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

1.2 A Short History of Food Regulation in the United States 3vii... 42 Specialized Ingredient Labeling Requirements 43 Incidental Additives and Processing Aids 44 Federal Food, Drug, and

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.

Identi fiers: 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.

Classi fication: LCC KF3875 F67 2017 | DDC 344.7304/232–dc23 LC record available at https://lccn.loc.gov/2016031565

Printed in the United States of America

Dedicated to

Katherine Fortin and Helen Fortin

1.2 A Short History of Food Regulation in the United States 3

vii

viii TABLE OF CONTENTS

1.5.2 Centers for Disease Control and Prevention (CDC) 151.5.3 USDA Food Safety and Inspection Service (FSIS) 15

1.5.6 Alcohol and Tobacco Tax and Trade Bureau (TTB) 16

2.1.2 FDA’s Jurisdiction and the Definition of Food 23

TABLE OF CONTENTS

What’s in a Name? Lean Finely Textured Beef A.K.A.

Ingredient Labeling: What’s in a Food? 42

Specialized Ingredient Labeling Requirements 43

Incidental Additives and Processing Aids 44

Federal Food, Drug, and Cosmetic Act 46

United States v 95 Barrels Alleged Apple Cider 47

United States v 432 Cartons Individually Wrapped Candy

3.10.2 “Generic” Approvals (Labels Without Prior Approval) 58

3.10.3 Safe Food Handling Instructions Raw Meat and Poultry 58

4.3.5 Specific Exemptions to Nutrition Facts Labeling 69

x TABLE OF CONTENTS

4.6.1 Nutrition Labeling of Standard Menu Items in Restaurants and

4.6.2 Calorie Labeling of Articles of Food in Vending Machines 74

4.7 Nutrient Content Claims (Nutrient Level Descriptors) 74

5.4.3 Dietary Saturated Fat and Cholesterol and Risk of

5.4.4 Sodium and Hypertension (High Blood Pressure) 855.4.5 Fiber-Containing Grain Products, Fruits, and Vegetables

5.4.6 Fruits, Vegetables, and Grain Products that Contain

Fiber, Particularly Soluble Fiber, and Risk of

5.4.9 Dietary Noncariogenic Carbohydrate Sweeteners

5.4.10 Dietary Soluble Fiber, Such As That Found in Whole

Oats and Psyllium Seed Husk, and Coronary Heart Disease 86

5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols 87

Central Hudson Gas & Electric v Public Service Commission

TABLE OF CONTENTS

5.8.2 Misbranded Drug Violations Based on Inadequate

FTC’s Dietary Supplements Advertising Guide for Industry 118

7.3.3 The Alcohol and Tobacco Tax and Trade Bureau (TTB) 124

xii TABLE OF CONTENTS

The Main Food Standards of Identity 131

What Are the Requirements Regarding Food Standards? 131

Carolene Products Co v United States 136

Libby, McNeil, & Libby v United States 143

Fake Food Fight: Substitution of a valuable ingredient 148

Table 8-2 Examples of Economic Food Adulterants

U.S v 1,500 Cases Tomato Paste 151

Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food 1528.4.2 Waiter, There’s a Fly in My Soup—FDA Defect Action Levels 153

The Food Defect Action Levels: Levels of natural or unavoidable defects in foods that present no health hazards

United States v 484 Bags, More or Less 155

United States v Capital City Foods, Inc. 157

TABLE OF CONTENTS xiii

United States v Nova Scotia Food Products Corp. 161

United States v 24 Cases, More or Less [Herring Roe] 163

United States v 298 Cases, etc., Ski Slide Brand Asparagus, etc 164

9 Regulation of Unintentional Poisonous or Deleterious Substances

9.1.1 Background—The Nature and Cost of Foodborne Illness 165

Tolerances for Poisonous or Deleterious Substances in Food 171

Young v Community Nutrition Institute et al. 171

United States v Anderson Seafoods, Inc. 175

Supreme Beef Processors, Inc v USDA 1839.6 FSMA Hazard Analysis and Preventive Control (HARPC) Plans 188

Hazard Analysis and Risk-Based Preventive Controls for

9.8.2 Shiga Toxin-Producing E coli Declared Adulterants 192

Texas Food Industry et al v Mike Espy et al. 192

xiv TABLE OF CONTENTS

9.9.3 Changes with the Food Safety Modernization Act 198

Table 9.1 Total RFR Entries Related to HVP Recall by

10 Regulation of the Safety of Intentional Components of Food: Food

Federal Food, Drug, and Cosmetic Act § 201 206

United States v Two Plastic Drums Black Currant Oil 208

United States v An Article of Food, Coco Rico, Inc. 222

Natick Paperboard Corp v Casper Weinberger and FDA 225

Federal Food, Drug, and Cosmetic Act § 201(t) 233

United States V An Article of Food Consisting of 12

Irradiation: A Safe Measure for Safer Food 237

Figure 10-1 Radura symbol for irradiated food 238

Federal Food, Drug, and Cosmetic Act § 201 245

TABLE OF CONTENTS xv

United States v Ten Cartons of Ener-B Nasal Gel 246

Dietary Supplement Health and Education Act of 1994 257

Federal Food, Drug, and Cosmetic Act 21 U.S.C § 342 261

Federal Food, Drug, and Cosmetic Act § 403B 263

Federal Food, Drug, and Cosmetic Act § 201 263

United States v Undetermined Quantities of Articles of Drug 272

12.2.1 Scientific Consensus on Genetic Engineering Safety 280

12.3.1 FDA’s Consultation for New Plant Varieties 283

xvi TABLE OF CONTENTS

12.4.4 The Plant Protection Act Preempts State GMO Plant

Robert Ito Farm, Inc v County of Maui 28812.5 EPAS Role—The Safety of Pesticides In Bioengineered Plants 289

12.6.1 FDA’s Authority Over Genetically Engineered Animals 29112.6.2 FDA’s Review and Approval of Genetically Engineered

Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed

FDA, Statement of Policy: Foods Derived from New Plant

International Dairy Foods Ass’n v Amestoy 301

Amestoy Mirror Image?–Int’l Dairy Foods Assn v Boggs 304

Alliance for Bio-Integrity v Shalala 305

TABLE OF CONTENTS xvii

Nicotine Poisoning After Ingestion of Contaminated Ground

14.3.4 Additional Forms for Certain Canned Foods, Milk, Cream,

14.3.7 Request for Authorization to Relabel or Perform Other Acts 329

14.3.8 Inspection After Reconditioning or Relabeling 329

14.4 The Food Safety Modernization Act—A New Paradigm For Importers 329

Enhanced Registered Facility Requirements 331

Inspection of Foreign Food Facilities 331

Capacity Building of Foreign Government Regarding Food

14.5.2 Animal and Plant Health Inspection Service (APHIS) 332

14.6.3 Alcohol and Tobacco Tax and Trade Bureau (TTB) 333

14.6.4 National Oceanic and Atmospheric Administration (NOAA) 334

U.S V 76,552 Pounds of Frog Legs 334

xviii TABLE OF CONTENTS

Update on Animal Dietary Supplements 344

Background on Antibiotics in Feed and Antibiotic Resistance 345

Baytril Withdrawn from Poultry Use 346

National Antimicrobial Resistance Monitoring System (NARMS) 346

Guidance for Industry #209: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals 346

Natural Resources Defense Council et al v FDA 350

Natural Resources Defense Council et al v FDA 351

Natural Resources Defense Council, Inc., et al v FDA 353

Agency Policies and Guidance Documents 362

16.3.2 Held for Sale after Shipment in Interstate Commerce 364

United States v 40 Cases “Pinocchio Brand

16.3.3 FD&C Act Interstate Commerce Presumption 365

TABLE OF CONTENTS xix

FSIS Letters of Warning and Notices of Intended

Denial of Import Entry for Refusal of Inspection 371

16.4.10 Inspection-Related Enforcement Powers of FSIS 372

North American Cold Storage Co v City of

17.4.2 Domestic Facility Risk Categorization and Risk-Based

Table 17-1 FSMA Factors in Risk Categorization 388

United States v Jamieson-McKames Pharmaceuticals, Inc. 388

United States v Thriftimart, Inc. 391

Is a Picture Worth More than 1,000 Words? 395

17.9.4 483 Inspectional Observations (FDA Form 483) 402

Image 17.1 Form FDA 483 Inspectional

17.10.3 FSIS’ International Inspection Activities 406

17.10.4 The Effect of Supreme Beef v USDA on Inspections 406

Supreme Beef Processors, Inc v USDA 407

18.3.1 Express Preemption of Inconsistent State Law 413

FD&C Act Preemptive Provisions 41318.3.2 Comprehensive Federal Scheme That Occupies the Field 413

Florida Lime and Avocado Growers, Inc v Paul 413

Hillsborough Co v Automated Medical Labs, Inc. 41518.3.3 Direct Conflict Between Federal and State Law 41818.3.4 State Law an Obstacle to the Purposes and Objectives of

TABLE OF CONTENTS xxi

Prescription Drug Marketing Act of 1987 422

Nutritional Labeling and Education Act of 1990 (NLEA) 422

POM Wonderful LLC v Coca–Cola Co. 426

Porteous v St Ann’s Café & Deli 434

Orthopedic Equipment Co v Eutsler 439

Blommer Chocolate Co v Bongards Creameries, Inc. 440

Florida ex rel Broward Co v Eli Lilly & Co. 445

Merrell Dow Pharmaceuticals, Inc v Thompson 445

Chocolate Manufacturers Assn of U.S v Block 449

United States v Nova Scotia Food Products Corp. 45320.2.4 Guidance, Interpreted Rule, or Substantive Rule? 456

Syncor International Corporation v Shalala 456

Michigan Example of a Disguised Rule 460

Promulgation without Notice and Comment 460

xxii TABLE OF CONTENTS

Environmental Defense Fund, Inc v Matthews 47020.7.2 Threshold for an Environmental Impact Statement and

Monsanto Co v Geertson Seed Farms 47420.7.3 Adequacy of the Environmental Impact Statement–The

Sierra Club v U.S Army Corps of Engineers 47720.7.4 Decision Making in Situations of Uncertainty 478

Incomplete or unavailable information 478

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 HealthLeadership Institute, and the NSF Council of Public HealthConsultants He served on the Dietary Supplement Committee

of the Food and Drug Law Institute He has been a curriculumadvisor to the International Food Protection Training Instituteand the University of Catalonia He is an emeritus member ofthe Association of Food and Drug Officials, the Food and DrugLaw Institute, a professional member of the Institute of FoodTechnologists, 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 primarydrafter of the Michigan Food Law of 2000

xxiii

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 trimmingsare heated and then processed by centrifuge action to separateand remove fat The lean beef extract is treated with ammo­nium gas to kill bacteria

Consumers were disturbed and even outraged to discoverthat USDA permitted the industrially processed, defattedfat trimmings—pink slime—to be labeled as “groundbeef.” The uproar caused sales of LFTB to plummet BeefProducts, Inc (BPI), the primary producer of LFTB, had toclose plants, lay off workers, and lost perhaps more than abillion dollars in sales.1

At the same time, a broader perception of the intercon­nectedness of food, agriculture, and law emerged AsWendell Berry observed, “Eating is an agricultural act.”Agricultural law affects our food, and thus in this senseswatches of agricultural law are part of“food law.” Today

“food law” is sometimes broadened in meaning to includeall law related to agricultural trade, such as how food isgrown, humane animal treatment, and environmental rulesfor farms and processors One can find many connectionsbetween these various areas and food For instance, the lawapplying to farm workers has implications in food safetybecause more than one foodborne illness outbreak has beenattributed to a lack of proper sanitation facilities for fieldworkers

However, this broad approach to food and agriculture law

is susceptible to the concern expressed by Judge FrankEasterbrook about teaching a course, “The Law of theHorse.” He said, “Lots of cases deal with sales of horses;others deal with people kicked by horses; still more deal withthe licensing and racing of horses, or with the care veterinari­ans give to horses, or with prizes at horse shows Any effort

1

For more on LFTB, see Chapter 3.

xxv

xxvi FOREWORD

to collect these strands into a course on ‘The Law of the

Horse’ is doomed to be shallow and to miss unifying

principles.”2

Judge Easterbrook’s point is a good one, but it applies

more to how a course in the food and agriculture law is taught

than to the concept of a broader sense of food law A law

student will better learn the law of torts in torts class rather

than studying torts related to personal injury from foodborne

illness Nevertheless, a chapter on food and product liability

is included here In part this is for the food scientists, who do

not take a torts law course, but also because it allows teaching

about the intersection of science and tort law For instance,

the proof of causation from foodborne illness injury is more

difficult than the contours of tort law

Judge Easterbrook, however, had an additional concern

about“The Law of the Horse” as “courses suited to dilet­

tantes.” He noted, “We are at risk of multidisciplinary

dilettantism, or, as one of my mentors called it, the

cross-sterilization of ideas Put together twofields about which you

know little and get the worst of both worlds.”3

It is not that multidisciplinary courses cannot be taught,

but that they should illuminate our entire understanding of

law For instance, a “Food Law for Public Health” course

taught by an attorney and public health professional is apt to

teach about the role of law as a tool in public health plus the

limits of law in public health

Food law can teach about the scope and limits of regula­

tory law and the direct and indirect effects of law For

instance, governmental approaches seeking to reduce

obesity might consider a law to tax obesity, such as charging

more for government health insurance for those who are

overweight The law could fund a public advertising cam­

paign about healthy weight and healthy diet The law could

regulate what foods are provided in school lunches The lawcould detail how foods are displayed at school lunch lines toencourage more fruit and vegetable consumption The lawcould tax“junk food” as a way to decrease their consump­tion The law of crop subsidies could be designed to makefruits and vegetables lower in price Each approach haslimits and costs Each approach also raises questions ofcultural values, such as the value we place on individualchoice An examination of these choices and mixes of thesechoices provides insight into the challenges facing themodern regulatory state

Still, Easterbrook’s concern remains, and we should becautious about accepting the beliefs of lawyers about farmprice support policy, journalists’ beliefs about food science,

or any non-scientist’s belief about molecular biology Whilecross-fertilization can provide real value, there remains therisk of cross-sterilization

In the end, I think broadening of the concept and interest

in food law is exciting and important A wideningrecognition of related areas, such as farm policy, publichealth, and food security, as a part of the broader whole

of food and agriculture law and policy is an importantevolution Food and agriculture law and policy are at thecenter of some of the world’s most pressing concerns Inaddition, food is often at the center of issues related to howour modern regulatory state should be ordered Nonetheless,

we should not forget that the primary practice area of foodlaw remains traditional food regulatory law The broaderinterest in food and agriculture law and policy needs to takemeasure of traditional food (regulatory) law lest its ideas fail

as a casualty of cross-sterilization

Neal FortinDecember 10, 2015

2

Frank H Easterbrook, Cyberspace and the Law of the Horse, U

OF C HICAGO L EGAL F ORUM

3

“Knowledge is the food of the soul.”

Plato

INTRODUCTION

Food regulation is a complex but fascinating field Study

in this area is richly rewarding From a human interest

perspective, food regulation touches the lives of nearly every

American every day Food issues often warrant headline

news because this is a subject that commands the public’s

attention, whether it be a newsflash on a foodborne illness

outbreak or information on diet that can help one live a

longer and healthier life

In addition, the regulation of food provides a snapshot of

the political, social, and economic currents in our society

Thus, the study of food law provides a fascinating look at

important policy decisions on vital aspects of people’s every­

day lives

ABOUT THE TEXT

This text is designed to provide an accessible guide to U.S

food regulation—to be enlightening, without being light

While the text contains in-depth discussion of the federal

statutes, regulations, and the regulatory agencies, the material

is not dense, and remains accessible to the average reader

Thus, Food Regulation is appropriate for a wide audience of

students and professionals

A modified casebook method is used The black letter law

is livened with discussion of emerging issues and trends plus

case studies that explore important issues These materials

explore not only regulation but also the science, policy, and

practice The reader is challenged to move beyond theory intoapplication of the theory

Much of the focus is on the Federal Food, Drug, andCosmetic Act (FD&C Act) and the Food and Drug Admin­istration (FDA) Nevertheless, an overview of food regula­tion by other agencies is covered, particularly at the U.S.Department of Agriculture (USDA) and the Federal TradeCommission (FTC) Moreover, readers are encouraged to seethe thread running between the different laws, such as thesimilarity of meaning of terms across FDA, USDA, and FTC.For instance, in the study of USDA Food Safety InspectionService (FSIS) regulation, some of the best court cases toreview involve FDA In addition, do not be surprised tofindthat some of the cases and references in this text are topharmaceuticals, medical devices, or cosmetics The FD&CAct regulates all these products, and there are commonalities

in the regulatory framework for all Sometimes a drug ormedical device case illustrates a point about food law betterthan anything directly about food

A ROAD MAP FOR READING THE MATERIALS IN THIS BOOK

This text presents diverse materials from pertinent sources.The author provides some commentary and context, but youshould digest these materials for yourself This can beespecially challenging to the novice because you not onlyhave to understand the materials but also have to jumparound the various writing styles, understand the context,and discern the relative value and weight of each source Staywith it, and you willfind it soon becomes easier

In keeping with the way information is encountered inpractice, not all materials in this text are equal Some may be

xxvii

xxviii PREFACE

read quickly Others will require close scrutiny Moreover,

materials will be presented in varying levels of formality

When possible, the materials are condensed to be easier for

you to read

If you are new to this teaching style, it may be discon­

certing atfirst Please do not let this throw you Persist and

trust your instincts You will find that your effort pays

dividends quickly In the end, you will learn much more

than the rules and develop and hone critical skills for

regulatory analysis These skills are not only vital in legal

analysis but are also extremely useful in winnowing through

the mountains of information available on the Internet In

addition, law and regulation are not static subjects, so

developing these dynamic skills will be beneficial in the end

Here are a few tips to those of you who are new to this

teaching method:

• Review your road map of each chapter—review the

chapter title, the other headings, and the table of con­

tents before reading These will provide you with an

overview of how the chapter material relates to the

overall text

• Put the material in context Note the source of the

material quoted Who wrote the material will tell you

what type of perspective is offered Often, regulations

reconcile conflicting interests; and understanding both

sides can be key to a complete picture Note the date

when the material was written, which may indicate that

the material is provided for historical perspective, or that

part of the information may be pertinent, but part may be

outdated

• In reading the cases, develop the ability to understand

how the court reasoned through the conflict to a solu­

tion Identify the particular factors used by the court to

decide the case the way it did Check to see if those

factors are present in a problem with which you are

dealing If the factors are not present, then ask yourself

if that justifies a different result If there are any changes

in the social or economic conditions that surrounded an

earlier decision, ask how that affects the problem now at

hand

• In short, learn to analyze the materials, rather than

merely read and memorize rules

EDITING

I have edited most of the footnotes and citations from the

court cases Remaining footnotes are renumbered with my

own footnotes Unless otherwise indicated, any footnotes

within the cases are those of the court In addition, materials

may be edited for typographic style without notation in

is covered by any statutory cross-references

A NOTE ON STATUTE CITATIONS

All federal statutes in force in the United States are codified inthe United States Code (U.S.C.) The U.S.C is organized intosubject matter titles In the course of this organization of thestatutes, necessarily section numbering of the laws must berenumbered For example, section 1 of the Food, Drug, andCosmetic Act is codified as 21 U.S.C § 301 Thus, you mayfind this section cited with one or the other or both referencenumbers, such as “Sec 1 [301].”

Statutory citations used in this material are to the FD&CAct statutory sections (which is the way practitioners refer tothem) The citation within the brackets is the U.S.C number.Nonetheless, occasionally you will see reference to a U.S.Code citation

FD&C ACT REFERENCES

Four free online locations for reference to the FD&C Actfollow:

Cornell’s LII: www.law.cornell.edu/uscode/text/21/chapter-9

Office of the Law Revision Counsel:http://uscode.house.gov

U.S Government Printing Office (GPO) Access: www.gpo.gov/fdsys/browse/collectionUScode.action?

PROBLEM EXERCISES

The Problem Exercises are designed to encourage critical

thinking They take on a variety of forms but some are

designed to provide practice answering essay questions in

food law

INTERNET CITATIONS

Thefluid nature of Internet addresses creates difficulty for a

textbook of this nature The food regulation information

available on the Internet is far too valuable not to include

some Internet addresses Inevitably, however, some of these

addresses will have changed or the documents will have been

removed within days of this book’s printing

Please realize that learning what types of materials are

available is more valuable thanfinding a specific document

When you find a broken Internet address, take the

opportunity to use search engines tofind the new location,

or tofind similar material on the web

In the types of materials referenced in this text, most ofthe broken Internet addresses result from reorganization oflarge document repositories If search engines cannot find

a particular document—and you believe it contains vitalinformation—you may be able to find the document usingInternet archives.1

CITATION FORMAT

Citations in this text generally follow The Bluebook: A

Uniform System of Citation (20th Ed.) However, some

conventions are modified to save space and repetition

I hope you find this text offers an appetizing menu forunderstanding food regulation in the United States

Neal D Fortin

1

For example, the Wayback Machine, which contains 462 billion web pages

archived from 1996, available athttp://www.archive.org/web/web.php (last accessed Jan 22, 2016).

It is impossible to write a text of this nature without owing

many people a debt of gratitude I cannot begin to list you all,

but extend a thank you to everyone who furthered my

scholarship on food law I also wish to acknowledge my

wife, Kathy, and daughter, Helen, who supported me through

the many months of writing, without which this book would

never have beenfinished

The following publishers, journals, and authors are

thanked for their generosity in granting permission for me

to publish excerpts from the following publications:

• Food and Drug Law Institute: Neal Fortin, The

Hang-Up with HACCP: The Resistance to Translating Science

into Food Safety Law, 58FoodANDDRUGLAWJOURNAL

565–594 (2003)

• Food Safety News: Richard Raymond and John Munsel,

Is AMI’s Hodges Slinging Mud in the Name of Science?

FOODSAFETY NEWS(Feb 24, 2012)

• International Food Information Council: FDA/IFIC,

Food Additives (1992).

• Journal of Food Law and Policy: Neal Fortin, Is a

Picture Worth More Than 1,000 Words? 1 JOURNAL

OF FOODLAW ANDPOLICY239–268 (Fall 2005)

• Thompson-West: James T O’Reilly, FOOD ANDDRUG

ADMINISTRATION, 2nd Ed (2004)

xxxi

PART I

INTRODUCTORY CHAPTERS

INTRODUCTION TO FOOD REGULATION

IN THE UNITED STATES

1.1 INTRODUCTION

This chapter provides basic information for students with

greatly varied backgrounds Necessarily, this information

may be repetitive or elementary for some readers Those

readers are encouraged to treat this material as a review and

refresher Most of the topics provided in overview in this

chapter will be covered later in more depth

This introduction also provides a historical background

that gives insight into the public policy decisions in food

regulation A general explanation of the legal system, regu­

latory law in general, and the legal basis of food regulation in

the United States are included To enhance an understanding

of the legal structures and to simplify its otherwise mysteri­

ousness, this chapter provides an overview of the history of

food regulation in the United States This history accounts for

and explains much of the current organization of federal and

state regulatory agencies

This chapter further presents an overview of the major

food statutes, regulations, and the jurisdictions of various

agencies This knowledge will allow you to enhance your

communication and functioning within this legal frame­

work In addition, a better understanding of the functions,

authority, and interrelationship of various regulatory agen­

cies promotes improved relations with those agencies This

understanding will also improve your ability to function

within the regulatory system

1.2 A SHORT HISTORY OF FOOD REGULATION

IN THE UNITED STATES 1.2.1 Why Do We Have Food Laws?

From the beginnings of civilization, people have been con­cerned about food quality and safety The focus of govern­mental protection originated to protect against economic fraudand to prevent against the sale of unsafe food As early as thefourth centuryBCE, Theophrastus (372–287BCE) in his ten-

volume treatise, Enquiry into Plants, reported on the use of

food adulterants for economic reasons Pliny the Elder’s(CE23–79) Natural History provides evidence of widespread

adulteration, such as bread with chalk, pepper with juniperberries, and even adulteration with cattle fodder.1 AncientRoman law reflected this concern for adulteration of food withpunishment that could result in condemnation to the mines ortemporary exile.2

Starting in the thirteenth century, the trade guildsadvanced higher food standards The trade guilds, whichincluded bakers, butchers, cooks, and fruiters among themany tradecrafts, held the power to search for and seizeunwholesome products

1

Peter Barton Hutt, Government Regulation of the Integrity of the Food Supply, 4 ANNUAL R EVIEW OF N UTRITION

2

Food Regulation: Law, Science, Policy, and Practice, Second Edition Neal D Fortin.

 2017 Neal D Fortin Published 2017 by John Wiley & Sons, Inc.

3

4 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES

Indeed, as the guilds policed the marketplace, they were

most interested to ensure continued and strong markets for

their goods Nonetheless, the guilds provide an early dem­

onstration how stringent product quality and safety standards

can bring a competitive economic advantage to industries

and nations Trust in food’s safety and wholesomeness is

necessary for the market to prosper A number of commen­

tators have noted the commonality of interest between

business self-interest and stringent product safety standards.3

Regulation of food in the United States dates back to the

colonial era, but the early food laws were nearly all state and

local regulations Federal activity was limited to imported

foods Thefirst federal food protection law was enacted by

Congress in 1883 to prevent the importation of adulterated

tea This was followed in 1896 by the oleomargarine statute,

which was passed because dairy farmers and the dairy

industry objected to the sale of adulterated butter and fats

colored to look like butter

∗ ∗ ∗ ∗ ∗

Passed March 8, 1785

An Act Against Selling Unwholesome Provisions

Whereas some evilly disposed persons, from motives of

avarice and filthy lucre, have been induced to sell diseased,

corrupted, contagious, or unwholesome provisions, to the

great nuisance of public health and peace:

Be it therefore enacted by the Senate and House of Repre­

sentatives, in General Court assembled, and by the authority

of the same, That if any person shall sell any such diseased,

corrupted, contagious or unwholesome provisions, whether

for meat or drink, knowing the same without making it

known to the buyer, and being thereof convicted before

the Justices of the General Sessions of the Peace, in the

county where such offence shall be committed, or the Justices

of the Supreme Judicial Court, he shall be punished by fine,

imprisonment, standing in the pillory, and binding to the

good behaviour, or one or more of these punishments, to be

inflicted according to the degree and aggravation of the

offence.

∗ ∗ ∗ ∗ ∗Although adulteration and mislabeling of food had been a

centuries-old concern, the magnitude of the problems

increased in the last half of the nineteenth century This

was an era of rapid development in chemistry, bringing

advancements in food science, new food additives and color­

ings, and new means of adulteration Fortunately, these

3

See, e.g., MICHAEL E P ORTER , T HE C OMPETITIVE A DVANTAGE OF N ATIONS

648

4

scientific advances also provided the tools for detectingadulteration

We face a new situation in history Ingenuity, striking handswith cunning trickery, compounds a substance to counterfeit

an article of food It is made to look like something it is not; totaste and smell like something it is not; to sell like something

it is not, and so deceive the purchaser

Congressional Record, 49 Congress I Session 1886

In this era, food production began shifting from the home tothe factory, from consumers buying basic ingredients fromneighbors in their community to food processors and manu­facturers more often at a distance With this trend, consumersfound it harder to determine the safety and quality of their food.Inevitably, the responsibility for ensuring the safety of foodsonly shifted from local to state government, and the demandfor federal oversight increased As national markets grew,legitimate manufacturers became concerned that their marketswere being harmed by the dishonest and unsafe goods

1.2.2 The 1906 Pure Food and Drug Act

In 1883, Dr Harvey Wiley became the chief chemist of theU.S Bureau of Chemistry (at that time part of the Department

of Agriculture) Dr Wiley expanded research and testing

of food and documented widespread adulteration.5 Hehelped spur public indignation by his publications and bycampaigning for a national food and drug law Wiley dra­matically focused concern about chemical preservatives asadulterants through his highly publicized “Poison Squad.”The Poison Squad consisted of live volunteers whoconsumed questionable food additives, such as boric acidand formaldehyde, to determine the impact on health Obser­vation and documentation of the ill effects and symptoms ofthe volunteers provided an appalling crude gauge of foodadditive safety.6 However crude by today’s standards,Wiley’s leadership with the tools of the day helped galvanizepublic awareness and advanced food safety

Public support for passage of a federal food and drug lawgrew as muckraking journalists exposed in shocking detailthe frauds and dangers of the food and drug trades, such

as the use of poisonous preservatives and dyes in food anddeadly opiate-laced syrups for children.7 A final catalystfor change was the 1905 publication of Upton Sinclair’s

The Jungle Sinclair portrayed nauseating practices and

unsanitary conditions in the meat-packing industry, such

as food handlers sick with tuberculosis and carcasses covered

Philip J Hilts, The FDA at Work: Cutting-Edge Science Promoting Public

A SHORT HISTORY OF FOOD REGULATION IN THE UNITED STATES

in rat droppings being made into sausage The book was a

best seller, and meat sales dropped by half.8

Outraged at the conditions described in The Jungle,

President Theodore Roosevelt sent his own investigators

to the Chicago packinghouses They found the situation as

revolting as Sinclair had described, including witnessing a

carcass falling into a latrine, being hauled back out, and put

back uncleaned with the other meat.9Even though leaders

within the meat industry were ready for new rules, Congress

refused to pass a bill President Roosevelt had held back his

investigators’ report, but when Congress would not act, he

released the report to the newspapers Soon Roosevelt had his

bill.10

On June 30, 1906, President Theodore Roosevelt signed

both the Pure Food and Drug Act11and the Meat Inspection

Act12 into law Passage of these two statutes began the

modern era of U.S food regulation While neither act could

be considered comprehensive, both responded to the con­

cerns of the day

The Pure Food and Drug Act added regulatory functions

to the U.S Bureau of Chemistry The Meat Inspection Act of

1906 required the U.S Department of Agriculture to inspect

all cattle, sheep, swine, goats, and horses when slaughtered

and processed into products for human consumption The

primary goals of the Meat Inspection Act were to prevent

adulterated livestock from being processed into food and to

ensure that meat was slaughtered and processed under sani­

tary conditions

1.2.3 Evolution of the Food Statutes

Not long after passage of the Pure Food and Drug Act,

legislative battles began to expand and strengthen the law

For instance, the act did not prohibit false therapeutic claims,

but only false and misleading statements about the ingredi­

ents or identity of a drug Therefore, the Food and Drug

Administration (FDA) could take no action against snake oil

with an illegitimate claim to cure cancer so long as the

product actually was oil from snakes In addition, leaders

in the food industry called for more stringent product quality

standards to create a level playingfield Members of Con­

gress called for better safety standards and fair dealing

However, major revision of the food law stalled until a

precipitous event fell while a significant segment of the

public was paying attention Sulfanilamide, one of the

new sulfa drugs, was being used effectively to treat strep

throat and other bacterial diseases (Figure 1.1) To increase

the palatability of the bad tasting drug, a drug company

mixed the antibiotic with diethylene glycol, a sweet tasting

FIGURE 1.1 Elixir of sulfanilamide (Image courtesy of FDA.)

liquid The mixture was called elixir of sulfanilamide andshipped in the fall of 1937 Within weeks, deaths werereported to FDA The manufacturer admitted they performed

no safety tests None were required At least 107 died in anoften agonizing death Many of the dead were children whoreceived the elixir for strep throat.13

The tragedy spurred legislative action, and in 1938, theFood, Drug, and Cosmetic (FD&C) Act was enacted TheFD&C Act required premarketing approval and proof ofthe safety of drugs The act also:

• extended government control to cosmetics and thera­peutic devices,

• provided that safe tolerances be set for unavoidablepoisonous substances in food,

• authorized standards of identity, quality, and fill-of­container for foods,

• authorized factory inspections, and

• added court injunctions to the previous penalties ofseizures and prosecutions

The food laws continued to evolve based on the concerns andissues of the times In the 1950s, concerns over synthetic food

13

P HILIP J H ILTS , P ROTECTING A MERICA ’ S H EALTH : T HE FDA, B USINESS , AND

6 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES

additives, pesticides, and cancer were high Consequently, in

1958, the Food Additives Amendment to the FD&C Act was

enacted, requiring the evaluation of food additives to establish

safety The Delaney Clause forbade the use of any food additive

that was found to cause cancer in humans or animals In 1960,

the Color Additive Amendment to the FD&C Act was enacted,

which required manufacturers to establish the safety of color

additives in foods, drugs, and cosmetics

After a number of well-publicized outbreaks of botulism

food poisoning from canned foods, the FDA issued Low-Acid

Food Processing Regulations in 1973 After deaths from

cyanide placed in Tylenol capsules, FDA issued the

Tam-per-Resistant Packaging Regulations in 1982 In 1983, Con­

gress passed the Federal Anti-Tampering Act, which makes it a

federal crime to tamper with packaged consumer products

Throughout the 1980s, there was a growing interest in the

effect of nutrition on health along with increased marketing of

foods to fulfill health concerns At the same time, food process­

ing continued a trend toward becoming nationally distributed

rather than local Various states implemented nonuniform laws

to regulate health and nutrition claims, which the national

industry found hindered interstate commerce In 1990, Congress

enacted the Nutritional Labeling and Education Act (NLEA),

which requires nearly all packaged foods to bear nutritional

labeling The act also requires nutritional and health claims for

foods to be consistent with terms defined by the FDA

Then impetus grew for enhanced food safety regulation

over several years of high-profile food recalls, foodborne

illness outbreaks, and consumer advisories In 2006, fresh

spinach sickened over 200, and the fresh greens industry

suffered huge losses In 2007, nearly 2,000 pet food products

were recalled due to melamine adulteration of gluten In

2007, more than 600 people became ill from contaminated

peanut butter In 2008, imported peppers sickened over

1,400, but not before tomatoes were misidentified, causing

huge losses to the tomato industry In 2009—in what may

have been the precipitating event—nine deaths and hundreds

of illnesses were traced back to peanut paste from the Peanut

Corporation of America In the end, nearly 4,000 consumer

products were recalled with an unusually long recall span of

over a year Finally, in 2010, nearly 2,000 cases of illness

were linked to eggs from two farms in Iowa, and more than

500 million eggs were recalled

On January 4, 2011, President Barack Obama signed the

FDA Food Safety Modernization Act (FSMA) into law.14

This amendment of the FD&C Act is the most significant

revision of U.S food law since 1938 when the Food, Drug,

and Cosmetic Act replaced the Food and Drug Act of 1906

The law is historic both in breadth and depth of it coverage

With this background, it is time to review some aspects of

the U.S legal system

14

The FDA Food Safety Modernization Act, Pub L 111-353 (2011).

1.3 THE U.S LEGAL SYSTEM

To understand the legal basis of food regulation in the UnitedStates, it is necessary to have an overall understanding of theU.S legal system and some of the key concepts in Americanjurisprudence First, let us look at the basic terminology

Law: (1) a binding custom of a community; (2) a rule of

conduct or action prescribed or enforced by a control­ling authority; (3) the whole body of such rules; (4) thecontrol brought about by the enforcement of such law;(5) the legal process; and (6) the whole body of lawsrelating to one subject

As you can quickly see, even defining the term “law” isnot a simple proposition To simplify the terminology, thistext follows the predominant American meanings for theterm“law” and its synonyms:

Law implies imposition by a sovereign authority Law

commonly refers to the entire body of law on thesubject, but also is a synonym for“statute.”

Statute means a law enacted by a legislative body Regulation implies prescription by administrative agency

to carry out their statutory responsibilities Federalregulations arefirst published in the Federal Register,

which is published daily and organized by date andpage number Later the regulations are codified in theCode of Federal Regulations.15

Rule applies to more restricted or more specific laws than

statutes.“Rule” often is an abbreviated form of the term

“administrative rule,” which is a law promulgated by

an administrative agency Administrative rules are alsocalled regulations However, administrative rules areonly one form of rules Some administrative orders,resolutions, and formal opinions are also“rules.”

Guideline suggests something advisory rather than

binding

Ordinance applies to an order enforced by a local unit of

government, such as a city

The system of U.S laws can be divided into four parts:

15 “Codification” is the arrangement of the laws (statutes or regulations) into

an organized code The volumes of the Code of Federal Regulations are organized by subject matter.

THE U.S LEGAL SYSTEM

1.3.1 The Constitution16

The U.S Constitution provides the framework for the U.S

legal system The Constitution both empowers and limits

government The Constitution provides the supreme law of

the land, and it is, by design, difficult to alter as a way of

protecting long-standing values

The U.S Constitution creates the federal government and

divides the power into the three branches, legislative, exec­

utive, and judicial The legislative power is vested in the U.S

Congress (Article I) (However, additional laws can be

created by the executive and judicial branches.) The exec­

utive power is placed in the President (Article II) The

judicial power is vested in the courts (Article III) This

“separation of powers” was designed to create checks and

balances to protect against tyrannical rule Each of the three

branches is considered separate but equal

This caution over the concentration of power is a theme

that runs throughout U.S law The Constitution, in addition

to granting powers to government, also limits government’s

powers and functions, particularly of the federal govern­

ment The first ten amendments of the Constitution are

known as the Bill of Rights,17and they protect individual

rights by setting restrictions on the activities of the federal

government

1.3.2 Statutes

Within their power granted by the U.S and state constitutions

respectively, Congress and state legislatures enact public

acts, also called statutes (Cities and other municipalities

generally call their enactments of law “ordinances.”) All

statutes must be consistent with the U.S Constitution State

and local laws must also be consistent with the applicable

state constitution

1.3.3 Regulations

Although Congress and state legislatures have the primary

authority to enact laws, they often delegate some of this

authority to administrative agencies This is particularly true

for areas requiring technical expertise, such as health and

science matters The laws promulgated by administrative

agencies are called regulations or administrative rules

In theory, the administrative agencies merely execute the

laws enacted by the legislature However—because the

legislatures often provide only a broad mandate—the agen­

cies have considerable leeway in interpreting and applying

their mandate Typically, an administrative agency promul­

gates the detailed regulations that are necessary to translate

16

Although the U.S Constitution is at the root of all American law,

nonlawyers seldom read the document Do not be intimidated by the

document’s importance Its language is surprisingly simple to understand.

17

See the appendix to this chapter.

the legislative mandate into operating standards The regula­tions must fall under the scope of authority delegated by thelegislature in statute Regulations must also be consistentwith other relevant constitutional and statutory requirements.Generally, regulations have the full force of law found in theenabling statute

The executive branch agencies have increased in number,size, and importance since the 1930s However, it is impor­tant to remember that the agencies can only carry out that,which they are authorized to do by the legislature In addi­tion, the legislature determines the amount of funding theagencies receive It is common for legislatures to grant enactpopular statutes with noble sounding mandates but then fail

to provide the necessary funds to agencies to carry out thenew legislative mandate

1.3.4 Case Law and Common Law

Both case law and common law are based on judicialdecisions Case law is the law established by the precedents

of judicial decisions in cases (as distinguished from lawscreated by legislatures) Case law is important because of thetradition of following precedents When a court addresses alegal dispute, it is usually guided by what has been decidedpreviously in similar cases These precedents become thecase law The general concept is that judges should follow theprinciples of law set down in prior decisions, unless it wouldviolate justice or fair play to do so Reliance on precedentserves to promote uniformity, predictability, and foster trust

in a rule by law, not by person Case law precedence is onlyset by the appellate courts

Common law is the body of law based on legal tradition,custom, and general principles Common law is embodied incase law and that serves as precedent or is applied tosituations not covered by statute U.S common law wasoriginally derived from English legal principles and tradi­tions, but now includes the precedents that have developedover time from the decisions of U.S courts

Common law generally applies only to areas of law wherethere is no statutory law For example, if afirm dischargesfood processing waste on afield, and a foul smell permeatesnearby homes, this may violate the common law of nuisance.Private nuisance common law might allow individuals to suethe processing plant Public nuisance common law mightallow a government official to take action However, if astatute regulates acceptable waste-handling methods forprocessing plants, then the legislative law can override thecommon law

1.3.5 Federalism

To understand how the U.S system of law interrelates, oneneeds to understand federalism The Constitution divides thepower of government vertically between federal and state

8 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES

governments Federalism is the term used to refer to this

division of power Federalism also limits the ability of a state

to interfere or burden other states An important example is

that states cannot regulate or tax commerce in a way that

places an undue burden on interstate commerce

The Supremacy Clause of the Constitution provides that

the Constitution and the federal laws are the supreme law of

the land.18This provision, as a general matter, means that the

federal laws preempt state and local laws if they conflict.19

However, federal law can only preempt state law where

there is authorization by the Constitution The federal gov­

ernment only holds the powers delegated to it by the Consti­

tution; other powers are reserved to the states or to the

people.20

This division of power has been a great debate throughout

U.S history However, the growth of national and interna­

tional commerce and the problems of the modern age have

led to a very expansive interpretation of the federal power

The Commerce Clause of the Constitution grants Congress

plenary power to regulate commerce.21Commerce covers a

wide range of activities, not just direct interstate commerce,

but any activities indirectly affecting interstate commerce

Today, given the nationally integrated economy of the United

States, nearly all commerce is interstate or has an interstate

impact, thus it is under federal purview

However, states retain control over all matters not specifi­

cally delegated to the federal government.22The key area here

is that only the states possess the power to regulate specifically

for the health and welfare of the people.23Police power is the

term used to refer to this exclusive state power, the broad

powers traditionally possessed by governments and exercised

to protect the health, safety, welfare, and general well being of

18

The U.S Constitution provides that the Constitution, and the Laws of the

United States which shall be made in pursuance thereof; and all Treaties

made, or which shall be made, under the Authority of the United States, shall

be the supreme Law of the Land; and the Judges in every State shall be bound

thereby, anything in the Constitution or Laws of any State to the Contrary

notwithstanding U.S C ONST art.VI.

19 Of course, state and federal laws may be different without direct con flict.

Generally, states may pass more restrictive or stringent food safety laws (or

weaker laws) than those promulgated at the federal level, so long as there is

no direct con flict in the specifics of the laws.

20 “The powers not delegated to the United States by the Constitution, nor

prohibited by it to the States, are reserved to the States respectively or to the

people ” U.S C ONST amend X.

21

Article I of the Constitution authorizes Congress to make all laws which

shall be necessary and proper for carrying into execution the government ’s

constitutional powers The “Commerce Clause,” in article I, section 8,

clause 3 of the Constitution, authorizes Congress to regulate commerce

with foreign nations, among the several States and with the Indian tribes.

22 “The powers not delegated to the United States by the Constitution, nor

prohibited by it to the States, are reserved to the States respectively or to the

people.” U.S C ONST amend X.

23

United States v Lopez, 514 U.S 549 (1995).

the citizenry.24Authority to make food inspection laws andhealth laws are part of the traditional police powers.Nevertheless, often the federal government may regulate

an activity that falls under the police power category, because

it also falls under federal authority via another power, such asthe power to regulate interstate commerce For example, thefederal government could not regulate the minimum cold-holding temperatures of foods for health and safety reasons,but it may do so for the purpose of regulating interstatecommerce

In theory, this limitation on the federal government reach

is considerable In practice due to the interconnected nature

of the food supply, most food businesses would be consid­ered to have an effect on interstate commerce For instance,use of a single ingredient that was shipped in interstatecommerce in a multi-ingredient food would create federaljurisdiction and fall within the scope of the FD&C Act.25The end result of federalism is the states’ independentpower creates more regional differences in the law andregulation than would occur if there were a single nationallegal standard In addition, states are free to legislate andregulate any arena that has not been preempted by federallaw.26However, any additional restriction passed by a statemust not place an unreasonable burden on interstatecommerce

Accordingly, firms shipping into various states must becareful that they meet both federal and state requirements.This patchwork of different laws has been criticized as being

of burden tofirms shipping to several states

While troublesome from a commercial standpoint, thisdecentralization of power was intentional to prevent againsttyranny There is also the benefit of different localities havingthe opportunity to propose laws that best serve the needs oftheir community For instance, coastal states often havecloser scrutiny for seafood harvests than states withoutfisheries.27

The experience of trying out new ideas and conductingthese regulatory experiments in local settings may yielduseful information for future efforts to solve problems thatface all communities.28For example, because sulfites can bedangerous to sensitive individuals, Michigan requires the

24 Gibbons v Ogden, 22 U.S 1 (1824) (Police powers

of this mass.

25

See Chapter 15 for greater details and United States v 40 Cases

26 27

At least 16 states have shell

28

labeling of sulfite use on salad bars.29 California, a major

producer of canned food, adopted the first regulation for

mandated thermal processing controls for canned food in

1920.30 California’s updated low-acid canning regulation

eventually served as the model for the FDA low-acid canning

regulation promulgated in 1973

At the beginning of the twentieth century, increased

distribution of milk to growing population centers resulted

in outbreaks of milk-borne diseases The city of Chicago

passed thefirst mandatory milk pasteurization law in 1908

In 1947, Michigan became the first state to require milk

pasteurization.31 Other states soon followed, but federal

regulation did not prohibit unpasteurized milk until 1987.32

Consistent with the principles of federalism and of state’s

rights, courts have generally held that states may enact and

enforce food laws that are different from the federal law so

long as the state laws are not inconsistent with the federal

law, and do not unreasonably burden interstate commerce

“Inconsistent” generally means direct or indirect conflict

between the state and federal law.33

To prevent the problems from inconsistency, cooperative

and educational efforts at uniformity have been an important

part of the legal landscape in food law For example, the FDA

issues a model Food Code for retail food establishment, and

the Association of Food and Drug Officials issues a model

Food, Drug, and Cosmetic Act When the models or the

federal laws are perceived as adequate by state governments,

usually the states will adopt the model or federal regulations

essentially word for word into state law

1.4 AGENCY PROCEDURAL REGULATION

The chief executive (the president or governor) bears the

ultimate responsibility for executing the laws enacted by

the legislative branch of government This responsibility is

carried out by the administrative agencies that are part of the

executive branch of government

In addition to following the requirements of the Constitu­

tion and the enabling statutes, administrative agencies must

comply with a number of procedural statutes Following

three are the most important:

Administrative Procedure Act (APA), which specifies

requirements for rulemaking (the process by which

29

MCL §289.8103; for background on sulfites, see Ruth Papazian, Sulfites:

Safe for Most, Dangerous for Some, FDA CONSUMER

30

Food and Drug Branch, California Department of Public Health, History of

States and Canada) involving 1319 cases and 851 deaths.

31

32

33

AGENCY PROCEDURAL REGULATION

federal agencies make regulations) and agencyadjudication

Federal Advisory Committee Act (FACA), which

requires that certain kinds of groups whose advice isrelied upon by the government be chartered as advisorycommittees, that they be constituted to provide bal­ance, to avoid a conflict of interest, and to holdcommittee meetings in public with an opportunityfor comment from those outside the committee

Freedom of Information Act (FOIA), which provides the

public with a right to access agency information

1.4.1 The Administrative Procedure Act

The federal Administrative Procedure Act (5 U.S.C § 551

et seq.) provides for basic procedural safeguards in the

federal regulatory system, and establishes and defines judi­cial review authority over the federal regulatory agencies

A major thrust of the APA is to ensure due process in therulemaking and adjudication by administrative agencies

In simplest terms, due process means fairness The threemost basic elements of due process are that those affected bythe regulatory process are guaranteed notice, an opportunity

to be heard, and a record for use in judicial appeals Themajor statutory requirements of procedural fairness in thefederal Administrative Procedure Act are paralleled in stateadministrative procedure acts

1.4.2 Rulemaking

Rulemaking involves the development of administrativerules or regulations for future enforcement Generally, regu­lations specify the technical details that are necessary tocomply with a law’s much broader requirements For exam­ple, the FD&C Act, section 403, states in part,“A food shall

be deemed to be misbranded (a) If (1) its labeling is false ormisleading in any particular .” Regulations are promul­gated by the FDA to define specific information required on alabel to avoid being false or misleading in any particular.The APA specifies minimum procedural safeguards thatagencies must follow when engaged in rulemaking Notice ofany proposed rule must be published by the proposing

agency in the Federal Register The agency must allow

interested parties time to submit comments In some instan­ces, public hearings must be conducted with an officialrecord and formal rules Public comments must be reviewedand considered by the agency before final adoption of aregulation The agency must explain why it did or did notincorporate suggestions in thefinal regulation Final regula­tions must be published at least 30 days before they are to takeeffect, so as to allow an opportunity both for legal challengeand for adjustments necessary for compliance with theregulation Note, however, that unless Congress specifies