Order Code RS20975
Updated September 19, 2005
CRS Report for Congress
Received through the CRS Web
Food Labeling: Allergy Information
Donna V. Porter
Specialist in Life Sciences
Domestic Social Policy Division
Summary
Media attention to food allergies is the result of the recent tracking of food allergy
sufferers and a clear rise in the number of affected individuals. Several efforts are
underway to improve the ability of individuals who have a food allergy to avoid
products that cause symptoms that can range from mild to serious. The Food and Drug
Administration (FDA) and the Food Allergy Issues Alliance each have released
guidelines to address the issues of labeling and cross-contamination. Nine state
attorneys general have petitioned FDA for stricter rules, which are also supported by
some consumer groups. The FY2002 agriculture appropriations bill directed FDA to
address and report on cross-contamination; however, this report had not yet been
submitted. Most recently, the Food Allergen Labeling and Consumer Protection Act of
2004 (P.L. 108-282) was enacted on August 2, 2004. This report will provide
background on food allergies and review efforts to provide improved labeling
information for food allergy sufferers; it will be updated to reflect legislative or other
activity.
Background
The media attention to the reported incidence of food allergies and a number of fatal
reactions seems to be the result of recent government tracking of the incidence of this
health problem as well as a recognized increase in the number of cases.1 The most
common food allergies are caused by milk, tree nuts, fish, shellfish, soy, eggs, peanuts
and wheat. These foods account for about 90% of all food allergies. Food allergies are
estimated to affect about 4 million individuals in the United States. Sensitive individuals
can develop a range of symptoms that can be mild or life-threatening allergic reactions,
if exposed to a causative allergen. There is no known cure for food allergies and they can
only be managed by avoiding foods containing the known allergens. Recent research
1 S. Dominus, The Allergy Prison New York Times Magazine, Section 6, June 10, 2001, p. 62.
Congressional Research Service ˜ The Library of Congress

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suggests that a monoclonal antibody being studied may provide short-term protection
against most unintended ingestion of peanuts.2
A number of different conditions tend to fall under the heading of food allergies in
the common vernacular. In most cases, the term “allergy” is used to describe the reaction
to a food ingredient that causes a sensitivity response in the person who consumed it. A
classic allergy occurs when the body’s immune system mistakes a harmless food protein
(amino acid sequence) for a virus or bacterium. Antibodies attach themselves to the food
molecule which then signal other immune cells to attack by releasing histamines or other
destructive chemicals. The body’s attempt to rid itself of this “foreign substance” can
produce various symptoms, including skin rash, nausea, vomiting, diarrhea, intestinal
cramps and spasm, headache or migraine, and swelling in various parts of the body.
A small percentage of food-allergic individuals experience severe reactions, called
anaphylaxis. Anaphylactic shock is a relatively rare, but severe and potentially life-
threatening, allergic reaction resulting in swelling of the throat and air passage
constrictions. Symptoms usually appear within minutes of exposure to the allergen and
immediate medical attention is necessary. This reaction requires the intravenous
administration of epinephrine (adrenaline) to open the airways, and close medical
followup. An estimated 150 Americans die each year from severe allergic reactions to
food, such as the reaction to peanuts.
There are several adverse reactions to foods that involve the body’s metabolism, but
not the immune system, and therefore, the sensitivity is not a true allergy. Food
intolerance occurs when the body is unable to metabolize certain foods because of food
poisoning or the inability to digest certain food components, such as lactose (milk sugar),
usually due to a lack of a particular enzyme. Food aversion is a dislike and avoidance of
a food or foods for purely psychological reasons, usually due to an association of that
food with a traumatic event or an eating disorder. Food addiction involves the body
craving one particular food and suffering withdrawal symptoms when it is removed from
the diet. For general sensitivity, the cause is usually unknown, but chemical additives or
pesticide residues may be a factor.
FDA Activities
FDA issued an Allergy Warning Letter in June 1996,3 which sought to alert food
manufacturers to the agency’s concerns about the labeling of foods that contain allergenic
substances. The letter followed numerous reports to FDA concerning consumers who had
experienced adverse reactions after exposure to an allergenic substance in a food that did
not declare the allergen in the food labeling. While the Food, Drug and Cosmetic Act
(FDCA) requires, in virtually all cases, a complete listing of all ingredients of a food, two
narrow exemptions appear to provide the reason for recent allergic incidents. The first
exemption provides for spices, flavorings and colorings to be declared collectively,
2 D. Leung, et al., Effect of Anti-IgE Therapy in Patients with Peanut Allergy, New England
Journal of Medicine, vol. 348, no. 11, Mar. 13, 2003, pp. 986-993.
3 U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, FDA
Allergy Warning Letter: Label Declaration of Allergenic Substances in Foods, from Fred Shank,
June 10, 1996, p. 3.

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without naming each one present. The second exemption from ingredient declarations
concerns incidental additives, such as processing aids, that are present in insignificant
amounts and do not provide a technical or functional effect in the finished food. For the
allergic individual, knowledge that a specific allergenic spice, flavoring or color or
incidental additive, even in insignificant amounts, is present, may be very important in
avoiding these foods.
In the spring of 2000, FDA received a petition from attorneys general in nine states
requesting that the agency issue new labeling regulations for food allergens.4 The petition
requested that a symbol (such as the letter A in a circle) be created and prominently
displayed on the upper right corner of food packages, a toll-free hotline be set up for
reliable food ingredient information, food labels be required to specify when allergen
ingredients were known to be used, and food industry guidelines be established to prevent
cross-contamination. Allergenic ingredients can be inadvertently introduced into a food
through “cross-contamination,” which is the migration of such substances from
equipment and utensils resulting in an allergenic food. FDA has yet to respond to this
petition in the form of regulations.
In April 2001, FDA released its most recent voluntary guidance on this issue, which
is the compliance policy guide entitled Statement of Policy for Labeling and Preventing
Cross-contact of Common Food Allergens.5 The FDA guide recommends complete
listing of direct addition of an allergenic ingredient (or sub-ingredient), no ingredient
labeling exemptions for incidental additives known to be allergens, and sanitary practices
to prevent potential allergen cross-contact. The compliance policy guidance also contains
regulatory action criteria for determining when product seizure and legal action are
necessary, because of mislabeling or adulteration of the product containing a known food
allergen.
FDA announced plans to conduct inspections of plants to assure that allergenic
ingredients are not becoming part of the food and candy inadvertently through cross-
contamination.6 The agency stated in 2001 that it would inspect thousands of candy
makers, bakeries and other food manufacturers over the next two years. Candy is a
particular problem because of the frequent use of nuts and peanut oil in some products
and not in others, but cross-contamination occurs due to residues left after inadequate
cleaning of assembly line equipment.
The agency convened a public meeting on August 13, 2001 to discuss the labeling
of foods containing allergens and the inadvertent addition of allergens due to processing
4 Citizen Petition to the Food and Drug Administration, at [http://www.oag.state.ny.us/press/
2000/may/may26a_attach_00.html].
5 Food and Drug Administration, Compliance Policy Guide, Compliance Policy Guidance for
FDA Staff, Notice to Manufacturers on Policy for Labeling and Preventing Cross-Contact of
Common Allergens, at [http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm].
6 FDA to continue allergen inspections, Food Chemical News, vol. 43, no. 18, June 18, 2001, pp.
27-28.

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practices.7 The session focused on whether the source of the ingredient or plain English
labeling should be used, the need for supplemental labeling (such as “may contain”), and
labeling of ingredients exempted from declaration, such as common or usual names of
flavorings, colors and spices. A subsequent workshop on food labeling and allergen
declaration was convened in January 2002 in Kansas City at the request of the State of
Missouri to address these issues and the particular impact on small business and startups.8
In July 2004 FDA announced plans to propose rules by the end of 2004 to require
companies to clearly label the color additives carmine and cochineal extract when used
in food products, because they can illicit the same symptoms as the other known food
allergens. On August 19, 2005, FDA convened a public meeting to obtain comments on
defining and permitting voluntary use on food labeling of the term ‘gluten-free’.9 The
meeting focused on food manufacturing, analytical methods and consumer issues related
to reduced levels of gluten in food. No further regulatory action has been taken on either
issue.
Voluntary Guidelines
In May 2001 the Food Allergy Issues Alliance submitted to FDA a consensus
document entitled Food Allergen Labeling Guidelines.10 The Alliance is a group of food
trade associations and other interested organizations that convene to discuss allergy
issues. The Guidelines are intended to assist food manufacturers to inform food allergic
consumers about the presence of the eight major food allergens in their products in
consumer-friendly terms. These terms would be listed on the information panel of food
products separate from the ingredient declaration. The Alliance seeks FDA clarification
through appropriate guidance that presentation of this information would not be
considered mislabeling. The Guidelines are presented as an option that would not require
new regulations.
The Food Allergen Labeling Guidelines contain four parts. They identify the eight
types of allergens that are estimated to cause more than 90% of all food reactions (see
listing on page 1). The Guidelines specify the use of ingredient terms commonly
understood by consumers so that the words eggs, fish, milk, peanuts, shrimp, soy, walnut
or wheat would be disclosed following the label declaration. Product labels complying
with these Guidelines would contain a label declaration of a major food allergen, by
highlighting its presence in one of several ways (specific statement, asterisk,
parenthetical, naming or bolding). Supplemental allergen statements would be used in
rare cases where the inadvertent and uncontrollable contact with a major food allergen
7 U.S. Food and Drug Administration, Food Safety and Food Labeling: Presence and Labeling
of Allergens in Foods, Announcement of Public Meeting, Federal Register, vol. 66, no. 143, July
25, 2001, p. 38572.
8 U.S. Food and Drug Administration, FDA Food Labeling and Allergen Declaration; Notice of
Public Workshop, Federal Register, vol. 66, no. 246, Dec. 21, 2001, p. 65976.
9 U.S. Food and Drug Administration, Food Labeling; Gluten-Free Labeling of Foods; Public
Meeting; Request for Comments, Federal Register, vol. 70, no. 137, July 19, 2005, p. 41356.
10 Food Allergy Issues Alliance, Food Allergen Labeling Guidelines, May 22, 2001, p. 6.

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occurs, although the Guidelines indicate that these statements are not a substitute for good
manufacturing practices.
Legislation
In recent Congresses, constituent mail has generated concern about the food allergy
labeling issue. Several transportation funding bills have contained provisions that would
limit the availability of peanut snacks on airplane flights. However, none of these
provisions have ever passed in the final appropriations bills. Several resolutions have
been introduced in past years that would direct the Department of Transportation to
rescind an earlier DOT directive to establish peanut-free zones on airplane flights when
the problem of allergic reactions to air travel peanut snacks first began to occur.
On June 13, 2001, the House Committee on Appropriations adopted an amendment
encouraging FDA to promulgate regulations to prevent cross-contamination of foods by
undeclared allergens. The Committee adopted the amendment offered by Representative
Lowey during its consideration of the FY2002 appropriations bill for the Department of
Agriculture and FDA (P.L. 107-76). The amendment also required FDA to report to the
Committee by March 1, 2002 on its plans for preventing cross-contamination of foods by
undeclared allergens. However, FDA’s two-year inspection survey of manufacturing
operations, which started in 2001, was to provide the data for this report, which the
agency anticipated delivering by the end of 2003. Thus far, this report has not been
submitted.
Bills were introduced in the last three Congresses to require the labeling of food
products to provide specific information on known allergens. Most recently, the Food
Allergen Labeling and Consumer Protection Act of 2004 was introduced as companion
bills, S. 741 and H.R. 3684, by Senator Sessions and Representative Lowey and enacted
as P.L.108-282 on August 2, 2004. The new law requires that food labeling list in
common language any of the eight known food allergens and their food source contained
in a product. The labeling requirements apply to raw agricultural commodities, spices,
flavorings, colorings, and incidental additives, if food allergens are present. The law also
specifies two format options for allergen information to appear on products, and provides
for civil penalties for noncompliance after the effective date of January 1, 2006. The
legislation requires the Secretary to issue a report to Congress within 18 months of
enactment about food allergen cross-contact, advisory labeling and food allergen
inspections conducted under this authority. The Secretary is to issue a proposed rule,
within two years and a final rule within four years, that defines the term gluten-free for
voluntary use in food labeling. The Centers for Disease Control and Prevention will be
required to establish a system for tracking food-allergic-related deaths and other clinically
significant and serious adverse events. The National Institutes of Health is directed to
convene an expert panel to develop recommendations for research activities concerning
food allergens within a year. The Secretary is directed to pursue revision of the Food
Code to provide guidelines for preparing allergen-free foods in food establishments and
provide technical assistance relating to emergency treatment of allergic responses to
foods.

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Observations on Food Allergy Labeling
For food allergy sufferers, providing ingredient information that will facilitate their
selection of foods that do not contain allergens will be useful. Easy identification, by use
of a well-recognized symbol and/or specific terms or phrases on packages, frequently
suggested in the past, is now mandated under the new law. The requirements for full
listing of all known allergenic ingredients, without exceptions for spices, flavoring and
colors, the adoption of good manufacturing practices that eliminate the cross-
contamination of food products, and identification of incidental additives are several
mechanisms that had been sought by various proponents of food allergy labeling. Also
suggested have been the elimination of peanut snacks on airlines and peanut butter in
school/child care settings. The recent tracking of the incidence and severity of food
allergies in some individuals led to increased support for additional labeling information
on food packages, since the number of affected individuals seems to have increased.
However, alternative options and additional issues may be raised. Consumer
education on the terms, technical or not, and symbols that assist in identifying
ingredients that individuals wish to avoid may be necessary to alert food allergy sufferers
of the presence of potential allergens. The separate listing of potential allergens, while
easily identifiable, may create space and printing size problems on small food packages.
Many food allergy reactions occur in situations outside of individuals’ homes where label
information is not available. The law has addressed this situation by requiring revision
of the food code for restaurants, schools, day care, summer camps, grocery store
delicatessens and bakeries. In the early 1990s, when sulfites in salad bars were a
problem, restaurants used posted signs to alert consumers. Some child care centers and
schools have considered an outright ban on peanut butter in their facilities. While this
solution appears easy on the surface, it assumes 100% compliance and could create a
more hazardous situation, if no one is prepared and trained to assist a child when
someone unwittingly sends a peanut butter sandwich to school. Someone could be
designated as the individual in a particular school to be prepared to administer injections
of epinephrine to a child who has a reaction. However, this decision would be made
within local school districts, along with consideration of training and liability.
A recent concern related to food allergy has been development of genetically
modified foods and the potential for certain genes to cause food allergies when inserted
into other plants and animals. There has been no evidence to date that this technology
has resulted in any allergenic problems. Use of these foods will continue to be closely
monitored by the federal agencies and outside groups with interest in food allergy
problems. FDA’s policy continues to be that the presence of any known allergen needs
to be labeled. On the other hand, genetically modified foods may hold the potential to
eliminate food allergies by removing the allergenic gene from plants or animal products
that otherwise need to be avoided by individuals who are allergic to a particular food.
Congressional interest in this issue is likely to continue, with the reports required to
be prepared for its use by FDA on regulating the labeling of food allergens, CDC data
collection on the food-related allergic response and NIH on research needs. Completion
of the reports may become the issue, as the FDA cross-contamination report requested
in the FY2002 agriculture appropriation by March 1, 2002 has not yet been transmitted.
Future attention will likely be through oversight of the new law’s impact on addressing
the problems of consumers with allergic reactions to certain food constituents.

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