Running Head: LIABILITY OF FOOD MANUFACTURERS 1

Liability of Food Manufacturers for Failing to Disclose Allergen Information

Ross Dictado

First Colonial High School

Legal Studies Academy

LIABILITY OF FOOD MANUFACTURERS 2

Abstract

In this paper the author will be discussing the liability of food manufacturers when the

manufacturer failed to disclose allergen information on the product's nutrition label. First, by

giving the reader background information on allergies the author allows the reader to grasp the

severity of allergies. The author then describes the importance of nutrition labels and disclosing

information regarding allergenic material. The author will also state the problems that are

produced from the manufacturers using may contain advisory warnings. Continuing to talk

about allergens, the author describes the way the FDA and how the administration handles

mislabeled food products, in regards to allergen labelling. Thereafter, the author gives details of

cases pertaining to the issue. Followed by a comparison of how a different country, The United

Kingdom, tackles the issue of allergen labelling. Finally, the author brings light to allergy

awareness week and its significance in the education and advocacy of the issue of allergies.

Keywords: Allergies, Nutrition Labels, May contain, GMPs

LIABILITY OF FOOD MANUFACTURERS 3

Liability of Food Manufacturers for Failing to Disclose Allergen Information

People who suffer from allergies rely on nutrition labels and the labels ingredient list to

ensure the allergy sufferer doesnt come in contact with any potential allergenic material. Due to

the Consumer Protection and Allergen Labeling Act, food manufacturers have to provide

information regarding the use of any of eight allergens in the manufacturers product. Although

he act requires the manufacturers to disclose the use of any allergenic material in their product,

the act does not require the manufacturers to include information about any accidental

contamination of the product, nor does this act regulate the use of any advisory warnings of the

potential contamination.

The lack of regulations surrounding the use of the may contain advisory warning on

nutrition labels fails to adequately protect consumers because the warning is both vague and

widely overused. In a University of Pennsylvania Law review gives details as to why the

advisory warning has no more meaning. As the use of the advisory warning becomes more

common in the food manufacturing community, the FDA needs to provide more concrete

requirements and minimal standards when manufacturers decide the use of the advisory warning

is necessary.

Allergies

An allergy is the reaction the body has to certain allergens. Allergens are harmless

substances that your body mistakes for a dangerous substance. The first reaction that your body

has to an allergen is to release immunoglobulin (IgE) antibodies (Aaaai, n.d.). These IgE

antibodies then release histamines and chemicals that cause your body to react. The most severe

allergic reaction is called anaphylaxis (Henochowicz, 2014, May 10); anaphylaxis occurs when

someone who has an allergy consumes an allergen. The symptoms of anaphylaxis include, hives
LIABILITY OF FOOD MANUFACTURERS 4
covering the body, widespread redness, short of breath, increased heart rate, repetitive vomiting,

lightheadedness, significant swelling of the lips or tongue, anxiety, etc (FARE, n.d.).

Nutrition Labels

The Nutrition Labeling and Education Act of 1990, required that all packaged

manufactured food goods have a nutrition label and all health claim made by the manufacture be

consistent with the actually product; if a manufacturers states that a product is gluten-free or is

only 100 calories then the product must be gluten-free or only 100 calories. The FDA didnt

require food manufacturers to label the any allergens that is present in packaged food products

until the Consumer Protection and Allergen Labeling Act of 2004, as known as The Food

Allergen Act ("Lose Weight & Improve Your Health with a Real Food Diet | Fooducate," n.d.).

Why Allergen Labeling is Important

People who have food allergies are struggling everyday to avoid their food allergens.

Many food manufacturers use confusing abbreviations to indicate potential allergenic

contamination. Manufacturers might use the abbreviation of DE, dairy equipment. Parents of

children who have food allergies were tested to see how accurately they can find allergens listed

in a nutrition label. These parents were tested because of their higher familiarity with nutrition

labels (Wood, 2002).

The Consumer Protection and Allergen Labelling Act

Also known as the Food Allergen Act, it requires that food labels in the USA have the

eight major allergens clearly labelled. This helps ensure consumers that suffer from allergies can

stay away from their allergen. The eight major allergens include, milk, eggs, fish, tree nuts,

peanuts, soybeans, wheat and crustaceans(University of Nebraska-Lincoln, n.d.). These

allergens are considered the eight major allergens because they consist of 90% of all the
LIABILITY OF FOOD MANUFACTURERS 5
allergens in the United States. This act applies to all food products, as long as the product is

subject to FDA regulation. Exceptions to this act are the raw agricultural ingredients and the

highly refined oils and anything derived from the highly refined oils of one of the eight major

allergens (FDA, 2006).

Before the creation of the Act was established, foods made from more than one ingredient

had to have all ingredients listed using their common name. The Food Allergen Act didnt require

the labelling of allergens in food products before January 1, 2006 (FDA, 2016).

May contain advisory warning

There has been noted confusion with the now voluntary warning labels put on

manufactured goods ("Are Allergy Warnings on Food Labels Confusing?; Vague Allergy

Warnings on Food Labels Could Lead to Serious Illness and Even Death," 2007). The may

contain labels were being put onto the nutrition labels of foods to show there is a small chance of

cross-contamination. The term cross-contamination refers to a small amount of allergenic

material potentially crossing into a product's production. Although the Food Allergen Act had

made major strides on the labelling of food allergens, it doesnt specify any regulations about the

may contain advisory warning (Besnoff, 2014).

Food manufacturers put advisory warnings on their products to ensure that the

manufacturer is not held liable for any cross-contamination of their product with any allergenic

material. The manufacturers are still putting the warning on their product whether the chances of

cross-contamination is large or non-existent. Currently the advisory labels put on nutrition labels

are meaningless (M. Shaw, 2016). When consumers look at the advisory warning they are

oftentimes ignored due to the fact that the warning is on most products.
LIABILITY OF FOOD MANUFACTURERS 6
Food manufacturers who have multiple products, including, a product that contains an

allergen and a different product that contains no allergen at all, should have a plan in place to

reduce the risk of cross- contamination. The majority of large food manufacturing corporations

that produce a variety of products have the capability of eliminating the risk for cross-

contamination. The ability of ridding the risk of cross- contamination of an allergen to an

allergen free product is more in the reach of large manufacturing companies. The may contain

advisory warning is more suitable for smaller food manufacturing companies who dont have the

ability to eliminating the risk of cross- contamination. Many of the larger food manufacturers,

however, look at eliminating the risk of cross- contamination as too expensive and decide to

implement the less expensive option of the may contain advisory warning (Besnoff, 2014).

Regarding the overuse of the advisory warning, the FDA should establish certain

threshold when looking for the potential of cross-contamination in a product. The FDA should

also develop certain GMPs, good manufacturing practices, that food manufacturers will be able

to test their product against the standard that these GMPs employ. Understanding that the amount

of an allergen present in a product that is enough to trigger anaphylaxis varies among each

individual. The threshold established is better than no threshold at all. Due to varying amount

needed to cause anaphylaxis there is a small minority group that will be affected by the

contamination of a product that falls below the threshold (Besnoff, 2014).

With every amendment to the GMPs the FDA provides food manufacturers a way of

avoiding the measures for consumer safety. As well as developing thresholds to that the advisory

warning is usable, the FDA needs to enforce the use of GMPs and ensure manufacturers are

displaying GMPs. The FDA stated that they cannot require food manufacturers to validate that

they are displaying GMPs and using adequate allergy control plans due to the fact the
LIABILITY OF FOOD MANUFACTURERS 7
requirements are not made through scientific techniques and the gathering of information. The

FDA should create tests within new amendments that prove that the current GMPs are able or

unable to prevent cross- contamination; furthermore, the FDA should create additional measure

to work towards the complete prevention of cross-contamination through new GMPs (Besnoff,

2014).

Mislabelled Food labels.

Any food will be considered misbranded if the product is not a raw product of the

allergenic material. The label can avoid being deemed misbranded unless the word contains

follows the list of ingredients and the usual name of the allergen follows the word. The source of

the allergen needs to listed in parentheses after the allergen is listed, unless the common name of

the derived allergen source appears somewhere else in the in ingredient list (Food, drug, and

cosmetic act).

When any food is found to be deemed misbranded, in violation of the Food, Drug and

Cosmetic act, the FDA is allowed to halt the import and export of the misbranded product. In that

case the producer of the misbranded product has the opportunity to change the nutrition label to

adhere to the rules set by the Food, Drug, and Cosmetic Act. In most cases the FDA will send the

manufacturer a warning label about the misbranded product. The manufacturer will mostly

respond with contacting the FDA to ask about fixing the misbranded labels. However, in the

cases where the manufacturer doesnt fix or contact the FDA about fixing the label, then the

manufacturer may face legal action to remove the product from the markets. These products that

have been forcibly removed from the product markets manufacturers will need to provide proof

that the misbranded product has been fixed and adheres to the rules set by the Food, Drug and

Cosmetics Act ("FDA: Foods Must Contain What Label Says," 2016).
LIABILITY OF FOOD MANUFACTURERS 8
Lawsuits

Newly Wed Foods v. Superior Nut.

Newly Wed Foods, Inc. (Newly Wed) bought a large quantity of sesame seeds

from the Superior Nut Co., Inc. (Sup. Nut). Newly Wed bought 11,800 lbs. of sesame seeds from

the manufacturer, Sup. Nut. The order form received by Sup. Nut read toasted sesame seeds

Sup. Nut completed the order by sending Newly Wed a number of twenty-five pound boxes with

labels stating TOASTED SESAME SEEDS as well as the date manufactured, lot number, and

box weight. However, the boxes failed to have an allergy warning. Newly Wed collected samples

from each box of sesame seeds sent to them, in order to compare it with the boxes previously

sent to them. After sending these samples to an outside laboratory for testing, at least five of the

samples collected were found to contain peanut parts and skins. Newly Wed has stated that they

only sell peanut-free products. Therefore, Newly Wed decided to withdraw the product from the

markets, as well as refusing to accept Sup. Nuts contaminated sesame seeds (Newly Wed Foods

v. Sup. Nut Co).

The FDA stated in 1996 that food manufacturers must label any allergens that are

present in their products as undeclared allergens pose a major health hazard. Further, the FDA

made clear that any food product that fails to disclose any allergen in their product is considered

adulterated and misbranded. The FDA also encouraged all food manufacturers to also declare

whether or not their products were processed on any equipment that also processed products of

allergens. Based on these standards, an expert from Newly Wed stated that labels on the boxes

should have been labelled as TOASTED SESAME SEED MANUFACTURED ON SHARED

EQUIPMENT failure to disclose the shared equipment Sup. Nut had violated good

manufacturing practices (Newly Wed Foods v. Sup. Nut Co).

LIABILITY OF FOOD MANUFACTURERS 9
When testifying, Sup. Nuts Vice-President, Justin Hintilian (Hintilian), stated that he

knew that the toasted sesame seed product had contained traces of peanuts for over ten years.

Hintilian also stated that he told a FDA inspector in 2003 that the toasted sesame seed product

had contained peanut traces. Sup. Nut had been aware that they could not ensure the sesame seed

product was completely peanut-free due to the shared equipment also processing peanuts and

tree nuts, as well as the equipment collect peanut dust from the process. Sup. Nut had been using

a low-cost air blowing technique to make sure the shared manufacturing equipment didnt collect

peanut dust. Sup. Nut was aware that the superior practice would have been to warn customers of

the shared equipment. After the Newly Wed recall of their product in 2003, Sup. Nut had ceased

production of their toasted sesame seed product to save cost of have a production line solely for

sesame seeds (Newly Wed Foods v. Sup. Nut Co).

Instead of informing Newly Wed of the shared equipment when asked about the peanut

contamination, Sup. Nut decided to try and cover-up their poor manufacturing practices. Sup.

Nut denied any knowledge of the contamination and denied Newly Wed and access to their

manufacturing facilities (Newly Wed Foods v. Sup. Nut Co).

Newly Wed had destroyed the seventy-nine boxes of the contaminated sesame seeds; this

included the unused product sent back from Newly Weds customers and the 2,500 lbs. of sesame

seeds used in their own blends. They also destroyed all of the contaminated sesame seeds Newly

Wed also payed $392,411.92 to various customers of the Newly Wed as compensation for the

sesame seed recall. Newly Wed also declared that they had also incurred damages in the travel,

testing, and long-distance phone calls, relating to tracing the source of the peanut contamination

(Newly Wed Foods v. Sup. Nut Co).

LIABILITY OF FOOD MANUFACTURERS 10
Newly Wed sought double or triple to damages incurred by the fraudulent and deceptive

mislabeling practices and concealing information regarding the source of the peanut

contamination, as well as seeking damages for the attorney and court costs of the case from Sup.

Nut (Newly Wed Foods v. Sup. Nut Co).

The courts, after reviewing the evidence, found that Sup. Nut was in violation of Mass.

G. L. ch. 93A, section 2, and Newly Wed is also entitled to compensation under G.L.c. 93A,

section 11. Mass. G. L. ch. 93A, section 2 states that the willful deception of act or practices in

regards to commerce and trade is unlawful (M. G. L. ch. 93A section 2). Due to Sup. Nuts

deception and withholding of information from New Wed, Newly Wed is entitles to

compensation.

Any person who engages in the conduct of any trade or commerce and who suffers any

loss of money or property, real or personal, as a result of the use or employment by

another person who engages in any trade or commerce of an unfair method of

competition or an unfair or deceptive act or practice declared unlawful by section two . . .

may . . . bring an action in the superior court . . . for damages and such equitable relief,

including an injunction, as the court deems to be necessary and proper. -M. G. L. ch. 93A

section 11

Under the precedent set by this case, food manufacturers who fail to disclose the

information of possible cross-contamination by means of shared manufacturing equipment are

held liable for any loss of money or damages to any receiving part of the misbranded product. In

this case the manufacturer was required to pay for the loss of money and loss of product Newly

Wed had incurred.

Lindsey Bresnahan v. Jimmy Johns

LIABILITY OF FOOD MANUFACTURERS 11
Lindsey Bresnahan is a woman from Grand Rapids, MI, after going to a Jimmy Johns

and ordering a sandwich, letting the sandwich maker know of her allergy to dijon mustard, she

found out the sandwich had mustard on it. Bresnahan had an allergic reaction. After taking three

benadryl and calling the Jimmy Johns, she went on with her life. The doctor only told her to

keep taking benadryl to subside her symptoms. A long period of time passed were Bresnahan had

been coughing severely and vomiting frequently. After her symptoms of the reaction went away,

she was unable to talk anything louder than a whisper. Now she is suing Jimmy John's as a

company because her speaking impairment has caused her not to be able to work. The outcome

of this case will create a precedent that says that fast food manufacturers can be held liable for

damages in cases where they failed to accommodate for people with allergies (Jagar@mlive.com,

2016). The outcome of this case shows whether fast food franchises can be held liable when

given information of an allergy and not accommodating the sensitivity of the consumer.

United Kingdom

In the United Kingdom the government agency that regulates the labelling and the recall

of any foods is The Food Standards Agency (The Agency). The agency had created new laws

regarding the labelling of any allergenic materials present in packaged foods in 2014. With the

new laws, however, the companies supplying the packaged foods have a three year period where

the companies are able to make any adjustments necessary to accommodate for the changes in

the United Kingdoms policies (Food standards agency, n.d.).

The United Kingdom has fourteen different allergens that are recognized as the most

common allergies in the United Kingdom. All of the ingredients that are derived from these

allergens, and all of the processing aids that are from the fourteen allergens, must also be

labelled. A processing aid that needs to be labeled, for instance, is the use of wheat flour to help
LIABILITY OF FOOD MANUFACTURERS 12
roll-out a dough that is made of rye flour. The fourteen allergens that must be labelled in The

United Kingdom are, mollusks, lupin, nuts, eggs, fish, sulphur dioxide or any concentration of

sulphur that is more than 10 mg/kg, mustard, sesame seeds, celery, milk, soybeans, peanuts,

crustaceans, and any cereals that contain gluten (Food standards agency, n.d.).

In regards to the may contain advisory labels, the agency hasnt made any regulations

the require the food manufacturers to add the label in their ingredient lists. However, the same

issue is present in the United Kingdom as in the United States. Since the may contain warning

doesnt have any regulation, food manufacturers put the label on any product that have any risk,

whether micro or macro (Food standards agency, 2015).

When labelling allergens in products, the FSA, food Safety Administration, has broad

guidelines that food manufacturers have to follow. For instance, manufacturers do not have to

label the specific species of egg that is present in the product as the term egg encompasses all

of the eggs laid by the bird population. This includes, duck, chicken, gull, and guinea fowl. The

same goes for fish and crustaceans the terms for both of these allergens, fish and

crustaceans, includes all species of the allergen. However, if the allergens designated term in

part of a different word in the ingredient list, then the manufacturer has to distinguish the word

within the ingredient list by means of changing the font, for example, wheat flour is to be

changed to wheat flour. This causes the allergen to be emphasized and the consumer is able to

clearly see the allergen is present in the ingredient list (Food standards agency, 2015).

There are exceptions to when the allergens dont have to be labelled. Fish products dont

have to be labelled if the fish product was used as a fining agent in beer or wine. Soybean

products do not have to be disclosed on the nutrition label if the soybean product was used to

create an oil or fat product and the soybean material used was fully refined. Food manufacturers
LIABILITY OF FOOD MANUFACTURERS 13
are allowed to use icons or symbols in order to inform consumers of the presence of allergenic

material in a product; however, the icon must be accompanied with numbers and letters to ensure

all consumers understand. There is currently no set of icons that is cumulatively agreed upon in

Europe to indicate the presence of allergenic material in a product. The United Kingdom,

however, does not require that manufacturers put a list of allergens at the end of a list of

ingredients as the allergenic material in emphasized within the ingredient list itself (Food

standards agency, 2015).

Food Allergy Research and Education

The advocacy group FARE, Food Allergy Research and Education, is the large resource

for allergy research. This organization hires clinical researchers all over the world in order to

research how to prevent allergic reactions, understand why we develop food allergies, and

discover the effect having a food allergy has on someone both economically and psychosocially.

This organization sponsors a week-long event in order to educate and bring attention to the issue

of food allergies (FARE, 2016). The event that is sponsored by FARE is food allergy awareness

week; the overall theme for the 2016 food allergy awareness week is the Food allergies: React

with Respect. The organization encourages individuals to react with respect when they are

being told about someones allergic reactions (FARE, 2016). After being educated about the

epidemic of allergies, the population of non allergy sufferers will be more able to accommodate

for people who have allergies. The food allergen awareness week for 2017 has not yet been

released, but during the whole month of May the organization encourages people to do a task

everyday to help spread awareness for the epidemic (FARE, n.d.).

This organization has also partnered with the Discovery Channel to produce a

documentary film depicting the struggles of having a life-threatening allergy and how various
LIABILITY OF FOOD MANUFACTURERS 14
families take action to educate the people in their communities about the severity of allergies.

This documentary is narrated by Steve Carell and is entitled An Emerging Epidemic: Food

Allergies in America. During the production of the film, filmmakers interviewed various experts

in the field of food allergies (FARE, n.d.).

Conclusion

The lack of regulations regarding the use of the may contain allergen advisory warning

on the nutrition labels of manufactured products fails to protect consumer health as the advisory

warnings are widely overused and vague. In a University of Pennsylvania Law Review, Besnoff

discusses the use of the may contain advisory warning in regards to how manufacturers use this

warning to cut corners in production of products that are supposed to be allergen free (Besnoff,

2014). This is shown in the case of Newly Wed inc. v. Superior Nut Co., the supply of a toasted

sesame product instead of using good manufacturing practices and ensuring all shared equipment

is clean of any allergenic material before producing an allergen free product, Sup. Nut turned to a

cheaper option of only using a compressed air cleaner to ensure the build-up of any allergenic

dust was minimized. This cheaper option did not prove to be effective as the product supposed to

be allergen free contained fragments of allergenic material (Newly Wed Foods v. Sup. Nut Co).

As described in the Review written by Besnoff, the use of the may contain allergen

warning needs to be regulated by the FDA, furthermore, amendments to the Consumer

Protection and Allergen Labelling act should be made to give specific guidelines and/ or

requirements to food manufacturers on when the advisory warning is need and should be used.

With this amendment to the act, consumers with allergies can have more caution when deciding

to consume a product with the advisory warning on the nutrition label as the use of the advisory

warning will be reduced. With these amendments to the Food Allergy Act, the FDA will establish
LIABILITY OF FOOD MANUFACTURERS 15
threshold where the advisory warning is adequately used. Eventually, the current GMPs will be

amended to go towards the end goal of complete prevention of cross- contamination of allergen-

free products with any allergenic material at all.

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LIABILITY OF FOOD MANUFACTURERS 16
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LIABILITY OF FOOD MANUFACTURERS 19
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