I 
116TH CONGRESS 
1ST SESSION H. R. 2117 
To improve the health and safety of Americans living with food allergies 
and related disorders, including potentially life-threatening anaphylaxis, 
food protein-induced enterocolitis syndrome, and eosinophilic gastro-
intestinal diseases, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 8, 2019 
Ms. MATSUI introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To improve the health and safety of Americans living with 
food allergies and related disorders, including potentially 
life-threatening 
anaphylaxis, 
food 
protein-induced 
enterocolitis syndrome, and eosinophilic gastrointestinal 
diseases, 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 Allergy Safety, 
Treatment, Education, and Research Act of 2019’’ or the 
‘‘FASTER Act of 2019’’. 
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SEC. 2. FOOD ALLERGY SAFETY RECOMMENDATIONS OF 
THE NATIONAL ACADEMY OF MEDICINE. 
(a) COLLECTION OF FOOD ALLERGY DATA.—The 
Public Health Service Act is amended by inserting after 
section 317T of such Act (42 U.S.C. 247b–22) the fol-
lowing new section: 
‘‘SEC. 317U. COLLECTION OF FOOD ALLERGY DATA. 
‘‘The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall— 
‘‘(1) expand and intensify the collection of in-
formation on the prevalence of food allergies for spe-
cific allergens in the United States, such as through 
the National Health and Nutrition Examination 
Survey; and 
‘‘(2) include such information within annual or 
other periodic reporting to the Congress and the 
public on other surveillance activities.’’. 
(b) ALLERGEN LABELING.— 
(1) MAJOR
ALLERGEN
DEFINITION.—Section 
201(qq)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 3211(qq)(1)) is amended by striking 
‘‘and soybeans’’ and inserting ‘‘soybeans, and ses-
ame’’. 
(2) ADDITIONAL ALLERGENS.—Section 201(qq) 
of the Federal Food, Drug, and Cosmetic Act (21 
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U.S.C. 3211(qq)(1)) is amended by adding at the 
end the following: 
‘‘(3) Any other food ingredient that the Sec-
retary determines by regulation to be a major food 
allergen, based on the prevalence and severity of al-
lergic reactions to the food ingredient.’’. 
SEC. 3. REPORT ON USE BY FDA OF PATIENT EXPERIENCE 
DATA ON TREATMENTS FOR PATIENTS WITH 
FOOD ALLERGIES. 
Section 3004 of the 21st Century Cures Act (21 
U.S.C. 355 note) is amended— 
(1) by striking ‘‘Not later than’’ and inserting 
the following: 
‘‘(a) IN GENERAL.—Not later than’’; and 
(2) by adding at the end the following: 
‘‘(b) TREATMENTS FOR PATIENTS WITH FOOD AL-
LERGIES.—Each report under subsection (a) shall include 
a synopsis of the use by the Food and Drug Administra-
tion in regulatory decisionmaking of patient experience 
data on treatments for patients with food allergies.’’. 
SEC. 4. STUDY ON ECONOMIC COSTS OF FOOD ALLERGIES. 
The Director of the National Institutes of Health 
shall seek to enter into an arrangement with the National 
Academies of Sciences, Engineering, and Medicine (or if 
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the National Academies decline to enter into an arrange-
ment, another appropriate entity) to— 
(1) study the economic costs of food allergies in 
the United States, both individually and for the food 
allergy population overall; and 
(2) not later than 1 year after the date of en-
actment of this Act— 
(A) complete such study; 
(B) submit to the Congress a report on the 
results of such study; and 
(C) publish such report. 
Æ 
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