I 
107TH CONGRESS 
2D SESSION 
H. R. 5747
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 
requirements regarding allergenic substances in food, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 14, 2002
Mrs. LOWEY (for herself, Mr. WAXMAN, Mr. BROWN of Ohio, Ms. DELAURO, 
Mr. SMITH of Washington, Ms. LEE, Mr. HOLT, Mr. HINCHEY, Mr. 
DEFAZIO, Ms. ROYBAL-ALLARD, Mr. LANGEVIN, Ms. RIVERS, Mr. 
LEVIN, Ms. NORTON, Mr. PRICE of North Carolina, Mr. NADLER, Mr. 
FROST, Mr. PALLONE, Mr. ROTHMAN, Mr. RANGEL, and Mr. GEORGE 
MILLER of California) introduced the following bill; which was referred 
to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish labeling requirements regarding allergenic sub-
stances in food, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food Allergen Label-
ing and Consumer Protection Act’’. 
SEC. 2. FINDINGS. 
Congress finds that—
(1) it is estimated that—
(A) approximately 2 percent of adults and 
about 5 percent of infants and young children 
in the United States suffer from food allergies; 
and 
(B) each year, roughly 30,000 individuals 
require emergency room treatment and 150 in-
dividuals die because of allergic reactions to 
food; 
(2)(A) Eight major foods or food groups—milk, 
eggs, fish, Crustacean shellfish, tree nuts, peanuts, 
wheat, and soybeans—account for 90 percent of 
food allergies; 
(B) at present, there is no cure for food aller-
gies; and 
(C) a food allergic consumer must avoid the 
food to which the consumer is allergic; 
(3)(A) in a review of randomly selected manu-
facturers of baked goods, ice cream, and candy in 
Minnesota and Wisconsin in 1999, the Food and 
Drug Administration found that 25 percent of sam-
pled foods failed to list peanuts or eggs as ingredi-
ents on the food labels; and
(B) nationally, the number of recalls because of 
unlabeled allergens rose to 121 in 2000 from about 
35 a decade earlier; 
(4) a recent study shows that many parents of 
children with a food allergy were unable correctly to 
identify in each of several food labels the ingredients 
derived from major food allergens; 
(5)(A) ingredients in foods must be listed by 
their ‘‘common or usual name’’; 
(B) in some cases, the common or usual name 
of an ingredient may be unfamiliar to consumers, 
and many consumers may not realize the ingredient 
is derived from, or contains, a major food allergen; 
and 
(C) spices, flavorings, and certain colorings and 
incidental additives are exempt from ingredient la-
beling requirements that would allow consumers to 
avoid those to which they are allergic; and 
(6)(A) celiac disease is an immune-mediated 
disease that causes damage to the gastrointestinal 
tract, central nervous system, and other organs; 
(B) the current recommended treatment is 
avoidance of glutens in foods that are associated 
with celiac disease; and
determines that the modification or elimination of the re-
quirement is necessary to protect the public health. 
‘‘(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 de-
termined by the Secretary by regulation, shall be disclosed 
in a manner specified by the Secretary by regulation.’’. 
(b) EFFECT ON OTHER AUTHORITY.—This section 
does not alter the authority of the Secretary of Health 
and Human Services under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) to require the label-
ing of other food allergens. 
(c) CONFORMING AMENDMENTS.—
(1) Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding 
at the end the following: 
‘‘(ll) The term ‘major food allergen’ means any of the 
following: 
‘‘(1) Milk, egg, fish (e.g. bass, flounder, or 
tuna), Crustacean shellfish (e.g. crab, lobster, or 
shrimp), tree nuts (e.g. almonds, pecans, or wal-
nuts), 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 al-
lergic response that poses a risk to human health).’’. 
(2) Section 403A(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(2)) is 
amended by striking ‘‘or 403(i)(2)’’ and inserting 
‘‘403(i)(2), 403(t), or 403(u)’’. 
(d) EFFECTIVE DATE.—A food that is labeled on or 
after January 1, 2006, and that is, or that intentionally 
bears or contains, a major food allergen (as defined in the 
amendment made by subsection (c)) shall be labeled in 
compliance with the requirements of the amendment made 
by subsection (a). 
SEC. 4. REPORT ON FOOD ALLERGENS. 
Not later than June 30, 2004, the Secretary of 
Health and Human Services shall submit to the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of 
the House of Representatives a report that—
(1)(A) analyzes—
(i) the ways in which foods, during manu-
facturing and processing, can be unintentionally 
contaminated with major food allergens, includ-
ing contamination caused by the use by manu-
facturers of the same production line to produce 
both products for which major food allergens
are intentional ingredients and products for 
which major food allergens are not intentional 
ingredients; and 
(ii) the ways in which foods produced on 
dedicated production lines might nonetheless 
become 
unintentionally 
contaminated 
with 
major food allergens; and 
(B) estimates how common those practices are 
in the food industry, with breakdowns by food type 
as appropriate; 
(2) recommends good manufacturing practices 
or other methods that can be used to reduce or 
eliminate cross-contact of foods with the major food 
allergens; 
(3) describes—
(A) the various types of advisory labeling 
(such as use of the words ‘‘may contain’’) used 
by food producers; 
(B) the conditions of manufacture of food 
that are associated with the various types of ad-
visory labeling; and 
(C) the extent to which advisory labels are 
being used on food products; 
(4) determines how consumers with food aller-
gies or the caretakers of consumers would prefer in-
formation about the risk of cross-contact be commu-
nicated on food labels by using appropriate survey 
mechanisms; and 
(5) identifies the circumstances, if any, under 
which advisory labeling could appropriately be used. 
SEC. 5. INSPECTIONS RELATING TO FOOD ALLERGENS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall give priority to increasing the num-
ber of inspections under section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374) of facilities in 
which foods are manufactured, processed, packed, or 
held—
(1) to ensure that the foods comply with prac-
tices to reduce or eliminate cross-contact of a food 
with major food allergen residues that are not inten-
tional ingredients of the food; and 
(2) to ensure that major food allergens are 
properly labeled on foods. 
(b) REPORTS.—On October 1, 2003, and biennially 
thereafter, the Secretary shall submit to the Committee 
on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the 
House of Representatives a report that—
(1) states the number of inspections conducted 
in the previous 2 years and the numbers of facilities
and food labels that were found to be in compliance 
or out of compliance; 
(2) describes the nature of the violations found; 
(3) includes the number of voluntary recalls, 
and their classifications, of foods with undeclared 
major food allergens; 
(4) assesses the extent of use of advisory lan-
guage found and the appropriateness of that use; 
and 
(5) assesses the extent to which the Secretary 
and the food industry have effectively addressed 
cross-contact issues. 
SEC. 6. LABELING OF GLUTENS AND CELIAC DISEASE. 
(a) CONTRACT WITH INSTITUTE OF MEDICINE.—
The Secretary of Health and Human Services (in this sec-
tion, the ‘‘Secretary’’) shall enter into a contract with the 
Institute of Medicine for—
(1) the conduct of a review of the science relat-
ing to—
(A) the glutens in food that are associated 
with celiac disease;
(B) the means of preventing and treating 
celiac disease; and 
(C) the methodologies for detecting such 
glutens in foods; and
(2) the submission to the Secretary, the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and 
Commerce of the House of Representatives, not later 
than 2 years after the date of enactment of this Act, 
of a report concerning the review conducted under 
paragraph (1). 
(b) REQUIREMENTS OF EXPERTISE.—The Institute 
of Medicine shall conduct the review under subsection 
(a)(1) and make the report under subsection (a)(2) in con-
junction with experts in celiac disease, including experts 
in the pathogenesis, epidemiology, and biochemistry of ce-
liac disease, the sensitivity to, and tolerance of, the glutens 
in food that are associated with celiac disease, and the 
clinical aspects of celiac disease, including prevention and 
treatment. 
(c) GLUTEN LABELING.—Considering the review con-
ducted under paragraph (a)(1), the Secretary shall, not 
later than 4 years after the date of enactment of this Act, 
issue a proposed rule to define, and permit use of, the 
term ‘‘gluten-free’’ on the labeling of foods. Not later than 
6 years after the date of enactment of this Act, the Sec-
retary shall issue a final rule to define, and permit use 
of, the term ‘‘gluten-free’’ on the labeling of foods.
(d) REPORT.—Not later than 2 years after submis-
sion to the Secretary of the report under subsection (a)(2), 
the Secretary shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report 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, identifies 
the types of such labeling. 
SEC. 7. DATA ON FOOD-RELATED ALLERGIC RESPONSES. 
(a) STUDY.—Not later than one year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services (in this section referred to as the 
‘‘Secretary’’), in consultation with consumers, providers, 
State governments, and other relevant parties, shall com-
plete a study for the purposes of—
(1) determining whether existing systems for 
the reporting, collection and analysis of national 
data accurately capture information on—
(A) the prevalence of food allergies; 
(B) the incidence of clinically significant or 
serious adverse events related to food allergies; 
and
(C) the use of different modes of treatment 
for and prevention of allergic responses to 
foods; and 
(2) identifying new or alternative systems or en-
hancements to existing systems (including by edu-
cating physicians and other health care providers), 
for the reporting collection and analysis of national 
data on—
(A) the prevalence of food allergies; 
(B) the incidence of clinically significant or 
serious adverse events related to food allergies; 
and 
(C) the use of different modes of treatment 
for and prevention of allergic responses to 
foods. 
(b) IMPROVEMENT AND PUBLICATION OF DATA.—On 
completion of, and consistent with the findings of, the 
study conducted under subsection (a), the Secretary, act-
ing through the Director of the Centers for Disease Con-
trol and Prevention and in consultation with the Commis-
sioner of Foods and Drugs, shall improve the collection 
of, and publish as it becomes available, national data on—
(1) the prevalence of food allergies; 
(2) the incidence of clinically significant or seri-
ous adverse events related to food allergies; and
(3) the use of different modes of treatment for 
and prevention of allergic responses to foods. 
(c) REPORT
TO CONGRESS.—Not later than 30 
months after the date of the enactment of this Act, the 
Secretary shall submit to the Congress a report on the 
progress made with respect to subsections (a) and (b). 
(d) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary. 
SEC. 8. FOOD ALLERGIES RESEARCH. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, through the National Institutes of 
Health, shall convene a panel of nationally recognized ex-
perts to review current basic and clinical research efforts 
related to food allergies. The panel shall develop a plan 
for expanding, intensifying, and coordinating research ac-
tivities concerning food allergies. 
(b) REPORT TO CONGRESS.—Not later than 1 year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit a plan under 
subsection (a) to the Committee on Energy and Commerce 
in the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions in the Senate.
SEC. 9. FOOD ALLERGENS IN THE FOOD CODE. 
The Secretary of Health and Human Services shall, 
in the Conference for Food Protection, as part of its coop-
erative activities between the States under section 311 of 
the Public Health Service Act (42 U.S.C. 243), pursue 
revision of the Food Code to provide guidelines for pre-
paring allergen-free foods in food establishments, includ-
ing in restaurants, grocery store delicatessens and bak-
eries, and elementary and secondary school cafeterias. The 
Secretary shall consider public and private guidelines and 
recommendations for preparing allergen-free foods in pur-
suing this revision. 
SEC. 10. RECOMMENDATIONS REGARDING RESPONDING TO 
FOOD-RELATED ALLERGIC RESPONSES. 
The Secretary of Health and Human Services shall, 
in providing technical assistance relating to trauma care 
and emergency medical services to State and local agencies 
under section 1202(b)(3) of the Public Health Service Act 
(42 U.S.C. 300d–2(b)(3)), include technical assistance re-
lating to the use of different modes of treatment for and 
prevention of allergic responses to foods.
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