Enforcement; 11.5 Good Manufacturing Practices (GMPS); 11.6 Labels; 11.7 Health Claims; 11.8 Problem Supplements; 11.9 Street Drug Alternatives 12 Genetic Engineering and Other Biotechnology Part A. Regulation of production 12.1 Introduction; 12.2 Background; 12.3 FDA’S Regulatory Review of New Plant Varieties; 12.4 USDA APHIS Role; 12.5 EPAS Role—The Safety of Pesticides In Bioengineered Plants; 12.6 Regulation of Genetically Engineered Animals Part B. Labeling 12.7 Labeling Part C. Disputed cases 12.8 The Right to Know; 12.9 Genetic Contamination Part D. Other biotechnology 12.10 Nanotechnology;12.11 in Vitro Meat; 12.12 Cloning 13 Food Defense 13.1 Introduction; 13.2 The Anti-Tampering Act; 13.3 Food Terrorism; 13.4 The Bioterrorism Act and FDA’s New Powers; 13.5 FSMA Food Defense Mandates; 13.6 Conclusions 14 Importation and Exportation 14.1 Introduction; 14.2 The Major Federal Agencies; 14.3 The FDA Import Process; 14.4 The Food Safety Modernization Act-A New Paradigm For Importers; 14.5 USDA’s Import System; 14.6 Other Import Controls; 14.7 Challenges Facing Import Regulation; 14.8 Export 15 Animal Food 15.1 Introduction; 15.2 Animal Feed Regulation; 15.3 Drugs For Animals Raised For Food; 15.4 BSE (Mad Cow Disease) Part V Inspection and Enforcement 16 Federal Enforcement 16.1 Introduction; 16.2 Statutory Authorities; 16.3 Enforcement Jurisdiction; 16.4 Administrative Enforcement; 16.5 FDA Civil Court Actions; 16.6 Criminal Actions; 16.7 Other Remedies and Concerns 17 Inspections 17.1 Introduction; 17.2 Constitutional Limits;17.3 Statutory Power For Inspections;17.4 Inspection Frequency;17.5 The Warrantless Inspection Exception;17.6 Consent to Inspect 39117.7 Scope of FDA Inspection Authority; 17.8 Refusal to Permit Access; 17.9 Planning For The Inspection; 17.10 FSIS Inspection Authority 18 State Laws and Their Relationship to Federal Laws 18.1 Introduction; 18.2 State Inspection and Enforcement Powers; 18.3 Federal Preemption of States; 18.4 Federal Laws Delegating Authority to The States Part VI General Chapters 19 Private Actions 19.1 Introduction; 19.2 Competitor Lawsuits; 19.3 Products Liability; 19.4 The False Claims Act; 19.5 No Private Cause of Action Under The Fd&C Act 20 Administrative Law and Food Regulation 20.1 Introduction; 20.2 Rulemaking—The Power to Legislate; 20.3 The Power to Adjudicate; 20.4 Executive Control of The Agencies; 20.5 Administrative Discretion; 20.6 Public Access to Agency Information; 20.7 Environmental Assessment 21 International Food Law 21.1 Introduction; 21.2 International Food Standards; 21.3 Foreign Regulatory Systems 22 Ethics 491 22.1 Professionalism and Ethics; 22.2 Ethical Practice Pointers; 22.3 Attorney Rules of Ethics; 22.4 Criminal Statutes Related to Ethics; 22.5 Resources Glossary of Abbreviations and Specialized Terms Table of Cases Index; Law N2 - Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduce students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about the application of the law, policy questions, and emerging issues; "This text provides an accessible guide to United States food regulation -- essential information for anyone not only studying or involved with the US food industry, but also internationally for exporting food to the US market"-- ER -