North South University Library OPACFood regulation :
Fortin, Neal D.,
Food regulation : law, science, policy, and practice / Neal D. Fortin. - 2nd ed. - Hoboken : Wiley, c2017. - xxxi, 511 p. : ill. ; 29 cm.
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
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"--
9781118964477 (hardback)
Food law and legislation--United States.
Food industry and trade--Safety regulations--United States.
Food adulteration and inspection--United States.
TECHNOLOGY & ENGINEERING / Food Science.
SOCIAL SCIENCE / Agriculture & Food.
LAW / Agricultural.
KF3875 / .F67 2017
344.7304/232
Food regulation : law, science, policy, and practice / Neal D. Fortin. - 2nd ed. - Hoboken : Wiley, c2017. - xxxi, 511 p. : ill. ; 29 cm.
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
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"--
9781118964477 (hardback)
Food law and legislation--United States.
Food industry and trade--Safety regulations--United States.
Food adulteration and inspection--United States.
TECHNOLOGY & ENGINEERING / Food Science.
SOCIAL SCIENCE / Agriculture & Food.
LAW / Agricultural.
KF3875 / .F67 2017
344.7304/232