Neal D. Fortin - Food Regulation

1 COVER

2 TITLE PAGE

3 COPYRIGHT PAGE

4 DEDICATION PAGE

5 ABOUT THE AUTHOR

6 FOREWORDWHAT 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

8 ACKNOWLEDGMENTS

9 PART I: INTRODUCTORY CHAPTERS 1 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES1.1 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 CLAIMS4.1 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 CLAIMS5.1 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 LABELING6.1 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 LABELING7.1 INTRODUCTION 7.2 FEDERAL TRADE COMMISSION 7.3 OTHER REGULATORY CONSIDERATIONS WITH ADVERTISING 7.4 COMPETITOR CHALLENGES

11 PART III: REGULATION OF THE COMPOSITION OF FOOD 8 ECONOMIC AND AESTHETIC ADULTERATION8.1 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 FOOD9.1 INTRODUCTION 9.2 PESTICIDE RESIDUES 9.3 ENVIRONMENTAL CONTAMINANTS 9.4 SCIENCE‐BASED, RISK‐CONTROL PLANS 9.5 FSMA HAZARD ANALYSIS AND PREVENTIVE CONTROL (HARPC) PLANS 9.6 PRODUCE SAFETY STANDARDS 9.7 FSMA PERFORMANCE STANDARDS 9.8 SPECIFIC FOOD PROCESS CONTROL RULES 9.9 REPORTABLE FOOD REGISTRY 10 REGULATION OF THE SAFETY OF INTENTIONAL COMPONENTS OF FOOD: FOOD ADDITIVES, FOOD COLORINGS, AND IRRADIATION10.1 INTRODUCTION 10.2 HISTORY 10.3 BACKGROUND 10.4 FOOD ADDITIVES 10.5 PRIOR‐SANCTIONED SUBSTANCES 10.6 GRAS (GENERALLY RECOGNIZED AS SAFE) 10.7 INDIRECT ADDITIVES 10.8 SOME CONTROVERSIAL FOOD ADDITIVES AND SUBSTANCES 10.9 COLOR ADDITIVES 10.10 FOOD IRRADIATION

12 PART IV: SPECIALIZED FOOD REGULATION 11 DIETARY SUPPLEMENTS11.1 INTRODUCTION 11.3 APPROVAL AND 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 GENETICALLY ENGINEERING AND OTHER BIOTECHNOLOGY12.1 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 12.7 THE ADEQUACY OF REGULATION OF GMO SAFETY12.8 LABELING 12.9 GMO FREE LABELING12.10 THE RIGHT TO KNOW 12.11 GENETIC CONTAMINATION12.12 NANOTECHNOLOGY 12.13 IN VITRO MEAT 12.14 CLONING 13 FOOD DEFENSE13.1 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 EXPORTATION14.1 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 FOOD15.1 INTRODUCTION 15.2 ANIMAL FEED REGULATION 15.3 DRUGS FOR ANIMALS RAISED FOR FOOD 15.4 BSE (MAD COW DISEASE)

13 PART V: INSPECTION AND ENFORCEMENT 16 INSPECTIONS16.1 INTRODUCTION 16.2 FOOD FACILITY REGISTRATION 16.3 CONSTITUTIONAL LIMITS 16.4 STATUTORY POWER FOR INSPECTIONS 16.5 INSPECTION FREQUENCY 16.6 THE WARRANTLESS INSPECTION EXCEPTION 16.7 CONSENT TO INSPECT 16.8 SCOPE OF FDA INSPECTION AUTHORITY 16.9 REFUSAL TO PERMIT ACCESS 16.10 PLANNING FOR THE INSPECTION 16.11 FSIS INSPECTION AUTHORITY 17 FEDERAL ENFORCEMENT17.1 INTRODUCTION 17.2 STATUTORY AUTHORITIES 17.3 ENFORCEMENT JURISDICTION 17.4 ADMINISTRATIVE ACTIONS 17.5 FDA CIVIL COURT ACTIONS 17.6 CRIMINAL PROSECUTION 17.7 OTHER REMEDIES AND CONCERNS 18 STATE LAWS AND THEIR RELATIONSHIP TO FEDERAL LAWS18.1 INTRODUCTION 18.2 STATE INSPECTION AND ENFORCEMENT POWERS 18.3 FEDERAL PREEMPTION OF STATES 18.4 FEDERAL LAWS DELEGATING AUTHORITY TO THE STATES

14 PART VI: GENERAL CHAPTERS 19 PRIVATE ACTIONS19.1 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 REGULATION20.1 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 LAW21.1 INTRODUCTION 21.2 INTERNATIONAL FOOD STANDARDS 21.3 FOREIGN REGULATORY SYSTEMS 21.4 INTERNATIONAL TRADE DISPUTES 22 ETHICS22.1 PROFESSIONALISM AND ETHICS 22.2 ETHICAL PRACTICE POINTERS 22.3 ATTORNEY RULES OF ETHICS 22.4 CRIMINAL STATUTES RELATED TO ETHICS 22.5 RESOURCES

15 GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS A B C D E F G H I J L M N O P Q R S T U V W

16 TABLE OF CASES

17 INDEX

18 END USER LICENSE AGREEMENT

1 Chapter 7TABLE 7.1 Comparison of False and Misleading

2 Chapter 8TABLE 8.1 The Main Food Standards of IdentityTABLE 8.2 Examples of Economic Food Adulterants from FDA’s Files

3 Chapter 9TABLE 9.1 Total RFR Entries Related to HVP Recall by Commodity

4 Chapter 10TABLE 10.1 Categories of Intentional Components of FoodTABLE 10.2 Safety Standards for Substances Added to FoodTABLE 10.3 Colors Exempt from Certification Permitted in FoodTABLE 10.4 Certifiable Color Additives for Food Use

5 Chapter 11TABLE 11.1 Requirement for NDI Notification and NDI Adulteration Standard

6 Chapter 12TABLE 12.1 Oversight of Biotechnology in Food Products by EPA, FDA, and USD...TABLE 12.2 Main Statutes in Food Regulation of Biotechnology Food Products...

7 Chapter 14TABLE 14.1 Countries Eligible to Export Meat and Poultry to the United Stat...

8 Chapter 16TABLE 16.1 FSMA Factors in Risk Categorization

1 Chapter 1 FIGURE 1.1 Elixir of sulfanilamide. FIGURE 1.2 Overlapping statutory authority.

2 Chapter 3 FIGURE 3.1 Statement of identity flowchart.

3 Chapter 4 FIGURE 4.1 Example of a Nutrition Fact Panel Tabular Format. FIGURE 4.2 Standard vertical format 101.9(d)(12).

4 Chapter 6 FIGURE 6.1 The USDA Organic seal. 7 C.F.R. § 205.311.FIGURE 6.2 The Union of Orthodox Jewish Congregations kosher symbol.FIGURE 6.3 The Organized Kashruth Laboratories kosher symbol.FIGURE 6.4 USDA Process Verified seal.