I 
108TH CONGRESS 
1ST SESSION H. R. 3684
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 
requirements with respect to allergenic substances in foods, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 8, 2003
Mrs. LOWEY (for herself, Mr. GREENWOOD, Mr. LATOURETTE, Ms. WOOL-
SEY, Mr. SERRANO, Mr. PALLONE, Mr. HOEFFEL, Ms. SLAUGHTER, Mr. 
HINCHEY, Ms. NORTON, Ms. DELAURO, Mr. GEORGE MILLER of Cali-
fornia, Mr. BROWN of Ohio, Ms. ROYBAL-ALLARD, and Mr. WAXMAN) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish labeling requirements with respect to allergenic 
substances in foods, 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 of 2003’’. 
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 the foods of randomly se-
lected manufacturers of baked goods, ice cream, and 
candy in Minnesota and Wisconsin in 1999, the 
Food and Drug Administration found that 25 per-
cent of sampled foods failed to list peanuts or eggs 
as ingredients 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 to correctly 
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) in other cases, the ingredients may be de-
clared as a class, including spices, flavorings, and 
certain colorings, or are exempt from the ingredient 
labeling requirements, such as incidental additives; 
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
(C) a multicenter, multiyear study estimated 
that the prevalence of celiac disease in the United 
States is 0.5 to 1 percent of the general population. 
SEC. 3. FOOD LABELING; REQUIREMENT OF INFORMATION 
REGARDING ALLERGENIC SUBSTANCES. 
(a) IN GENERAL.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 
adding at the end the following: 
‘‘(w)(1) If it is not a raw agricultural commodity and 
it is, or it contains an ingredient that bears or contains, 
a major food allergen, unless either—
‘‘(A) the word ‘Contains’, followed by the name 
of the food source from which the major food aller-
gen is derived, is printed immediately after or is ad-
jacent to the list of ingredients (in a type size no 
smaller than the type size used in the list of ingredi-
ents) 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 paren-
theses by the name of the food source 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 in-
gredient uses the name of the food source from 
which the major food allergen is derived; or 
‘‘(ii) the name of the food source from 
which the major food allergen is derived ap-
pears elsewhere in the ingredient list, unless the 
name of the food source appears elsewhere in 
the ingredient list only in the common or usual 
name of foods that are food ingredients that are 
not 
major 
food 
allergens 
under 
section 
201(qq)(2)(A) or (B). 
‘‘(2) As used in this subsection, the term ‘name of 
the food source from which the major food allergen is de-
rived’ means the name described in section 201(qq)(1); 
provided that in the case of a tree nut, fish, or Crustacean 
shellfish, the term ‘name of the food source from which 
the major food allergen is derived’ means the name of the 
specific type of nut or species of fish or Crustacean shell-
fish. 
‘‘(3) 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 suffi-
cient to protect the public health. A finding by the Sec-
retary under this paragraph (including any change in an
earlier finding under this paragraph) is effective upon 
publication in the Federal Register as a notice. 
‘‘(4) Notwithstanding subsection (g), (i), or (k), or 
any other law, a flavoring, coloring, or incidental additive 
that is, or that bears or contains, a major food allergen 
shall be subject to the labeling requirements of this sub-
section. 
‘‘(5) The Secretary may by regulation modify the re-
quirements of subparagraph (A) or (B) of paragraph (1), 
or eliminate either the requirement of subparagraph (A) 
or the requirements of subparagraph (B) of paragraph 
(1), if the Secretary determines that the modification or 
elimination of the requirement of subparagraph (A) or the 
requirements of subparagraph (B) is necessary to protect 
the public health. 
‘‘(6)(A) Any person may petition the Secretary to ex-
empt a food ingredient described in section 201(qq)(2) 
from the allergen labeling requirements of this subsection. 
‘‘(B) The Secretary shall approve or deny such peti-
tion within 180 days of receipt of the petition or the peti-
tion shall be deemed denied, unless an extension of time 
is mutually agreed upon by the Secretary and the peti-
tioner. 
‘‘(C) The burden shall be on the petitioner to provide 
scientific evidence (including the analytical method used
to produce the evidence) that demonstrates that such food 
ingredient, as derived by the method specified in the peti-
tion, does not cause an allergic response that poses a risk 
to human health. 
‘‘(D) A determination regarding a petition under this 
paragraph shall constitute final agency action. 
‘‘(E) The Secretary shall promptly post to a public 
site all petitions received under this paragraph within 14 
days of receipt and the Secretary shall promptly post the 
Secretary’s response to each. 
‘‘(7)(A) A person need not file a petition under para-
graph (6) to exempt a food ingredient described in section 
201(qq)(2) from the allergen labeling requirements of this 
subsection, if the person files with the Secretary a notifica-
tion containing—
‘‘(i) scientific evidence (including the analytical 
method used) that demonstrates that the food ingre-
dient (as derived by the method specified in the noti-
fication, where applicable) does not contain aller-
genic protein; or 
‘‘(ii) a determination by the Secretary that the 
ingredient does not cause an allergic response that 
poses a risk to human health under a premarket ap-
proval or notification program under section 409.
‘‘(B) The food ingredient may be introduced or deliv-
ered for introduction into interstate commerce as a food 
ingredient that is not a major food allergen 90 days after 
the date of receipt of the notification by the Secretary, 
unless the Secretary determines within the 90-day period 
that the notification does not meet the requirements of 
this paragraph, or there is insufficient scientific evidence 
to determine that the food ingredient does not contain al-
lergenic protein or does not cause an allergenic response 
that poses a risk to human health. 
‘‘(C) The Secretary shall promptly post to a public 
site a list of all notifications received under this subpara-
graph within 14 days of receipt and promptly post any 
objections thereto by the Secretary. 
‘‘(x) Notwithstanding subsection (g), (i), or (k), or 
any other law, a spice, flavoring, coloring, or incidental 
additive that is, or that 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.’’. 
(b) EFFECT ON OTHER AUTHORITY.—The amend-
ments made by this section that require a label or labeling 
for major food allergens do not alter the authority of the 
Secretary of Health and Human Services under the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) to require a label or labeling for other food allergens. 
(c) CONFORMING AMENDMENTS.—
(1) Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) (as amended by sec-
tion 2(b)) is amended by adding at the end the fol-
lowing: 
‘‘(qq) The term ‘major food allergen’ means any of 
the following: 
‘‘(1) Milk, egg, fish (e.g., bass, flounder, or 
cod), Crustacean shellfish (e.g., crab, lobster, or 
shrimp), tree nuts (e.g., almonds, pecans, or wal-
nuts), wheat, peanuts, and soybeans. 
‘‘(2) A food ingredient that contains protein de-
rived from a food specified in paragraph (1), except 
the following: 
‘‘(A) Any highly refined oil derived from a 
food specified in paragraph (1) and any ingre-
dient derived from such highly refined oil. 
‘‘(B) A food ingredient that is exempt 
under paragraph (6) or (7) of section 403(w).’’. 
(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(w), or 403(x)’’.
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply to any food that is labeled on or 
after January 1, 2006. 
SEC. 4. REPORT ON FOOD ALLERGENS. 
Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services 
(in this section referred to as the ‘‘Secretary’’) shall sub-
mit 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)(A) analyzes—
(i) the ways in which foods, during manu-
facturing and processing, are 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 are unintentionally 
contaminated with major food allergens; and
(B) estimates how common the practices de-
scribed in subparagraph (A) are in the food indus-
try, with breakdowns by food type as appropriate; 
(2) advises whether good manufacturing prac-
tices or other methods 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 labeling that uses the words ‘‘may con-
tain’’) 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) describes how consumers with food allergies 
or the caretakers of consumers would prefer that in-
formation about the risk of cross-contact be commu-
nicated on food labels as determined by using appro-
priate survey mechanisms; 
(5) states the number of inspections of food 
manufacturing and processing facilities conducted in 
the previous 2 years and describes—
(A) the number of facilities and food labels 
that were found to be in compliance or out of 
compliance with respect to cross-contact of 
foods with residues of major food allergens and 
the proper labeling of major food allergens; 
(B) the nature of the violations found; and 
(C) the number of voluntary recalls, and 
their 
classifications, 
of 
foods 
containing 
undeclared major food allergens; and 
(6) assesses the extent to which the Secretary 
and the food industry have effectively addressed 
cross-contact issues. 
SEC. 5. INSPECTIONS RELATING TO FOOD ALLERGENS. 
The Secretary of Health and Human Services shall 
conduct inspections consistent with the authority under 
section 704 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 374) of facilities in which foods are manufac-
tured, processed, packed, or held—
(1) to ensure that the entities operating the fa-
cilities comply with practices to reduce or eliminate 
cross-contact of a food with residues of major food 
allergens that are not intentional ingredients of the 
food; and 
(2) to ensure that major food allergens are 
properly labeled on foods.
SEC. 6. GLUTEN LABELING. 
Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services, 
in consultation with appropriate experts and stakeholders, 
shall issue a proposed rule to define, and permit use of, 
the term ‘‘gluten-free’’ on the labeling of foods. Not later 
than 4 years after the date of enactment of this Act, the 
Secretary shall issue a final rule to define, and permit use 
of, the term ‘‘gluten-free’’ on the labeling of foods. 
SEC. 7. IMPROVEMENT AND PUBLICATION OF DATA ON 
FOOD-RELATED ALLERGIC RESPONSES. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Director of the Cen-
ters for Disease Control and Prevention and in consulta-
tion with the Commissioner of Food and Drugs, shall im-
prove (including by educating physicians and other health 
care providers) 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. 
(b) 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, acting through the Director of the Na-
tional Institutes of Health, shall convene an ad hoc panel 
of nationally recognized experts in allergy and immunology 
to review current basic and clinical research efforts related 
to food allergies. 
(b) RECOMMENDATIONS.—Not later than 1 year 
after the date of enactment of this Act, the panel shall 
make recommendations to the Secretary for enhancing 
and coordinating research activities concerning food aller-
gies, which the Secretary shall make public. 
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 ef-
forts to encourage cooperative 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 pro-
vide guidelines for preparing allergen-free foods in food 
establishments, including in restaurants, grocery store 
delicatessens and bakeries, and elementary and secondary 
school cafeterias. The Secretary shall consider guidelines 
and recommendations developed by public and private en-
tities for public and private food establishments for pre-
paring allergen-free foods in pursuing this revision.