RES PUB Fraud Report

white paper
The Pursuit of
Food Authenticity:
recommended legal & policy strategies
to eradicate Economically Motivated
Adulteration (food fraud)
Michael T. Roberts
Whitney Turk
Acknowledgements
This White Paper was researched and written by Michael T. Roberts and Whitney Turk and produced by the Resnick Program
for Food Law and Policy at the University of California, Los Angeles School of Law. Tiana Carriedo assisted with cite-checking
sources, Emilie Aguirre provided editing suggestions, and Rudi Vanzin provided editing, design, and formatting assistance.
Additionally, the following scientists, consumer advocates, food industry leaders, and legal practitioners experienced on
issues related to economically motivated adulteration, reviewed and advised on portions of the contents of this white paper:
Jeffrey Moore, United States Pharmacopeia

Karen D. Everstine, United States Pharmacopeia
Paul Miller, Australian Olive Oil Association, Ltd
Michael R. Reese, Reese LLP
Adam Gutride, Gutride Safier LLP
This White Paper was made possible due to a generous gift by the Cortopassi Family Foundation.
The recommendations in this White Paper do not necessarily represent the views of these the reviewers, the contributors,
or the University of California, Los Angeles School of Law.
About the Resnick Program

for Food Law & Policy
The Resnick Program for Food Law and Policy studies and advances solutions for improving the modern food system. Based
at UCLA School of Law, the Resnick Progrm is a national think tank focused on developing key legal and policy strategies,
timely research, and practical tools to foster a food system that benefits consumers.
Statement of Independence and Objectivity:

The Resnick Program for Food Law and Policy is committed to the highest standards of independent inquiry, academic
excellence and rigor. Research findings and conclusions are never altered to accommodate other interests, including those
of funders, other organizations, or government bodies and officials.
The Resnick Program for Food Law and Policy [email protected]

UCLA School of Law www.law.ucla.edu/resnick
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contents
I. Introduction 4
2. The Modern Problem of EMA 6

Defining Economically Motivated Adulteration (EMA) 6
Foods Most Commonly Subject to EMA 11
Challenges in Detection and Testing 12
Harms Caused by EMA 15
3. Government Enforcement Against EMA 17

Early Regulation 17
FDCA Section 401: The Rise and Fall of Standards of Identity 18
Additional Enforcement Tools 20
FSMA: Focus on Safety not EMA 20
EU Criminal Enforcement: Harbinger for the US? 21
Status Quo: Minimal Enforcement Activity 22
4. Legal and Policy Strategies 22

Enforce Against EMA as Fraud: Putting Consumers First 22
Define EMA More Completely 24
Develop High Priority List for Standards Making and Testing Strategy 24
Promote Authenticity as a Public Value 25
Improve Effective Use of Class-Action Litigation 27
5. Conclusion 29
preface
This White Paper recognizes that the current political reality likely translates into less, not more federal government
regulation of food. Hence, it should be noted that this paper does not advocate new administrative regulations or
rules.
This paper simply recommends that the FDA enforce the existing statutory mandate against food fraud for the benefit
of American consumers in a smart, efficient manner by setting enforcement priorities and by collaborating with science
experts and the food industry.
This paper further recommends that the food industry eradicate food fraud by embracing the norm of authenticity and
establishing self-governance rules as it has done so with sustainability.
Last, this White Paper proposes specific rules changes in litigation against food fraud that courts could take to enhance
the use of the tool of litigation in combating food fraud.
list of Abbreviations
CSR Corporate Social Responsibility
EMA Economically Motivated Adulteration
FDA Food and Drug Administration
FDCA Food, Drug, and Cosmetic Act
FMIA Federal Meat Inspection Act
FSMA Food Safety Modernization Act
GMA Grocers Manufacturing Association
International Multidimensional
IMAS Authenticity Specification
National Advertising Division of the
NAD Council of Better Business Bureau
PPIA Poultry Products Inspection Act
PFDA Pure Food and Drug Act
United States Department of
USDA Agriculture
USP US Phamacopeial Convention
1. introduction to EMA, examining the challenges of detecting EMA,
and accounting for the harms of EMA. Part II surveys the
legal tools currently used by the government to combat
EMA, commenting on their strengths and weaknesses.
Food fraud is both an old and modern problem. A major Part III sets forth five specific legal and policy strategies to
form of food fraud—referred to in modern terminology combat EMA. The first strategy is to put consumers first
as Economically Motivated Adulteration (EMA)—includes and to adhere to the statutory mandate to enforce against
the padding, diluting, and substituting of food product for EMA as fraud, rather than a lower tier of adulteration
the purpose of economic gain that may or may not affect that is only of interest to government agencies if there
the safety of the product. EMA harms consumers, honest is a food safety crisis. The second strategy is to define
merchants, and undermines the credibility of regulatory EMA more completely in order to guide the government
agencies that have jurisdiction over the quality and safety agencies and the food industry and to frame expectations
of food. for compliance. The third strategy is to create a high
priority category for the most problematic EMA foods
This form of cheating targeted wines, spices, meat, and that would subject these foods to standards making and
bread, as early as in the Roman Empire. Legal responses testing without overburdening government capacity. The
to EMA-type fraud have historically been suited to the fourth strategy is for the food industry to self-regulate
sensibilities for the time. During the reign of Edward the food authenticity through corporate social responsibility
Confessor in the eleventh century, for example, brewers of
poor quality beer in the city of Chester were condemned
to stand in the tumbril or dung-cart.1 In early fourteenth-
century London, the baker who sold underweight bread Although the definition of
would have the offending loaf slung around his neck and
be drawn through the dirtiest streets in town on a mobile “authenticity” is multifaceted,
pillory to be jeered at and targeted by flying debris hurled especially as applied to food, this paper
from fellow citizens.2
takes a practical approach and regards
In the modern food system, trade flows of varieties of food “authentic food” as food that is what it
products and ingredients from multiple locations around purports to be, and as food that is not
the world increase the level of EMA. This dynamic poses
unique challenges to good governance. Enforcement subject to fraud, including economically
against modern EMA calls for legal solutions beyond motivated adulturation.
the dung-cart or mobile pillory, practical solutions that
recognize the sophistication and systemic nature of the
cheating and protect consumers. These practical solutions
should include effective legal and policy tools and inspire
new ways of thinking about food fraud.
To this end, this White Paper in four parts documents

the modern problem of EMA and proposes legal and
policy strategies in dealing with EMA. Part I addresses
the modern problem of EMA in the United States by
defining EMA, documenting the foods commonly subject Source: Public Domain. http://bit.ly/2my4O07
5 The Pursuit of Food Authenticity

“By now we know that not every
food is what it seems.
But if you really want to get paranoid, peek into

the USP Food Fraud Database. It’s a searchable
trove of humankind’s ceaseless efforts to swindle,
hoodwink and defraud
with food, worldwide.
Source: http://www.npr.org/sections/the-
salt/2013/03/26/175377244/food-fraud-database-lets-us-all-play- That’s where I learned that hucksters sometimes
detective use Sudan red dye to amp up paprika, which in
its natural state is often a demure reddish brown.
Sudan red is a potent carcinogen, banned for use
commitments and voluntary standards, thereby delivery
in food worldwide. Eek!”
to consumers food that is EMA-free. The fifth and last
strategy recommends specific changes to class action
litigation rules that would enhance the effectiveness of
this tool in combatting EMA.
2) a 2013 report issued by the United Kingdom’s
(UK) Department of Environment, Food
This White Paper acknowledges the important work being
and Rural Affairs, titled Elliott Review into
done by others in combatting EMA. US Pharmacopeial
the Integrity and Assurance of Food Supply
Convention (USP) in recent years has produced a guidance
Networks;
document on Food Fraud Mitigation, convened food fraud
workshops, and created a Food Fraud Database. Michigan
3) a 2014 Congressional Research Service (CRS)
State University’s Food Fraud Initiative includes a food fraud
report, titled, Food Fraud and “Economically
blog, an online course, and workshops. The newly formed
Motivated Adulteration” of Food and Food
International Food Authenticity Assurance Organization
Ingredients.
is creating molecular profiles for food ingredients and
methodologies to determine whether food ingredients
Articles and books in popular press have also in recent
are authentic or not.
years called attention to fake food or food fraud. Examples
of books include: Bee Wilson, Swindled: The Dark History
Three notable government reports that address EMA
of Food Fraud, From Poisoned Candy to Counterfeit Coffee
include:
(2008); Tom Mueller, Extra Virginity: The Sublime and
Scandalous World of Olive Oil (2012); and Larry Olmstead,
1) a 2011 US Government Accountability Office
Real Food Fake Food: Why You Don’t Know What You’re
(GAO) report, titled, Better Coordination
Eating And What You Can Do About It (2016).
Could Enhance Efforts to Address Economic
Adulteration and Protect the Public Health; This White Paper adds to all of these efforts by addressing
legal and policy strategies for the US to combat EMA.
The Pursuit of Food Authenticity 6

2. the modern has delegated the bulk of federal responsibility for the
direct regulation of food in the US to the Food and Drug
problem of Administration (FDA) and the US Department of Agriculture
(USDA). In general, the USDA oversees meat, poultry, and
Economically eggs and administers the National Organic Program, and
Motivated the FDA regulates everything else, which gives the FDA
jurisdiction over most food products. The complete web
adulteration of responsibilities across government agencies is much
more complex, but the bulk of responsibility for defining
and enforcing laws against EMA rests primarily with the
Defining Economically Motived FDA and secondarily with the USDA.3
Adulteration (EMA)
The FDA’s Development of a Definition of EMA
Defining Agencies
No less complicated than the organizing of the
defining agencies is the actual defining of EMA
Defining EMA is the responsibility of the governing
and all of its component parts. Prior to 2009, the
agencies with jurisdiction over food. Determining which
FDA had not defined EMA. It took a food scandal
government agency has jurisdiction over a particular food
in 2007-08 involving Melamine being added to pet
is often no easy task. Government regulation of food in
food and infant formula in China to prompt the FDA
the US is a patchwork of federal, state, and local laws. In
to define EMA, albeit that this definition is sparse.
response to food safety, integrity, and quality concerns,
Congress has passed major legislation to govern food,
Melamine is a widely used chemical found in hard
including acts referenced in this White Paper: the 1906
plastic dishes and linings of food containers. In 2007,
Pure Food and Drug Act (PFDA); the 1907 Federal Meat
Melamine was added to pet food that was imported
Inspection Act (FMIA); the 1938 Federal Food, Drug, and
into the US in order to boost the pet food’s protein
Cosmetic Act (FDCA); and the 1957 Poultry Products
content, resulting in the recall of 150 brands of pet
Inspection Act (PPIA).
food and in animal deaths in the US.4 In 2008, it
was discovered that Melamine had been added to
Under these and subsequent federal food acts, Congress
Source: https://nyti.ms/2jSS9Ge “Chinese officials on Monday issued a higher estimate for the
number of children affected by tainted dairy products, saying that
as many as six babies might have died and nearly 300,000
were sickened after consuming contaminated milk powder.”

infant formula by Chinese milk dealers and suppliers (2) if any substance has been substituted
in an effort to increase protein content and profits, wholly or in part therefor; or
resulting in 50,000 infant hospitalizations and six (3) if damage or inferiority has been concealed
infant deaths in China. In 2009, on the heels of a in any manner; or
public outcry over these incidents, the FDA issued a (4) if any substance has been added thereto or
Notice of Public Hearing to address EMA.5 The FDA’s mixed or packed therewith so as to increase its
Notice of Public Hearing expressly cited these two bulk or weight, or reduce its quality or strength,
events (as well as two drug EMA incidents) as reasons or make it appear better or of greater value
for addressing EMA. The Notice of Public Hearing than it is.7
also stated that the FDA’s EMA Working Group had
defined EMA as the It should be noted that Section 402(b) does not
expressly use the descriptor “economically motivated
fraudulent, intentional substitution or addition adulteration.” It is generally accepted, as evidenced
of a substance in a product for the purpose of by the EMA Working Group’s definition, that Section
increasing the apparent value of the product 402(b) implicitly provides that the acts enumerated
or reducing the cost of its production, i.e., in the section—substitution, addition, omission,
for economic gain. EMA includes dilution dilution, and concealment—are intended by the
of products with increased quantities of an adulterators to produce economic gain.
already present substance (e.g., increasing
inactive ingredients of a drug with a resulting Thus, EMA is an intentional act. The most obvious
reduction in strength of the finished product, or way to produce economic gain is to increase profits.
watering down of juice) to the extent that such This may occur, for example, when a manufacturer
dilution poses a known or relative health risk to uses cheap filler that is easily disguised to increase the
consumers, as well as the addition or substitution product volume and in turn increase the profit margin.
of substances in order to mask dilution.6
The UDSA’s Definition of EMA
This working group definition remains the first and last
definition of EMA issued by the FDA. In 1994, the FMIA was amended to prohibit expressly
a category of adulteration that roughly matches the
The EMA Working Group’s definition of EMA derives FDA’s description of EMA:
from the FDCA’s definition of “adulteration.” The FDCA
gives authority to the FDA to regulate food, drugs, and The term “adulterated” shall apply to any carcass,
cosmetics. Section 402(b) of the FDCA (codified at 21 part thereof, meat or meat food product…if any
U.S.C. § 342(b)) lists a range of actions that constitute EMA valuable constituent has been in whole or in
for food products. Section 402(b) states: part omitted or abstracted therefrom; or if any
substance has been substituted, wholly or in part
A food shall be deemed to be adulterated— therefor; or if damage or inferiority has been
… concealed in any manner; or if any substance has
(b) Absence, substitution, or addition of been added thereto or mixed or packed therewith
constituents so as to increase its bulk or weight, or reduce its
(1) If any valuable constituent has been in quality or strength, or make it appear better or of
whole or in part omitted or abstracted greater value than it is.8
therefrom; or

This same definition is also found in the PPIA, an enabling Delineating Statutory EMA Actions
statute giving authority to the USDA to inspect poultry
and poultry products capable for use as human food.9
Neither Section 402(b) nor the EMA Working Group define
with specificity the EMA actions of substitution, addition,
Additional Non-Government Definitions of omission, dilution, and concealment. In an effort to flesh
EMA out the meaning of these terms, we group together real
life examples of EMA actions. This grouping shows some
As noted in the 2014 CRS Report, “[r]esearchers and overlap and blurring between the types.
industry groups working actively in this area have myriad
definitions of food fraud and EMA.” For example, the • Substitution
Grocery Manufacturers Association (GMA) defines
“economic adulteration” as: Substitution is the most common type of EMA.
Substitution occurs when a substance of less value replaces
the intentional fraudulent modification of a a food substance.12 Substitution is common in fish, where
finished product or ingredient for economic tilapia, for example, is often substituted in place of more
gain through the following methods: expensive fish or farmed salmon is substituted for wild
unapproved enhancements, dilution with a salmon.13 Other common examples of substitution include
lesser-value ingredient, concealment of damage where sugar and other sweeteners are used instead of
or contamination, mislabeling of a product honey,14 cow’s milk is used for more expensive sheep’s or
or ingredient, substitution of a lesser-value goat’s milk, and common wheat for durum wheat. In the
ingredient or failing to disclose required product British Isles in 2013, the substitution of horsemeat for beef
information.10 attracted widespread media attention.15 Substitution can
also be linked to the false declaration of the production
GMA’s definition is consistent with Section 402(b), but also process, such as when food is falsely labeled or certified
includes the intentional mislabeling of food product within as organically produced or poor quality filtered honey or a
the scope of EMA. honey substitute product is labeled as raw honey.16
USP defines EMA of food ingredients in the following • Addition

statement:
Food products are often sold by weight either at the
Food Fraud in the context of food ingredients register or at some point in processing. One way to increase
refers to the fraudulent addition of non- the price of these goods is to add inexpensive material to
authentic substances or removal or replacement the product to increase weight. The scandal involving the
of authentic substances without the purchaser’s adding of melamine to infant formula in China is an obvious
knowledge for economic gain of the seller. It example.17 Other examples include the padding of cumin
is also referred to as economic adulteration, with ground peanut shells,18 excessive cellulose in grated
economically motivated adulteration, intentional Parmesan cheese,19 and “over-glazing” (adding more than
adulteration, or food counterfeiting.11 the allowed amount of water to) seafood and meats.20
USP’s definition is notable because in addition to • Omission

equating EMA to food fraud, it refers to authenticity and
inauthenticity as linchpins of the EMA or fraud assessment. Omission occurs when some valuable constituent is
missing from the product. An example of omission is

The discovery of horsemeat in processed beef products sold by a number of UK supermarket chains in March of 2013 resulted in a series of
product recalls and threw the spotlight on the food industry’s supply chain. Source: http://www.mirror.co.uk/news/uk-news/findus-beef-lasa-
gne-could-100-1593248
when Beech-Nut Corporation’s “apple juice” actually • Concealment

contained no apple.21 Other examples include “100%
Parmesan cheese” that is actually only imitation cheese Concealment occurs when inferior quality is disguised
and trimmings of Swiss, mozzarella, white cheddar, and through the use of some artifice, such as adding chlorophyll
Havarti;22 “paprika” that is actually only the leftover to olive oil to make it greener.27 While it is a well-accepted
product after fats and flavors have been extracted for purpose for food dyes and added flavors to elevate a less
paprika-flavored extracts;23 and “extra virgin olive oil” that desirable food into a more desirable one, years ago in
is actually refined olive oil.24 Some honey producers in the the US, substances were added to rancid flour and milk in
US and elsewhere have argued that the omission of pollen order to make them whiter.28
from honey should be considered an adulteration, but
current US regulations do not include that requirement.25 Distinguishing EMA from Food Safety
Adulteration
• Dilution
In cases where EMA of food under the jurisdiction of
Dilution is where the amount of authentic food relative the FDA causes food safety problems, the offending
to other ingredients that may or may not be listed on the food company likely would be violating the food safety
package is reduced. Dilution typically happens in concert requirements of Section 402(a), as well as the EMA
with other forms of adulteration: a valuable ingredient requirements of Section 402(b). Section 402(a) considers
might be partially removed, a less valuable ingredient “poisonous” and “contaminated” food as adulterated.
added in to make up the difference, and a concealing Rounding out Section 402(a) is the aggregation of food
agent applied to cover up the misdeed. For example, the safety regulations, rules, and guidance, all of which regard
addition of melamine to wheat gluten and infant formula in food as being adulterated if it contains a harmful substance
China was an effort to conceal the inferior protein content that may pose a safety risk or it contains a substance that
of diluted food products.26 The most common and has been intentionally added to the food but that has not
obvious example of dilution, however, is watered-down, been approved or otherwise sanctioned for use by statute
under-poured alcoholic drinks in a bar or restaurant. or the FDA.29

Notwithstanding the possible concurrent violation of adulteration, such as sabotage (possibly leading to terrorist
the these two sections, the statutory framework clearly acts), the primary purpose of which is to cause physical
distinguishes EMA, as defined in FDCA’s Section 402(b), and life-threatening harm, rather than economic gain.31
from the food safety criteria encapsulated and enumerated EMA is also distinguishable from counterfeiting, another
in the Section 402(a) (as well as in the FMIA and PPIA for category of food fraud, which involves the unauthorized
meat and poultry products). EMA under Section 402(b) representation of a registered trademark carried on goods
focuses on certain actions of economic cheating with similar to goods for which the trademark is registered,
the incidental danger to health.30 To illustrate, while the with the intent to deceive the purchaser into believing that
intentional substituting horsemeat for beef for economic they are buying the original food product.32
gain may be repulsive to the sensibility of many consumers,
horsemeat generally was not viewed in the UK as posing a Foods Most Commonly Subject to EMA
food safety hazard and thus would meet the definition of
Section 402(b) rather than Section 402(a). Dearth of Data
Distinguishing EMA from Other Forms of Researchers contend that the foods most often subject
Adulteration and Food Fraud to EMA are fish and seafood, milk and dairy products, oils
and fats (especially olive oil), meats, alcoholic beverages,
EMA is distinguishable also from other forms of intentional fruit juices, grains, honey and other sweeteners, spices
The most egregious early example of food fraud in the US reportedly involved milk and the
deaths of infants. In 19th-century New York, rapid industrialization meant the elimination
of pastureland inside the city, but many Americans still relied on milk as a staple food for
children and infants, especially as breastfeeding fell out of favor. Dairy farmers raised cows
outside the city and shipped milk in by rail. Others raised cows inside New York City in filthy
pens attached to distilleries, and the cows ate alcoholic mash—a byproduct of distilling.
“Swill milk,” as it would become known, was modified with plaster, magnesia, flour, starch,
and molasses to give it the color and consistency of real milk. Real milk shipped in from
neighboring counties was commonly diluted with water and given similar treatment. The
practice continued for decades, and it remains hard to estimate how many children died from
milk poisoning and contagion (milk pasteurization did not become common practice until the
mid-1890s), but an 1858 article in the New York Times estimated 8,000 children died every
year from drinking swill milk.
New York passed laws against milk adulteration and banned distillery dairies, but enforce-
ment was rare and ineffective.
Wilson, B. (2008). Swindled: The Dark History of Food Fraud, From Poisoned Candy to Counterfeit Coffee , 154-63.

and extracts, produce, and coffee and tea.33 No one glycol73 or infant formula for melamine.74 EMA is designed,
knows exactly how prevalent EMA is, however, and how by its nature, not to be detected.
many products are affected.34 While imported food seems
to be disproportionately represented in the data that Testing
exists for EMA, this could be the result of more focused
attention on imported foods. In terms of financial impact, Even once specific adulterants are detected, the testing
the GMA estimates EMA costs the food industry fifteen that targets these specific adulterants can quickly become
billion dollars per year, but it is difficult to substantiate this obsolete when chemists working on behalf of fraudulent
estimate.35 food producers devise new, substitute adulterants. For
example, following the 2008 melamine scandal in China,
Summary of What We Know officials began to test dairy products for melamine.75 In
2009, hydrolyzed leather was found in Chinese infant
The chart below identifies and briefly summarizes what is formula being used for the same purpose as melamine: to
known about the foods most commonly subject to EMA. boost apparent protein content.76
Challenges in Detection and Testing Testing a food product’s authenticity, rather than focusing
on a specific adulterant, can also be difficult to manage
Detection because the composition of food products often varies
by location, growing conditions, production methods,
EMA can be very sophisticated and difficult to detect. In and other variables.77 Devising a test to account for these
1985, a massive international wine fraud was only discovered variables requires sophisticated authentication standards,
because a tax inspector noticed large deductions taken by such as one developed for pomegranate juice as delineated
an Austrian winery for diethylene glycol, a sweet-tasting in a publication entitled International Multidimensional
industrial solvent that serves no purpose in winemaking.72 Authenticity Specification (IMAS) Algorithm for Detection
Normally, one would not inspect wine for diethylene of Commercial Pomegranate Juice Adulteration.78 The
Seafood is probably the largest category of foods subject to EMA. Numerous studies have found rampant species
substitution—where a lower-value fish is labeled as a higher-value fish—in restaurants, grocery stores, and fish markets.36
Seafood is also subject to over-glazing: increasing the weight (and therefore price) by artificially increasing water and
ice.37 These problems are extremely common in the US and worldwide.38
Olive oil is the world’s most adulterated oil.39 “Extra virgin” is the highest and most expensive grade of olive oil; it also has
the most health benefits and best flavor.40 In order to qualify as extra virgin, the oil must be separated from the fruit using
only mechanical means (generally a crusher and centrifuge), have an olive fruit flavor, and be free of defects.41 Extra virgin
olive oil is most often diluted with lower-grade or refined olive oil, though it is sometimes diluted with seed oils.42 Any
addition of lower-grade oil renders the whole product lower-grade. Extra virgin olive oil is expensive to produce, but
lower quality oils can be produced inexpensively in amounts that fill tanker ships.43 The price premium for extra virgin
olive oil is therefore extremely attractive for fraud, especially when consumers do not know that extra virgin olive oil
should have a powerful bouquet of flavor. Olive oil is not the only oil subject to EMA: higher-value fats of every kind are
typically diluted with lower-value fats.44
Milk adulteration has a long history in the US45 but is now aggressively controlled.46 However, milk and dairy adulteration
is common in China, where dairy production is relatively new and domestic supply cannot meet increased demand.
Infant formula is subject to EMA at such a high rate in China that it has created a grey market in illegally imported formula.47
Cheeses are subject to adulteration worldwide, mostly by substituting lower-value cheeses for higher-value ones.48

Meat EMA takes the form of species substitution, substitution of lower-value cuts for higher-value cuts, and over-
glazing.49 Denatured pork and beef products have been injected into chicken to increase water retention, artificially
increasing weight and price.50
The most common EMA of alcoholic beverages is undoubtedly water dilution and under-pouring in bars and restaurants.
Many wine frauds involve the substitution of less valuable grapes or grapes from the wrong region.51 Some wine frauds
involve diluting more valuable wines with less valuable wines or wines of different types.52 Among the most dangerous
forms of EMA typically happens in combination with liquor counterfeiting: the perpetrators use methanol to increase
alcohol content.53 Methanol is a toxic (poisonous) alcohol and is less expensive than ethanol, the alcohol we drink.
Fruit juices are particularly susceptible to EMA because their major adulterants, water and sweeteners, are present in the
authentic products in large quantities. Other adulterants include pulpwash solids, unapproved preservatives, and less
valuable juices; labeling reconstituted juices as fresh-squeezed is also EMA. The US General Accounting Office, in a report
in 1995, estimated the rate of orange juice adulteration in the US could be up to 20%, but they also said that addressing
that EMA was probably too costly.54
Grains are subject to additions like adding urea to flour or melamine to wheat gluten to fool lab tests for protein content.55
Higher value grains like Basmati rice may be diluted with lower value grains.56 Grains, like many other products, may also
be deliberately mislabeled as organic when they are conventionally grown; the Italians uncovered an organic labelling
conspiracy in 2011 that included various grains.57
Honey, like olive oil, is at the forefront of the worldwide food fraud fight. Because of rampant dilution with high fructose
corn syrup and other cheap sweeteners, some countries, including the US, created tariffs on honey from China to prevent
“dumping” low-cost honey on the market.58 The European Union (EU) and Canada banned imports of Chinese honey
for ten years after the discovery of chloramphenicol, a dangerous and highly controlled antibiotic, in imported honey
in 2002.59 As a result of tariffs and bans, much of the honey coming out of China is now ultra-filtered to remove all trace
minerals and pollen that would allow scientists to identify the origins of honey samples.60 Chinese honey is commonly
shipped to other countries and repackaged before exporting to the US and elsewhere in order to avoid tariffs and bans;
many countries export more honey than they produce.61 The US does grow its own honey adulterations: in the late
1990s, two brothers were convicted for selling honey and maple syrup diluted with corn syrup at farmers markets for
more than twenty years.62
Spices and extracts are common targets of EMA, often at the production level (by contrast, fishers rarely see the profits
from species substitutions or advanced over-glazing methods).63 This is because spices are typically sold in powdered
form and sourced from small producers in parts of the world with little oversight or accountability.64 The production of
“extracts” often leaves spent spice behind to be dyed and sold as if it were full strength; highly toxic industrial dyes often
conceal the inferiority of spent or poor spices.65 Non-spice bulking agents like ground peanut shells may also be used
to dilute spice.66
Fresh produce is has been subject to organic labeling fraud.67 This type of fraud is a substitution: conventionally grown
produce is substituted for organically grown produce, and the culprit gains the value of the organic price premium. In
the US, the USDA oversees the National Organic Program (NOP) and certification of organic food production. Because of
the way the NOP works, organic labelling fraud in the US is most often a result of fraudulent documentation, especially as
there are no tests to tell whether a product is organically grown.68
Coffee and tea have EMA histories as long and complex as wine.69 Tea adulteration is ubiquitous in India.70 Tea and coffee
are both subject to the addition of organic bulking agents. In tea, that usually means spent leaves, stems and stalks, and
non-tea plant matter; in coffee, it means corn, barley, rye, caramel, and bean husks.71 In the US, these adulterations are
most easily avoided by buying whole-bean coffee and loose tea, though false origin and organic claims can remain.

“The Canadian Broadcasting Corp.’s
‘Marketplace’ news program recently
Source: https://www.washingtonpost.com/news/morning-mix/
wp/2017/03/02/subway-fires-back-with-its-own-study-to-prove-its- had a DNA lab analyze chicken meat and
chicken-is-chicken/?utm_term=.c839f77c2146 strips cooked in popular fast-food chains.
Subway meat, the report indicated, showed
significant amounts of non-chicken DNA. . .
IMAS algorithm serves to identify pomegranate juice Subway responded Wednesday with a
authenticity and adulteration, which enables companies prickly condemnation of the news report
using these methods to identify problems in their own that suggested its chicken meat was diluted
supply chains or adulterants in competitors’ products.79 with unusually high levels of soy. . . ‘The
It was developed through evaluation of a comprehensive stunningly flawed test by ‘Marketplace’ is
chemical characterization of forty-five commercial juice a tremendous disservice to our customers,’
samples from twenty-three different manufacturers in the said Suzanne Greco, Subway president
US and samples from Iran, Turkey, Azerbaijan, Syria, India, and chief executive, in a statement issued
and China.80 Wednesday night. . .
For foods that have DNA, DNA testing can be used to It bolstered its response by releasing the
help pinpoint the identity of the product.81 This is most
results of its own study, commissioned in the
wake of the CBC report. . . .[characterizing]
useful for species substitutions in meat and fish and is
the CBC report as misleading and demanded
actively being used by some grocery retailers to ensure
a retraction. . .
the authenticity of the foods they sell.82 It is important
to note, however, that DNA testing is expensive (often But the Canadian news company did not
prohibitively so) and cannot be used in foods that have no budge, either. It cited. . . a University of
DNA in them as a result of processing.83 Also, as evidenced Guelph biologist, who said that although
by the recent dispute over the authenticity of Subway’s DNA ‘cannot be taken as exact mass ratios in
chicken, even when DNA testing can be used, the results the product,’ the genetic material could serve
are not always conclusive. as a proxy for amounts of soy in the meat.”
The expense of developing authoritative, public testing

standards sophisticated enough to authenticate food
but also affordable and accessible has helped prompt elaborates on standards for testing the authenticity and
USP to get involved in standard making.84 As a scientific purity of food ingredients (albeit not as sophisticated as
nonprofit organization, USP sets standards for medicines, the IMAS used for pomegranate juice authentication) in
food ingredients, and dietary supplements.85 USP the Food Chemicals Codex, an internationally recognized

compendium of monographs and reference standards in great detail as it relates to fraudulent extra virgin olive
for food ingredients.86 Notwithstanding USP’s expansive oil, a product commonly sold for prices below the price
standards development efforts—by 2016, USP had over of honest production.90 In order to compete in this and
1,200 testing standard monographs for food ingredients87 other markets, producers are compelled to participate in
—testing may still miss adulterants and be expensive to the “race to the bottom” or to leave the market entirely,
administer.88 in which case authentic food cannot be had at any price.
Harms Caused by EMA Food Safety Risks
The harms caused by EMA are far-reaching. These harms • Safety Incidents
include economic harms to consumers and honest food
companies, potentially devastating food safety risks, As previously noted, while EMA under Section 402(b) is
and systemic harms that undermine confidence in the distinctive from food safety adulteration under Section
governance of the food system. 402(a), in some cases EMA leads to serious food safety
concerns. As observed by former FDA Commissioner
Economic Harms David A. Kessler: “[i]n most cases of adulteration, it turns
out to be just economic and nobody gets hurt—but there
• Consumers
EMA cheats consumers. When consumers buy a product,

they are entitled to receive the product they agreed to
buy for the price they agreed to pay—the “benefit of the
bargain.”89 When a product is adulterated, consumers miss
out on the full benefit of their bargains. This harm impacts
all consumers who are seeking authentic food products
for whatever the reason, including for health benefits or
for pure enjoyment.
• Honest Purveyors of Food
EMA also cheats honest purveyors of food. Consumers

might buy a jar of honey on occasion, but food
processors—companies that make more complex foods
from several ingredients—buy it by the drum. They, too,
lose the benefit of their bargain if the large quantities of
food they buy are subject to EMA. If food producers have
to compete with lower-priced frauds, they cannot make a
living. Some forms of EMA are so rampant in some places
that the fraudulent goods have been able to push honest
producers out of the market because they cannot produce
an honest product at a competitive price. In his bestselling
book, Extra Virginity: The Sublime and Scandalous World
Mueller, T. (2011). Extra Virginity: The Sublime and Scandalous
of Olive Oil, author Tom Mueller explains this problem World of Olive Oil. WW Norton & Company.

is always that potential.”91 It stands to reason that cheaters
may not be very concerned about safety while adulterating
Many historians begin the
a product for profit. The most obvious example is
story of modern EMA
the melamine scandal in China, where the addition of
with Friedrich Accum and
melamine to infant formula resulted in hospitalizations and
A Treatise on the Adulteration
deaths of infants. Fraud was also a motive behind Peanut
Corporation of America’s actions in connection with the of Foods and Culinary Poisons,
Salmonella outbreak in 2009, which killed nine people and published in England in 1820.
sickened 700.92
Accum’s treatise exposed food
A more recent example involves spices: since 2014, fraud and marked how the
hundreds of food products containing “cumin” have been Industrial Revolution increased
recalled due to undeclared peanut shells.93 Although the the scope and sophistication of food
source of the peanut shells appears to be Turkey, experts fraud.
believe that cheap peanut and almond shells are being used
secretly in place of cumin after a disastrous crop in India
drove the spice’s price up.94 While the shells themselves
are not dangerous, they often come with pieces of peanut
attached, which are potential hazards for consumers with
peanut allergies.95
Food Governance Harms
It stands to reason that non- or under enforcement against

EMA undermines the credibility of government agencies
entrusted to ensure the integrity and authenticity of food.
This erosion of authority contributes to a growing cynicism
of the modern food system and likely encourages further
malfeasance and inappropriate risk-taking with food.
Image source: California Digital Library Internet Archive

https://archive.org/details/treatiseonadulte00accurich

3. Government Criminal Enforcement of EMA under PFDA
Enforcement In 1906, socialist muckraker Upton Sinclair published The
Against EMA Jungle, a book about the deplorable labor conditions in

Chicago stockyards. In actuality, readers were appalled by
the unsanitary conditions he described in the meatpacking
industry. The ensuing public furor led to passage in 1906 of
Government enforcement against EMA has changed
the PFDA and the FMIA, thus commencing the modern era
over time in the US and abroad. Approaches have
of US food regulation.
included criminal law and administrative regulation.
The challenge for enforcement authorities has been
to adapt to the growing sophistication of EMA and to
prioritize enforcement of EMA, especially where there
“I aimed at the
is no direct threat to the safety of the adulterated food.
Today, enforcement is infrequent and ad hoc. What little public’s heart and
enforcement activity there is has typically involved honest
purveyors of food seeking address and not ordinary by accident hit it in the
consumers who generally are not even aware of the fraud stomach.”
in the first place. This regulatory inertia is due to a lack
of clarity about what constitutes EMA and a failure to
prioritize EMA as a problem meriting enforcement in the
- Upton Sinclair
interest of consumers.
Early Regulation
State Laws Banning Imitation Products
Throughout the nineteenth century, federal legislation

of any kind against adulteration was rare, which left it to
states to form food economic adulteration laws. A popular
type of state law then concerned margarine, which is
imitation butter made from vegetable oil or seed oils.96
Before legislation banning the practice and long before
comprehensive labeling laws, margarine producers dyed
their products so that they could resemble—or sometimes
pass for—authentic butter.97 The Supreme Court upheld
the constitutionality of these laws and the rights of states
to regulate public health in this way in cases like Capital
City Dairy Co. v. Ohio.98
Sinclair, U. (1906). The Jungle. Doubleday, Page and

Company.

Early enforcement of the 1906 PFDA involved frequent became the development of “standards of identity,” which
use of criminal misdemeanor provisions related to EMA. set out the formula or method of production required for
In Schraubstadter v. United States, defendants were certain foods defined by the FDA.107
convicted and fined $300 each for three counts of shipping
and selling carbonated wine labeled as champagne.99 Section 401 of the FDCA gives the FDA broad authority to
In Union Dairy Co. v. United States, the defendant was choose to develop these standards:
convicted for shipping milk diluted with water.100 In Frank
v. United States, the defendants were convicted and fined Whenever in the judgment of the Secretary such
$50 for shipping white pepper diluted with ground corn.101 action will promote honesty and fair dealing in
the interest of consumers, he shall promulgate
Tapering off of Criminal Prosecution regulations fixing and establishing for any
food, under its common or usual name so far as
Despite these cases and others like them,102 criminal practicable, a reasonable definition and standard
prosecutions under the PFDA tapered off in the 1920s. One of identity, a reasonable standard of quality, or
reason for the decrease was that the law failed to keep pace reasonable standards of fill of container.108
with new food technologies that rendered the adulteration
of food more difficult to detect. Another reason is that The enforcement provision for violating standards of
regulators focused on prosecuting imitation products identity is Section 403(g):
that were merely likely to mislead consumers, rather than
the more typical forms of EMA, which resulted in courts A food shall be deemed to be misbranded—
curtailing the government’s enforcement reach.103 This …
limitation of prosecutorial authority was exemplified in If it purports to be or is represented as a food
the oft-cited case of United States v. Ten Cases, More or for which a definition and standard of identity
Less, Bred Spred, decided by the Eighth Circuit. The case has been prescribed by regulations as provided
involved fruit-based sandwich spread that was mostly by section 401 of this title, unless (1) it conforms
sugar, water, and pectin and relatively low on actual fruit.104 to such definition and standard, and (2) its label
The government argued that Bred Spred was an imitation bears the name of the food specified in the
of jam, which was conventionally made of equal portions definition and standard, and, insofar as may
of sugar and fruit, so it had to be labeled “imitation” or it be required by such regulations, the common
was misbranded.105 The Eighth Circuit held that Bred Spred names of optional ingredients (other than spices,
was not misbranded and did not have to be labeled an flavoring, and coloring) present in such food.109
imitation because nothing on the label indicated that Bred
Spred was anything other than Bred Spred.106 Proliferation of Standards of Identity
From the enactment of the FDCA in 1938 through the 1960s,

FDCA Section 401: The Rise and Fall of
the FDA developed and enforced standards of identity for
Standards of Identity many staple foods.110 The result of this development effort
is three hundred extant standards of identity in twenty
Statutory Framework food categories.111
The passage of the FDCA in 1938 was in part intended to By far the largest category of food standards belongs
remedy the perceived problem of imitation food as well as to milk and milk products—a reasonable choice given
EMA in general. The principal approach under the FDCA both the centuries-long battle for safe, authentic milk

and the prevalence of dairy in the American diet.112 The convinced Congress and the FDA to alter many
milk standard is extremely detailed: the “milk and cream” aspects of the development of new standards, but the
section of the Code of Federal Regulations is about thirty practice never fully recovered.119
pages long and covers the range of acceptable additives
for the whole spectrum of dairy products, including Any residual momentum of standards-making was
yogurt, buttermilk, sour cream, heavy cream, and even grounded when Vice-President Al Gore expressed shock
eggnog.113 The milk standard is extremely rigid, which is at learning that the FDA set forth precise standards for
likely why milk is such a uniform product across brands and the shapes in which canned beans could be sold, spurring
why milk EMA has become so rare in the US. a 1995 advanced notice of proposed rulemaking to solicit
comments on the viability of food standards.120 Given the
Criticism of Standards of Identity administrative and political ramifications, the FDA is no
longer in the business of developing standards of identity.
Notwithstanding the success of standards of identity in
preserving authentic categories of food, such as milk, The discontinuance of the development of standards
the development of these standards by the 1970s began of identity has not stopped a few producer groups—
to lose favor with the FDA. Advances in preservatives, namely, honey and olive oil—from requesting federal
freezing, shipping, flavoring, and methods of cooking standards of identity for their products lines in an
foods fundamentally altered the nature of artificial attempt to eradicate EMA of imported honey and
enhancement, and even without food technology, the olive oil products. In 2011, on grounds that food
variety of foods available to the modern consumer standards are of limited use and do not benefit
outstripped the ability of the FDA to develop standards. consumers, the FDA denied a citizen’s petition from
US honey producers that requested the FDA to
The emerging view that the standards were too adopt a honey standard of identity established by
unwieldy and time consuming to develop was the food international standards-setting body, Codex
punctuated by the decade-long hearing on the Alimentarius Commission.121 In 2012, the FDA denied
identity of peanut butter that commenced in 1959 a citizen’s petition by US olive oil producers to adopt
and took a decade to resolve.114 The issue began an olive oil standard of identity established by the
much earlier with the question of whether peanut International Olive Council (IOC). It should be noted
butter could have ingredients other than peanuts; that Connecticut and California have elected to create
some people prefer peanut butter that is slightly their own standards for olive oil, including extra virgin
sweetened, that does not separate, and that is easier olive oil, which follow the IOC standards.
to spread than peanuts-only peanut butter.115 By the
time the FDA proposed developing a standard, some It is important to remember that existing standards
manufacturers sold peanut butters that were 20% of identity for food are still enforceable law. This
non-peanut ingredients, including hydrogenated can cause some surprising problems for some food
vegetable oils, which are far less expensive than producers, such as when Hampton Creek received
peanuts and peanut oil.116 The FDA proposed a a warning letter from the FDA in August 2015, saying
standard of 95% peanuts and 5% optional ingredients that the Just Mayo products, which are vegan
from a list of approved, common additives.117 The mayonnaise substitutes, were misbranded because
manufacturers of Skippy, Jif, and Peter Pan fought this they did not meet the definition and standard
proposal, and the process of public hearings, research, of identity for mayonnaise.122 According to the
lobbying, and further standard development dragged FDA standard, eggs are required ingredients for
out over the next ten years.118 The protracted process mayonnaise.

Additional Enforcement Tools competitors through voluntary enforcement mechanisms,
upon request by Campbell, referred the “advertising” for
In addition to fines and seizure actions for violations the butter cookies to the FTC and FDA for further review.128
of the FDCA sections pertaining to EMA, honest FTC has the authority to stop “unfair methods of
purveyors of food in competition with cheaters have competition in commerce” and “unfair or deceptive acts
at their disposal a few other regulatory tools. or practices in commerce.”129 Arguably, EMA is an “unfair
method of competition” and an unfair or deceptive act or
Import Alerts: FDCA Section 801 practice;” however, the agency has deferred to the FDA in
the handling of EMA. A Working Agreement established
Import alerts can be an effective law enforcement in 1954 between the FDA and FTC provides that unless
mechanism for the FDA to use to prevent adulterated the agencies otherwise agree, the FTC will exercise sole
foods from entering the US. The FDA’s authority over jurisdiction over all advertising of food and the FDA
imported food is derived from Section 801 of the FDCA, will exercise sole jurisdiction over all labeling of these
which prescribes that a food may be refused entry into products. It is likely that FTC regards EMA of food primarily
the US if it appears to be adulterated.123 For example, an as a deceptive labeling problem and thus an FDA problem,
import alert was issued in 2009 for morel mushrooms, except, perhaps in cases like Danisa® Traditional Butter
due both to microbial contamination and substitution of Cookies, where the advertising is clearly the issue.
less valuable mushrooms for a portion of the morels.124
Import alerts are the result of an administrative process, Campbell could have brought a state claim in court against
and they allow foods to be held at ports of entry without the distributor Takari (the cookies were manufactured in
inspection.125 Import alerts are public records and are Indonesia and sold in packages that display Scandinavian
accessible and searchable on the FDA’s website.126 While imagery) or file a complaint directly with the FTC, but
consumers conceivably could request an import alert on both of these paths can be cumbersome. Campbell also
EMA product, the normal course of business is where considered filing for an import alert, but this need was
a company impacted by the EMA requests the FDA to averted when Takari ceased to import the cookies into the
impose the alert on an offending importer. US, presumably in response to NAD’s finding that Takari
had not brought its advertising into compliance with
Deceptive Advertising NAD’s recommendations and subsequent referral of the
advertising to the FTC and FDA.130
Another tool for food companies harmed by EMA is to
pursue a claim of deceptive advertising. An example FSMA: Focus on Safety not EMA
of how this strategy works is seen through a matter
involving imported Danisa® Traditional Butter Cookies, Heralded as the most significant food legislation in the US
which allegedly had been diluted with an undisclosed fat since the 1938 FDCA, the 2011 Food Safety Modernization
ingredient, most likely a vegetable oil, Campbell Soup Act (FSMA) introduced a new regime of food safety
and its subsidiary Kelsen, Inc., argued in correspondence regulation. FSMA was passed in response to food safety
with FDA that use of a less expensive shortening in the concerns both to domestic and imported foods. In short,
butter cookies was EMA and use of the name “butter FSMA dramatically strengthened the FDA’s commitment
cookies” violated the standard of identity requirement to a proactive and preventive approach to food safety.
that a “butter cookie” use only a butter shortening.127
The National Advertising Division of the Council of Better
Business Bureau (NAD), whose purpose it is to provide
cost-effective resolution to disputes between market

Intentional Adulteration Provision Rule). The problem with this approach, however, is that
the Preventive Controls Rule focuses almost exclusively
A provision in FSMA that dealt with intentional adulteration on food safety and the management of health hazards like
was initially viewed as a possible route for the FDA to develop pathogen contamination. These rules are important for
rules on EMA; however, the provision was silent about its food safety, but they treat EMA as a matter of regulation
extension to EMA.131 Not too surprisingly, FDA’s Final Rule and enforcement only as an incidental threat to health.
that governs how intentional adulteration is regulated The Preventive Controls Rule does not address preventing
focused exclusively on what experts call “food defense.”132 EMA itself, only the health and safety hazards that may
Food defense is the aspect of intentional adulteration that occur as a result of EMA.134
deals with hazards deliberately introduced to the food
system, usually under political motivations, otherwise
EU Criminal Enforcement: Harbinger for
known as bioterrorism.133
the US?
Preventive Controls Rule
Food Fraud Network
When the FDA’s Final Rule on intentional adulteration was
published, the agency remarked that EMA would be handled In contrast to the US approach, food fraud has become
under the food safety rule Hazard Analysis and Risk-Based an international cooperative law enforcement agenda
Preventive Controls for Human Food (Preventive Controls item in the UK and in the EU.135 Spurred on by the
Public version of the Operation Opson IV report available at https://www.europol.europa.eu/sites/default/files/documents/report_op-

son_iv_public_version.pdf

horsemeat scandal in 2013, the EU established the Food faire policy, especially when it comes to consumer interest.
Fraud Network, which is a database that operates among
Member States, unifying the international approach to
EMA.136 The system is still in its early stages, but it may
eventually serve to eliminate some of the problems of
4. Legal and
international transshipment of adulterated foods, at least
those that flow through the EU.
Policy Strategies
Europol-Interpol Food Fraud Task Force To remedy the problem of EMA food, this White
Paper proposes five legal and policy strategies to be
In some cases, EU member countries have begun acting implemented by the government, the food industry, and
aggressively to combat EMA: for example, Italy has consumer litigation.
stepped up its enforcement of strict criminal and civil
penalties for olive oil frauds.137 Europol and Interpol are
Enforce Against EMA as Fraud:
now treating food fraud as a significant activity and source
of revenue for transnational organized crime. Operation
Putting the Consumers First
OPSON IV, the fourth iteration of the Europol-Interpol
The FDA’s failure to enforce against EMA food for the
food fraud task force, resulted in the seizure of more than
benefit of consumers is shortsighted and wrong given that
eleven thousand metric tons of fraudulent goods in 2015
the statutory thread that runs through FDCA Sections 401,
by utilizing the cooperation of law enforcement agencies
402, and 403 clearly obligates the FDA to do something
in forty-seven countries, including the US.138
more about EMA than wait for a food safety problem to
arise. The FDA routinely regulates food where there is
Status Quo: Minimal Enforcement not a food safety or public health threat, as in the case
Activity of mislabeling. Moreover, the US Supreme Court has
expressly acknowledged that the FDA is responsible under
Notwithstanding these various legal tools—standards the FDCA to issue certain regulations to “promote honest
of identity, import alerts, deceptive advertising claims, and fair dealing in the interest of the consumer.”139
and the FSMA Preventive Control Rule—the prosecution
of EMA is rare. Enforcement against EMA has not • Treat EMA as Fraud
been a priority of the FDA or any other federal agency.
Instead, EMA has been relegated as a second-tier EMA is by all definitions fraud and should be treated as
form of adulteration that almost exclusively demands such. The absence of a food safety consequence does not
enforcement only when a food safety concern is at stake. lessen the fraudulent nature of the offense. This type of
Food companies and producer groups who are driven by fraud unabated invites an insidious form of criminality that
market incentives to eliminate competitive food products turns into systematic fraud that is difficult to eradicate. As
that are adulterated in some cases after a lot of effort are noted in the UK Elliott Review:
able to mobilize the FDA to implement an import alert.
Consumers are not so fortunate. Consumers are generally Concerns have been expressed during this
not even aware of the fraud being committed when they review that the term food fraud creates an
purchase and consume EMA food. Moreover, there is no impression of some kind of low grade infraction
specific formal mechanism for consumers to complain to of the law, of a harmless minor breach of
the FDA about an EMA food product. When it comes to technical regulations of the kind that many hard
EMA food, the government in practice follows a laissez- pressed businesses may be tempted to resort

Elliott Review into the Integrity and Assurance of Food Supply Networks –
Final Report
A National Food Crime Prevention Framework July 2014
Source: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/350726/elliot-review-final-report-july2014.pdf
to in difficult times. But the serious end of food and this means giving food safety and food crime
fraud is organised crime, and the profits can prevention—i.e. the deterrence of dishonest behaviour—
be substantial. The recommendations in this absolute priority over other objectives.”
report will not stop food crime, but are intended
to make it much more difficult for criminals to Putting the consumer first will require that the FDA change
operate in the UK.140 its way of thinking about EMA. Too often the FDA does not
view EMA in terms of the ultimate victim, both in economic
Treating EMA as fraud would motivate the FDA and USD and public health terms, which is the consumer. It is
to prioritize the enforcement of EMA and to recognize tempting for the FDA to view EMA solely as an economic
its short-term and long-term consequences. These cheat against an honest purveyor of food goods. In reality,
agencies should also follow the lead of the EU and the effect is much more pervasive. Putting the consumer
develop a cooperative approach with other domestic first means that the FDA should define EMA with the
and international law enforcement agencies and states in consumer in mind, enforce vigorously against cheats in
aggressive enforcement campaigns. the food system, and communicate its efforts clearly and
openly to consumers through the Internet, public service
• Put the Consumer First announcements, and social media.
To facilitate the treatment of EMA as fraud, the FDA should Informing consumers of EMA will likely engage positive
embrace the concept advanced by the UK Elliott Review of market responses favoring authenticity. For the market
putting the consumer first. Sparked by the horsemeat food to respond, however, consumers have to want authentic
fraud scandal in the UK, the report is a systems approach food and be deliberate and vocal in their demands for
based on eight pillars of integrity. Although the pillars authenticity. For consumers to demand authentic food,
are interconnected, the one pillar that stands out for its they need to know about food fraud in the first place and
novelty when applied as a norm to the food fraud problem what factors lead to the likelihood of adulterants in foods.
is “Consumers First.” The preface to this pillar in the Elliott The growing food movement, evidenced by consumer
Review states: “Industry, Government and enforcement interest in nutrition, local foods, and sustainability,
agencies should, as a precautionary principle, always put makes it highly probably that consumers are interested in
the needs of consumers above all other considerations, authentic food.

Develop High Priority List for
Define EMA More Completely Standards Making and Testing
Strategy
The FDA in collaboration with the USDA should define A novel approach that would allow the FDA to conserve
EMA. Although the definition advanced by the FDA’s EMA its resources and focus on the most persistent cases of
Working Group validates that Section 402(b) adulteration EMA is to create a high priority list of food products most
is in fact economically motivated, it does not delineate susceptible to EMA and to develop a strategy of testing and
the full scope of EMA or the nuances between the critical standards making. In addition to susceptibility, additional
components or even the relationship between EMA and prioritization criteria should be consumer-based and not
mislabeling. limited to food safety risks. This approach comports with
the flexibility and prosecutorial discretion afforded by the
• Delineate EMA Components FDCA EMA provisions.
Defining EMA more expressly and completely would • Model high priority list after FSMA
enable the FDA and the food industry to recognize more
readily EMA, thereby allowing a more proactive approach The development of a high priority list of EMA products
in abating this fraud. A complete definition should capture could be modeled after the FDA’s approach to high risk in
the full range of adulteration components listed in the food safety. Under FSMA, FDA identifies high-risk facilities
FDCA and distinguish between these components.141 It and allocates resources to inspect registered facilities
would be most helpful for the FDA to provide real and according to their risk profile, based on a number of food
contemporary examples of what would constitute EMA, as safety factors, including the known safety risks of the food
this White Paper has attempted to do. manufactured, processed, packed, or held at the facility.142
FDA also inspects imported foods according to their risk
• Send a messaage profile, based on known safety risks of the imported food
and of the countries or regions of origin and transport of
Providing a complete definition of EMA would also send the imported food.
a clear message to the food industry that the agency is
serious about its statutory charge over all forms of EMA, • Collaboration is key
not just EMA that raises food safety concerns. Food
companies would evaluate more accurately their supply Developing a high priority list for EMA products could
lines to ensure that their products do not violate sections be accomplished by collaborating with credible sources,
401 and 402(b). such as the USP food fraud database and the Oceana
report on seafood fraud. The FDA could also confer with
• Harmonization the USDA for possible inclusion of meat products on
the list. The EMA high priority list could be refined over
Given that EMA is a global menace and threat in the time through the collection of data by various means. A
modern, global food system, a well-developed definition shared focus between the government, the food industry,
would help establish a regulatory bar that other countries and scientific organizations in obtaining data will lead
could emulate and would facilitate global harmonization. to a better understanding as to the scope of the EMA
problem and provide a clearer path forward to solutions.
Within appropriate legal bounds, the government could
provide a safe haven for food companies to self-report

and to collect and analyze data on EMA. Data could also be Promote Authenticity as a Public
garnered from international sources, including the Codex Value
Alimentarius Commission, foreign government agencies,
and other credible institutions.
The Food Industry should explore using corporate social
responsibility and voluntary standards (sometimes
• Standards, Testing, and Import Alert
referred to as “soft law” or self-regulation) to create a
social climate whereby food authenticity is diligently
The FDA should develop standards of identity for these
sought, measured, and validated by food enterprises.
high priority products most susceptible to EMA and of
most interest to consumers. These standards should be
• Sustainability CSR precedence
developed in connection with scientific bodies and other
leading food testing laboratories that can help develop
The good news is that there is precedence for this
authenticity specifications. The FDA may find that some
approach. In just the last decade, companies have moved
domestic producers, especially olive oil, spice, and honey
from the non-acknowledgement of environmental impact
producers, would cooperate enthusiastically with the
of food production and manufacturing to vocal advocacy
agency in the development of standards due to their
and corporate social responsibility (CSR) statements
concern over imported EMA product. By utilizing the best
on sustainability and reducing the farm-to-fork carbon
science available, the standards should be sophisticated
footprint.143 Fifteen years ago, organic food in many
enough to deal with the complexities of authentication,
grocery stores was a rarity, often set aside in its own
but also flexible enough to accommodate variant imported
tiny subsection of a produce aisle. Now, organics make
product types.
up a huge chunk of the market, as do many products
The FDA should regularly test these high-priority products
in accordance with sound science methods or develop a
certification scheme where these products are tested and
certified as authentic in accordance with the standard of
“We understand that increasing
identity. Once the high-priority EMA product meets a
certain threshold of authenticity for a certain period of numbers of consumers are
time, it could be removed from the priority list. At the seeking authentic, genuine
same time, the FDA should vigorously work with industry food experiences...and we know
to use the import alert tool when and where necessary
that they are skeptical of the
against particular food companies, regions, or even, when
ability of large, long-established
appropriate, countries.
food companies to deliver them.”
This focused approach would enable the FDA to enforce
directly against the food products most susceptible to -Campbell Soup Co. CEO
EMA and violative of consumer interests without having to
Denise Morrison
implement new sweeping programs or rules for all food
products that would drain agency resources. Source:
http://fortune.com/2015/05/21/the-war-on-big-food/

It is often the case
where those who
have resources—a
competitor food and
beverage enterprise
or a wealthy con-
noisseur—are able to
enforce against food
fraud. For example,
Rudy Kurniawan,
who amassed a
vast fortune in rare
wines, was found
to be engaged in a
sophisticated wine
fraud operation by
Laurent Ponsot, the
head of the Domaine
Ponsot House, and
Bill Koch, an Ameri-
can billionaire, who found fake wine bottles in his collection and hired private detectives and filed a lawsuit. Finally,
the FBI got involved and after a raid on Kurniawan’s house, it was discovered that he had been taking cheaper
wines and putting them in more expensive bottles or altering bottles to appear more valuable. In 2014, Kurniawan
was sentenced to ten years in a California prison for wine fraud. A new documentary, Sour Grapes, revisits the
story.
Image source: http://www.sourgrapesfilm.com/gallery/ (c) Dogwoof Ltd. 2016
touting their GMO-free production. These sustainable • Elevation of authenticity as a value

concepts—reducing pesticides, avoiding GMOs, requiring
environmental impact analyses—are production and Authenticity of food could follow suit. Elevating authen-
market responses to values-driven consumer concerns. ticity to a value similar to that of sustainability in the food
Sustainability now occupies a core piece of CSR for many sector via CSR would result in food companies dedicat-
food companies, becoming the basis in many instances ed to producing food free of EMA. This form of internal
for marketing and self-promotion on the part of these self-regulation would mean that food companies will not
companies. Research demonstrates the positive effect of tolerate adulteration of their products, and would prevent
corporate sustainability on organizational processes and it by managing every step of production and distribution
performance, giving credence to the adage, “do well by to eliminate the possibility of fraud.
doing good.”144

The most thorough way to eliminate fraud at the • Remedy for honest food companies: Lanham Act
enterprise level is a combination of vertical integration
(where the company owns and controls every or nearly Due to the omission of a private right of action under the
every aspect of food production, processing, packaging, FDCA, honest food companies who hope for enforcement
and distribution) and independent audits (testing at each against food companies peddling EMA food product
step and buying their own products off the retail shelf, typically have to file a complaint with the FDA, which the
then testing those to see if anything has been changed).145 agency may or may not pursue. Food companies can step
In the more likely scenario where the food manufacturer into the shoes of consumers, however, via the Lanham
does not have the resources for vertical integration, they Act, which allows for a company to sue another company
can ensure the authenticity of their products by assiduous for deceptive advertising.148 In the recent case of POM
attention to everyone involved with the food product Wonderful v. Coca-Cola, the US Supreme Court held that
before it reaches the consumer and, when possible, POM Wonderful was not precluded from suing Coca-Cola
testing the end product for EMA.146 In this manner, CSR even when Coca-Cola had followed FDA regulations.149
is internal to the company, but it parallels the kind of Thus, food companies may sue competitors for EMA even
activity one might expect from an external regulator. The if the FDA is unwilling to take enforcement actions.
food company gets the additional benefit of being able to
market their self-regulation of fraud as a value in the same • Remedy for consumers: class action litigation
way they might market other values like premium quality,
free trade, sustainability, and fair labor practices. Absent a private right of action under the FDCA,
consumers who purchase EMA products are left with suing
adulterating food companies. Suing for EMA, however,
Improve Effective Use of Class- requires being able to identify the adulteration in the first
Action Litigation place, which can involve expensive tests, and the legal
remedies available to successful litigants are minimal. The
Although litigation has proven thus far to be a limited legal mechanism for overcoming at least the cost barrier
tool in addressing EMA, consumer class actions and to litigation against EMA is the collective class action,
competitive lawsuits are a potentially important gap-filler which allows consumers to sue together as a class a food
tool in the absence of regulation and prosecution. company that has committed fraud.
• No private right of action under FDCA In recent years, there has been an explosion of class
action litigation over food labeling. For example, both
The FDCA does not include a private right of action to sue “natural” claims and inventive ingredients like “evaporated
the FDA for enforcement of the FDCA, including its EMA- cane juice” (otherwise known by its more conventional
related provisions. The omission of this tool in the FDCA name, “sugar”) are being litigated in many states.150 As a
contrasts with its inclusion in the major environmental result of this litigation, some food manufacturers have
statutes enacted between 1970 and 1980, allowing private changed their packaging, labeling, or ingredients. The
citizens and other interested stakeholders to bring suit cost of the litigation forces the company, to a degree,
against alleged violators of the statutes. These citizen-suit to internalize the cost of their practices: the individual
provisions introduce accountability into the regulation, consumers may only get a few dollars, but the settlement
as citizens or companies are able to take on the role of still costs the companies, which is a disincentive for further
law enforcement by suing polluters and the government. deceptions. That disincentive, along with the threat to
Notwithstanding the application of private rights of the food product’s brand, has a market effect: other
action in federal environmental statutes, there is not any companies might not want to get sued for the same kinds
momentum to implement this tool in the FDCA.147 of misbehavior.

The same enthusiasm for class actions over food labeling as opposed to the premium model theory—then food
has not been extended to EMA. A lawsuit for EMA can companies would have a much larger incentive not to
be more complicated than a simple labeling claim for cheat.
misrepresentation. In addition to finding a laboratory
to verify the fraud, the plaintiffs’ counsel must also deal • Class Certification
with complicated global supply lines to determine the
responsible party or parties. An ongoing case does show, Another significant barrier to EMA class actions is
perhaps, emerging interest in EMA litigation. In Kumar v. ascertaining what portion of the consumer class received
Salov North America Corp., the plaintiff sued Salov, the a food product that is different than they thought it
maker of Filippo Berio brand olive oil, claiming violations of would be. This difficulty makes it a challenge to certify a
various California consumer protection statutes, common class under Federal Rule of Civil Procedure (FRCP) 23. This
law fraud and deceit, breach of contract, and breach of problem would resolved if a presumption were adopted
the implied covenant of good faith and fair dealing. The that every purchaser of a particular EMA product is harmed
plaintiff alleged Salov deceptively labeled its olive oil as simply by purchasing a product where the manufacturing
“Imported from Italy” when the olives were not grown or process creates a significant possibility of inauthenticity.154
pressed in Italy, and as “extra virgin” when the way the oil This presumption would, for example, circumvent the
is bottled, transported, and stored allows it to degrade so problem of having to obtain a sensory test, say on olive oil,
that it may not be extra virgin by the time of sale or by the for every class litigant. There likely would need to be some
“best by” date. A federal district court in California allowed threshold for triggering the presumption; for example, a
many of the putative false labeling claims against Salov to certain number of failed tests amongst a certain volume
survive dismissal, suggesting, tentatively, that there may of food products.
be a future for EMA litigation.151
How to implement this presumption, however, is
Changes in the rules typically applied to class action problematic. The typical consumer protection statute
litigation on food cases would strengthen this tool for does not have such a statutory presumption. A recent
actions against EMA. These changes involve the theory decision by the US Supreme Court in the case of Tyson
of damages, class certification, and class standing Foods, Inc. v. Bouaphakeo, might encourage courts to
requirements. create a presumption if the state statute is remedial in
nature.155 The Supreme Court held that a plaintiff class in
• Class Action Damages a wage and hour case that sued for overtime under the
Fair Labor Standards Act could rely on statistical evidence
Adoption of what is known as the “full refund theory” where it was impossible to prove that the class members
would increase the amount of damages in an EMA case. met the overtime threshold due to a lack of time records.156
Otherwise, even when plaintiffs win, the individual payoff
can be nominal. It usually involves only the difference Such an evidentiary presumption of liability based upon
between what plaintiffs would have paid if they had known a representation sampling could have a similar dramatic
about the adulterant and what they actually paid—what’s impact in an EMA action. If a state were to adopt a
called the “benefit of the bargain.”152 Some settlements similar presumption for EMA litigation, the presumption
end up giving litigants coupons for food from the company arguably could be applied at the federal level through
they sued.153 This limited damages model is referred to FRCP 23. Also, Tyson suggests that a court could create
as the premium model theory. If courts were to accept the representational sampling presumption based on the
a full refund theory, requiring the food company to pay a remedial nature of a state consumer protection statute
full refund to the consumer for the product purchased— and its purposeful public policy.157

• Class Action Standing Requirements Authentic food is a social good that benefits consumers.
Ensuring that the food supply is authentic is good
In class action lawsuits, “standing” can be one of the most governance. The pursuit of a food system that is
fiercely litigated issues for a court to resolve in order authentic, as well as healthy and sustainable, should and
for the suit to go forward. Under Article III of the U.S. can be achieved by implementing the legal and policy
Constitution, a plaintiff in a lawsuit has standing if he or recommendations outlined in this report.
she suffered “an injury in fact.” In EMA cases, the problem
is that it is often not possible to test the specific fraudulent
food product that the plaintiff consumer purchased
because the consumer already consumed or discarded
it. A practical solution to this problem would be for the
plaintiff consumer to test similar products purchased from
similar retail outlets; however, courts have held that in this
scenario there is no evidence that the plaintiff consumer
actually received the adulterated product and thus has
no standing to sue.158 In fact, a California district court
has found that if a customer has paid a premium for an
assurance that a food product meets certain standards,
and the assurance turns out to be meaningless, the
premium that the customer has paid is an actual, personal,
particularized injury that is cognizable under Article III.159
5. Conclusion
The purpose of this White Paper has been to identify
and explain the problem of food fraud in the form of
economically motivated adulteration and its relationship
to the modern food system and to recommend legal and
policy changes to address the problem. EMA has been
treated as a second-tier adulteration that is viewed as a
problem only if the fraud compromises the safety of the
product. EMA has commanded attention as an economic
crime when a particular food company’s economic
interests are damaged due to the adulteration. It is rare,
however, for EMA to be enforced against or prosecuted
for the general welfare of ordinary consumers.

references
1
4 WILLIAM BLACKSTONE, COMMENTARTIES 157.
2
MICHAEL T. ROBERTS, FOOD LAW IN THE UNITED STATES 40 (2016).
3
Id. at 15-18.
4
Melamine Pet Food Recall – Frequently Asked Questions, U.S FOOD & DRUG ADMIN. (FDA).
5
FDA Notice of Public Meeting on Economically Motivated Adulteration, 74 Fed. Reg. 15,497 (April 6, 2009).
6
Id.
7
21 U.S.C. § 342(b).
8
21 U.S.C. § 601(m)(8).
9
21 U.S.C. § 453(g).
10
RENÉE JOHNSON, CONG. RESEARCH SERV., R43358, FOOD FRAUD AND “ECONOMICALLY MOTIVATED ADULTERATION” OF FOOD AND FOOD
INGREDIENTS 6 (2014) [hereinafter “CRS REPORT”], citing GROCERY MFRS. ASS’N, CONSUMER PRODUCT FRAUD: DETERRENCE, AND DETECTION
(2010).
11
Id., citing U.S. Pharmacopeial Convention (USP), Food Fraud Database, Glossary of Terms.
12
Jeffrey C. Moore et al., Development and Application of a Database of Food Ingredient Fraud and Economically Motivated Adulteration from 1980
to 2010, 77 J. OF FOOD SCIENCE [Moore], nr. 4 R118, R121 (2012).
13
Kimberly Warner et al., OCEANA STUDY REVEALS SEAFOOD FRAUD NATIONWIDE (Feb. 2013).
14
Karen Everstine et al., Economically Motivated Adulteration (EMA) of Food: Common Characteristics of EMA Incidents, 76 J. OF FOOD PROTEC-
TION, nr. 4 723, 727 (2013).
15
See generally Timeline on Horse Meat Issue, FOOD STANDARDS AGENCY; Q&A: Horsemeat Scandal, BBC.COM (Apr. 10, 2013).
16
CRS REPORT, supra note 10, at 8, citing Moore, generally.
17
Yanzhong Huang, The 2008 Milk Scandal Revisited, FORBES (July 16, 2014, 10:46 AM).
18
FDA Consumer Advice on Products Containing Ground Cumin with Undeclared Peanuts.
19
Lydia Mulvany, The Parmesan Cheese You Sprinkle on Your Penne Could Be Wood, BLOOMBERG (Feb. 16, 2016, 5:00 AM EST).
20
E.g. Karen Everstine, Economically Motivated Adulteration: Implications for Food Protection and Alternate Approaches to Detection 20 (May 2013)
(unpublished Ph.D. dissertation, University of Minnesota) (citing Martin Hickman, Chicken Injected with Beef Waste Sold in UK, THE INDEPENDENT
(June 3, 2009, at News:2); Paula Kurtzweil, Fake Food Fight, FDA CONSUMER (March-April 1999) (citing prosecution of executives of a seafood com-
pany that over-iced scallops).
21
United States v. Beech-Nut Nutrition Corp., 871 F.2d 1181 (2d Cir. 1989).
22
Mulvany, supra note 19.
23
Jeffrey C. Moore et al., supra note 12.
24
See generally Tom Mueller, EXTRA VIRGINITY: THE SUBLIME AND SCANDALOUS WORLD OF OLIVE OIL (2012). The “omission” here is of two kinds:
first, in a bottle of 100% refined olive oil, no extra virgin olive oil exists; and second, refining destroys most of the important, beneficial constituents
of extra virgin oil that buyers often seek for their health benefits.
25
See Brod v. Sioux Honey Ass’n, Co-op., 927 F. Supp. 2d 811 (N.D. Cal. 2015), aff’d 609 Fed. Appx. 415 (9th Cir. 2015).
26
Questions and Answers of Melamine, WORLD HEALTH ORGANIZATION (WHO).
27
See, e.g., María Roca et al., Control of Olive Oil Adulteration with Copper-Chlorophyll Derivatives, 58 (1) J. AGRIC. FOOD CHEM. 51 (2009).
28
E.g., U.S. v. Lexington Mill & Elevator Co., 232 U.S. 399 (1914).
29
MICHAEL T. ROBERTS, supra note 2, at 3.
30
See, e.g., Van Liew v. United States, 321 F.2d 664 (5th Cir. 1963) (where the government conceded that defendant’s orange drink was just as healthy
and palatable as freshly squeezed orange juice, but that the confusion caused by economic adulteration may result in dangers to health in some
situations).
31
Intentional adulteration with the intent to cause harm falls under the category of “food defense” and covers a broad spectrum of activity. For more
information about food defense, consider the FDA’s Food Defense category on their website (http://www.fda.gov/food/fooddefense/) or the
many resources available from the Food Protection and Defense Institute at the University of Minnesota (https://foodprotection.umn.edu/).
32
Counterfeiting of food falls under 21 U.S.C. § 331, the list of prohibited acts under the FDCA. Counterfeiting is described as one of the forms of
“misbranding” in § 343 of the Act, but there are other legal remedies and enforcement provisions elsewhere in US law that have much more severe
penalties; counterfeiting is therefore usually treated under those provisions that guard trademark and other intellectual property rights.
33
See generally Moore, supra note 12.
34
See generally CRS REPORT, supra note 10.

35
GROCERY MFRS. ASS’N ET AL., CONSUMER PRODUCT FRAUD: DETERRENCE AND DETECTION 1 (2010). The GMA report does not cite a source for
its claim, and other sources cite the GMA report without following up on source information. Peer-reviewed articles from academics shy away from
estimates, and most people deeply involved in EMA research say that it is extremely widespread and affects basically every food, but there is not
enough data to support quantitative estimates.
36
Everstine, supra note 14, at 724-25 (collecting studies, including: 2008 University of Guelph study comparing fish samples against DNA barcodes
and finding 26% species substitution; a much larger study by one of those authors, finding 25% species substitution; a National Seafood Inspection
Laboratory survey over nine years that found 37% species substitution; a Consumers Union study finding about one-third species substitution; and
numerous other journal articles and prosecutions).
37
Id. at 725.
38
Id.
39
Moore, supra note 12, at R121.
40
Mueller, supra note 24.
41
Id.
42
Id.
43
Id.
44
See, e.g., Nayelli Quiñones-Islas et al., Detection of adulterants in avocado oil by Mid-FTIR spectroscopy and multivariate analysis, 51 (1) FOOD
RESEARCH INT’L 148 (Apr. 2013) (describing ways to detect the adulteration of avocado oil with other edible oils, particularly sunflower, canola, and
soybean).
45
E.g. Union Dairy Co. v. United States, 250 F.2d 231 (7th Cir. 1918).
46
21 C.F.R. § 131.
47
Liza Lin & Julie Cruz, China’s Parents Crave Illegally Imported Baby Formula, BLOOMBERG (May 2, 2013, 3:56 PM EDT).
48
See Is There a Cheese Fraud Epidemic?, QSR MAGAZINE (May 15, 2015); Lydia Mulvany, The Parmesan Cheese You Sprinkle on Your Penne Could Be
Wood, Bloomberg (Feb. 16, 2016, 5:00 AM EST).
49
Everstine, supra note 14, at 729.
50
Id.
51
Id. at 728.
52
Id.
53
Id.
54
U.S. GEN. ACCOUNTING OFFICE, GAO/RCED-96-18, FRUIT JUICE ADULTERATION: DETECTION IS DIFFICULT, AND ENHANCED EFFORTS WOULD
BE COSTLY 1-4 (1995).
55
56
Id.
57
Italy cops seize 2,500 tons of false organic food, BOSTON.COM (Dec. 7, 2011).
58
Susan Berfield, The Honey Launderers: Uncovering the Largest Food Fraud in U.S. History, BLOOMBERG (Sept. 20, 2013 4:41 PM EDT).
59
Id.
60
Interview with Jeffrey Moore, Director, Science—Food Standards, US Pharmacopeial Convention, in Rockville, Md. (Aug. 5, 2015).
61
Berfield, supra note 58.
62
63
Id. at 727, 725.
64
Id. at 728 (“Spices are particularly susceptible to adulteration because they are typically sold in powdered form, they have long and complicated
supply chains, reliable and cost-effective testing methodologies for ground spices are challenging to develop, and performance losses in final food
products can be difficult to detect.”).
65
Id.
66
FDA Consumer Advice on Products Containing Ground Cumin with Undeclared Peanuts, U.S. FOOD & DRUG ADMIN. (Feb. 23, 2015).
67
Dan Charles, Can You Trust That Organic Label on Imported Food? NPR (July 23, 2014 6:14 PM ET); U.S. DEPT. OF AGRICULTURE, AGRICULTURAL
MARKETING SERVICE, PESTICIDE RESIDUE TESTING OF ORGANIC PRODUCE (2012) (finding 43% of the 571 “organic” produce samples tested positive
for prohibited pesticide due to either intentional mislabeling or inadequate protection from pesticide drift).
68
CRS REPORT, supra note 10, at 37-8. See also Stephen F. Hamilton & David Zilberman, Green markets, eco-certification, and equilibrium fraud, 52(3)
J. of Envtl. Econ. & Mgmt. 627 (Nov. 2006).
69
See FREDERICK ACCUM, A TREATISE ON THE ADULTERATIONS OF FOOD, AND CULINARY POISONS 163-186 (1820).
70
71
Id.
72
Karen Everstine & Jeffrey Moore, Uncovering Product Vulnerability, FOOD QUALITY & SAFETY (Dec. 12, 2014).

73
Id.
74
Anthony Kai-ching Hau et al., Melamine Toxicity and the Kidney, 20 J. AM. SOC. NEPHROLOGY 245, 245 (2009).
75
Cf. e.g., James Neal-Kababick, Screening for Melamine Adulteration in Protein-Based Foods by GC/MS, FOOD SAFETY MAGAZINE.COM (Oct.
2012).
76
Possible Carcinogenic Protein Found in Chinese Dairy Products, THE EPOCH TIMES (Oct. 1, 2015, 9:51 PM).
77
Interview, Moore, supra note 60.
78
Yanjun Zhang, et al., International Multidimensional Authenticity Specification (IMAS) Algorithm for Detection of Commercial Pomegranate Juice
Adulteration, 57 (6) J. AGRIC. FOOD CHEM. 2250 (2009).
79
Id.
80
Id.
81
Everstine, supra note 14, at 730-31.
88
Id.
83
See, e.g., Luís G. Dias, et al., Single-cultivar extra virgin olive oil classification using a potentiometric electronic tongue, 160 Food Chemistry 321, 322
(2014).
84
Interview, Moore, supra note 60.
85
About USP, U.S. PHARMACOPEIAL CONVENTION.
86
USP Food Ingredient Standards, U.S. PHARMACOPEIAL CONVENTION.
87
Food Ingredient Reference Standards, U.S. PHARMACOPEIAL CONVENTION.
88
Dias, supra note 83.
89
E.g. RESTATEMENT (SECOND) OF TORTS § 549 cmt. l (1977).
90
Mueller, supra note 24.
91
Diana B. Henriques, 10% of Fruit Juice Sold in the U.S. Is Not All Juice, Regulators Say, NY TIMES (Oct. 31, 1993).
92
CRS REPORT, supra note 10.
93
FDA Consumer Advice on Products Containing Ground Cumin with Undeclared Peanuts.
94
Ted Agres, The Cumin Scandal: Accidental or Fraudulent, FOOD QUALITY AND SAFETY (Mar. 17, 2015).
95
Id.
96
E.g. Yellow margarine: I Can’t Believe It’s Not Legal!, USA TODAY (Dec. 16, 2008, 6:02 PM).
97
Id.
98
Capital City Dairy Co. v. Ohio, 183 U.S. 238 (1902).
99
Schraubstadter v. United States, 199 F. 568 (9th Cir. 1912).
100
Union Dairy Co. v. United States, 250 F. 231 (7th Cir. 1918).
101
Frank v. United States, 192 F. 864 (6th Cir. 1911).
102
See e.g., United States v. Ninety-Five Barrels More or Less Alleged Apple Cider Vinegar, 265 U.S. 438 (1924).
103
Wallace F. Janssen, The Story of the Laws Behind the Labels, FDA CONSUMER (June 1981).
104
United States v. Ten Cases, More or Less, Bred Spred, 49 F.2d 87, 89 (8th Cir. 1931).
105
Id. at 90.
106
Id.
107
Janssen, supra note 103.
108
21 U.S.C. § 341.
109
21 U.S.C. § 343.
110
Janssen, supra note 103.
111
See 21 C.F.R. §§ 130-169.
112
21 C.F.R. § 131.
113
Id.
114
Food Standard Innovations: Peanut Butter’s Sticky Standard, FDA (Apr. 14, 2009).
115
Id.
116
Id.
117
Id.
118
Id.
119
Id.
120
121
Id.
122
Warning Letter from FDA to Joshua Tetrick, Founder and CEO of Hampton Creek (Aug. 12, 2015).
123
21 U.S.C. § 381.

124
Detention without Physical Examination of Morel Mushrooms due to Adulteration and Substitution, Food and Drug Administration, FDA Import
Alert 25-02 (March 18, 2011)
125
Id.
126
Import Alerts, FDA website (http://www.accessdata.fda.gov/cms_ia/default.html).
127
Correspondence from Steven H. Armstrong, Chief Food Law Counsel for Campbell Soup Company to William H. Correll, Director of Office of
Compliance, Center for Food Safety and Applied Nutrition, FDA (Mar. 17, 2015).
128
NAD, NAD Refers Advertising for ‘Danish’ Butter Cookie Made in Indonesia to FDA, FTC for Further Review (Nov. 19, 2015).
129
See 15 U.S.C. § 45(a)(1)-(2) and15 U.S.C. § 45.
130
Interview with Steven H. Armstrong, former Chief Food Law Counsel for Campbell Soup, in Los Angeles, CA (Feb. 2, 2017).
131
John Spink, Review: Final Rules for FSMA ‘Third-Party Certification,’ ‘Foreign Supplier Verification,’ and ‘Produce Rule’ Regarding Food Fraud and
EMA, MICHIGAN STATE UNIVERSITY FOOD FRAUD INITIATIVE (Jan. 28, 2016).
132
Riëtte van Laack, And Then there Were Seven: FDA Issues the Final Rule on Intentional Adulteration of Food; the Last Required by FSMA, FDA LAW
BLOG (May 31, 2016).
133
Id.
134
MICHAEL T. ROBERTS, supra note 2, at 51-52.
135
AGAINST ORGANIZED CRIME: INTERPOL TRAFFICKING AND COUNTERFEITING CASEBOOK 2014, INTERPOL (2014).
136
Food Fraud, European Commission, http://ec.europa.eu/food/safety/official_controls/food_fraud/index_en.htm.
137
Elisabetta Povoledo, Italy Moves to Toughen Penalties for Olive Oil Fraud, NY TIMES (Mar. 1, 2016).
138
Record Seizures of Fake Food and Drink in Interpol-Europol Operation, EUROPOL (Feb. 16, 2015).
139
62 Cases, More of Less, Each Containing Six Jars of Jam v. United States, 340 U.S. 593, 596 (1951).
140
ELLIOTT REVIEW INTO THE INTEGRITY AND ASSURANCE OF FOOD SUPPLY NETWORKS, HM GOVERNMENT (July 2014).
141
A GAO report on EMA reports that “A senior FDA official told us there is value in making a distinction between economic adulteration and other
forms of adulteration to guide the agency’s thinking about how to be more proactive in addressing this issue.” U.S. GOV’T ACCOUNTABILITY OFFICE,
GAO-12-46, FOOD AND DRUG ADMIN., BETTER COORDINATION COULD ENHANCE EFFORTS TO ADDRESS ECONOMIC ADULTERATION AND PRO-
TECT THE PUBLIC HEALTH (2011).
142
FSMA adds a new Section 421 to the FDCA (21 U.S.C. § 350j).
143
Sammi Caramela, What is Corporate Social Responsibility?, BUSINESS NEWS DAILY (June 19, 2015 10:12 AM EST).
144
Eccles, R., Ioannou, I., and Serafeim G., “The Impact of a Corporate Culture of Sustainability on Corporate Behavior and Performance,” Harvard
Business School, Working Paper 12-035, November 2011
145
USP, Appendix XVII: Guidance on Food Fraud Mitigation, US Pharmacopeia (Dec. 2014).
146
See id.; see also Marc S. Reisch, Momentum Builds to Keep Fraudulent Food Off of Store Shelves, 92 (34) CHEMICAL & ENGINEERING NEWS 8 (Aug.
25, 2014).
147
148
See POM Wonderful v. The Coca-Cola Co., 134 S. Ct. 2228 (2014).
149
Id.
150
David Schultz, Evaporated Cane Juice: Sugar in Disguise?, NPR, Oct. 18, 2012, 2:06 PM; Annie Wu, What Does a ‘Natural’ Label Really Mean? Lawsuits
Claim False Advertising, EPOCH TIMES, June 22, 2015 (9:16 PM).
151
Kumar v. Salov N. Am. Corp., Case No. 14-CV-2411-YGR (N.D. Cal., Feb 3, 2015).
152
E.g. RESTATEMENT (SECOND) OF TORTS § 549 cmt. l (1977).
153
Michelle Singletary, Class-action coupon settlements are a no-win for consumers, WASHINGTON POST, Apr. 27, 2011.
154
Interview with Adam Gutride, attorney for plaintiff in Kumar v. Salov North America Corp., in Los Angeles (Sept. 12, 2016).
155
Tyson Foods, Inc. v. Bouaphakeo et al., 136 S. Ct.1036 (2016).
156
Id. at 1046.
157
Id.
158
See Wallace v. ConAgra Foods, Inc. 747 F.3d 1025, 1031-31 (8th Cir. 2014) (holding that customers lacked Article III standing to bring a claim based
on allegedly false advertising of a product as using 100% kosher beef, where the plaintiffs could not show that the specific products they purchased
contained non-kosher beef).
159
See McCoy v. Nestle USA, Inc., No. 15-CV-04451-JCS, 2016 WL 1213904, at 8 (N.D. Cal. Mar. 29, 2015).

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white paper

Jeffrey Moore, United States Pharmacopeia

About the Resnick Program

Statement of Independence and Objectivity:

The Resnick Program for Food Law and Policy [email protected]

2. The Modern Problem of EMA 6

3. Government Enforcement Against EMA 17

4. Legal and Policy Strategies 22

To this end, this White Paper in four parts documents

5 The Pursuit of Food Authenticity

But if you really want to get paranoid, peek into

The Pursuit of Food Authenticity 6

7 The Pursuit of Food Authenticity

The Pursuit of Food Authenticity 8

USP defines EMA of food ingredients in the following • Addition

USP’s definition is notable because in addition to • Omission

9 The Pursuit of Food Authenticity

when Beech-Nut Corporation’s “apple juice” actually • Concealment

The Pursuit of Food Authenticity 10

11 The Pursuit of Food Authenticity

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The expense of developing authoritative, public testing

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Harms Caused by EMA Food Safety Risks

EMA cheats consumers. When consumers buy a product,

• Honest Purveyors of Food

EMA also cheats honest purveyors of food. Consumers

15 The Pursuit of Food Authenticity

Food Governance Harms

It stands to reason that non- or under enforcement against

Image source: California Digital Library Internet Archive

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Enforcement In 1906, socialist muckraker Upton Sinclair published The

Against EMA Jungle, a book about the deplorable labor conditions in

State Laws Banning Imitation Products

Throughout the nineteenth century, federal legislation

Sinclair, U. (1906). The Jungle. Doubleday, Page and

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From the enactment of the FDCA in 1938 through the 1960s,

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Public version of the Operation Opson IV report available at https://www.europol.europa.eu/sites/default/files/documents/report_op-

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A National Food Crime Prevention Framework July 2014

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touting their GMO-free production. These sustainable • Elevation of authenticity as a value

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