19–010

Calendar No. 739

107TH CONGRESS REPORT " SENATE ! 2nd Session 107–322

FOOD ALLERGEN LABELING AND CONSUMER PROTECTION 

ACT

OCTOBER 17, 2002.—Ordered to be printed 

Mr. KENNEDY, from the Committee on Health, Education, Labor, 

and Pensions, submitted the following 

R E P O R T

[To accompany S. 2499]

The Committee on Health, Education, Labor, and Pensions, to 

which was referred the bill (S. 2499) to establish labeling requirements regarding allergenic substances in food, and for other purposes, reports favorably thereon with an amendment and recommends that the bill (as amended) do pass.

CONTENTS

Page 

I. Purpose and Summary of the Bill ................................................................

II. Background and Need for the Legislation ...................................................

III. Legislative History and Committee Action ..................................................

IV. Explanation of the Legislation and Committee Views ...............................

V. Cost Estimate .................................................................................................

VI. Application of Law to the Legislative Branch .............................................

VII. Regulatory Impact Statement .......................................................................

VIII. Section-By-Section Analysis ..........................................................................

IX. Changes in Existing Law ..............................................................................

I. PURPOSE AND SUMMARY OF THE BILL

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires, 

with some exceptions, a complete listing of all the ingredients in 

a food on the food label. Currently, the FFDCA does not require the 

eight major food allergens to be identified, using plain English, on 

the food label when ingredients contain allergenic substances. The 

names of many ingredients do not clearly identify in plain English 

that the ingredient is the source of an allergen. 

There are also two exemptions from the requirement that each 

ingredient be listed in the food ingredient label. One exemption alVerDate 0ct 09 2002 05:37 Oct 19, 2002 Jkt 019010 PO 00000 Frm 00001 Fmt 6659 Sfmt 6602 E:\HR\OC\SR322.XXX SR322
2

lows for collective naming of flavors, certain colors, and spices. 

These terms are not completely descriptive, however; in particular, 

they do not identify if any components of the flavors, colors, and 

spices are allergens. Under the second exemption, incidental additives, which are food substances that are used in insignificant 

amounts and that do not have any technical or functional affect in 

the food, need not be identified in the food label. Although additives that contain a major food allergen are not considered to be 

incidental, these ingredients are nonetheless sometimes inadvertently left off of the food label. 

Food allergens also may inadvertently find their way into a food 

because of a firm’s production practices; for example, rework addition, product carryover due to use of common equipment or production scheduling. Such practices present an unintentional opportunity for a product that contains an allergen to come into crosscontact with a product that does not intentionally contain that particular allergen. Some food manufacturers have added statements, 

such as ‘‘May contain (allergic ingredient),’’ to their product labels 

to alert consumers to the possibility that the product may contain 

an allergic substance. 

The term ‘‘gluten-free’’ has not been defined by regulation. Persons with celiac disease must avoid certain types of gluten in foods 

associated with celiac disease. When gluten from certain cereal 

grains is ingested by individuals with celiac disease, damage to the 

gastrointestinal tract, central nervous system, and other organs 

may occur over time. Allowing the term ‘‘gluten-free’’ on food labels 

will assist consumers who have celiac disease avoid gluten. 

The committee has approved this legislation to address these and 

other issues related to food allergens and glutens in foods that are 

associated with celiac disease. 

1. THE LEGISLATION REQUIRES PLAIN ENGLISH INGREDIENT LABELING

OF THE EIGHT MAJOR FOOD ALLERGENS

The legislation amends the FFDCA to require that food ingredient statements identify in plain English when the food contains 

a major food allergen. The legislation also provides that food ingredient statements will identify when a food allergen is contained in 

spices, flavorings, colorings, and incidental additives. 

2. THE LEGISLATION PROVIDES FOR A REPORT ON FOOD ALLERGEN

CROSS-CONTACT AND ADVISORY LABELING AND FOR BIENNIAL REPORTS ON FOOD ALLERGEN INSPECTIONS

The legislation requires the Secretary of Health and Human 

Services (Secretary) to issue a report to Congress about food allergen cross contact and advisory labeling. The legislation also requires the Secretary to give priority to increasing the number of 

food allergen inspections and it requires biennial reports to Congress about such inspections. 

3. THE LEGISLATION PROVIDES FOR ENHANCED SURVEILLANCE AND

FOR A RESEARCH PLAN RELATING TO FOOD ALLERGENS

The legislation requires the Centers for Disease Control and Prevention (CDC) to track food-allergic-related deaths and other clinically significant and serious adverse events. It also directs the NaVerDate 0ct 09 2002 05:37 Oct 19, 2002 Jkt 019010 PO 00000 Frm 00002 Fmt 6659 Sfmt 6602 E:\HR\OC\SR322.XXX SR322
3

tional Institutes of Health (NIH) to convene a panel of experts to 

develop a plan for research activities concerning food allergies. 

4. THE LEGISLATION PROVIDES THAT THE FOOD CODE ADDRESS FOOD

ALLERGENS AND FOR TECHNICAL ASSISTANCE TO STATES REGARDING EMERGENCY TREATMENT OF ALLERGIC RESPONSES TO FOOD

The legislation directs the Secretary to pursue revision of the 

Food Code to provide guidelines for preparing allergen-free foods in 

food establishments. It also directs the Secretary to provide technical assistance relating to emergency treatment of allergic responses to foods. 

5. THE LEGISLATION PROVIDES FOR VOLUNTARY ‘‘GLUTEN-FREE’’ LABELING AND TWO REPORTS ON CELIAC DISEASE AND LABELING OF

GLUTENS IN FOODS ASSOCIATED WITH CELIAC DISEASE

The legislation requires the Secretary to contract with the Institute of Medicine to provide a report to Congress and the Secretary 

about the glutens in foods that are associated with celiac disease. 

The legislation requires the Secretary to define the term ‘‘glutenfree’’ for voluntary use in food labeling. In addition, the legislation 

requires the Secretary to submit a report to Congress about the labeling of gluten in foods that are associated with celiac disease. 

II. BACKGROUND AND NEED FOR THE LEGISLATION

Seven million Americans suffer from food allergies, approximately 2 percent of adults and 5 percent of infants and young children. Recent studies estimate that 150 Americans die each year 

and that 30,000 individuals require emergency room treatment because of allergic responses to food. Eight major foods or food 

groups—milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, 

wheat, and soybeans—account for 90 percent of food allergies. 

There is currently no cure for food allergies. Instead, people with 

a food allergy must avoid the food to which they are allergic. 

To avoid an allergen, food-allergic consumers must carefully read 

the labels for every food product they consume. This task is complicated because the names of many ingredients do not clearly 

identify that they are derived from an allergen. Currently, ingredients that may cause allergic reactions are listed on food labels 

using terms that do not identify the allergen in plain English. For 

example, whey and casein are foods derived from milk that cause 

allergic reactions in those allergic to milk. Currently, whey and casein are required to be identified in the food ingredient list only as 

whey and casein, however. A recent study showed that many parents of children with food allergy were unable to identify correctly 

several ingredients derived from major food allergens in each of 

several food labels. Use of plain English in food labels to identify 

the presence of the eight major food allergens will make the food 

label much more useful to consumers with food allergies. 

In addition, currently spices, flavorings, and certain colorings 

and incidental additives are exempt from ingredient labeling requirements and need only be identified collectively as spices or 

flavorings, for example. Because some of these ingredients contain 

allergens, this exemption can pose a health threat to susceptible 

consumers, even though spices, flavorings, colorings, and incidental 

4

additives are generally present in foods in only small quantities. 

Requiring the use of plain English to identify the presence of the 

eight major food allergens used in spices, flavors, and certain colors 

and incidental additives will also make the food label more useful 

to allergic consumers. 

Food allergens sometimes inadvertently find their way into a 

food because of a firm’s production practices; for example, rework 

addition, product carryover due to use of common equipment or 

production scheduling. Such practices present an unintentional opportunity for a product that contains an allergen to come into 

cross-contact with a product that does not intentionally contain 

that particular allergen. This problem of unintentional ‘‘cross-contact’’ deserves study and further action by both FDA and the food 

industry. 

Although FDA and the industry must identify and implement 

practicable steps to eliminating the possibility of cross-contact, it 

may be that, in some instances, even such procedures will not be 

sufficient to eliminate the presence of an allergen. In such instances, it will be appropriate for food manufacturers to use advisory labeling (such as ‘‘may contain’’) to indicate the possible presence of food allergens in a food product. Many food manufacturers 

currently use such advisory language. Many do so appropriately, 

given the current state of knowledge about processes and technologies to reduce cross-contact. Yet there is concern among the 

food allergenic community that some members of the food industry 

use advisory labeling inappropriately, or not at all when they 

should. FDA and the food industry should carefully consider the 

use of advisory labeling, which can save the life of a consumer 

when it is appropriately used. 

Although several studies have provided estimates, the prevalence 

of food allergies is uncertain. Currently, the CDC does not sufficiently track data on the prevalence of food allergies, incidence of 

clinically significant and serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses to foods. The CDC should improve the collection of this information to better determine the national significance of food allergies. 

Research on food allergies is being conducted by public and private organizations. The NIH should conduct a comprehensive review of completed and ongoing studies on food allergies. Based on 

their findings, NIH should make recommendations identifying clinical research that should be conducted. 

Numerous food establishments, including restaurants, grocery 

store delicatessens and bakeries, and school cafeterias are working 

to better serve those consumers with food allergies. Private guidelines demonstrating and recommending ways to prepare allergenfree foods have helped to educate such food establishments. Revision of the Food Code to include similar recommendations, however, will help to better alert the food establishments to the problem food allergies pose to public health and make the distribution 

of such information more widespread. 

Not all States and localities provide emergency medical technicians with adequate training to treat successfully a patient undergoing a food allergic response. The government should provide techVerDate 0ct 09 2002 05:37 Oct 19, 2002 Jkt 019010 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\SR322.XXX SR322
5

nical assistance to such States and localities to enhance their preparedness to address emergencies caused by food allergens. 

Celiac disease is an immune-mediated disease. When gluten from 

certain cereal grains is ingested by individuals with celiac disease, 

damage to the gastrointestinal tract, central nervous system, and 

other organs may occur over time. The response to glutens by those 

with celiac disease is not an allergic response. A multicenter, 

multiyear study estimated the prevalence of celiac disease in the 

United States to be 0.5 to 1 percent of the general population. The 

current recommended treatment is avoidance of glutens in foods 

that are associated with celiac disease. Allowing a clearly defined 

‘‘gluten-free’’ claim to appear on the labels of food products will assist individuals with celiac disease to avoid the glutens associated 

with the disease. 

III. LEGISLATIVE HISTORY AND COMMITTEE ACTION

On May 9, 2002, Senator Kennedy, for himself and Senator Clinton, introduced S. 2499, to amend the FFDCA to require plain 

English labeling of the eight major food allergens in food ingredient 

labeling. 

On September 25, 2002, the committee held an executive session 

to consider S. 2499. Senator Kennedy, for himself and Senators 

Gregg, Clinton, Roberts, and Frist, offered a substitute amendment 

as modified that was considered as original text by the committee. 

The committee approved S. 2499, as amended, by unanimous voice 

vote. 

IV. EXPLANATION OF THE LEGISLATION AND COMMITTEE VIEWS

Requirement of Plain English Labeling of the Eight Major Food Allergens 

The legislation amends section 201 of the FFDCA to define the 

term ‘‘major food allergen.’’ It is defined to mean the eight most 

significant food allergens—milk, egg, fish (e.g., bass, flounder, or 

tuna), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts 

(e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans—

and any proteinaceous substance derived from one of these eight 

food allergens, unless the Secretary determines that the substance 

does not cause an allergic response that poses a risk to human 

health. Fish, Crustacean shellfish, and tree nuts are collective 

names that include a variety of different items. For example, the 

term ‘‘tree nuts’’ refers to a variety of individual nuts, including almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts. Similarly, 

the term ‘‘Crustacean shellfish’’ refers to crabs, crawfish/crayfish, 

lobster, prawns, and shrimp. The term ‘‘fish’’ refers to a variety of 

different fish. The committee intends that the Secretary will provide guidance to industry on the information that would be useful 

for making a determination that a proteinaceous substance derived 

from one of the eight major food allergens does not cause an allergic response that poses a risk to human health. The committee also 

intends that the Secretary provide an appropriate process for providing such information to the Secretary that minimizes the burden 

on the food manufacturer. 

6

The legislation also amends section 403 of the FFDCA to provide 

two new misbranding provisions. The first of these, section 403(t), 

requires that the eight major food allergens be labeled on foods 

that are not raw agricultural products. Under section 403(t), manufacturers will have two options as to how they must label the eight 

major food allergens on such foods. Under either plain English allergen labeling option, the term for a major food allergen—milk, 

egg, wheat, peanuts, soybeans, or, in the case of the collective 

terms ‘‘fish,’’ ‘‘Crustacean shellfish,’’ or ‘‘tree nuts,’’ the common or 

usual name for the relevant specific members of the class, such as 

‘‘tuna,’’ ‘‘shrimp,’’ or ‘‘almond’’—will appear in the food label if the 

food is, or intentionally bears or contains, a major food allergen as 

defined in section 201(ll). These plain English allergen labeling requirements apply only to foods for which an ingredient list is required in a label or labeling under the FFDCA. 

Manufacturers may choose to summarize the allergen information using the terms for the major food allergens from which any 

ingredients in the food are derived in a statement at the end of, 

or immediately adjacent to, the ingredient list. This information 

must appear in a type size no smaller than the type size used in 

the ingredient list. 

Alternatively, manufacturers may place the term for the appropriate major food allergen in parentheses within the ingredient list 

after the common or usual name of the ingredient derived from 

that major food allergen. There are two exceptions to this requirement. First, the listing of the term for the food allergen is not required to appear in parentheses after an ingredient name if the ingredient name uses the term for the major food allergen (for example, ‘‘milk’’ need not appear in parentheses after ‘‘milk’’ or ‘‘milk byproduct,’’ nor need ‘‘almond’’ appear after ‘‘almond’’). Second, the 

term for a food allergen need not be placed after an ingredient if 

the term for that food allergen appears elsewhere in the ingredient 

list; the food allergen term need only appear once in the ingredient 

statement. 

These two options can be illustrated by an example. If a food 

were to have as ingredients semolina, rice flour, rolled oats, pine 

nuts, tomato juice, whey, sodium caseinate, and natural flavoring, 

with the natural flavoring including peanuts as a constituent, the 

major food allergens in the food could be labeled in two ways. First, 

the following statement could appear at the end of, or immediately 

adjacent to, the list of ingredients: ‘‘Contains wheat, milk, pine 

nuts, and peanuts.’’ Second, the ingredient list could read: ‘‘Ingredients: semolina (wheat), rice flour, rolled oats, pine nuts, tomato 

juice, whey (milk), sodium caseinate, and natural flavoring (peanuts).’’

These two examples illustrate several aspects of the allergen labeling requirements. In the second example, ‘‘milk’’ does not appear 

in parentheses after ‘‘sodium caseinate’’ because it has already appeared after ‘‘whey.’’ In the examples, the natural flavoring includes peanuts as a constituent and so peanuts is labeled as an allergen in the food. In other words, the food allergen labeling requirement applies to spices, flavorings, colorings, and incidental additives. Only the peanut constituent of the natural flavoring ingredient is identified, however; the other constituents of the flavoring—or indeed of any spice, coloring, or incidental additive—are 

7

not required to be listed under either plain English labeling option 

permitted under the legislation. 

The term ‘‘pine nuts’’ is in the summary of allergy information 

in the first example, but it need not appear after ‘‘pine nut’’ in the 

ingredient list in the second example because the repetition is unnecessary. The first example illustrates the committee’s intent that 

the term for the relevant specific member of the class ‘‘fish’’ or ‘‘Crustacean shellfish’’ or ‘‘tree nuts’’ is required to be used whenever an ingredient is, or is derived from, an example from one of 

these food categories. The second example illustrates the committee’s intent that an ingredient whose common or usual name uses 

the term for the major food allergen—in the example, ‘‘pine nuts’’ clearly uses the term for pine nuts—need not be followed by a parenthetical repeating the term. Finally, all major food allergens are 

required to be labeled consistently: either in the summary of allergen information at the end of, or immediately adjacent to, the ingredient list, or using parentheses after ingredients. 

The committee intends that the use of the term ‘‘milk’’ in either 

of these examples does not violate the standard of identity for milk 

established under FDA regulations. Used in this context, the term 

‘‘milk’’ is used to identify a major food allergen and not the identity 

of the ingredient or the food. 

The legislation gives FDA the authority to modify or eliminate 

these requirements by regulation. This authority is limited in a few 

respects, however. First, FDA may modify one or both labeling options. Second, FDA may not eliminate all major food allergen labeling by eliminating both labeling options; rather, FDA may eliminate only one of the approaches. Third, and most significantly, 

FDA must demonstrate in the regulation that modification or elimination of an allergen labeling requirement is necessary to protect 

public health. The committee considers this standard to impose a 

high burden on the Secretary to justify changing these requirements of the legislation. 

Section 403(t) is limited to foods that are not raw agricultural 

products. Accordingly, this legislation does not change the applicability of current misbranding and adulteration provisions to foods 

that are raw agricultural products. In particular, raw agricultural 

products into which major food allergens have been introduced by 

any means would be considered to be misbranded by FDA if not appropriately labeled under sections 201(n) and 403(a)(1) of the 

FFDCA, and even so may be considered to be adulterated by FDA 

under section 402(a)(1). 

In addition, the legislation amends section 403A of the FFDCA 

to give the modification to the ingredient label required by section 

403(t) the same preemptive effect over State and local ingredient 

labeling that the current ingredient labeling has. 

The labeling requirements of section 403(t) become effective for 

foods labeled on or after January 1, 2006. This effective date gives 

the food industry time to provide this essential public health information on the labels of their foods. Importantly, this requirement 

does not require the relabeling of food products that are in the 

marketplace before the effective date. In other words, this legislation does not require food products to be pulled from the marketplace and relabeled in conformance with the requirements of this 

legislation if they were labeled before January 1, 2006. 

8

The committee understands that many foods are already labeled 

in conformity with one of the plain English allergen labeling options, and it expects that most foods will be labeled in compliance 

with these requirements before January 1, 2006. In any case, all 

foods that intentionally bear or contain major food allergens must 

be labeled by January 1, 2006. This fixed date by which all affected 

foods must be relabeled will give consumers greater certainty that 

they will be able to rely on food labels as of that date. 

The committee intends the requirements of section 403(t) to be 

self-implementing. FDA will not be required, nor is it necessary for 

FDA, to issue regulations to implement section 403(t). FDA may 

issue guidance, should the agency find that guidance would assist 

manufacturers or distributors, particularly small businesses, to 

comply with the requirements in this legislation. 

The legislation also adds a second misbranding provision to account for other food allergens. In particular, section 403(u) provides 

that FDA has the authority to require by regulation appropriate labeling of any spice, flavoring, coloring, or incidental additive that 

is, or includes as a constituent, a food allergen that is not a major 

food allergen. In addition, the legislation provides that the amendments made by it do not otherwise alter FDA’s authority to require 

the labeling of other food allergens that are not major food allergens. Finally, the legislation amends section 403A of the FFDCA 

to give requirements under section 403(u)—which provides for an 

exception to a current labeling exemption for spices, flavorings, 

colorings, and incidental additives that has preemptive effect over 

State and local labeling requirements—the same preemptive effect 

over State and local labeling requirements that the current exemption has. 

Food Allergy Surveillance, Research, and Response 

The committee is concerned that the prevalence of food allergies 

is uncertain and the incidence of clinically significant and serious 

adverse events is not being systematically monitored. In response 

to these concerns, the legislation requires the Centers for Disease 

Control and Prevention to better capture information on the prevalence of food allergies, the incidence of clinically significant or serious adverse events related to food allergies, and the use of different 

modes of treatment for and prevention of allergic responses to 

foods. In addition, the legislation requires the National Institutes 

of Health to convene a panel of nationally recognized experts to review current clinical research efforts and develop a plan for expanding research activities concerning food allergies.

The legislation directs the Secretary, in the Conference for Food 

Protection, to pursue revision of the Food Code to provide recommendations and guidance on preparing allergen-free foods in 

food establishments. The Secretary should refer to private guidelines, including the Food Allergy and Anaphylaxis Network and 

Food Allergy Initiative’s document entitled: Food Allergy Training 

Guide for Restaurants and Food Services, as a model during development. 

Finally, the legislation directs the Secretary to provide technical 

assistance to States and localities about treatment of food allergic 

responses by trauma care and emergency medical services. Currently, the preferred treatment for anaphylaxis from food allergy is 

9

an auto-injector epinephrine device. The legislation does not specify 

this treatment, however, so that the Secretary will continue to provide such technical assistance as new treatments are developed. 

Celiac Disease and Gluten Labeling 

The legislation directs the Secretary to contract with the Institute of Medicine to conduct a review of the science relating to the 

glutens in food that are associated with celiac disease, the means 

of preventing and treating celiac disease, and the methodologies for 

detecting such glutens in food. This research should include information on both the sensitivity of individuals with celiac disease to 

gluten from different cereal grain sources and on gluten threshold 

levels (the amount of a gluten necessary to elicit the symptoms of 

celiac disease). The Institute of Medicine will provide a report to 

the Secretary and to Congress on this review not later than 2 years 

after the date of enactment of the legislation. 

The committee expects this report to inform a rule making required by the legislation, by which the Secretary is to define and 

permit the use of the term ‘‘gluten-free’’ as a voluntary claim on the 

food label. The committee intends that this ‘‘gluten-free’’ claim not 

be a claim for special dietary use, a nutrient content claim, or a 

health claim. Further, the committee intends that, under the regulation, foods that are ordinarily gluten-free may be appropriately 

identified as a gluten-free food in food labeling. The legislation requires that the proposed rule allowing this claim be issued not 

later than 4 years after the date of enactment of the legislation, 

and that the final rule be issued not later than 6 years after the 

date of enactment of the legislation. 

The committee also expects the Institute of Medicine report to inform a report by the Secretary to Congress on whether additional 

requirements for the labeling of gluten in food associated with celiac disease are warranted and necessary to better inform individuals with celiac disease. If the Secretary finds that other labeling 

of gluten in food associated with celiac disease is warranted and 

necessary, the report is to identify the types of such labeling and 

should describe why the different types of labeling are warranted 

and necessary. 

V. COST ESTIMATE

Due to time constraints the Congressional Budget Office estimate 

was not included in the report. When received by the committee, 

it will appear in the Congressional Record at a later time. 

VI. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

S. 2499 adds two misbranding provisions to section 403 the 

FFDCA to provide, first, that food labels include plain English labeling of the eight major food allergens and second, that food allergens other than the eight major food allergens can be identified 

when they are contained in spices, flavorings, colorings, or other incidental additives. It also requires reports to the Congress by the 

Department of Health and Human Services and the Institute of 

Medicine about various issues relating to food allergens, celiac disease, and gluten, and requires certain other actions by the DepartVerDate 0ct 09 2002 05:37 Oct 19, 2002 Jkt 019010 PO 00000 Frm 00009 Fmt 6659 Sfmt 6602 E:\HR\OC\SR322.XXX SR322
10

ment relating to food allergens and gluten. As such, it has no application to the legislative branch. 

VII. REGULATORY IMPACT STATEMENT

The legislation requires foods that contain one or more of the 

eight major food allergens to be labeled so as to disclose the presence of those allergens in plain English. Because many in the food 

industry have already begun the process of labeling their products 

to disclose these allergens, and because the legislation requires 

food manufacturers to comply with this requirement by January 1, 

2006, by which time most in the food industry may be expected to 

produce new labels for their foods notwithstanding the requirements of this legislation, the costs to most members of the food industry and to the food industry in aggregate of this requirement 

will be minimized. Accordingly, S. 2499 is not expected to increase 

costs to government. 

VIII. SECTION-BY-SECTION ANALYSIS

Sec. 1. Short Title 

Sec. 2. Findings 

Sec. 3. Food Labeling; Requirement of Information Regarding Allergenic Substances 

Section 3 amends the FFDCA to define the term ‘‘major food allergen’’ to mean one of the eight major food allergens (milk, egg, 

fish (e.g., bass, flounder, or tuna), Crustacean shellfish (e.g., crab, 

lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), 

wheat, peanuts, and soybeans) and any proteinaceous substance 

derived from one of these eight food allergens, unless the Secretary 

determines that the substance does not cause an allergic response 

that poses a risk to human health. Section 3 amends the FFDCA 

to require that food ingredient statements identify in plain English 

when a food that is not a raw agricultural product is, or intentionally bears or contains, a major food allergen. Section 3 requires 

that this information appear consistently within each such food’s 

label in one of two ways, either within the ingredient list in parentheses after the first ingredient that is derived from the allergen, 

or in summary form at the end of, or immediately adjacent to, the 

ingredient list. Section 3 requires that food ingredient statements 

identify in one of these ways when a major food allergen is used 

in spices, flavorings, colorings, and incidental additives. Section 3 

requires all foods that are not raw agricultural products and that 

are, or that intentionally bear or contain, major food allergens to 

be so labeled by January 1, 2006. Section 3 also amends the 

FFDCA to give the plain English allergen labeling the same preemptive effect over State and local ingredient labeling as current 

ingredient labeling. 

Section 3 provides that the FDA has the authority to require by 

regulation appropriate labeling of any spice, flavoring, coloring, or 

incidental additive that is, or intentionally includes as a constituent, a food allergen that is not a major food allergen. Section 

3 also provides that this regulatory exception to the current labeling exemption for spices, flavorings, colorings, and incidental additives has the same preemptive effect over State and local labeling 

11

requirements as the current exemption. In addition, section 3 provides that the amendments made by it do not otherwise alter 

FDA’s authority to require the labeling of other food allergens that 

are not major food allergens. 

Section 4. Report on Food Allergens 

Section 4 requires the Secretary to issue a report to Congress by 

June 30, 2004, analyzing the ways in which foods, during manufacturing and processing, can be unintentionally contaminated with 

major food allergens (cross-contact); estimating how common these 

practices are; recommending methods that can be used to reduce 

or eliminate cross-contact of foods with the major food allergens; 

describing the types of advisory labeling used by the food industry, 

the conditions of manufacture associated with use of advisory labeling, and the extent of use of advisory labeling; determining how 

consumers with food allergies or the caretakers of consumers would 

prefer information about the risk of cross-contact be communicated 

on food labels; and identifying the circumstances, if any, under 

which advisory labeling could appropriately be used. 

Section 5. Inspections Relating to Food Allergens 

Section 5 requires the Secretary to give priority to increasing the 

number of inspections to ensure that foods comply with practices 

to reduce or eliminate cross-contact of a food with major food allergen residues and that food allergens are properly labeled. Section 

5 also requires biennial reports to Congress to include information 

on the number of inspections conducted in the previous year and 

the number of facilities and food labels that were found to be in 

compliance or out of compliance; the nature of the violations found; 

the number and classification of voluntary recalls of foods with 

undeclared major food allergens; the extent of use of advisory labeling and the appropriateness of that use; and the extent to which 

the Secretary and the food industry have effectively addressed 

cross-contact issues. 

Sec. 6. Labeling of Glutens and Celiac Disease 

Section 6 requires the Secretary to contract with the Institute of 

Medicine, in conjunction with celiac disease experts, for a report, 

to be issued not later than 2 years after the date of enactment of 

the legislation to the Secretary and Congress, reviewing the science 

relating to glutens in foods that are associated with celiac disease, 

the means of preventing and treating celiac disease, and the methodologies for detecting such glutens in foods. Section 6 requires the 

Secretary, after reviewing the Institute of Medicine report, to issue 

a rule not later than 6 years after the date of enactment of the legislation defining and permitting voluntary use of the term ‘‘glutenfree’’ on food labeling. In addition, section 6 requires the Secretary 

to submit a report to Congress that assesses whether additional requirements for the labeling of gluten are warranted and necessary 

to better inform individuals with celiac disease, and if other labeling is warranted and necessary, that identifies the types of such labeling. 

12

Sec. 7. Data on Food-Related Allergic Responses 

Section 7 requires the Secretary, not later than 1 year after the 

date of enactment of the legislation, to complete a study to determine whether existing systems of reporting, collecting, and analyzing national data accurately capture information about the prevalence of food allergies, the incidence of clinically significant or serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses 

to foods, and to identify new or alternative systems or enhancements of current systems to better collect such information. On 

completion of this study, section 7 requires the CDC to improve the 

collection of such information, and publish it as it becomes available. Not later than 30 months after the date of enactment of the 

legislation, the Secretary must submit a report on the progress 

made in conducting the study and enhancing food allergy surveillance. Section 7 authorizes the appropriation of such sums as may 

be necessary to carry out its purposes. 

Sec. 8. Food Allergies Research 

Section 8 directs the NIH to convene a panel of nationally recognized experts to review current basic and clinical research efforts 

related to food allergies and to develop a plan for expanding, intensifying, and coordinating research activities concerning food allergies. Section 8 requires the Secretary to submit the plan to Congress not later than 1 year after the date of enactment of the legislation. 

Sec. 9. Food Allergens in the Food Code 

Section 9 directs the Secretary, in the Conference for Food Protection, as part of its cooperative activities between the States 

under section 311 of the Public Health Service Act, to pursue revision of the Food Code to provide guidelines for preparing allergenfree foods in food establishments, including in restaurants, grocery 

store delicatessens and bakeries, and elementary and secondary 

school cafeterias. 

Sec. 10. Recommendations Regarding Responding to Food-Related 

Allergic Responses 

Section 10 directs the Secretary to provide technical assistance 

relating to the use of different modes of treatment for and prevention of allergic responses to foods when it provides technical assistance relating to trauma care and emergency medical services under 

Section 1202(b)(3) of the Public Health Service Act. 

IX. CHANGES IN EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing 

Rules of the Senate, the following provides a print of the statute 

or the part or section thereof to be amended or replaced (existing 

law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed 

is shown in roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * *

13

SEC. 201. For the purposes of this Act—

(a)(1) * * *

* * * * * * *

(ll) The term ‘‘major food allergen’’ means any of the following: 

(1) Milk, egg, fish (e.g. bass, founder, or tuna), Crustacean 

shellfish (e.g. crab, lobster, or shrimp), tree nuts (e.g. almonds, 

pecans, or walnuts), wheat, peanuts, and soybeans. 

(2) A proteinaceous substance derived from a food specified in 

paragraph (1) (unless the Secretary determines that the substance does not cause an allergic response that poses a risk to 

human health).

* * * * * * *

SEC. 403. A food shall be deemed to be misbranded—

(a) * * *

* * * * * * *

(t)(1) If it is not a raw agricultural commodity and it is, or it intentionally bears or contains, a major food allergen, unless either—

(A) Contains, which statement is followed by the name of the 

food source as described in section 201(ll)(1) from which the 

major food allergen is derived, follows immediately after or is 

adjacent to (in a type size no smaller than the type size used 

in the list of ingredients) the list of ingredients required under 

subsections (g) and (i); or 

(B) the common or usual name of the major food allergen in 

the list of ingredients required under subsections (g) and (i) is 

followed in parentheses by the name of the food source as described in section 201(ll)(1) from which the major food allergen 

is derived, except that the name of the food source is not required when—

(i) the common or usual name of the ingredient uses the 

term used to describe a major food allergen in section 

201(ll)(1), or

(ii) the name of the food source as described in section 

201(ll)(1) appears elsewhere in the ingredient list; and 

Provided all major food allergens are labeled in a consistent 

manner either as specified in clause (A) or as specified in clause 

(B). 

(2) The information required under this subsection may appear in 

labeling in lieu of appearing on the label only if the Secretary finds 

that such other labeling is sufficient to protect the public health. A 

finding by the Secretary under this subparagraph is effective upon 

publication in the Federal Register as a notice (including any 

change in an earlier finding under this subparagraph). 

(3) Notwithstanding subsection (g), (i), or (k), or any other law, 

a spice, flavoring, coloring, or incidental additive that is, or that intentionally bears or contains, a major food allergen shall be subject 

to the labeling requirements of this subsection. 

(4) The Secretary may by regulation modify the requirements of 

subparagraph (A) or (B) of paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirement of subparagraph 

(B), if the Secretary determines that the modification or elimination 

of the requirement is necessary to protect the public health. 

14

(u) Notwithstanding subsection (g), (i), or (k), or any other law, 

a spice, flavoring, coloring, or incidental additive that is, or that intentionally bears or contains, a food allergen (other than a major 

food allergen), as determined by the Secretary by regulation, shall 

be disclosed in a manner specified by the Secretary by regulation. 

* * * * * * *

Sec. 403A. (a) Except as provided in subsection (b), no State or 

political subdivision of a State may directly or indirectly establish 

under any authority or continue in effect as to any food in interstate commerce—

(1) any requirement for a food which is the subject of a 

standard of identity established under section 401 that is not 

identical to such standard of identity or that is not identical to 

the requirement of section 403(g), except that this paragraph 

does not apply to a standard of identity of a State or political 

subdivision of a State for maple syrup that is of the type required by sections 401 and 403(g). 

(2) any requirement for the labeling of food of the type required by section 403(c), 403(e), or ø403(i)(2)¿, 403(i)(2), 403(t), 

or 403(u) that is not identical to the requirement of such section, except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the 

type required by section 403(c) and that is applicable to maple 

syrup. 

(3) * * *

* * * * * * *

Æ