Reducing the Risks
Food allergies can range from merely irritating to life-threatening.
Approximately 30,000 Americans go to the emergency room each year to
get treated for severe food allergies, according to the Food Allergy
and Anaphylaxis Network (FAAN). It is estimated that 150 to 200 Americans
die each year because of allergic reactions to food.
Food allergies affect about two percent of adults and four to
eight percent of children in the United States, and the number
of young people with food allergies has increased over the last decade,
according to a recent report by the Centers for Disease Control
and Prevention (CDC). Children with food allergies are more likely
to have asthma, eczema, and other types of allergies.
Some food allergies can be outgrown. Studies have shown that
the severity of food allergies can change throughout a person’s
“There is no cure for food allergies,” says Stefano Luccioli,
M.D., senior medical advisor in the Food and Drug Administration’s
(FDA) Office of Food Additive Safety (OFAS). “The best way for
consumers to protect themselves is by avoiding food items that will
cause a reaction.” OFAS is part of FDA’s Center for Food
Safety and Applied Nutrition (CFSAN).
To reduce the risks from allergic reactions, FDA is working to ensure
that major allergenic ingredients in food are accurately labeled in
accordance with the Food Allergen Labeling and Consumer Protection
Act of 2004 (FALCPA). Allergenic ingredients are substances that
are capable of causing an allergic reaction.
In addition, there has been widespread use of allergen advisory
labels on products that may have allergenic ingredients that were introduced
by way of cross contact during the manufacturing process. Cross contact
occurs when a residue or other trace amount of an allergenic food is
unintentionally incorporated into another food.
Because FALPCA does not require the declaration of allergenic ingredients
introduced through cross contact, FDA is developing a long-term
strategy that will help manufacturers use voluntary allergen advisory
Is not misleading
Conveys a clear and uniform message
Adequately informs food-allergic consumers and their caregivers
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What is a Food Allergy?
A food allergy is a specific type of adverse food reaction involving
the immune system. The body produces what is called an allergic, or
immunoglobulin E (IgE), antibody to a food. Once a specific food is
ingested and binds with the IgE antibody, an allergic response ensues.
A food allergy should not be confused with a food intolerance or other
nonallergic food reactions. Various epidemiological surveys have indicated
that almost 80 percent of people who are asked if they have a food
allergy respond that they do when, in fact, they do not have a true
IgE-mediated food allergy.
Food intolerance refers to an abnormal response to a food or
additive, but it differs from an allergy in that it does not involve
the immune system. For example, people who have recurring gastrointestinal
problems when they drink milk may say they have a milk allergy. But
they really may be lactose intolerant.
“One of the main differences between food allergies and food
intolerances is that food allergies can result in an immediate, life-threatening
response,” says Luccioli. “Thus, compared to food intolerances,
food allergic reactions pose a much greater health risk.”
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Signs and Symptoms
Symptoms of a food allergy usually develop within about an hour after
eating the offending food. The most common signs and symptoms of a
food allergy include:
Hives, itching, or skin rash
Swelling of the lips, face, tongue and throat, or other parts
of the body
Wheezing, nasal congestion, or trouble breathing
Abdominal pain, diarrhea, nausea, or vomiting
Dizziness, lightheadedness, or fainting
In a severe allergic reaction to food—called anaphylaxis—you
may have more extreme versions of the above reactions. Or you may experience
life-threatening signs and symptoms such as:
Swelling of the throat and air passages that makes
it difficult to breathe
Shock, with a severe drop in blood pressure
Rapid, irregular pulse
Loss of consciousness
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Major Food Allergens
FALCPA, a comprehensive food labeling law, has been in effect
since January 1, 2006.
Under FALCPA, food labels are required to state clearly whether the
food contains a major food allergen.
A major food allergen is defined as one of the following foods or
food groups, or is an ingredient that contains protein derived
from one of the following foods or food groups:
Tree nuts such as almonds, walnuts, and pecans
Shellfish such as crab, lobster, and shrimp
“These foods or food groups account for 90 percent of all food
allergies in the United States, and FALCPA focuses on IgE-related food
allergies,” according to Luccioli. “This law does not protect
everyone with a food allergy, but should protect the majority of people
who may have severe allergic responses to foods,” he says.
More than 160 different foods have been reported to cause allergies;
the list of major allergens in the United States is limited to eight
foods. “Other countries may have different foods on their lists
because food allergies reflect patterns of consumption,” Luccioli
says. “For example, in Europe there is a high prevalence of allergies
to mustard and celery.”
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FDA Public Hearing on Labeling
FDA held a public hearing on September 16, 2008, to help the
agency determine how manufacturers use advisory labeling for food allergens.
FDA is also evaluating how consumers interpret different advisory
labeling statements, as well as what wording is likely to be most effective
in communicating the likelihood that an allergen may be present in
“The public hearing was held in part to address labeling that
manufacturers voluntarily use because of cross contact concerns,” says
Felicia Billingslea, director of the Food Labeling and Standards
Staff in FDA’s Office of Nutrition, Labeling and Dietary Supplements.
Cross contact may occur during:
Many food manufacturers may try to prevent cross contact through the
use of dedicated facilities or dedicated production lines. Also, a
variety of advisory statements are used on package labels to indicate
possible cross contact. For example, a label might indicate: “Produced
in a plant that processes wheat.”
FDA asked twelve questions at the public hearing that related to the
use of specific advisory statements and advisory labeling in general.
Some of the questions asked were:
What specific advisory statements adequately inform consumers
of the potential risk of cross contact with allergenic materials?
What advisory statements most accurately communicate to consumers
and their caregivers the potential risk of the presence of an allergen? Why?
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Advice for Consumers
If you have food allergies, you must be prepared for unintentional
exposures. To protect yourself, the National Institute of Allergies
and Infectious Diseases (NIAID) recommends that you:
Wear a medical alert bracelet or necklace stating that you
have a food allergy and are subject to severe reactions.
Carry an auto-injector device containing epinephrine (adrenaline)
that you can get by prescription and give to yourself if you think
you are experiencing a food allergic reaction.
Seek medical help immediately if you experience a food allergic reaction,
even if you have already given yourself epinephrine, either by calling 911
or getting transportation to an emergency room.
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For More Information
CFSAN Food Labeling and Nutrition page
CFSAN Information About Food Allergies
The Food Allergy and Anaphylaxis Network
CDC Press Release: Study on Food Allergies in Children
Date Posted: January 23, 2009