Summer Smith

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 SmithDecember 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 exempts “the

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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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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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Summer Smith

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.

29

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.

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.

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.

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/.

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).

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.

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).

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).

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 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).