Оглавление
Neal D. Fortin. Food Regulation
Table of Contents
List of Tables
List of Illustrations
Guide
Pages
FOOD REGULATION. Law, Science, Policy, and Practice
ABOUT THE AUTHOR
FOREWORD. WHAT IS FOOD LAW?
Notes
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
ACKNOWLEDGMENTS
1 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES. 1.1 INTRODUCTION
1.2 A SHORT HISTORY OF FOOD REGULATION IN THE UNITED STATES. 1.2.1 Why Do We Have Food Laws?
1.2.2 The 1906 Pure Food and Drug Act
1.2.3 Evolution of the Food Statutes
NOTE
1.3 THE U.S. LEGAL SYSTEM
1.3.1 The Constitution17
1.3.2 Statutes
1.3.3 Regulations
1.3.4 Case Law and Common Law
1.3.5 Federalism
1.4 AGENCY PROCEDURAL REGULATION
1.4.1 The Administrative Procedure Act
1.4.2 Rulemaking
1.4.3 Adjudication
1.4.4 Judicial Review
1.4.5 Federal Advisory Committee Act (FACA)
NOTES AND QUESTIONS
1.4.6 Freedom of Information Act (FOIA)
1.4.7 Constitutional Limitations on Agency Power
Free Speech
Searches
Self‐Incrimination
Due Process
Just Compensation for the Taking of Private Property
Equal Protection
Privacy Rights
1.5 AGENCY JURISDICTION
1.5.1 Food and Drug Administration48 (FDA) Oversees
Food Safety Role
1.5.2 Centers for Disease Control and Prevention (CDC) Food Safety Role
1.5.3 USDA Food Safety and Inspection Service (FSIS) Oversees
Food Safety Role
1.5.4 U.S. Environmental Protection Agency (EPA) Oversees
Food Safety Role
1.5.5 National Marine Fisheries Service (NMFS) Oversees
Food Safety Role
1.5.6 Alcohol and Tobacco Tax and Trade Bureau (TTB)
Oversees
Food Safety Role
1.5.7 U.S. Customs and Border Protection (CBP) Oversees
Food Safety Role
1.5.8 U.S. Department of Justice (DOJ) Food Safety Role
1.5.9 Federal Trade Commission (FTC) Oversees
Food Safety Role
NOTE
1.5.10 State and Local Governments
QUESTION
1.6 MAJOR FEDERAL LAWS. 1.6.1 The Main Statutes
Food, Drug, and Cosmetic Act (FD&C Act)
Federal Meat Inspection Act (FMIA)
Poultry Products Inspection Act (PPIA)
Egg Products Inspection Act (EPIA)
1.6.2 Other Statutes
The Food Additive Amendment of 1958
The Color Additive Amendment of 1960
Food Quality Protection Act (FQPA) in 1996
FDA Modernization Act of 1997
Food Safety Modernization Act (FSMA) in 2011
1.6.3 The Regulations
1.7 INFORMATIONAL RESOURCES. 1.7.1 Government Agencies
1.7.2 Associations and Trade Groups
1.7.3 Other Sources
APPENDIX: CONSTITUTIONAL AMENDMENTS I THROUGH X (THE BILL OF RIGHTS)
Notes
2 WHAT IS FOOD? 2.1 INTRODUCTION TO THE FOOD, DRUG, AND COSMETIC ACT
2.1.1 Definitions
2.1.2 FDA’s Jurisdiction and the Definition of Food
NOTE AND QUESTION
2.1.3 Specific Food Classifications. Meat, Poultry, and Processed Eggs
Water
2.2 WHAT MAKES AN ARTICLE A FOOD OR A DRUG?
2.3 THE CENTRAL ROLE OF INTENDED USE
2.3.1 Products Ordinarily Considered Foods
2.3.2 Evidence of Intended Use
2.4 OTHER CONSIDERATIONS. 2.4.1 Products Intended to Be Processed into Food
2.4.2 Products No Longer Fit for Food
2.4.3 Packaging Materials
DISCUSSION QUESTIONS
Notes
3 FOOD LABELING
3.1 INTRODUCTION
3.2 LEGAL AUTHORITIES
3.3 LABELING TERMINOLOGY
3.3.1 Label Versus Labeling
The Scope of Labeling
3.3.2 Labeling Versus Food Advertising
3.3.3 The Internet and Labeling
QUESTIONS AND NOTES
3.4 AFFIRMATIVE LABEL REQUIREMENTS
3.4.1 Label Terms
Principal Display Panel (PDP)
Information Panel
3.4.2 Statement of Identity
Prominence
Standardized Foods
Undefined Foods—Common or Usual Name
Forms of a Food
Fanciful Names
Misleading Names
QUESTIONS
What’s in a Name? Lean Finely Textured Beef A.K.A. “Pink Slime”
NOTES AND QUESTIONS
Artificially Flavored
Imitation
Beverages Containing Juice
3.4.3 Net Quantity
Metric
Moisture Loss
NOTE
3.4.4 Ingredient Declaration
NOTES
3.4.5 Name and Address of the Responsible Party
3.4.6 Labeling Special Circumstances. Product Dates and Codes
NOTES
3.5 MISBRANDED FOOD: PROHIBITED REPRESENTATIONS. 3.5.1 SEC. 403. Misbranded
DISCUSSION QUESTION
DISCUSSION QUESTIONS
False or Misleading as a Matter of Law
NOTES AND QUESTIONS
Discussion
NOTES AND QUESTIONS
The Battles Over Labeling Substitute Foods
Soymilk
You Say Meat, I Say ‘Schmeat
3.6 DECEPTIVE PACKAGING
3.7 WARNING STATEMENTS. 3.7.1 Product Requiring Warning Statements
3.7.2 Food Labeling Warning and Notice Statements, 21 C.F.R. 101.17
NOTES
3.8 ALLERGENS. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
3.8.1 Petitions for Exemption
3.8.2 Notifications for Exemption
NOTES
3.8.3 Gluten
Gluten Free
NOTE
3.9 ALCOHOLIC BEVERAGES
Allergen Labeling
General Labeling Requirements
Label Approval
Warning Statement
Wine Coolers versus Flavored Wine
NOTES
3.10 USDA FSIS
3.10.1 Labeling Approval
3.10.2 “Generic” Approvals (Labels Without Prior Approval)
3.10.3 Safe Food Handling Instructions Raw Meat and Poultry
Safe Handling Instructions
3.10.4 Additional Information Required
3.10.5 Recordkeeping
Notes
4 NUTRITIONAL LABELING AND NUTRIENT LEVEL CLAIMS. 4.1 INTRODUCTION
NOTES AND QUESTIONS
4.2 THE NUTRITION LABELING AND EDUCATION ACT (NLEA)
4.3 THE NUTRITION FACTS PANEL
4.3.1 The Nutrients
4.3.2 Daily Value (DV)
DRVs
RDIs
4.3.3 Nutrition Facts Format6
Standard
Dual Column8
Simplified Format
Food for Infants and Children
Small and Intermediate‐Size Packages
Shortened Format11
Aggregate Display
4.3.4 Serving Sizes
RACC
Discrete Units
50 Percent or Less of the RACC13
More Than 50 Percent but Less Than 67 Percent of the RACC14
67 to 200 Percent of the RACC15
200 Percent or More of the RACC16
Additional Rules on Determining Serving Size
Individual Units in a Multiserving Package20
Products Sold in Individual Containers Containing Less Than 200 Percent of the RACC21
4.3.5 Declaration of Serving Size. Common Household Measures
4.3.6 Specific Exemptions to Nutrition Facts Labeling
Small Businesses
No Nutritional Significance26
Dietary Supplements27
Medical Foods28
Bulk Shipments29
Raw Fruits and Vegetables and Fish30
Small Packages31
Bulk Containers32
DISCUSSION QUESTION
4.4 TRANS FATS. 4.4.1 Background on Trans Fat
4.4.2 Petition to Ban Hydrogenated Oil
4.4.3 The Trans Fat Labeling Rule
4.4.4 Partially Hydrogenated Oil De‐GRASed
4.5 NLEA AND RESTAURANTS
21 C.F.R. § 101.10 Nutrition labeling of restaurant foods
DISCUSSION QUESTION
4.6 MENU AND VENDING MACHINE LABELING REQUIREMENTS
4.6.1 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
4.6.2 Calorie Labeling of Articles of Food in Vending Machines
4.6.3 State and Local Preemption
4.6.4 Voluntary Election Covered by the Law
NOTE
4.7 NUTRIENT CONTENT CLAIMS (NUTRIENT LEVEL DESCRIPTORS)
4.7.1 Definition
4.7.2 Express versus Implied Claims
4.7.3 Core Nutrient Level Descriptors
Relative Claims83
Sugar Claims84
Inherent Claims85
Nutrient Statements That Are Not Nutrient Content Claims
4.7.4 Meals and Main Dishes
4.7.5 Modifications of Standardized Foods
4.7.6 Disclosure Statements90
4.7.7 Foods Intended for Infants
4.7.8 Exemptions. Brand Names
Diet Soft Drinks
Terms in Standardized Food Names
4.7.9 Statements That Are Not Implied Claims
4.7.10 New Nutrient Content Claim Approvals
Authoritative Statement (FDAMA) Claims
Choline Content Claims
Omega‐3 Nutrient Content Claims
4.7.11 Nutrient Content Claims Absent a Daily Value
4.8 FDA’S FORTIFICATION POLICY
NOTE
DISCUSSION QUESTIONS AND NOTES
Notes
5 HEALTH CLAIMS. 5.1 BACKGROUND
5.2 DEFINITIONS
5.2.1 The Categories of Health Claims
5.2.2 Summary of the General Requirements for Health Claims
5.2.3 Disqualifying Levels of Nutrients
5.2.4 Jelly Bean Rule
5.3 HEALTH‐RELATED CLAIMS THAT ARE NOT REGULATED AS HEALTH CLAIMS. 5.3.1 General Well‐Being Claims
5.3.2 Structure–Function Claims
5.3.3 Dietary Guidance
5.3.4 Nutrient Content Claims
5.4 PREAPPROVED HEALTH CLAIMS (NLEA)
5.4.1 Calcium and Osteoporosis16
Claim Requirements
5.4.2 Dietary Fat and Cancer17
Requirements
5.4.3 Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease18
Requirements
5.4.4 Sodium and Hypertension (High Blood Pressure)19
Requirements
5.4.5 Fiber‐Containing Grain Products, Fruits, and Vegetables and Cancer20
Requirements
5.4.6 Fruits, Vegetables, and Grain Products that Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease21
Requirements
5.4.7 Fruits and Vegetables and Cancer22
Requirements
5.4.8 Folate and Neural Tube Birth Defects23
Requirements
5.4.9 Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries (Cavities)24
Requirements
5.4.10 Dietary Soluble Fiber, Such As That Found in Whole Oats and Psyllium Seed Husk, and Coronary Heart Disease25
Requirements
5.4.11 Soy Protein and Coronary Heart Disease26
Requirements
5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols27
Requirements
5.5 AUTHORITATIVE STATEMENTS – FDA MODERNIZATION ACT
5.6 QUALIFIED CLAIMS
5.6.1 Restricting Commercial Speech
5.6.2 Compelling Commercial Speech
NOTE
5.6.3 Pearson v. Shalala38
NOTES AND QUESTIONS
5.6.4 FDA’s Changes After Pearson
5.6.5 The FDA‐Accepted Qualified Health Claims
NOTES AND DISCUSSIONS
5.6.6 The Pearson Claims Revisited
5.6.7 Assessing Significant Scientific Agreement
NOTES
5.6.8 Guidance for Qualified Health Claims
NOTE AND DISCUSSION
5.7 SUBSTANTIATION OF CLAIMS. 5.7.1 FDA’s Evidence‐Based Review System
5.7.2 Substantiation of Dietary Supplement Claims
Example 1:
Example 2:
Example 3:
Example 4:
Example 5:
Example 10:
5.8 MEDICAL FOODS
5.9 THERAPEUTIC AND RELATED DISEASE CLAIMS
5.9.1 Marketing an Unapproved New Drug
5.9.2 Misbranded Drug Violations Based on Inadequate Directions for Use
Notes
6 CREDENCE CLAIMS AND CONDITIONAL LABELING. 6.1 INTRODUCTION
6.2 COUNTRY OF ORIGIN LABELING
6.2.1 The Tariff Act of 1930
6.2.2 The Farm Bill Country of Origin Labeling (COOL)
COOL and unCOOL – The Trade Dispute
6.2.3 USDA FSIS Country of Origin
6.2.4 FDA and Country of Origin
6.3 ORGANIC FOODS
6.3.1 What is Organic
6.3.2 Certification
6.3.3 Labeling of Organic Products
6.4 NATURAL CLAIMS
6.4.1 USDA
6.4.2 FDA
6.4.3 Confusion and Controversy
Is High‐Fructose Corn Syrup (HFCS) Natural?
NOTE
Private Actions
NOTES
6.5 RELIGIOUS CERTIFICATION MARKS AND SYMBOLS
6.5.1 Kosher
6.5.2 Halal
6.6 GEOGRAPHIC INDICATIONS
6.7 USDA PROCESS VERIFIED
6.8 CONDITIONAL CLAIMS AND MARKS
6.8.1 USDA Food Grades
6.8.2 Trademarks
6.8.3 Copyright
6.8.4 Universal Product Code
Notes
7 ADVERTISING AND OTHER REGULATION OF LABELING. 7.1 INTRODUCTION
7.2 FEDERAL TRADE COMMISSION
7.2.1 Deceptive Advertising and Unfair Practices
7.2.2 Substantiation of Claims
7.2.3 Comparison of FTC and FDA Approaches
7.2.4 FTC Enforcement Procedures
7.3 OTHER REGULATORY CONSIDERATIONS WITH ADVERTISING. 7.3.1 Federal Communications Commission
7.3.2 The U.S. Postal Service
7.3.3 The Alcohol and Tobacco Tax and Trade Bureau (TTB)
7.3.4 State Attorney Generals
7.4 COMPETITOR CHALLENGES
7.4.1 Cease and Desist Letters
7.4.2 NAD or CARU Complaint. NAD
CARU
7.4.3 Alerting Regulators
7.4.4 Lanham Act and Similar Litigation
Notes
8 ECONOMIC AND AESTHETIC ADULTERATION. 8.1 INTRODUCTION
8.1.1 Adulterated
8.1.2 Misbranded
DISCUSSION QUESTIONS
8.2 FOOD STANDARDS: REGULATION OF FOOD IDENTITY AND QUALITY
QUESTION
8.2.1 Historical Overview
8.2.2 The Power to Set Food Standards of Identity
NOTE
NOTES AND QUESTIONS
8.2.3 The Fall of Food Standards?
DISCUSSION QUESTIONS
8.2.4 Are Standards Needed Today?
DISCUSSION QUESTION
8.2.5 Penalties
8.2.6 Temporary Marketing Permits
8.2.7 Imitation
QUESTION
8.2.8 Limits on Standards
NOTE AND QUESTION
8.3 ECONOMIC ADULTERATION. 8.3.1 Substitution of a Valuable Ingredient
8.3.2 Made to Appear Better or of Greater Value
NOTE
8.4 SANITATION AND AESTHETIC ADULTERATION
NOTES
8.4.1 CGMP Regulation
8.4.2 Waiter, There’s a Fly in My Soup—FDA Defect Action Levels
8.4.3 The FDA Food Defect Level Handbook
8.4.4 Blending
8.4.5 De Minimis Filth
8.4.6 Decomposition
8.4.7 Insanitary Conditions
8.4.8 Challenge to the Good Manufacturing Practices
8.4.9 Otherwise Unfit for Food
NOTE
Notes
9 REGULATION OF UNINTENTIONAL POISONOUS OR DELETERIOUS SUBSTANCES IN FOOD. 9.1 INTRODUCTION
9.1.1 Background: The Nature and Cost of Foodborne Illness1
9.1.2 Poisonous and Deleterious Substances
9.1.3 Added Substances
9.1.4 Non‐Added Substances
DISCUSSION QUESTIONS
9.1.5 Tolerances for Unavoidable or Necessary Poisonous and Deleterious Substances
9.2 PESTICIDE RESIDUES
NOTES
9.2.1 Pesticide Residues in Processed Food
9.2.2 Pesticide Residues on Non‐Target Crops
NOTE
9.2.3 Food Quality Protection Act and Risk Analysis. The Evolution of Risk Analysis
Risk Assessment Under FQPA
NOTES
9.3 ENVIRONMENTAL CONTAMINANTS
DISCUSSION QUESTION
9.3.1 Pesticide Contaminants as Food Additives
9.4 SCIENCE‐BASED, RISK‐CONTROL PLANS. 9.4.1 HACCP
9.4.2 HACCP Implementation for Canned Food
9.4.3 Seafood HACCP
9.4.4 Juice HACCP
9.4.5 HACCP Implementation for Meat and Poultry
NOTES AND QUESTIONS
9.4.6 Shiga Toxin‐Producing E. coli Declared Adulterants
NOTES AND QUESTIONS
9.5 FSMA HAZARD ANALYSIS AND PREVENTIVE CONTROL (HARPC) PLANS
9.6 PRODUCE SAFETY STANDARDS
9.6.1 Summary of the Produce Rule
Health and Hygiene
Training
Manure and Compost
Domesticated and Wild Animal
Growing, Harvesting, Packing, and Holding Activities
Equipment, Tools, Buildings, and Sanitation
Sprouts
Recordkeeping
9.6.2 Exemptions
9.7 FSMA PERFORMANCE STANDARDS
9.8 SPECIFIC FOOD PROCESS CONTROL RULES
9.8.1 Low‐Acid Canned Food and Acidified Food
9.8.2 Bottled Drinking Water
9.8.3 Infant Formula
9.8.4 Dietary Supplements
9.8.5 The Egg Safety Rules. Refrigeration of Shell Eggs Held for Retail Distribution
Production, Storage, and Transportation of Shell Eggs
9.9 REPORTABLE FOOD REGISTRY
9.9.1 Exclusions
9.9.2 Reporting
9.9.3 Changes with the Food Safety Modernization Act
NOTES AND QUESTIONS
Notes
10 REGULATION OF THE SAFETY OF INTENTIONAL COMPONENTS OF FOOD: FOOD ADDITIVES, FOOD COLORINGS, AND IRRADIATION. 10.1 INTRODUCTION
10.2 HISTORY. 10.2.1 The Food Additives Amendment of 1958
NOTE
10.3 BACKGROUND
Why Are Additives Used in Foods?
What Is a Food Additive?
What Is a Color Additive?
How Are Additives Regulated?
How Are Additives Approved for Use in Foods?
10.4 FOOD ADDITIVES
10.4.1 FD&C Act Definition
NOTE
10.4.2 Additive Safety and Approval
10.4.3 New Food Additive Petition
Approval of Uses of a Substance
Two Steps for Approved Use in Meats and Alcoholic Beverages
No Permanent Approval
Timeline
10.4.4 Whole Food Versus a Component
DISCUSSION QUESTIONS AND NOTES
10.4.5 Carcinogens
10.4.6 The Delaney Clause
De Minimis and Food Additives
NOTES
10.5 PRIOR‐SANCTIONED SUBSTANCES
10.6 GRAS (GENERALLY RECOGNIZED AS SAFE)
10.6.1 The GRAS Safety Standard
GENERAL RECOGNITION
NOTES
10.7 INDIRECT ADDITIVES
Subcategories of Food Additives
Is Packaging Food?
NOTES AND DISCUSSION
Indirect Food Additive Compliance
Food Contact Notification (FCN) System
Threshold of Regulation (TOR) Exemptions
Manufacturer Postmarket Responsibility with Food Additives
DISCUSSION QUESTION
10.8 SOME CONTROVERSIAL FOOD ADDITIVES AND SUBSTANCES. 10.8.1 Caffeine
10.8.2 MSG
Special Labeling Requirement
10.8.3 Preservatives
10.8.4 Sulfites
10.8.5 Botanicals and Other Novel Ingredients
10.8.6 Hemp and CBD
NOTES
10.9 COLOR ADDITIVES. 10.9.1 Color Additive Amendments of 1960
No Natural Added Coloring
Color Additives are not Food additives
NOTE
10.9.2 Provisional Listing
QUESTIONS AND NOTES
10.9.3 Animal Feed as Food Coloring
10.10 FOOD IRRADIATION
10.10.1 Irradiation Source as a Food Additive
10.10.2 Safety Issues
10.10.3 Labeling
10.10.4 Agricultural Pests
DISCUSSION QUESTIONS AND NOTES
Notes
11 DIETARY SUPPLEMENTS. 11.1 INTRODUCTION
NOTE AND QUESTION
11.1.1 Background to DSHEA
11.1.2 Brief History
11.2 THE STATUTORY DEFINITION
11.2.1 What is a Dietary Supplement
PROBLEM EXERCISE
11.2.2 What is Not a Dietary Supplement
Represented as a Conventional Food
Sole Item of a Meal or Diet
Not Intended for Ingestion
New Drugs
Tobacco
BACKGROUND
FINDINGS AND CONCLUSIONS BY JUDGE ROSS
NATURE’S BOUNTY’S OBJECTIONS
DISCUSSION
CONCLUSION AND ORDER
New Drug Ingredients
Pharmanex v. Shalala
NOTE
11.3 APPROVAL AND SAFETY. 11.3.1 Presumption of Safety
11.3.2 No Food Additive Approval
11.3.3 New Dietary Ingredients (Post‐1994)
Reporting to the FDA
Adequate Information on Safety
11.3.4 Adulteration
NOTES AND QUESTIONS
11.4 ENFORCEMENT
11.4.1 Hurdles for the FDA
Burden of Proof of Adulteration
Advanced Notice of Prosecution
De Novo Review
11.4.2 Adverse Publicity
11.4.3 Other Tools
11.5 GOOD MANUFACTURING PRACTICES (GMPS)
11.6 LABELS. 11.6.1 Basic Labeling Requirements
Iron Supplement Warning
Recommended Use
11.6.2 Literature and Labeling. Definition of Labeling
Drug Claims on Foods
NOTE
11.7 HEALTH CLAIMS. 11.7.1 Background
Health‐Related Claims that are not Considered Health Claims
The Categories of Health Claims
11.7.2 DSHEA Specially Authorized Health‐Related Claims
Substantiation
Notification
Disclaimer for the Special Dietary Supplement Health‐Related Claims
Limit on “Labeling”
11.7.3 Drug Claims
Whitaker v. Thompson
11.8 PROBLEM SUPPLEMENTS. 11.8.1 Ephedra
11.8.2 Androstenedione—Mark McGwire’s Tonic
NOTE
11.8.3 FDA Warnings
11.8.4 Third‐Party Certification
11.9 STREET DRUG ALTERNATIVES
PROBLEM EXERCISE
NOTES AND QUESTIONS
Notes
12 GENETICALLY ENGINEERING AND OTHER BIOTECHNOLOGY. PART A. REGULATION OF PRODUCTION. 12.1 INTRODUCTION
NOTE
12.2 BACKGROUND
12.3 FDA’S REGULATORY REVIEW OF NEW PLANT VARIETIES
12.3.1 FDA’s Consultation for New Plant Varieties
12.3.2 FDA’s Evaluation of New Plant Varieties
Regulatory Overview Example
NOTES AND QUESTIONS
12.3.3 Enhancing the FDA Oversight
12.4 USDA APHIS’ ROLE
12.4.1 Permits and Notifications
12.4.2 Nonregulated Status
12.4.3 Court Ban on Planting of GE Alfalfa
12.4.4 The Plant Protection Act Preempts State GMO Plant Prohibitions
NOTES AND QUESTIONS
12.5 EPA’S ROLE—THE SAFETY OF PESTICIDES IN BIOENGINEERED PLANTS. 12.5.1 Pesticidal Substances in Food
12.5.2 StarLink Corn Investigation and Recall
NOTES AND QUESTIONS
12.5.3 Hypothetical Case Study64
Trends in GE Plant Adoption
12.6 REGULATION OF GENETICALLY ENGINEERED ANIMALS. 12.6.1 FDA’s Authority Over Genetically Engineered Animals
12.6.2 FDA’s Review and Approval of Genetically Engineered Animals
12.6.3 USDA FSIS
12.6.4 GE Animals and the National Environmental Policy Act
12.6.5 AquaBounty’s Genetically Engineered Salmon
NOTES
12.7 THE ADEQUACY OF REGULATION OF GMO SAFETY. 12.7.1 Scientific Consensus on Genetic Engineering Safety
12.7.2 Risks and GMOs
NOTES
PART B. LABELING. 12.8 LABELING
12.8.1 Vermont’s GMO Labeling Law
12.8.2 National Bioengineered Food Disclosure Standard
Disclosure Method
Derived from Bioengineering Disclosure
Exemptions and Exclusions
Negative Claims
NOTES AND QUESTIONS
12.8.3 FD&C Act and Labeling of Recombinant Breeding
12.8.4 Labeling Food from GE Animals
NOTES AND QUESTIONS
12.9 GMO FREE LABELING
Non‐GMO Project Verified
USDA GMO Process Verified
PART C. DISPUTED CASES. 12.10 THE RIGHT TO KNOW
NOTES AND QUESTIONS
Amestoy Mirror Image?—Int’l Dairy Foods Assn. v. Boggs
NOTES AND QUESTIONS
CONCLUSION
NOTES
12.11 GENETIC CONTAMINATION
Rice Contamination with GE Genes
PART D. OTHER BIOTECHNOLOGY. 12.12 NANOTECHNOLOGY
12.13 IN VITRO MEAT
12.14 CLONING
Notes
13 FOOD DEFENSE. 13.1 INTRODUCTION
The Food Defense Roles of the Agencies
13.2 THE ANTI‐TAMPERING ACT
13.3 FOOD TERRORISM. 13.3.1 The Threat
13.3.2 Illness and Death
13.3.3 Economic and Trade Effects
13.3.4 Social and Political Implications
13.3.5 Examples of Contamination. A Salmonella Tainted Election
NOTES
Pesticide Poisoning in Michigan
13.4 THE BIOTERRORISM ACT AND FDA’S NEW POWERS
13.4.1 Food Facility Registration
13.4.2 New Penalties. New Animal Enterprise Terrorism Penalties
Debarment
13.5 FSMA FOOD DEFENSE MANDATES
13.6 CONCLUSIONS
Notes
14 IMPORTATION AND EXPORTATION. 14.1 INTRODUCTION
14.2 THE MAJOR FEDERAL AGENCIES
14.3 THE FDA IMPORT PROCESS
14.3.1 Basic Import Procedure
14.3.2 Prior Notice of Import
14.3.3 Import Food Facility Registration
14.3.4 Additional Forms for Certain Canned Foods, Milk, Cream, and Infant Formula
14.3.5 When a Violation is Found
14.3.6 When a Notice of Action is Issued
14.3.7 Request for Authorization to Relabel or Perform Other Acts
14.3.8 Inspection After Reconditioning or Relabeling
14.3.9 Enforcement
14.4 THE FOOD SAFETY MODERNIZATION ACT—A NEW PARADIGM FOR IMPORTERS
14.4.1 Foreign Supplier Verification Program
Who is the Importer?
Foods Exempt from FSVP
Other Exceptions and Modifications
Small Importers and Small Suppliers
NOTE
14.4.2 A Voluntary Qualified Importer Program
14.4.3 A Mandatory Import Certification Authority
14.4.4 A Third‐Party Auditor Accreditation System
14.4.5 Other Provisions Related to Imported Foods. Port Shopping Provision
Enhanced Registered Facility Requirements
Inspection of Foreign Food Facilities
Capacity Building of Foreign Government Regarding Food Safety
Laboratory Accreditation for Food Testing
14.5 USDA’S IMPORT SYSTEM. 14.5.1 Food Safety Inspection Service (FSIS)
14.5.2 Animal and Plant Health Inspection Service (APHIS)
14.6 OTHER IMPORT CONTROLS. 14.6.1 Customs and Border Protection (CBP)
14.6.2 Environmental Protection Agency (EPA)
14.6.3 Alcohol and Tobacco Tax and Trade Bureau (TTB)
14.6.4 National Oceanic and Atmospheric Administration (NOAA)
14.7 CHALLENGES FACING IMPORT REGULATION
14.8 EXPORT
14.8.1 Export Exemption
14.8.2 Import for Export
14.8.3 Export Certificates
NOTES AND QUESTIONS
Notes
15 ANIMAL FOOD. 15.1 INTRODUCTION
15.2 ANIMAL FEED REGULATION
15.2.1 AAFCO
15.2.2 Recycled Animal Waste in Feed
15.2.3 Animal Food Labeling
NOTE
15.2.4 CGMP and HARPC for Food for Animals
NOTE
15.2.5 Dietary Supplements for Animals
15.3 DRUGS FOR ANIMALS RAISED FOR FOOD
15.3.1 Bovine Somatotropin (BST)
NOTE
15.3.2 Steroid Hormone Implants Used for Growth in Food‐Producing Animals
15.3.3 Drug Residues
15.3.4 Antibiotics in Feed. Background on Antibiotics in Feed and Antibiotic Resistance
Baytril Withdrawn from Poultry Use
National Antimicrobial Resistance Monitoring System (NARMS)
15.3.5 FDA’s Voluntary Guidance
15.3.6 NRDC v. FDA I
15.3.7 NRDC v FDA II
CONCLUSION
15.4 BSE (MAD COW DISEASE)
Notes
16 INSPECTIONS. 16.1 INTRODUCTION
16.2 FOOD FACILITY REGISTRATION
16.3 CONSTITUTIONAL LIMITS
16.4 STATUTORY POWER FOR INSPECTIONS
16.5 INSPECTION FREQUENCY. 16.5.1 Mandated Inspection Frequency
16.5.2 Domestic Facility Risk Categorization and Risk‐Based Inspection Frequencies
16.5.3 Reliance on Other Agency Inspections
16.6 THE WARRANTLESS INSPECTION EXCEPTION
16.7 CONSENT TO INSPECT
16.8 SCOPE OF FDA INSPECTION AUTHORITY. 16.8.1 Statements by Firm Representatives
16.8.2 Affidavits
16.8.3 Records Access. Preventative Controls Records
Records for Foods that may Cause Adverse Health Consequences—§ 414
Exclusions
Specialized Food Records
16.8.4 Traceability Records
One‐Forward, One‐Back Traceability
Data Requirements
Future Enhanced Recordkeeping Requirements
16.9 REFUSAL TO PERMIT ACCESS
NOTE
16.9.1 Records
16.9.2 Photography During Inspections
16.10 PLANNING FOR THE INSPECTION
16.10.1 Policies
16.10.2 Training
16.10.3 FDA’s Notice of Inspection
16.10.4 483 Inspectional Observations (FDA Form 483)
16.10.5 Times of Inspection
16.10.6 Samples
16.10.7 Follow‐up Information
16.10.8 Etiquette for Dealing with FDA Inspectors
16.11 FSIS INSPECTION AUTHORITY
16.11.1 Major Enforcement Powers
16.11.2 Records Access
16.11.3 FSIS’ International Inspection Activities
16.11.4 The Effect of Supreme Beef v. USDA on Inspections
Supreme Beef Processors, Inc. v. USDA
NOTES AND QUESTIONS
Notes
17 FEDERAL ENFORCEMENT. 17.1 INTRODUCTION
17.1.1 A Note on Materials. Statutes
Regulations
Agency Policies and Guidance Documents
17.1.2 The Role of the States
17.1.3 Public Records
17.1.4 Key FSMA Provisions Related to Enforcement
17.2 STATUTORY AUTHORITIES
17.2.1 Prohibited Acts
17.2.2 FDA’s Enforcement Discretion
17.2.3 Role of the Justice Department
17.3 ENFORCEMENT JURISDICTION. 17.3.1 Introduction into Interstate Commerce
17.3.2 Held for Sale after Shipment in Interstate Commerce
17.3.3 FD&C Act Interstate Commerce Presumption
17.3.4 FDA Jurisdiction Over Restaurants
17.4 ADMINISTRATIVE ACTIONS. 17.4.1 List of Inspectional Observations
17.4.2 Warning Letters. FDA Warning Letters
FDA Cyber Letters
FDA Untitled Correspondence
FSIS Letters of Warning and Notices of Intended Enforcement Action (NOIE)
17.4.3 Recalls
Recall Procedures
NOTES
17.4.4 Debarment
17.4.5 Detentions
Administrative Detentions
Import Detentions
17.4.6 Import Denial of Entry
Denial of Import Entry for Refusal of Inspection
17.4.7 Suspension of Registration
17.4.8 Civil Penalties. Civil Money Penalty Authority
Consent Decrees
Injunctions
Fencing In
17.4.9 Withdrawal of Product Approvals
17.4.10 Inspection‐Related Enforcement Powers of FSIS
17.5 FDA CIVIL COURT ACTIONS. 17.5.1 Seizure
USDA
Remedies and Consequences
Role of the States in Seizures
The Exclusionary Rule and Seized Food
17.5.2 Injunction
17.5.3 Contempt Action
17.5.4 Destruction of Products without a Hearing
17.6 CRIMINAL PROSECUTION
17.6.1 Strict Liability
NOTES
17.6.2 Penalties
17.7 OTHER REMEDIES AND CONCERNS. 17.7.1 Adverse Publicity
NOTES
17.7.2 Referral to State Agencies
17.7.3 Post‐Enforcement Compliance Monitoring
17.7.4 Criminal Code Charges
CASE STUDY: PEANUT CORP OF AMERICA
17.7.5 Whistleblower Protection
NOTES AND QUESTIONS
Notes
18 STATE LAWS AND THEIR RELATIONSHIP TO FEDERAL LAWS. 18.1 INTRODUCTION
18.1.1 Overview of the Role of States
18.1.2 Reliance on State and Local Inspections
18.1.3 FSIS
18.1.4 Related Authorities
18.1.5 National and State Cooperation
18.1.6 Uniformity
18.1.7 California Proposition 65
NOTES AND QUESTIONS
18.1.8 Organizations Fostering Uniformity
NOTE AND QUESTION
18.2 STATE INSPECTION AND ENFORCEMENT POWERS
18.2.1 Seizure and Condemnation
18.2.2 Destruction of Products without a Hearing
18.3 FEDERAL PREEMPTION OF STATES
18.3.1 Express Preemption of Inconsistent State Law
Meat Inspection Programs
State Meat Inspection Programs
FD&C Act Preemptive Provisions
18.3.2 Comprehensive Federal Scheme That Occupies the Field
18.3.3 Direct Conflict Between Federal and State Law
18.3.4 State Law When an Obstacle to the Purposes and Objectives of Congress
18.3.5 Unreasonable Burden on Interstate Commerce
NOTE
18.4.FEDERAL LAWS DELEGATING AUTHORITY TO THE STATES
Prescription Drug Marketing Act of 1987
Nutritional Labeling and Education Act of 1990 (NLEA)
Notes
19 PRIVATE ACTIONS. 19.1 INTRODUCTION
19.2 COMPETITOR LAWSUITS
19.2.1 The Lanham Act
19.2.2 Intersection of Two Federal Laws
NOTES AND QUESTIONS
19.2.3 Unfair Trade Practices
19.3 PRODUCTS LIABILITY. 19.3.1 The Hot Coffee Case
19.3.2 Products Liability
19.3.3 Strict Liability
19.3.4 Breach of Implied Warrant
19.3.5 Breach of Express Warranty
19.3.6 Negligence
Foreign‐Natural Test vs. Reasonable Expectation
DISCUSSION
TORT CLAIM
Duty of the Defendant
Breach of Duty
DECREE
NOTE
9.3.7 Negligence Per Se
19.3.8 Punitive Damages
NOTE AND QUESTION
19.3.9 Preemption of Tort Claims. Generally
Rebuttal Presumption of Non‐Liability
NOTES AND QUESTIONS
19.4 THE FALSE CLAIMS ACT
19.5 NO PRIVATE CAUSE OF ACTION UNDER THE FD&C ACT
NOTE
Notes
20 ADMINISTRATIVE LAW AND FOOD REGULATION. 20.1 INTRODUCTION
20.2 RULEMAKING—THE POWER TO LEGISLATE. 20.2.1 Procedural Requirements
20.2.2 The Importance of Contemporaneous Record of the Reasoning
QUESTIONS AND NOTES
20.2.3 Informal Rulemaking Notice and Comment
NOTES AND QUESTIONS
NOTE AND QUESTION
20.2.4 Guidance, Interpreted Rule, or Substantive Rule?
Michigan Example of a Disguised Rule
NOTE
20.3 THE POWER TO ADJUDICATE
20.4 EXECUTIVE CONTROL OF THE AGENCIES. 20.4.1 HHS oversight
20.4.2 OMB
20.4.3 Executive Orders
20.5 ADMINISTRATIVE DISCRETION. 20.5.1 Congressional Review
20.5.2 Review of Agency Enforcement Discretion
NOTES
20.5.3 Regulatory Delay and Timeliness
CONCLUSION
NOTE
20.6 PUBLIC ACCESS TO AGENCY INFORMATION. 20.6.1 FOIA
Confidentiality of Trade Secrets
Reverse FOIA
20.6.2 Open Meetings Act
20.7 ENVIRONMENTAL ASSESSMENT
20.7.1 FDA’s Obligation to Comply with NEPA
20.7.2 Threshold for an Environmental Impact Statement and Adequacy of an Environmental Assessment
NOTE
20.7.3 Adequacy of the Environmental Impact Statement—The Hard Look Doctrine
20.7.4 Decision‐making in Situations of Uncertainty
Notes
21 INTERNATIONAL FOOD LAW. 21.1 INTRODUCTION
21.2 INTERNATIONAL FOOD STANDARDS
21.2.1 Codex Alimentarius
Codex Membership
Organizational Structure
Trade Disputes
Codex Alimentarius and U.S. Agencies
NOTES AND QUESTIONS
21.2.2 The WTO and International Trade Agreements
The SPS Agreement
The TBT Agreement
DISCUSSION QUESTIONS
21.2.3 U.S. Jurisprudence
21.3 FOREIGN REGULATORY SYSTEMS
21.3.1 Background on the European Union
21.3.2 EU Food Issues with the United States
21.4 INTERNATIONAL TRADE DISPUTES. 21.4.1 Beef Hormones
21.4.2 The GMO Food Fight
Differing Approval Systems
NOTES AND QUESTIONS
21.4.3 EU Labeling
NOTES AND QUESTIONS
21.4.4 The Precautionary Principle
DISCUSSION QUESTIONS
Notes
22 ETHICS. 22.1 PROFESSIONALISM AND ETHICS
22.2 ETHICAL PRACTICE POINTERS
22.3 ATTORNEY RULES OF ETHICS
DISCUSSION QUESTION
22.4 CRIMINAL STATUTES RELATED TO ETHICS
22.5 RESOURCES
Notes
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
TABLE OF CASES
INDEX
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