Food Regulation : Law, Science, Policy, and Practice.

Intro -- Title Page -- Copyright -- Dedication -- About the Author -- Foreword -- Preface -- Acknowledgments -- Part I: Introductory Chapters -- Chapter 1: Introduction to Food Regulation in the United States -- 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 -- Chapter 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 -- Chapter 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 -- Chapter 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) -- Chapter 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 -- Chapter 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 (Figure 6.4) -- 6.8 Conditional Claims and Marks -- Chapter 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 -- Chapter 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 -- Chapter 9: Regulation of Unintentional Poisonous or Deleterious Substances in Food -- 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 -- 9.8 Additional Food Safety Performance Standards -- 9.9 Reportable Food Registry -- Chapter 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 -- Chapter 11: Dietary Supplements -- 11.1 Introduction -- 11.2 The Statutory Definition -- 11.3 Approval &amp -- 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 -- Chapter 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 EPA's 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 -- Chapter 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 -- Chapter 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 -- Chapter 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 -- Chapter 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 -- Chapter 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 -- 17.7 Scope of FDA Inspection Authority -- 17.8 Refusal to Permit Access -- 17.9 Planning for the Inspection -- 17.10 FSIS Inspection Authority -- Chapter 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 -- Chapter 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&amp -- C ACT -- Chapter 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 -- Chapter 21: International Food Law -- 21.1 Introduction -- 21.2 International Food Standards -- 21.3 Foreign Regulatory Systems -- 21.4 International Trade Disputes -- Chapter 22: Ethics -- 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 -- End User License Agreement.

Description based on publisher supplied metadata and other sources.

Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.