Food regulation law, science, policy, and practice, 2nd edition

FOOD REGULATION



FOOD REGULATION
Law, Science, Policy, and Practice
Second Edition

NEAL D. FORTIN


Copyright  2017 by Neal D. Fortin. All rights reserved
Published by John Wiley & Sons, Inc., Hoboken, New Jersey
Published simultaneously in Canada
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Library of Congress Cataloging-in-Publication Data:
Names: Fortin, Neal D., author.
Title: Food regulation : law, science, policy, and practice / Neal D. Fortin.

Description: Second edition. | Hoboken : Wiley, 2017. | Includes index.
Identifiers: LCCN 2016031565| ISBN 9781118964477 (hardback) | ISBN
9781118964491 (epub)
Subjects: LCSH: Food law and legislation–United States. | Food industry and
trade–Safety regulations–United States. | Food adulteration and
inspection–United States. | BISAC: TECHNOLOGY & ENGINEERING / Food
Science. | SOCIAL SCIENCE / Agriculture & Food. | LAW / Agricultural.
Classification: LCC KF3875 .F67 2017 | DDC 344.7304/232–dc23 LC record available at />Printed in the United States of America
10 9 8

7 6 5 4

3 2 1


Dedicated to
Katherine Fortin
and
Helen Fortin



TABLE OF CONTENTS

ABOUT THE AUTHOR
FOREWORD

xxiii
xxv

PREFACE

xxvii

ACKNOWLEDGMENTS

xxxi

PART I INTRODUCTORY CHAPTERS
1

Introduction to Food Regulation
1.1
Introduction
1.2
A Short History of Food Regulation in the United States
1.2.1
Why Do We Have Food Laws?
1.2.2
The 1906 Pure Food and Drug Act
1.2.3
Evolution of the Food Statutes
1.3
The U.S. Legal System
1.3.1
The Constitution
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)
1.4.6
Freedom of Information Act (FOIA)
1.4.7
Constitutional Limitations on Agency Power
1.5
Agency Jurisdiction
1.5.1
Food and Drug Administration

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1.6

1.7

2

1.5.2
Centers for Disease Control and Prevention (CDC)
1.5.3
USDA Food Safety and Inspection Service (FSIS)
1.5.4
U.S. Environmental Protection Agency (EPA)
1.5.5
National Marine Fisheries Service (NMFS)
1.5.6
Alcohol and Tobacco Tax and Trade Bureau (TTB)
1.5.7
U.S. Customs and Border Protection (CBP)
1.5.8
U.S. Department of Justice (DOJ)
1.5.9
Federal Trade Commission (FTC)
1.5.10 State and Local Governments
Major Federal Laws
1.6.1
The Main Statutes
1.6.2
Other Statutes
1.6.3
The Regulations
Informational Resources
1.7.1
Government Agencies
1.7.2
Associations and Trade Groups

1.7.3
Other Sources

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
2.1.3
Specific Food Classifications
Meat, Poultry, and Eggs
Water
2.2
What Makes an Article a Food or a Drug?
Nutrilab, Inc. v. Schweiker
2.3
The Central Role of Intended Use
2.4
Other Considerations
2.4.1
Products Ordinarily Considered Foods
2.4.2
Products Intended to Be Processed into Food
2.4.3
Products No Longer Fit for Food
2.4.4
Packaging Materials
2.4.5

Evidence of Intended Use

PART II REGULATION OF LABELING, ADVERTISING, AND CLAIMS
3

Food Labeling
3.1
Introduction
3.2
Legal Authorities
3.3
Labeling Terminology
3.3.1
Label versus Labeling
3.3.2
The Scope of Labeling
Kordel v. United States
3.3.3
Labeling versus Food Advertising
3.3.4
The Internet and Labeling
3.4
Affirmative Label Requirements
3.4.1
Label Terms
3.4.2
Statement of Identity
Name of the Food
Prominence
Standardized Foods

Undefined Foods—Common or Usual Name

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4

Forms of a Food
Fanciful Names

Federation of Homemakers v. Butz
What’s in a Name? Lean Finely Textured Beef A.K.A.
“Pink Slime”
Artificially Flavored
Imitation
Beverages Containing Juice
When Is Peach Juice Apple Juice?
3.4.3
Net Quantity
3.4.4
Ingredient Declaration
Ingredient Labeling: What’s in a Food?
Specialized Ingredient Labeling Requirements
Incidental Additives and Processing Aids
3.4.5
Name and Address of the Responsible Party
3.4.6
Labeling Special Circumstances
3.5
Misbranded Food: Prohibited Representations
3.5.1
Sec. 403. Misbranded
Federal Food, Drug, and Cosmetic Act
Misbranded Food
FD&C Act § 201(n)
United States v. 95 Barrels Alleged Apple Cider
United States v. 432 Cartons Individually Wrapped Candy
Lollipops
Misleading to Whom?
U.S. v. Manischewitz Diet Thins

3.6
Deceptive Packaging
United States v. 174 Cases Delson Thin Mints
3.7
Warning Statements
3.7.1
Product Requiring Warning Statements
3.8
Allergens
3.9
Alcoholic Beverages
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
3.10.4 Additional Information Required
3.10.5 Record Keeping

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Nutritional Labeling and Nutrient Level claims
4.1
Introduction
McF at Litigation
Pelman ex rel. v. McDonald’s Corp.
4.2
The Nutrition Labeling and Education Act (NLEA)
Good Reading for Good Eating
4.3
The Nutrition Facts Panel
4.3.1
Daily Value (DV)
4.3.2
Nutrition Facts Format
4.3.3
Serving Sizes
4.3.4
Declaration of Serving Size
Common Household Measures
4.3.5
Specific Exemptions to Nutrition Facts Labeling
Small Businesses

4.4
Trans Fats

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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
NLEA and Restaurants
Public Citizen and CSPI v. Shalala
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
Nutrient Content Claims (Nutrient Level Descriptors)
4.7.1
Definition
4.7.2
Express versus Implied Claims
4.7.3
Core Nutrient Level Descriptors
4.7.4
Meals and Main Dishes
4.7.5
Modifications of Standardized Foods
4.7.6
Disclosure Statements
4.7.7
Exemptions
4.7.8
New Nutrient Content Claim Approvals

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Health Claims
5.1
Background
5.2
Definitions
5.2.1
The Categories of Health Claims
5.3
Health-Related Claims That Are Not 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 Osteoporosis
5.4.2
Dietary Fat and Cancer
5.4.3
Dietary Saturated Fat and Cholesterol and Risk of
Coronary Heart Disease
5.4.4
Sodium and Hypertension (High Blood Pressure)
5.4.5

Fiber-Containing Grain Products, Fruits, and Vegetables
and Cancer
5.4.6
Fruits, Vegetables, and Grain Products that Contain
Fiber, Particularly Soluble Fiber, and Risk of
Coronary Heart Disease
5.4.7
Fruits and Vegetables and Cancer
5.4.8
Folate and Neural Tube Birth Defects
5.4.9
Dietary Noncariogenic Carbohydrate Sweeteners
and Dental Caries (Cavities)
5.4.10 Dietary Soluble Fiber, Such As That Found in Whole
Oats and Psyllium Seed Husk, and Coronary Heart Disease
5.4.11 Soy Protein and Coronary Heart Disease
5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols
5.5
Authoritative Statements: FDA Modernization Act
5.6
Qualified Claims
5.6.1
Commercial Speech
Central Hudson Gas & Electric v. Public Service Commission
of New York

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4.5
4.6

4.7

5

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5.6.2

5.7

5.8

Pearson v. Shalala
Pearson v. Shalala
5.6.3
FDA’s Changes After Pearson
5.6.4

The Accepted Qualified Health Claims
5.6.5
The Pearson Claims Revisited
5.6.6
Assessing Significant Scientific Agreement
5.6.7
Guidance for Qualified Health Claims
Substantiation of Claims
5.7.1
FDA’s Evidence-Based Review System
5.7.2
Substantiation of Dietary Supplement Claims
Therapeutic and Related Disease Claims
5.8.1
Marketing an Unapproved New Drug
5.8.2
Misbranded Drug Violations Based on Inadequate
Directions for Use

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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
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
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

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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
FTC’s Dietary Supplements Advertising Guide for Industry
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

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7.4

Competitor Challenges
7.4.1
Cease and Desist Letters
7.4.2
NAD or CARU Complaint
7.4.3
Alerting Regulators
7.4.4
Lanham Act and Similar Litigation

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PART III REGULATION OF THE COMPOSITION OF FOOD

127

8

Economic and Aesthetic Adulteration
129
8.1
Introduction
129
8.1.1
Adulterated
129
Food, Drug, and Cosmetic Act (21 U.S.C.§ 301 et seq.)
129
8.1.2
Misbranded
130
8.2
Food Standards: Regulation of Food Identity and Quality
130
8.2.1
Historical Overview
130
The Main Food Standards of Identity
131
What Are the Requirements Regarding Food Standards?
131
The Rise and Fall of Federal Food Standards in the
United States: The Case of the Peanut Butter and Jelly
Sandwich
132

8.2.2
The Power to Set Food Standards of Identity
136
Carolene Products Co. v. United States
136
Columbia Cheese Co. v. McNutt
137
Code of Federal Regulations
139
Corn Products Co. v. Dept. of HEW
140
Libby, McNeil, & Libby v. United States
143
8.2.3
Are Standards Needed Today?
144
8.2.4
Penalties
145
8.2.5
Temporary Marketing Permits
145
8.2.6
Imitation
145
62 Cases of Jam v. United States
145
8.2.7
Limits on Standards
146

Milnot Co. v. Richardson
147
8.3
Economic Adulteration
148
8.3.1
Substitution of a Valuable Ingredient
148
Fake Food Fight: Substitution of a valuable ingredient
148
Table 8-2 Examples of Economic Food Adulterants
from FDA’s Files
150
8.3.2
Made to Appear Better or of Greater Value
150
8.4
Sanitation and Aesthetic Adulteration
150
U.S. v. 1,500 Cases . . . Tomato Paste
151
8.4.1
CGMP Regulation
152
Current Good Manufacturing Practice (CGMP) in
Manufacturing, Packing, or Holding Human Food
152
8.4.2
Waiter, There’s a Fly in My Soup—FDA Defect Action Levels 153
8.4.3

The FDA Food Defect Level Handbook
153
The Food Defect Action Levels: Levels of natural or
unavoidable defects in foods that present no health hazards
for humans
153
8.4.4
Blending
155
8.4.5
De Minimis Filth
155
United States v. 484 Bags, More or Less
155
United States v. Capital City Foods, Inc.
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8.4.6
8.4.7

8.4.8
8.4.9

9

Decomposition
U.S. v. An Article of Food . . . 915 Cartons of Frog Legs

Insanitary Conditions
U.S. v. 1,200 Cans Pasteurized Whole Eggs by Frigid Food
Products
Good Manufacturing Practices
United States v. Nova Scotia Food Products Corp.
Otherwise Unfit for Food
United States v. 24 Cases, More or Less [Herring Roe]
United States v. 298 Cases, etc., Ski Slide Brand Asparagus, etc.

Regulation of Unintentional Poisonous or Deleterious Substances
in Food
9.1
Introduction
9.1.1
Background—The Nature and Cost of Foodborne Illness
9.1.2
Poisonous and Deleterious Substances
9.1.3
Added Substances
United States v. Lexington Mill & Elevator Co.
9.1.4
Non-Added Substances
U.S. v. 1231 Cases American Beauty Brand Oysters
9.1.5
Tolerances for Unavoidable or Necessary Poisonous and
Deleterious Substances
Tolerances for Poisonous or Deleterious Substances in Food
Young v. Community Nutrition Institute et al.
9.2
Pesticide Residues

9.2.1
FIFRA and EPA
9.2.2
FQPA and Risk Assessment
9.3
Environmental Contaminants
United States v. Anderson Seafoods, Inc.
9.4
Specific Food Safety Rules
9.4.1
Low-Acid Canned Food and Acidified Food
9.4.2
Bottled Drinking Water
9.4.3
Infant Formula
9.4.4
Dietary Supplements
9.4.5
The Egg Safety Rules
9.5
Science-Based, Risk-Control Plans
9.5.1
HACCP
9.5.2
HACCP Implementation for Canned Food
9.5.3
Seafood HACCP
9.5.4
Juice HACCP
9.5.5

HACCP Implementation for Meat and Poultry
Supreme Beef Processors, Inc. v. USDA
9.6
FSMA Hazard Analysis and Preventive Control (HARPC) Plans
Hazard Analysis and Risk-Based Preventive Controls for
Human Food
Small Food Producer Exemption
9.7
Produce Safety Standards
9.7.1
Summary of the Produce Rule
9.7.2
Exemptions
9.8
Additional Food Safety Performance Standards
9.8.1
FSMA Performance Standards
9.8.2
Shiga Toxin-Producing E. coli Declared Adulterants
Texas Food Industry et al. v. Mike Espy et al.
9.9
Reportable Food Registry

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9.9.1
9.9.2
9.9.3

10

Exclusions
Reporting
Changes with the Food Safety Modernization Act

Table 9.1 Total RFR Entries Related to HVP Recall by
Commodity
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
10.3.1 The Food additives amendment of 1958
10.3.2 FD&C Act Definition
Federal Food, Drug, and Cosmetic Act § 201
21 C.F.R. Part 170—Food Additives
10.3.3 Additive Safety and Approval
10.3.4 New Food Additive Petition
United States v. Two Plastic Drums . . . Black Currant Oil
10.3.5 Carcinogens
10.3.6 The Delaney Clause
Scott v. FDA
Monsanto Co. v. Kennedy
Public Citizen v. Young
10.4 Prior Sanctioned Substances
10.5 GRAS (Generally Recognized As Safe)
United States v. An Article of Food, Coco Rico, Inc.
10.6 Indirect Additives
Natick Paperboard Corp. v. Casper Weinberger and FDA
10.7 Some Controversial Food Additives and Substances
10.7.1 Preservatives
10.7.2 Botanicals and Other Novel Ingredients
10.8 Color Additives
10.8.1 Color Additive Amendments of 1960
10.8.2 Provisional Listing

Federal Food, Drug, and Cosmetic Act § 201(t)
10.8.3 Animal Feed as Food Coloring
United States V. An Article of Food Consisting of 12
Barrels . . . Lumpfish Roe
10.9 Food Irradiation
10.9.1 Irradiation Source as a Food Additive
10.9.2 Safety Issues
Irradiation: A Safe Measure for Safer Food
Approved Uses of Irradiation
Figure 10-1 Radura symbol for irradiated food
10.9.3 Labeling
10.9.4 Agricultural Pests

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PART IV SPECIALIZED FOOD REGULATION

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11

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Dietary Supplements
11.1 Introduction
11.1.1 Background to DSHEA
11.1.2 Brief History
11.2 The Statutory Definition
Federal Food, Drug, and Cosmetic Act § 201


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11.2.1
11.2.2

11.3

11.4

11.5
11.6

11.7

11.8

11.9
12

What is a Dietary Supplement
What is Not a Dietary Supplement
United States v. Ten Cartons of Ener-B Nasal Gel
New Dietary Ingredients
Pharmanex v. Shalala
Approval & Safety
11.3.1 Presumption of Safety
Dietary Supplement Health and Education Act of 1994
11.3.2 No Food Additive Approval
11.3.3 New Dietary Ingredients (Post-1994)
11.3.4 Adulteration
Federal Food, Drug, and Cosmetic Act § 402(f)
Enforcement
11.4.1 Hurdles for the FDA
11.4.2 Adverse Publicity
Kava Linked to Liver Damage
11.4.3 Other Tools
Good Manufacturing Practices (GMPS)
Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 342
Labels
11.6.1 Basic Labeling Requirements
Figure 11–1 Supplement label
11.6.2 Literature and Labeling
Federal Food, Drug, and Cosmetic Act § 403B

Federal Food, Drug, and Cosmetic Act § 201
Health Claims
11.7.1 Background
11.7.2 DSHEA Specially Authorized Health-Related Claims
11.7.3 Drug Claims
Federal Food, Drug, and Cosmetic Act
Whitaker v. Thompson
Problem Supplements
11.8.1 Ephedra
11.8.2 Androstenedione—Mark McGwire’s Tonic
11.8.3 FDA Warnings
11.8.4 Third Party Certification
Street Drug Alternatives
United States v. Undetermined Quantities of Articles of Drug

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Genetic Engineering and Other Biotechnology

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PART A. REGULATION OF PRODUCTION
12.1 Introduction

12.2 Background
Genetically Modified Foods: Experts View Regimen of Safety
Tests as Adequate, but FDA’s Evaluation Process Could Be
Enhanced
12.2.1 Scientific Consensus on Genetic Engineering Safety
12.2.2 Risks from GMOs
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
12.3.3 Enhancing the FDA Oversight

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12.4

13

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
Robert Ito Farm, Inc. v. County of Maui
12.5 EPAS Role—The Safety of Pesticides In Bioengineered Plants
12.5.1 Pesticidal Substances in Food
12.5.2 StarLink Corn Investigation and Recall
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

286
286
287
287

PART B. LABELING

12.7 Labeling
12.7.1 Labeling of Recombinant Breeding
Guidance for Industry: Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Developed
Using Bioengineering
12.7.2 Labeling Food from GE Animals
12.7.3 GMO Free Labeling
Non-GMO Project Verified
USDA GMO Process Verified
12.7.4 Vermont’s GMO Labeling Law

293
293
293

PART C. DISPUTED CASES
12.8 The Right To Know
FDA, Statement of Policy: Foods Derived from New Plant
Varieties
International Dairy Foods Ass’n v. Amestoy
Amestoy Mirror Image?–Int’l Dairy Foods Assn. v. Boggs
Alliance for Bio-Integrity v. Shalala
12.9 Genetic Contamination
Rice Contamination with GE Genes

301
301
301
301
304

305
311
311

PART D. OTHER BIOTECHNOLOGY
12.10 Nanotechnology
12.11 in Vitro Meat
12.12 Cloning

312
312
313
313

Food Defense
13.1 Introduction
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

317
317
318
318
318
319
319

319

287
288
289
289
290
291
291
291
292
292
292

294
298
300
300
300
300


TABLE OF CONTENTS

13.3.5

14

15

Examples of Contamination
Nicotine Poisoning After Ingestion of Contaminated Ground
Beef—Michigan, 2003
13.4 The Bioterrorism Act and FDA’s New Powers
13.4.1 Food Facility Registration
13.4.2 New Penalties
13.5 FSMA Food Defense Mandates
13.6 Conclusions

319

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
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
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
U.S. V. 76,552 Pounds of Frog Legs
14.8.3 Export Certificates

325
325
326
326
327
327
328

331

331
331
332
332
332
333
333
334
334
334
334
334
334
336

Animal Food
15.1 Introduction
15.2 Animal Feed Regulation
15.2.1 AAFCO
15.2.2 Recycled Animal Waste in Feed

339
339
339
342
342

320
321
322

322
322
323

328
328
328
329
329
329
329
330
330
330
330
331
331
331
331

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TABLE OF CONTENTS

15.2.3
15.2.4
15.2.5

Animal Food Labeling
CGMP and HARPC for Food for Animals
Dietary Supplements for Animals
Update on Animal Dietary Supplements
15.3 Drugs For Animals Raised For Food
15.3.1 Bovine Somatotropin (BST)
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
Guidance for Industry #209: The Judicious Use of Medically
Important Antimicrobial Drugs in Food-Producing Animals
FDA (April 13, 2012)
Guidance for Industry #213
15.3.6 NRDC v. FDA I
Natural Resources Defense Council et al. v. FDA
Natural Resources Defense Council et al. v. FDA
15.3.7 NRDC v FDA II
Natural Resources Defense Council, Inc., et al. v. FDA
15.4 BSE (Mad Cow Disease)

343
343
344
344

344
344
345
345
345
345
346
346
346
346
346
349
350
350
351
352
353
357

PART V INSPECTION AND ENFORCEMENT

359

16

361
361
361
361
361

362
362
362
362
362
363
363
363
363
363
364

Federal Enforcement
16.1 Introduction
16.1.1 A Note on Materials
Statutes
Regulations
Agency Policies and Guidance Documents
16.1.2 The Role of the States
16.1.3 Public Records
16.1.4 Key FSMA Provisions Related to Enforcement
16.2 Statutory Authorities
16.2.1 Prohibited Acts
16.2.2 FDA’s Enforcement Discretion
16.2.3 Role of the Justice Department
16.3 Enforcement Jurisdiction
16.3.1 Introduction into Interstate Commerce
16.3.2 Held for Sale after Shipment in Interstate Commerce
United States v. 40 Cases . . . “Pinocchio Brand . . .
Blended . . . Oil”

16.3.3 FD&C Act Interstate Commerce Presumption
16.3.4 FDA Jurisdiction over Restaurants
16.4 Administrative Enforcement
16.4.1 List of Inspectional Observations
16.4.2 Warning Letters
FDA Warning Letters
FDA Cyber Letters
FDA Untitled Correspondence

364
365
366
366
366
366
366
368
368


TABLE OF CONTENTS

FSIS Letters of Warning and Notices of Intended
Enforcement Action (NOIE)
16.4.3 Recalls
Recall Procedures
16.4.4 Debarment
16.4.5 Detentions
Administrative Detentions
Import Detentions

16.4.6 Import Denial of Entry
Denial of Import Entry for Refusal of Inspection
16.4.7 Suspension of Registration
16.4.8 Civil Penalties
Civil Money Penalty Authority
Consent Decrees
16.4.9 Withdrawal of Product Approvals
16.4.10 Inspection-Related Enforcement Powers of FSIS
16.5 FDA Civil Court Actions
16.5.1 Seizure
Remedies and Consequences
Role of the States in Seizures
16.5.2 Injunction
16.5.3 Contempt Action
16.5.4 Destruction of Products without a Hearing
North American Cold Storage Co. v. City of
Chicago et al.
16.6 Criminal Actions
16.6.1 Strict Liability
United States v. Park
16.6.2 Fines, Prison
16.7 Other Remedies and Concerns
16.7.1 Adverse Publicity
16.7.2 Referral to State Agencies
16.7.3 Postenforcement Compliance Monitoring
16.7.4 Criminal Code Charges
17

Inspections
17.1 Introduction

17.2 Constitutional Limits
17.3 Statutory Power For Inspections
17.4 Inspection Frequency
17.4.1 Mandated Inspection Frequency
17.4.2 Domestic Facility Risk Categorization and Risk-Based
Inspection Frequencies
Table 17-1 FSMA Factors in Risk Categorization
17.4.3 Reliance on Other Agency Inspections
17.5 The Warrantless Inspection Exception
United States v. Jamieson-McKames Pharmaceuticals, Inc.
17.6 Consent to Inspect
United States v. Thriftimart, Inc.
17.7 Scope of FDA Inspection Authority
17.7.1 Statements by Firm Representatives
17.7.2 Affidavits
17.7.3 Records Access
Preventative controls records

368
368
368
369
370
370
370
371
371
371
371
371

372
372
372
373
373
373
374
374
374
374
374
377
377
378
381
382
382
382
382
382
385
385
385
386
387
387
387
388
388
388

388
391
391
392
392
392
392
392

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TABLE OF CONTENTS

Records for foods that may cause adverse health
consequences–§ 414
Exclusions
Specialized food records
17.7.4 Traceability Records
17.8 Refusal to Permit Access
17.8.1 Records
17.8.2 Photography During Inspections
Is a Picture Worth More than 1,000 Words?
17.9 Planning For The Inspection
17.9.1 Policies
17.9.2 Training
17.9.3 FDA’s Notice of Inspection
17.9.4 483 Inspectional Observations (FDA Form 483)

Image 17.1 Form FDA 483 Inspectional
Observations – Sunland, Inc.
17.9.5 Times of Inspection
17.9.6 Samples
17.9.7 Follow-up Information
17.9.8 Etiquette for Dealing with FDA Inspectors
17.10 FSIS Inspection Authority
17.10.1 Major Enforcement Powers
17.10.2 Records Access
17.10.3 FSIS’ International Inspection Activities
17.10.4 The Effect of Supreme Beef v. USDA on Inspections
Supreme Beef Processors, Inc. v. USDA
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
California Proposition 65
18.1.7 Organizations Fostering Uniformity
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
Florida Lime and Avocado Growers, Inc. v. Paul
Hillsborough Co. v. Automated Medical Labs, Inc.
18.3.3 Direct Conflict Between Federal and State Law
18.3.4 State Law an Obstacle to the Purposes and Objectives of
Congress
Jones v. Rath Packing Co.
18.3.5 Unreasonable Burden on Interstate Commerce
18.4 Federal Laws Delegating Authority To The States

393
393
393
393
393
394
395
395
401
402
402
402
402
403
404
404
404
404

404
405
406
406
406
407
409
409
409
409
410
410
410
410
410
411
412
412
412
412
413
413
413
413
413
413
415
418
418
418

421
422


TABLE OF CONTENTS

Prescription Drug Marketing Act of 1987
Nutritional Labeling and Education Act of 1990 (NLEA)

422
422

PART VI GENERAL CHAPTERS

423

19

Private Actions
19.1 Introduction
19.2 Competitor Lawsuits
19.2.1 The Lanham Act
19.2.2 Intersection of Two Federal Laws
POM Wonderful LLC v. Coca–Cola Co.
19.2.3 Unfair Trade Practices
19.3 Products Liability
19.3.1 Products Liability
19.3.2 Strict Liability
19.3.3 Breach of Implied Warrant
19.3.4 Breach of Express Warranty

19.3.5 Negligence
Porteous v. St. Ann’s Café & Deli
Jackson v. Nestle-Beich, Inc.
19.3.6 Negligence Per Se
Orthopedic Equipment Co. v. Eutsler
Blommer Chocolate Co. v. Bongards Creameries, Inc.
19.3.7 Punitive Damages
19.3.8 Preemption of Tort Claims
19.4 The False Claims Act
19.5 No Private Cause of Action Under The Fd&C Act
Florida ex rel. Broward Co. v. Eli Lilly & Co.
Merrell Dow Pharmaceuticals, Inc. v. Thompson

425
425
425
425
426
426
431
431
432
432
432
433
433
434
436
439
439

440
442
443
444
445
445
445

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
Federation of Homemakers v. Butz
20.2.3 Informal Rulemaking Notice and Comment
Chocolate Manufacturers Assn. of U.S. v. Block
United States v. Nova Scotia Food Products Corp.
20.2.4 Guidance, Interpreted Rule, or Substantive Rule?
Syncor International Corporation v. Shalala
Berlex Laboratories, Inc. v. FDA
Michigan Example of a Disguised Rule
Promulgation without Notice and Comment
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

447
447
447
447
448
448
449
449
453
456
456
458
460
460
461
461
461
461
461
461
461

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TABLE OF CONTENTS

20.5.2

Review of Agency Enforcement Discretion
Heckler v. Chaney
20.5.3 Regulatory Delay and Timeliness
Center for Food Safety v. Hamburg
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
Calvert Cliffs Coordinating Committee v. U.S. Atomic Energy
Commission
20.7.1 FDA’s Obligation to Comply with NEPA
Environmental Defense Fund, Inc. v. Matthews
20.7.2 Threshold for an Environmental Impact Statement and
Adequacy of an Environmental Assessment
Hanly v. Kleindiest
Geertson Farms Inc. v. Johanns
Monsanto Co. v. Geertson Seed Farms
20.7.3 Adequacy of the Environmental Impact Statement–The
Hard Look Doctrine
Sierra Club v. U.S. Army Corps of Engineers
20.7.4 Decision Making in Situations of Uncertainty
Incomplete or unavailable information

461

461
465
465
468
468
468
469
469
469

21

International Food Law
21.1 Introduction
21.2 International Food Standards
21.2.1 Codex Alimentarius
21.2.2 The WTO and International Trade Agreements
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
21.4.3 EU Labeling
21.4.4 The Precautionary Principle

481
481
481

482
483
484
485
485
485
485
485
486
488
489

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

491
491
492
493
495
495

469
470

470
471
472
472
474
477
477
478
478

GLOSSARY OF ABBREVIATIONS AND SPECIALIZED TERMS

497

TABLE OF CASES

505

INDEX

507


ABOUT THE AUTHOR

Neal Fortin is the Director of the Institute for Food Laws &
Regulations (www.IFLR.msu.edu) at Michigan State Uni­
versity and Professor in the Department of Food Science and
Human Nutrition. He is also an Adjunct Professor of Law and
Director of the Master’s Program in Global Food Law at the

Michigan State University College of Law (http://globalfood.
law.msu.edu). Mr. Fortin teaches courses in U.S. Food Law,
International Food Law, Codex Alimentarius, and Food and
Drug Law.
Neal Fortin was the 2009 recipient of a Michigan State
University Distinguished Faculty Award for his teaching in
food safety. He is ex-President of the North Central Associa­
tion of Food & Drug Officials. He served as a Commissioner

for the Michigan Local Public Health Accreditation Program,
the Advisory Council of the Michigan Community Health
Leadership Institute, and the NSF Council of Public Health
Consultants. He served on the Dietary Supplement Committee
of the Food and Drug Law Institute. He has been a curriculum
advisor to the International Food Protection Training Institute
and the University of Catalonia. He is an emeritus member of
the Association of Food and Drug Officials, the Food and Drug
Law Institute, a professional member of the Institute of Food
Technologists, and the State Bar of Michigan. As an attorney,
Fortin concentrated in food law, food safety, food labeling,
ingredient evaluation, and advertising. He was the primary
drafter of the Michigan Food Law of 2000.

xxiii



FOREWORD

WHAT IS FOOD LAW?

“What is food law?” may be a surprising question in a book
titled Food Regulation. When I entered this field, the answer
was a simple one. Then “food law” meant food regulatory
law. Food law had two main audiences: lawyers and the
regulated food industries. At the universities, these audiences
were reflected in courses at law schools and in food science
departments. Food law was not a stand-alone course at law
schools but rather was a subset of food and drug law courses.
There it dealt largely with the regulation of food by the Food
and Drug Administration (FDA). In food science depart­
ments, the food law courses covered the law that the regu­
lated food businesses needed to know, mostly the regulation
by FDA, the U.S. Department of Agriculture (USDA), and
related state agencies.
This traditional approach to food law remains important
today, and this book largely follows that traditional meaning
of food law as food regulatory law. Foremost, food regula­
tory law remains the main practice area for attorneys
involved in food law and the main interest of professionals
working in the food industry. This book uniquely approaches
food regulatory law as a single subject for both the lawyer
and the food scientist.
In recent years, the question “What is food law?” has
become much more complex due to the growing food move­
ments. Writers like Michael Pollan, Eric Schlosser, Greg
Critser, and Barbara Kingsolver have brought new interest
and attention to food and food policy. The power of this public
desire to know where their food comes from was observed in
the barrage of criticism and consumer backlash to “pink
slime.”

“Pink slime” is a pejorative term for a defatted beef
product that USDA euphemistically termed “lean finely

textured beef” or “LFTB.” To make LFTB, beef trimmings
are heated and then processed by centrifuge action to separate
and remove fat. The lean beef extract is treated with ammo­
nium gas to kill bacteria.
Consumers were disturbed and even outraged to discover
that USDA permitted the industrially processed, defatted
fat trimmings—pink slime—to be labeled as “ground
beef.” The uproar caused sales of LFTB to plummet. Beef
Products, Inc. (BPI), the primary producer of LFTB, had to
close plants, lay off workers, and lost perhaps more than a
billion dollars in sales.1
At the same time, a broader perception of the intercon­
nectedness of food, agriculture, and law emerged. As
Wendell Berry observed, “Eating is an agricultural act.”
Agricultural law affects our food, and thus in this sense
swatches of agricultural law are part of “food law.” Today
“food law” is sometimes broadened in meaning to include
all law related to agricultural trade, such as how food is
grown, humane animal treatment, and environmental rules
for farms and processors. One can find many connections
between these various areas and food. For instance, the law
applying to farm workers has implications in food safety
because more than one foodborne illness outbreak has been
attributed to a lack of proper sanitation facilities for field
workers.
However, this broad approach to food and agriculture law
is susceptible to the concern expressed by Judge Frank

Easterbrook about teaching a course, “The Law of the
Horse.” He said, “Lots of cases deal with sales of horses;
others deal with people kicked by horses; still more deal with
the licensing and racing of horses, or with the care veterinari­
ans give to horses, or with prizes at horse shows. Any effort
1

For more on LFTB, see Chapter 3.

xxv