Table of Contents 1
COVER
6
FOREWORD
WHAT IS FOOD LAW?
7
PREFACE
INTRODUCTION
ABOUT THE TEXT
A ROAD MAP FOR READING THE MATERIALS IN THIS BOOK
EDITING
STATUTORY RESEARCH USING THE FEDERAL REGISTER, CFRS, AND STATUTES
A NOTE ON STATUTE CITATIONS
FD&C ACT REFERENCES
DISCUSSION QUESTIONS
PROBLEM EXERCISES
INTERNET CITATIONS
CITATION FORMAT
NOTE
9
PART I: INTRODUCTORY CHAPTERS
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
APPENDIX: CONSTITUTIONAL AMENDMENTS I THROUGH X (THE BILL OF RIGHTS)
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
10
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 REGULATED AS 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 MEDICAL FOODS
5.9 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