How the Federal Labeling Statutes Create a Legal Right to Know What’s Really in Your Food & How This Right Improves Farm Animal Welfare Standards in the United States

1. Summer Smith
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Misleading, Misbranding &
Deceptive Labeling in the Livestock
Industry – The Need for Truth-in-
Labeling
How the Federal Labeling Statutes
Create a Legal Right to Know
What’s Really in Your Food & How
This Right Improves Farm Animal
Welfare Standards in the United
States
Summer Smith
December 14, 2012

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I. Introduction
Consumers have a legal and moral right to know all of the harmful
ingredients in their food products, especially when human health and welfare is at
stake. This legal and moral right includes, inter alia, the right to know about
hormones, antibiotics, animal drugs, and anti-parasitic drugs in meat and dairy
products that are sold in the United States. The federal statutes governing food
labeling, combined, mandate transparency and truth-in-labeling. These statutes
create an affirmative duty, upon federal regulatory agencies, to notify consumers of
all harmful ingredients in their food products and to warn consumers of the possible
consequences of consuming such harmful ingredients.
If a basic goal of the FDA is to ensure a safe food supply, then “[c]ompanies
and people engaged in the food business [also] have an affirmative duty to ensure
that the food they sell to the public is safe and properly labeled.”1 Despite this duty,
the majority of meat and dairy products fail to adequately alert consumers about the
hidden dangers in their food. Thus, meat and dairy products are misbranded,
misleading, and lacking in transparency. This opacity in the livestock industry is
deceptive because consumers are intentionally shielded from the true ingredients in
their food, and thus, they are stripped of their right to make informed decisions.
Truth-in-labeling has important ramifications for consumer health and
safety, farm animal health and safety, and environmental safety. If consumers know
the ingredients in their food, they will be less likely to support foods with unsafe

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ingredients, and in turn, producers will be compelled to stop using the unsafe
ingredients, and in turn, animals will not be subjected to the cruel side effects from
many of these unsafe ingredients. Truth-in-labeling will have a circular effect which
ultimately improves farm animal welfare.
II. Harmful Ingredients in Meat and Dairy Products
A. Growth-Promoting Hormones
In 2011, “more than 34 million cattle and 850,000 calves were slaughtered to
provide beef for U.S. consumers.”2 It is estimated that hormones were used in 80%
of that cattle to make the animals gain weight faster.3 As a result of hormone use,
less feed is eaten by the animal prior to slaughter and the overall waiting time for
slaughter is shortened.4 Hormones are used so that the livestock industry can take a
shortcut and earn higher profits.
In the U.S., there are currently six different kinds of steroid hormones that
are approved by the FDA for use in food production (and are specifically
administered to beef cattle and sheep): estradiol, progesterone, testosterone,
zeranol, trenbolone acetate, and melengestrol acetate.5 Three of them are natural
sex hormones – estradiol and progesterone are natural female sex hormones and
testosterone is the natural male sex hormone; and three of them are synthetic
hormones – zeranol, trenbolone acetate and melengesterol acetate are synthetic
growth promoters that make the animals grow faster.6
Since estradiol, progesterone, and testosterone are naturally-made sex
hormones, federal agency regulatory monitoring of these hormones is impossible, as

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one cannot differentiate whether the hormone was made naturally by the animal’s
body or was administered for growth promotion.7 As for zeranol and trembolone
acetate, the FDA has set tolerance levels, which are “the maximum amount of a
particular residue that may be permitted in or on food.”8 Trenbolone “is thought to
have 8 to 10 times greater anabolic activity than testosterone,”9 which demonstrates
the potency of these synthetic hormones.
It is widely acknowledged10 that the hormones, mentioned above, remain in
the meat of treated animals, and can possibly affect the age of puberty for girls,
interfere with the reproductive system, lead to breast, prostate, or colon cancer, and
negatively affect overall human health.11 Europe recognizes the danger of using
hormones in cattle production, and since 1988, the use of steroid hormones has
been illegal in cattle production.12 According to the European Commission’s
Scientific Committee on Veterinary Measures Related to Public Health, “the decision
to ban the use of such hormones was based on accumulating evidence on the
fragility of the endocrine equilibrium in all stages of life as well as the potential
genotoxicity of these compounds and their metabolites.” 13 The Committee
concluded that “even exposure to residual amounts of hormonally active
compounds as present in meat and meat products need to be evaluated in terms of
potentially adverse effects to public health.”14
These hormones are not only injurious to human health, they are also
harmful to animal health, and undesirable side effects of hormone treatment do
occur. For example, as a result of hormone treatment, bulling has occurred with
increased frequency.15 Bulling, or the buller steer syndrome16, “is a behavioral

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problem among feedlot steers and is characterized by the repeated mounting of a
steer (referred to as the buller) by a group of steers (known as the riders) who
persistently follow and perform the mounting behavior.”17 Bulling is harmful to
animal health because “[a]s a recipient of the excessive riding, the buller steer
becomes exhausted, often shows loss of hair, swelling and trauma on the rump and
tail head and in extreme cases can suffer broken bones or may even die from
injuries.”18 The buller steer syndrome occurs so frequently that it actually “ranks as
one of the top three health problems (along with respiratory disease and foot rot) in
the feedlot industry.”19
B. The New Animal Drug, Ractopamine
Ractopamine is an animal drug used in in the U.S. in beef cattle, pigs, and
turkeys to “increase the body’s synthesis of protein – thereby causing [the] animals
to bulk up and yield more meat.”20 Ractopamine has been “banned in 160 countries,
including across Europe, China, and Taiwan,” yet the FDA continues to allow this
drug to be used in the U.S. livestock industry.21 Ractopamine is yet another shortcut
that the livestock industry uses to earn higher profits.
Ractopamine is required by the FDA to be labeled for the initial
administration of the drug (i.e. ractopamine is labeled for the initial administration
as an animal feed additive). This label states, “Not for use in humans. Individuals
with cardiovascular disease should exercise special caution to avoid exposure. Use
protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved
dust mask.”22 As the label indicates, ractopamine is clearly dangerous to human
health, yet the FDA still allows food products containing ractopamine residue to be

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consumed without a label notifying the consumer of its presence in the product.
While the administration of hormones and antibiotics must be stopped as slaughter
nears, ractopamine is administered to livestock immediately prior to slaughter.23
Ractopamine is sold under three brand names, all made
by the same company: Paylean, Optaflexx, and Tomax.
Paylean is fed to pigs for the last 28 days of their lives,
Optaflexx to cattle for the last 28 to 42 [days], and
Tomax to turkeys for the last 7 to 14 [days]. According
to [the] manufacturer, Elanco Animal Health (a division
of Eli Lilly), fully 45 percent of U.S. pigs and 30 percent
of non-grass-fed cattle receive some form of
ractopamine.
Research “has shown that up to 20 percent of ractopamine given to an animal
remains active in its meat after slaughter.”24 And, according to the Sichuan Pork
Trade Chamber of Commerce, “[m]ore than 1,700 people were poisoned after eating
ractopamine-fed pigs in 1998.”25 In reality, “food consumers are metabolic,
neurological and carcinogen guinea pigs so that agribusiness can make a profit.”26
Ractopamine “increases profits despite greater livestock death and
disability.”27 Ractopamine causes adverse side effects to the target animals, such as
hyperactivity, muscle breakdown, and 10% mortality in pigs.28 Animals treated
with ractopamine “are more active, more difficult to handle and find it harder to
deal with adverse situations,” such as transportation to slaughter.29 Studies in
humans have resulted in cardiac health effects, and population subsets, such as
people with cardiac disease (15% of the population), have not been adequately
considered in terms of labeling requirements.30
It is crucial that the FDA require ractopamine to be labeled on consumer
meat products so that public pressure can force the livestock industry to stop using

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ractopamine. Without public pressure, the livestock industry will continue to use
the drug, putting consumers’ health at risk. And, farm animals will continue to
suffer from the side effects.
C. rBGH
Since 1994, recombinant bovine growth hormone, also known as rBGH or
rBST, has been used in the U.S. dairy industry to increase milk production. The
hormone is injected into dairy cows and generally increases milk production by an
average of 11 to 15%.31 Since 1999, Canada and the European Union have refused
to approve rBGH’s use, “officially citing harm to cows’ health” as their reason for
disapproval.32 Australia, New Zealand, and Japan have also prohibited the use of
rBGH.33 rBGH is extremely harmful to dairy cows. In addition to the Canadian and
European research, “the FDA’s analysis of the data submitted by Monsanto (the
company that developed rBGH) demonstrated that use of rBGH increases the
incidence of 16 different harmful conditions in cows, including birth disorders, hoof
problems, heat stress, diarrhea, increased somatic cell count, and mastitis.”34 Based
on this evidence, the FDA requires rBGH package inserts to disclose these risks, but
there is no disclosure on finished dairy products.35
Due to increased milking, hormone-treated cows are more susceptible to
mastitis, which is a painful infection of the udders.36 Symptoms of mastitis include,
inter alia, general malaise or feeling ill and pain or burning sensation.37 Mastitis
results in the administration of antibiotics to treat the infection in the cows, which
leads to more antibiotic residues in the final milk product.38 Thus, rBGH use is
harmful to human health because it creates antibiotic resistance.39

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Furthermore, “[s]cientific committees for Health Canada and the European
Commission have also raised concerns about the potential effects of rBGH on
cancer”40 –
Insulin-like Growth Factor-1 (IGF-1) is a necessary
growth hormone present and identical in both cows and
humans. However, elevated IGF-1 levels in human blood
are associated with higher rates of colon, breast, and
prostate cancers. On the basis of data submitted by
Monsanto, FDA determined that rBGH use raises levels of
IGF-1 in cow’s sera and cow’s milk. These data also
show that IGF-1 survives pasteurization. Animal models
show that most IGF-1 survives digestion, reaching the
bloodstream where it may promote cancer. The United
Nations’ main food safety body, the Codex Alimentarius
Commission, determined in 1999 that rBGH could not be
declared safe for human health.41
Despite the dangerous health consequences to humans who consume rBGH dairy
products, rBGH is not required to appear on the food label. A “2008 national poll
showed that more than 90% of consumers favor labeling of rBGH-free products.”42
In February 2007, Monsanto appealed, unsuccessfully, to the FDA and the FTC to
limit the labeling of dairy products as rBGH-free.43 Meanwhile, “policymakers in
eight states have attempted to ban or restrict the labeling of rBGH-free dairy
products through bills or administrative rules, [and] [a]ll failed except in Ohio,
where the proposed rules are being challenged in court.”44
D. Sub-Therapeutic Antibiotics
The livestock industry administers small doses of antibiotics, known as “sub-
therapeutic” doses, on a daily basis to cause the animals to gain weight. Some
evidence suggests “that the antibiotics kill the flora that would normally thrive in
the animals’ intestines, thereby allowing the animals to utilize their food more

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efficiently.”45 Since “[t]he meat industry doesn’t publicize its use of antibiotics, …
accurate information on the amount of antibiotics given to food animals is hard to
come by.”46 Producers of meat products “are not required to report how they use
the drugs – which ones, on what type of animal, and in what quantities.”47 It has
been estimated that “15-17 million pounds of antibiotics [are] used sub-
therapeutically in the U.S. each year.”48 And, “approximately 80 percent of all
antibiotics sold in the U.S. are used by the meat and poultry industry to make
animals grow faster or to prevent disease in crowded and unsanitary conditions.”49
Evidence suggests that the sub-therapeutic use of antibiotics in livestock
poses a risk to human health, because over time bacteria become resistant to the
drug.50 Antibiotic-resistant strains are a serious public health concern because the
antibiotics we give to animals are similar to those we give to humans, so the
antibiotic–resistant strain in the meat product may be untreatable by human
antibiotics. This year, the federal government released that “[a] ferocious germ
resistant to many types of antibiotics had increased tenfold on chicken breasts, the
most commonly eaten meat on the nation’s dinner tables.”51
While the U.S. still uses antibiotics sub-therapeutically in livestock,
“[c]oncern about the growing level of drug-resistant bacteria has led to the banning
of sub-therapeutic use of antibiotics in meat animals in many countries in the
European Union and Canada.”52 In 1977, the FDA attempted to ban some
agricultural uses of antibiotics, but the House and Senate appropriations
committees passed resolutions against the ban, due, of course, to the heavy
influence and dominance of agricultural interests.53

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While antibiotic use in humans is strictly monitored by the health care
system, animal antibiotics are sold freely by feed suppliers with no prescription
needed. Another issue with the sub-therapeutic use of antibiotics is that nobody is
in charge of the problem – the FDA regulates drugs, the USDA regulates agriculture,
and the Center for Disease Control is responsible for the illness aspects, but no one
is stepping up to take charge, and there remains little to no progress in terms of
regulations.54
If little to no progress is being made in terms of regulations for sub-
therapeutic antibiotics, then consumers need the ability to act. In order to have the
ability to act, antibiotics need to be labeled on the food product itself. Awareness
will raise concern, concern will create action, and action will help to fight against the
use of sub-therapeutic antibiotics in the meat industry. “No antibiotics” labeling
claims, such as “No antibiotics added” or “Never ever given antibiotics” are currently
used, but labeling that the animal (i.e. the meat product) was given antibiotics is not
a mandatory measure.55 “No antibiotics” claims can be “USDA Process Verified”
which makes the label more reliable because the claim has been verified, but only a
handful of products qualify for that label.56 Unfortunately, as of now, there is still no
uniform way for consumers to know whether their meat products have been treated
with sub-therapeutic antibiotics. Thus, the public pressure needed to influence the
livestock industry has not yet gained momentum.57
E. Antibiotics Used to Prevent and Treat Illness
Antibiotics are administered to all types of farm animals to prevent and treat
illness. One of the most egregious examples of antibiotic use is that of layer hens in

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battery cages. The battery system could not exist without antibiotics.58 Many “of
the antibiotics used to control rampant viral and bacterial diseases of chickens in
crowded confinement can also be used to manipulate egg production.”59 For
example, “virginiamycin is said to increase feed conversion per egg laid, bacitracin
to stimulate egg production, and oxytetracycline to improve eggshell quality.”60 In
fact, “virtually 100 percent of laying hens in the United States are routinely dosed
with antibiotics.”61 Thus, consumers of battery cage egg products are consuming
antibiotic residues, and are more likely to become ill from antibiotic-resistant
strains of bacteria. Yet, the use of antibiotics is not required to be labeled on the
egg product. Thus, the horrific battery cage conditions and extreme antibiotics use
continues unchecked so that egg producers can earn higher profits. And,
consumers, and most especially the layer hens, are harmed by the excruciatingly
cruel and barbaric battery cage practices.
F. Anti-Parasitic Drugs
Veterinary drugs, called anthelmintics, are used extensively to treat parasitic
worms in beef cattle and dairy cattle.62 Studies show that the majority of these
drugs “remain in the beef through the processes of cooking and consumption.”63 In
fact, “the anthelmintic drugs oxyclozanide, clorsulon, albendazole, closantel,
ivermectin, mebendazole and fenbendazole all remained in beef throughout a
roasting or frying cooking process, [and] [t]he drugs nitroxynil, levamisol,
rafoxanide and triclabendazole were reduced, though not eliminated, by
conventional cooking.”64 Thus, anti-parasitic drugs are yet another residue found in

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meat and dairy products, and there is no labeling of these drugs to inform the
consumer of their presence in the product.
Treatment with anti-parasitic drugs, such as ivermectin, has been shown to
cause neurotoxicity in horses, cattle, pigs, and rabbits, and symptoms include
depression, ataxia, rigidity, and impaired vision.65
An “animal is better able to resist or tolerate internal parasites when its
living conditions are good.”66 But, living conditions on factory farms are far from
“good.” And, “[o]verpopulation increases the concentrations of parasites.”67 Factory
farms are overpopulated, and anti-parasitic drugs are a quick solution to the
overpopulation and unsanitary living conditions.
III. A Legal Right-to-Know v. A Moral Right-to-Know
Legal rights are bestowed onto a person through the law, and are established
through legislation or through court precedent. Moral rights are given to a person
because it is “ethically obligatory for someone to provide it to them.”68 Rights “are
mechanisms for protecting important human interests.” 69 With respect to
information, “an individual has a right to a piece of information when having that
information is necessary for promoting or protecting his or her most important
interests.”70 Furthermore,
[w]hen it comes to debates over the right to a specific
piece of information about what we’re eating, we need to
think seriously about whether (a) that bit of information
is central to protecting an individual’s interests, (b)
whether those interests are ones that we can agree,
socially, are in need of protecting, and (c) whether
recognizing such a right would impose undue burdens
on others.

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The right to know about harmful ingredients in food is central to protecting an
individual’s interest to live a safe and healthy life, and living a safe and healthy life is
an interest that most people would agree, socially, is in need of protecting, and the
right to know about harmful ingredients in food would not impose undue burdens
on others, relatively speaking. Thus, consumers have a right to information as to
whether a food product contains harmful ingredients. I will argue that we not only
have a moral right to know the harmful ingredients in our food, but we also have a
legal right to know the harmful ingredients in our food.
IV. How the Federal Labeling Laws Create a Legal Right to Know
The federal regulatory agencies, that have jurisdiction to govern the labeling
of meat and dairy products, obtain their authority from several principle statutes –
the Federal Meat Inspection Act (FMIA)71, the Poultry Products Inspection Act
(PPIA)72, the Egg Products Inspection Act (EPIA)73, the Agricultural Marketing Act
(AMA)74, the Federal Food, Drug, and Cosmetic Act (FDCA)75, the Fair Packaging and
Labeling Act (FPLA)76, and the Nutrition Labeling and Education Act (NLEA)77.78
These principle statutes, collectively, bestow upon consumers a legal right to know
all of the harmful ingredients, or potentially harmful ingredients, in their food
products.
A. The Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act
(PPIA)
The FMIA and the PPIA “are parallel in most respects, and identical in others,
and are construed to have the same meaning, when possible, in view of their
common purpose to prohibit the movement or sale in interstate commerce of meat

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and poultry products which are adulterated or misbranded.”79 The FMIA requires
the USDA “to insure that meat and meat food products distributed to consumers are
wholesome, unadulterated, and properly marked, labeled and packaged and that
meat products are made available to consumers in a form and manner consistent
with the public health and welfare.”80 Thus, the FMIA creates a legal right to meat
food products that are properly labeled.
Under the FMIA and the PPIA, the USDA’s Food Safety and Inspection Service
(FSIS) has primary responsibility for the regulation of food labeling for meat and
poultry products. The FMIA and the PPIA define a food “label” as “a display of
written, printed, or graphic matter upon the immediate container of any article.”81
“Labeling” is defined as “all labels and other written, printed or graphic matter (1)
upon any article or any of its containers or wrappers, or (2) accompanying such
article.”82 The USDA is “authorized under the FMIA and the PPIA to regulate
marking, labeling, or packaging of meat, poultry, or processed parts to prevent the
use of any false or misleading mark, label, or container.”83
The FMIA specifies the circumstances when products are misbranded. The
FMIA states that a meat or meat food product is “misbranded … if the product’s
labeling is false or misleading in any particular.”84 The “statutory language does not
require that the false or misleading statements be ‘material.’”85 The FMIA states
that a meat or meat food product is “misbranded … if any word, statement, or other
information required by [the FMIA] … to appear on the label … is not prominently
placed thereon with such conspicuousness … as to render it likely to be read and

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understood by the ordinary individual under customary conditions of purchase and
use.”86
FSIS has similar authority under the PPIA with regard to poultry products.
The PPIA requires that “the health and welfare of consumers be protected by
assuring that poultry products distributed to them are wholesome, not adulterated,
and properly marked, labeled, and packaged.”87 The PPIA’s “Congressional
statement of findings” specifically states that
[i]t is essential in the public interest that the health and
welfare of consumers be protected by assuring that
poultry products distributed to them are wholesome, not
adulterated, and properly marked, labeled, and
packaged. Unwholesome, adulterated, or misbranded
poultry products impair the effective regulation of
poultry products in interstate or foreign commerce, are
injurious to the public welfare, destroy markets for
wholesome, not adulterated, and properly labeled and
packaged poultry products, and result in … injury to
consumers.88
The statute clearly and explicitly states that the purpose of the PPIA is “to protect
the health and welfare of consumers.”89 Pursuant to the PPIA, “[n]o person shall …
sell, transport, offer for sale or transportation, in commerce, any poultry products
which are capable of use as human food and are adulterated or misbranded…”90
In National Pork Producers Council v. Bergland, the court recognized that,
Congress expressly charged the USDA with ‘assuring that
meat and meat food products distributed to (consumers)
are wholesome, not adulterated, and properly marked,
labeled, and packaged.’ In our view, this directive
authorizes the Department to ensure that the products
desired by consumers be made available to them in a
form and manner consistent with the public health and
welfare. Every time the Secretary approves a product’s
ingredients or label, he, in one sense, is promoting that
product.91

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Thus, this court recognized that consumers have a legal right to products that are
consistent with public health and welfare. The court in Bergland goes on to say that
the USDA “should not promote a particular company or a particular product of a
particular company; [however], merely fulfilling consumer desires while insuring
consumer health and safety does not constitute such unlawful promotion.”92 In
applying this rationale to the use of ractopamine, rBGH, or sub-therapeutic
antibiotics in food products, it means that labeling a product as containing-“the bad
ingredient” or not-containing-“the bad ingredient” does not result in promoting a
particular product or a particular company. It results in fulfilling consumer desires
by providing for truth-in-labeling, and by allowing consumers to make educated and
informed choices in their food purchases, for the overall purpose of ensuring
consumer health and safety.
With respect to consumer health and safety, it is important to note that the
USDA has implemented a basic five-point food safety strategy to reduce the
incidence of foodborne illness.93 One of the points of the strategy is to enhance
public education efforts. Without labeling, the harmful ingredients will largely go
unnoticed and consumers will be unable to educate themselves on the possible
effects of consuming these harmful ingredients in their meat and dairy products.
Federal regulations “require that all ingredients used to formulate a meat or
poultry product must be listed by their common or usual name on labeling.”94
However, there are two exceptions to these rules: secondary direct additives and
incidental additives.95 Secondary direct additives do not need to be labeled
“because it has only a momentary technical effect in food by definition.”96 FSIS

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exempts “the mandatory declaration of ‘incidental additives’ from an ingredients
statement if they are present in insignificant amounts and serve no technical or
functional effect in food, are used as a processing aid, or have migrated to food from
equipment or packing materials.”97 Processing aids “are a subcategory of incidental
additives and are not considered ingredients since they are essentially substances
that are added to a food for their technical or functional effect in the processing but
are present in the finished food at insignificant levels and do not have any lasting
technical effect in that food.”98 It is important to note that “FSIS does not have a
definition for incidental additives or processing aids.”99
One can argue that ractopamine, sub-therapeutic antibiotics, hormones, and
anti-parasitic drugs are incidental additives or secondary direct additives. It is
important to note that these two exceptions (secondary direct additives and
incidental additives) “do not apply where the FDA regulations require that use of a
specific substance be disclosed for health or other reasons.”100 Thus, if ractopamine,
sub-therapeutic antibiotics, hormones, and anti-parasitic drugs are incidental
additives or secondary direct additives they can and should be disclosed for health
or other reasons.
For example, the “FDA requires that sulfiting agents that qualify as incidental
additives must be labeled if present at levels exceeding an established level
(10ppm).”101 Sulfiting agents are dangerous because they “can cause a wide
spectrum of adverse reactions including severe asthmatic attacks and anaphylactic
reactions.”102 What about the adverse reactions of consuming hormones, or
ractopamine, or antibiotics? These are ingredients of public health concern, yet they

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do not appear on the label, despite the fact that FSIS “emphasizes the importance of
accurate, informative product labeling.”103 One can argue that it is arbitrary and
capricious for the FDA to require certain incidental additives, such as sulfiting
agents, to appear on the label, but to not require ingredients like ractopamine
residues, rBGH, or sub-therapeutic antibiotics to appear on the label.
Furthermore, an “ingredients statement is required when a product is
fabricated from two or more ingredients.”104 The “list of ingredients shall show the
common or usual names of the ingredients arranged in the descending order of
predominance,” with exceptions.105 “Product ingredients which are present in
individual amounts of 2 percent or less by weight may be listed in the ingredients
statement in other than descending order of predominance.”106 The FSIS recognizes
the need to provide consumers with more ingredient information. FSIS Directive
7237.1 states that
[o]n January 6, 1993, FDA published regulations
amending its ingredients labeling requirements for
standardized foods, color additives, and protein
hydrolysates. FDA amended the regulations in response
to the Nutrition Labeling and Education Act of 1990. The
regulations are intended to provide consumers with
more information on the ingredients in their foods to
assist in making sound personal food choices. The
amended regulations require the listing of the common
or usual names of all ingredients in standardized foods
and all FDA-certified color additives. … The intent of the
subject FDA ingredient labeling changes is to provide
more ingredient information for the consumer. FDA has
always required the ingredients in non-standardized
FDA-foods and food ingredients to be fully disclosed on
the labels of such products.107

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Clearly, based on this FSIS policy directive, the FDA recognizes that consumers have
a legal right, or in the very least a need, to full disclosure regarding the ingredients
in their food.
Furthermore, the regulations state that “[t]he common or usual name of a
food, which may be a coined term, shall accurately identify or describe, in as simple
and direct terms as possible, the basic nature of the food or its characterizing
properties or ingredients.”108 The “common or usual name of a food shall include
percentage(s) of any characterizing ingredient(s) or component(s) when the
proportion of such ingredient(s) or component(s) in the food has a material bearing
on price or consumer acceptance…”109 This regulation recognizes that the
ingredients in a food product can have an effect on consumer acceptance of the
product. Consumers will be less likely to accept a product, or purchase a product, if
the label clearly states that the product contains hormones, or sub-therapeutic
antibiotics, or ractopamine residues. Food labels are required to include ingredients
such as artificial flavorings, colorings, and chemical preservatives,110 so why not
ractopamine, hormones, or antibiotics?
The FMIA specifies circumstances when a meat or meat food product is
“adulterated.”111 A meat or meat food product is “adulterated … if it bears or
contains any poisonous or deleterious substance which may render it injurious to
health…”112 A meat or meat food product is “adulterated … if it bears or contains (by
reason of administration of any substance to the live animal or otherwise) any
added poisonous or added deleterious substance … which may, in the judgment of
the Secretary, make such article unfit for human food.”113 A meat or meat food

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product is “adulterated … if it consists in whole or in part of any filthy, putrid, or
decomposed substance or is for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food.”114 In order for the Secretary to
approve the use of hormones, antibiotics, and ractopamine, the Secretary must
make a determination that there is no substantial possibility that the presence of
these ingredients in processed products could harm the health of those ingesting the
products.115 One could argue that the Secretary has not made such determinations
with the required thoroughness. The Secretary is required by section 606 of the
FMIA to prevent the sale of any adulterated meat food products.116 Thus, consumers
have a legal right to food products that are not adulterated.
Section 403 of the FMIA117 … “provides, in part, that any meat food product
which is capable of use as human food and is adulterated or misbranded shall be
liable to be proceeded against and seized and condemned, at any time, on a libel of
information in any United States District Court within the jurisdiction of which the
article is found…”118 One can argue, based on the arguments made supra, that meat
products containing ractopamine, antibiotics, hormones, and anti-parasitic drugs
are adulterated and misbranded, and therefore, shall be liable to be proceeded
against and seized and condemned.
B. The Egg Products Inspection Act (EPIA)
The EPIA “Congressional statement of findings” specifically states that
[i]t is essential, in the public interest, that the health and
welfare of consumers be protected by the adoption of
measures prescribed herein for assuring that eggs and
egg products distributed to them and used in products
consumed by them are wholesome, otherwise not
adulterated, and properly labeled and packaged. Lack of

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21
effective regulation for the handling or disposition of
unwholesome, otherwise adulterated, or improperly
labeled or packaged egg products … is injurious to the
public welfare … and results in … injury to consumers.119
Thus, consumers have a legal right to wholesome, properly labeled egg products.
Furthermore, each of the ingredients “used in egg products must be declared on the
label as required by 21 C.F.R. Parts 101 and 130.”120 Optional ingredients, such as
preservatives, anticaking ingredients, and color additives must be included on the
ingredients statement.121 The term “’misbranded’ shall apply to egg products which
are not labeled and packaged in accordance with the requirements prescribed by
regulations of the Secretary under section 1036…”122 Furthermore, “[n]o labeling or
container shall be used for egg products at official plants if it is false or
misleading.”123
C. The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938
The FDA has primary statutory authority to establish labeling requirements
for foods and food ingredients pursuant to the FDCA. The FDCA states, in a manner
similar to the statutes enforced by the USDA, that a food product is misbranded if
“its labeling is false or misleading in any particular…”124 Any information required
to appear on a label must be prominent, conspicuous, and clearly understood by the
ordinary person under normal circumstances.125 Representations made on the
labeling, or the labeling’s failure to reveal material facts, determine whether a
product is misleading, and, therefore, misbranded.126 Thus, a food product’s
labeling may be misleading because it fails to include information. The statute
specifically states that

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[i]f an article is alleged to be misbranded because the
labeling or advertising is misleading, then in
determining whether the labeling or advertising is
misleading there shall be taken into account (among
other things) not only representations made or
suggested by statement, word, design, device, or any
combination thereof, but also the extent to which the
labeling or advertising fails to reveal facts material in
the light of such representations or material with
respect to consequences which may result from the use
of the articles to which the labeling or advertising
relates under the conditions of use prescribed in the
labeling or advertising thereof or under such conditions
of use as are customary or usual.127
Thus, the failure to reveal material facts, such as the presence of ractopamine, sub-
therapeutic antibiotics, and hormones in the food products is misleading, and
therefore, the food products are misbranded, contrary to the mandates of the FDCA.
Furthermore, and more importantly, the FDCA specifically states that “[a]
food shall be deemed to be misbranded … [if there is a] failure to label [a] health
threat.”128 The FDCA specifically states that “[a] food shall be deemed to be
misbranded … [i]f the Secretary finds that the food presents a threat of serious
adverse health consequences or death to humans or animals.”129 In United States v.
Bradshaw, the Eleventh Circuit concluded that “the general scheme of the FDCA and
its legislative history indicate that the overriding congressional purpose was
consumer protection – the protection of the public against any misbranded or
adulterated food, drug, device, or cosmetic.”130 Thus, consumers have a legal right
to food products that are not misbranded or adulterated.
As mentioned supra, “a food may be considered misbranded if the absence of
labeling ‘fails to reveal facts material … with respect to consequences which may
result from the use of the [food].’”131 Thus,

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any omitted information that can be characterized as a
material fact is subject to mandatory labeling under the
statute. In evaluating the need for a mandatory label to
identify a particular characteristic of a given product, the
FDA first determines whether that characteristic is
material; it then considers whether consumers would be
unaware of that material characteristic in the absence of
labeling. Thus, mandatory labeling does not need to be
based on scientific evidence of health and safety
concerns, since materiality circumvents the need for a
purely scientific justification.132
For example, in 1999, the FDA required that meat and poultry treated with radiation
were required to be labeled as such.133 The FDA reasoned that “such irradiation is a
material fact that must be disclosed to consumers through labeling to avoid
deception, since it can affect the meat or poultry products in a manner that is not
obvious to consumers…”134 This case indicates that the “materiality requirement
appears to be a low hurdle for proponents of food labeling who seek statutory
justification because virtually any product trait or production method could be
characterized as one that materially affects a consumer’s purchasing decision.”135
Thus, consumers have a legal right to know about material facts that are not obvious
to consumers in order to avoid deception.
In order to avoid deception, the FDA has the authority to use section 201(n)
to require warnings on a food product’s label.136 The fat substitute “olestra” is a
recent example of the FDA using section 201(n) to require warnings on a food label.
Research showed that olestra has the “potential to cause abdominal cramping and
loose stools in some individuals, and it inhibits the body’s absorption of certain
soluble vitamins and nutrients.”137 The FDA required manufacturers to use the
following “boxed” warning: “This product contains olestra. Olestra may cause

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abdominal cramping and loose stools. Olestra inhibits the absorption of some added
vitamins and other nutrients…” 138 In the agency’s view, the data of the
consequences of olestra demonstrated that such consequences were “material,” as
opposed to mild responses in consumers, and, thus, a warning was appropriate.139
Surely, the data behind the use of sub-therapeutic antibiotics, hormones, and
ractopamine demonstrates that the consequences of consuming such ingredients
are “material,” and thus a warning statement is warranted on food products
containing those deleterious ingredients.
A “food additive” has been defined to include “all substances …, the intended
use of which results or may reasonably be expected to result, directly or indirectly,
either in becoming a component of food or otherwise affecting the characteristics of
food.”140 The “essential question in determining whether a food additive is unsafe
within the meaning of the law is whether the particular material was so recognized
as having been adequately shown through scientific procedures to be safe under the
conditions of the intended use.”141 The
Senate Committee Report accompanying the Food
Additives Amendment of 1958 explains that the concept
of safety used in this legislation involves the question of
whether a substance is hazardous to the health of man or
animal, that this criterion requires proof of a reasonable
certainty that no harm will result from the proposed use
of an additive, but that it does not, and cannot, require
proof beyond a reasonable doubt that no harm will
result under any conceivable circumstance. The Senate
Report continues that in determining the safety of an
additive, scientists must take into consideration the
cumulative effect of such additive in the diet of man or
animals over their respective life spans together with
any chemically or pharmacologically related substances
in their diet, so that the safety of a given additive would
involve informed judgments based on educated

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estimates by scientists and experts of the anticipated
ingestion of an additive by man and animals in the likely
patterns of use.142
Clearly, food additives must be safe for human consumption, and at the very least,
food additives with the potential to be unsafe for human consumption should be
labeled so that consumers have the ability to make informed decisions about their
food.
D. The Fair Packaging and Labeling Act (FPLA) of 1967
The FDA also has regulatory authority for labeling under the Fair Packaging
and Labeling Act (FPLA). The purpose of the FPLA “is to avoid the misbranding of
food and to inform consumers of the actual characteristics and properties of food
products.”143 The FPLA “Congressional declaration of policy” states that “[i]nformed
consumers are essential to the fair and efficient functioning of a free market
economy.”144 The FPLA directs the FTC and the FDA “to issue regulations requiring
that all ‘consumer commodities’ be labeled to disclose net contents, identity of [the]
commodity, and [the] name and place of business of the product’s manufacturer,
packer, or distributor.”145 The Act also authorizes “additional regulations where
necessary to prevent consumer deception (or to facilitate value comparisons) with
respect to description of ingredients…”146 The purpose of the FPLA is to “facilitate
value comparisons and to prevent unfair or deceptive packaging and labeling of
many household ‘consumer commodities.’”147 Thus, consumers are given a legal
right to an adequate description of the ingredients of a food product.
E. The Nutrition Labeling and Education Act (NLEA) of 1990

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Congress addressed the need for truth-in-labeling through the passage of the
Nutrition Labeling and Education Act (NLEA) of 1990, which amended the FDCA.148
The goal of the NLEA is “the communication of essential information to enable
consumers to choose foods more wisely.”149 The NLEA provides FDA “with specific
authority to require nutrition labeling of most foods regulated by the Agency; and to
require that all nutrient content claims (i.e. ‘high fiber,’ low fat,’ etc.) and health
claims be consistent with agency regulations.”150 The NLEA also permits “the
Secretary of Health and Human Services to add or delete nutrients included in the
nutrition label in order to ‘assist consumers in maintaining healthy dietary
practices.’”151 Thus, consumers are given a legal right to know the essential
information of a food product.
F. The Federal Trade Commission Act (FTCA)
Pursuant to section 12 of the Federal Trade Commission Act (FTCA), the FTC
must prohibit the false advertisement of “food, drugs, and cosmetics.”152 It is
important to note, however, that the definition of “advertisement” excludes
labeling.153 But, pursuant to section 5 of the FTCA, the FTC has the authority to
prevent “unfair or deceptive acts or practices in or affecting commerce,” and this
authority gives the FTC the power to proceed against all unfair or deceptive
business practices, including food products that have false or misleading labeling.154
G. The FDA’s Consumer Health Information for Better Nutrition Initiative
On December 18, 2002, the Commissioner of Food and Drugs “announced a
major new initiative to make available more and better information about foods and
dietary supplements, to help American consumers prevent diseases and improve

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their health by making sound dietary decisions.”155 The Consumer Health
Information for Better Nutrition Initiative “seeks to help consumers improve their
understanding of how their diet choices may influence their health, to promote
competition among product developers to find better ways to help improve health
through better diets, and ultimately to prevent serious and life-threatening diseases
through better dietary choices by Americans.”156 This initiative demonstrates that
the FDA recognizes the importance of consumer labeling and the need for
consumers to have the relevant information to make informed decisions. The FDA
needs to follow its own policy advice and initiatives, and mandate truth-in-labeling
for meat and dairy products so that consumers can prevent life-threatening diseases
and adverse effects from food.
V. The Power of Labels
The characteristics of products are extremely important to consumers in the
marketplace. This is especially true when it comes to food products because of the
potential health impacts regarding food choice. Is the food product
environmentally-friendly? Where was the food product manufactured? What is the
fat content and caloric content of the food product? These are just some basic
questions that consumers have regarding food products, and labels help to provide
easy answers to these questions. But, labels are useful for more than just answering
consumer questions, they actually have the power to influence markets and change
industry standards.
Eco-labels are now used in many countries to highlight the environmental
features of “green” products. And, “[f]rom a policy perspective, one aim of eco-

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labels is to educate consumers about the environmental impacts of the product’s
manufacture, use, and disposal, thereby leading to a change in purchasing behavior
and ultimately, to a reduction in negative impacts.”157 The dolphin-safe labeling
measure is a prime example of how consumer behavior can be altered simply by
implementing a labeling measure.158 And,
[i]n addition to changes in consumer behavior the
presence of eco-labeling may alter manufacturer
behavior. That is, if a significant portion of the
consumer population demands environmentally
friendly products, the presence of an eco-labeling
program may provide firms an incentive to differentiate
and market their products [based on] environmental
characteristics.159
Furthermore, labeling is easier to implement and enforce when compared to
implementing and enforcing specific, targeted regulations, and, thus, policymakers
should welcome labeling measures as an effective means to create positive change.
VI. Conclusion
The federal statutes mentioned supra, combined, mandate transparency and
truth-in-labeling in the livestock industry. They create a legal right to know all of
the harmful ingredients in a food product. They create a duty to warn consumers of
the possible consequences of consuming hormones, ractopamine, antibiotics, rBGH,
and anti-parasitic drugs. Yet, meat and dairy products have no consumer alerts.
Food products containing these harmful ingredients are misbranded due to the fact
that the labeling is misleading. The labeling is misleading because it fails to include
information that the products contain these harmful ingredients, and the labeling is
deceptive because it does not include information on the possible consequences of
consuming the product.160

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From a policy standpoint, labeling is not an extraordinary hardship to impose
on the livestock industry and, relatively speaking, it is not a difficult measure to
implement and enforce. Courts have recognized that “[t]he paramount public
interest to be vindicated here is the protection of the consuming public…”161
Federal regulatory agencies need to stand up to the dominance of the livestock
industry, and they need to fulfill their duty to protect the consuming public. These
harmful ingredients are only used so that the livestock industry can realize higher
profits. If federal regulatory agencies continue to enable and contribute to the
opacity and deception of the livestock industry, then consumers will continue to be
harmed and farm animals will continue to suffer. The dominance, deception,
misleading, and misbranding of the livestock industry will greatly be reduced if the
legal “right to know” is recognized and implemented in the United States.
1 35A Am. Jur. 2d Food § 23; see also U.S. v. Jorgensen, 144 F.3d 550 (8th Cir. 1998).
2 Grace Communications Foundation, Hormones, at 1, at
http://www.gracelinks.org/258/hormones.
3 See Id.
4 See Renu Gandhi, Ph.D. and Suzanna M. Snedeker, Ph.D., Consumer Concerns About
Hormones in Food, June 2000, at 2, at
http://envirocancer.cornell.edu/factsheet/diet/fs37.hormones.cfm.
5 Id.
6 Id.
7 Id.
8 Id. at 3.

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30
9 American Public Health Association, Opposition to the Use of Hormone Growth
Promoters in Beef and Dairy Cattle Production, November 10, 2009, at 1, at
http://www.apha.org/advocacy/policy/policysearch/default.htm?id=1379.
10 See Id.
11 Gandhi, supra note 4, at 3.
12 See American Public Health Association, supra note 9, at 1.
13 Id.
14 Id.
15 Weirt Velle, The Use of Hormones in Animal Production, at 5.7, at
http://www.fao.org/docrep/004/X6533E/X6533E01.htm.
16 “Several causative factors [of the buller steer syndrome] have been implicated by
feedlot operators as contributing to the incidence of bullers. Suggested factors
include the use of anabolic agents, improper implantation, reimplantation or double
dosing, changes in weather and seasonal factors, excessive mud or dusty pen
conditions, entry weights, disease, group size, improper or late castration, feeding
management, transportation, handling, mixing, dipping and aggressive social
dominance behavior. Of these factors, entry weights, weather and seasonal factors
have not withstood scientific scrutiny…” See Joseph M. Stookey, Buller Steer
Syndrome, Alberta Feedlot Management Guide, at 1, at
http://www.usask.ca/wcvm/herdmed/applied-ethology/articles/bullers.html.
17 Joseph M. Stookey, Buller Steer Syndrome, Alberta Feedlot Management Guide, at
1, at http://www.usask.ca/wcvm/herdmed/applied-ethology/articles/bullers.html.
18 Id.
19 Id.
20 David Gutierrez, FDA Allows Unsafe Drugs to Be Fed to Livestock, July 9, 2010, at 1,
at http://www.naturalnews.com/z029169_livestock_chemicals.html.
21 Id.
22 Id.
23 Id.
24 Id.

31. Summer Smith
31
25 Id.
26 Id.; citing to Martha Rosenberg, Counterpunch.
27 Id.
28 Oldman, Jr., Ractopamine Banned in 160 Countries (Even in China) and the FDA
Says It Is Safe for Humans, February 6, 2010, at http://www.bbsradio.com/cgi-
bin/webbbs/webbbs_config.pl?md=read;id=5837.
29 Chris Wang, British Expert Explains the EU Ban on Ractopamine, March 30, 2012,
at http://www.taipeitimes.com/News/taiwan/archives/2012/03/30/2003529068.
30 Michael Hansen, PhD, and Urvashi Rangan, PhD, Letter to The Honorable Margaret
Hamburg, Commissioner, December 4, 2012, at 2, at
http://www.consumersunion.org/pdf/FDA_Stop_Use_of_Ractopamineractopamine_
1212.pdf.
31 See American Public Health Association, supra note 9, at 1.
32 Id. at 2.
33 See Id. at 1.
34 Id. at 2.
35 See Id.
36 See Gandhi, supra note 4, at 4.
37 Wikipedia, Mastitis, at http://en.wikipedia.org/wiki/Mastitis.
38 See Gandhi, supra note 4, at 4
39 See American Public Health Association, supra note 9, at 2.
40 Id.
41 American Public Health Association, supra note 9, at 2.
42 Id.
43 See Id.

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32
44 Id.
45 Frontline – Modern Meat, Antibiotic Debate Overview, at 1, at
http://www.pbs.org/wgbh/pages/frontline/shows/meat/safe/overview.html.
46 Id.
47 Sabrina Tavernise, Farm Use of Antibiotics Defies Scrutiny, New York Times,
September 4, 2012, at http://www.nytimes.com/2012/09/04/health/use-of-
antibiotics-in-animals-raised-for-food-defies-scrutiny.html?pagewanted=all.
48 Frontline, supra note 45, at 1.
49 ConsumerReports.org, Antibiotics Are Widely Used by U.S. Meat Industry, June
2012, at 1, at http://www.consumerreports.org/cro/2012/06/antibiotics-are-
widely-used-by-u-s-meat-industry/index.htm.
50 Frontline, supra note 45, at 1.
51 Tavernise, supra note 47.
52 Frontline, supra note 45, at 1.
53 Tavernise, supra note 47.
54 See Id.
55 ConsumerReports.org, supra note 49, at 1.
56 Id.
57 See Chris MacDonald, The Right to Know What I’m Eating, September 28, 2010, at
http://food-ethics.com/2010/09/28/the-right-to-know-what-im-eating/.
58 Karen Davis, The Battery Hen: Her Life is Not For the Birds, at http://www.upc-
online.org/batthen.html.
59 Id.
60 Id.
61 Id.
62 See Jae Allen, Chemicals and Hormones in Beef, August 18, 2011, at 1, at
http://www.livestrong.com/article/519776-chemicals-and-hormones-in-beef/.

33. Summer Smith
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63 Id.
64 Id.
65 Emory, Ivermectin Fact Sheet, at 1, at
http://www.dar.emory.edu/pi/ivermectin.pdf.
66 Jean Duval, The Control of Internal Parasites in Ruminants, Ecological Agriculture
Products, at http://eap.mcgill.ca/agrobio/ab370-04e.htm.
67 Id.
68 MacDonald, supra note 57.
69 Id.
70 Id.
71 21 U.S.C. §§ 601 et seq.
72 21 U.S.C. §§ 451 et seq.
73 21 U.S.C. §§ 1031 et seq.
74 7 U.S.C. §§ 1621 et seq.
75 Pub. L. No. 75-717, 52 Stat, 10440 (codified as amended at 21 U.S.C. §§ 301 et seq.
(1994)).
76 15 U.S.C. §§ 1451 et seq.
77 Pub. L. No. 101-535, 104 Stat. 2353 (codified as amended at 21 U.S.C. § 343
(2004)).
78 See R. Post, C. Budak, et al., A Guide to Federal Food Labeling Requirements for
Meat and Poultry Products, August 2007, at 4, at
http://www.fsis.usda.gov/pdf/labeling_requirements_guide.pdf.
79 35A Am. Jur. 2d Food § 32, Meat – Federal Legislation.
80 35A Am. Jur. 2d Food § 32, Meat – Federal Legislation; see also Nat’l Pork
Producers Council v. Bergland, 631 F. 2d 1353 (8th Cir. 1980).

34. Summer Smith
34
81 Post, supra note 78, at 4; see also 21 U.S.C. § 601(o) and (p) (meat); 21 U.S.C. §
453(s) (poultry).
82 Id.
83 Post, supra note 78, at 4-5.
84 21 U.S.C. § 601(n)(1).
85 U.S. v. Jorgensen, 144 F.3d 550, 559 (8th Cir. 1998).
86 21 U.S.C. § 601(n)(6).
87 21 U.S.C. § 451.
88 Id.
89 Id.
90 21 U.S.C. § 458(a)(2).
91 National Pork Producers Council v. Bergland, 631 F.2d 1353, 1361 (8th Cir. 1980).
92 Id.
93 Dr. Merle D. Pierson, Implementing Food Safety Policies at the U.S. Department of
Agriculture: Overcoming Challenges and Showing Results, 59 Food & Drug L.J. 223
(2004).
94 Post, supra note 78, at 47.
95 Id.
96 Id.
97 Post, supra note 78, at 48.
98 Id.; emphasis added.
99 Id.
100 Id.
101 Id.

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35
102 William H. Yang, MD, Dangers of Sulfiting Agents in Food and Pharmaceuticals,
The Canadian Society of Allergy and Clinical Immunology, 1995, at 1, at
http://www.csaci.ca/index.php?page=358.
103 Post, supra note 78, at 49.
104 Post, supra note 78, at 43; see also 9 C.F.R. § 317.2(c)(2) (meat); 9 C.F.R. §
381.118 (poultry).
105 9 C.F.R. § 317.2(f)(1).
106 9 C.F.R. § 317.2(f)(1)(vi)(A).
107 FSIS Directive 7237.1(VI)(B) & (D), August 9, 1994.
108 21 C.F.R. § 102.5(a).
109 21 C.F.R. § 102.5(b).
110 21 U.S.C. § 343(k).
111 21 U.S.C. § 601(m).
112 21 U.S.C. § 601(m)(1).
113 21 U.S.C. § 601(m)(2)(A).
114 21 U.S.C. § 601(m)(3).
115 See Community Nutrition Institute v. Butz, 420 F. Supp. 751, 756 (D.C. D.C. 1976).
116 See 21 U.S.C. § 606.
117 21 U.S.C. § 673.
118 U.S. v. 2623 Pounds, More or Less, of Veal and Beef, 336 F. Supp. 140, 143 (D.C. Cal.
1971).
119 21 U.S.C. § 1031.
120 Post, supra note 78, at 102.
121 See Id.
122 21 U.S.C. § 1031(l).

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36
123 21 U.S.C. § 1036(b).
124 21 U.S.C. § 343(a).
125 21 U.S.C. § 343(f).
126 21 U.S.C. § 321(n).
127 Id.
128 21 U.S.C. § 343(v).
129 21 U.S.C. § 343(v)(2).
130 Roseann B. Termini, The Prevention of Misbranded Food Labeling: The Nutrition
Labeling and Education Act of 1990 and Alternative Enforcement Mechanisms, 18
Ohio N.U. L. Rev. 77, 80 (1991), citing to United States v. Bradshaw, 840 F.2d 871,
874 (11th Cir. 1988).
131 Steve Keane, Can a Consumer’s Right to Know Survive the WTO?: The Case of Food
Labeling, 16 Transnat’l L. & Contemp. Probs. 291, 299 (2006); see also 21 U.S.C. §
321(n); see also Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 178 (D.D.C.
2000) (“The FDCA, 21 U.S.C. § 321(n), grants the FDA limited authority to require
labeling.”).
132 Keane, supra note 131, at 299.
133 Id.; see also 21 U.S.C. § 343(q)(2)(A).
134 Keane, supra note 131, at 299; see also 21 U.S.C. § 343(q)(2)(A); see also
Irradiation of Meat Food Products, 64 Fed. Reg. at 72,158.
135 Keane, supra note 131, at 299.
136 See Frederick H. Degnan, The Food Label and the Right-to-Know, 52 Food & Drug
L.J. 49, 52 (1997).
137 Id.
138 Id.
139 See Id.
140 21 C.F.R. § 121.1(e).

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37
141 21 A.L.R. Fed. 314, § 5, Criterion of safety; generally recognized as safe (GRAS)
concept.
142 Id.; see also SR No. 2422 (1958) U.S. Code Cong & Adm News 5300; see also 21
C.F.R. §§ 121.1(i) & (k), 121.5, 121.6 and 121.40.
143 Lever Bros. Co. v. Maurer, 712 F. Supp. 645 (S.D. Ohio 1989); see also 35A Am. Jur.
2d Food §25.
144 15 U.S.C. § 1451.
145 Federal Trade Commission, What is the Fair Packaging and Labeling Act?, at 1, at
http://www.ftc.gov/os/statutes/fpla/outline.html.
146 Id.
147 Id.
148 Termini, supra note 130, at 108; citing to United States v. Bradshaw, 840 F.2d 871,
874 (11th Cir. 1988).
149 Degnan, supra note 136, at 54.
150 FDA, Guide to Nutrition Labeling and Education Act (NLEA) Requirements, August
1994, at 1, at
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074948.htm.
151 Keane, supra note 131, at 298; see also 21 U.S.C. § 343(q)(2)(A).
152 Post, supra note 78, at 11.
153 See Id.; see also 15 U.S.C. § 52.
154 See Post, supra note 78, at 11; see also 15 U.S.C. § 45(a)(1).
155 FDA, Consumer Health Information for Better Nutrition Initiative: Task Force Final
Report, July 10, 2003, at “Overview,” at
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/
QualifiedHealthClaimsPetitions/ucm096010.htm.
156 Id.
157 Mario F. Teisl, Brian Roe, and Robert L. Hicks, Can Eco-Labels Tune a Market?
Evidence From Dolphin-Safe Labeling, August 21, 2001, Journal of Environmental

38. Summer Smith
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Economics and Management, at 339, at
http://www.people.fas.harvard.edu/~hiscox/Teisl.pdf.
158 See Id.
159 Id. at 355-356.
160 Terence J. Centner & Kyle W. Lathrop, Labeling rbST-Derived Milk Products: State
Responses to Federal Law, 45 U. Kan. L. Rev. 511, 522 (1997) (similar argument
made where the FDA decided that labels on rbST-derived milk products would not
be required).
161 Community Nutrition Institute v. Butz, 420 F. Supp. 751, 756 (D.C. D.C. 1976).