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 gastrointestinal 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Allergy Safety, 

5 Treatment, Education, and Research Act of 2019’’ or the 

6 ‘‘FASTER Act of 2019’’. 


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1 SEC. 2. FOOD ALLERGY SAFETY RECOMMENDATIONS OF 

2 THE NATIONAL ACADEMY OF MEDICINE. 

3 (a) COLLECTION OF FOOD ALLERGY DATA.—The 

4 Public Health Service Act is amended by inserting after 

5 section 317T of such Act (42 U.S.C. 247b–22) the fol6 lowing new section: 

7 ‘‘SEC. 317U. COLLECTION OF FOOD ALLERGY DATA. 

8 ‘‘The Secretary, acting through the Director of the 

9 Centers for Disease Control and Prevention, shall— 

10 ‘‘(1) expand and intensify the collection of in11 formation on the prevalence of food allergies for spe12 cific allergens in the United States, such as through 

13 the National Health and Nutrition Examination 

14 Survey; and 

15 ‘‘(2) include such information within annual or 

16 other periodic reporting to the Congress and the 

17 public on other surveillance activities.’’. 

18 (b) ALLERGEN LABELING.— 

19 (1) MAJOR ALLERGEN DEFINITION.—Section 

20 201(qq)(1) of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 3211(qq)(1)) is amended by striking 

22 ‘‘and soybeans’’ and inserting ‘‘soybeans, and ses23 ame’’. 

24 (2) ADDITIONAL ALLERGENS.—Section 201(qq) 

25 of the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 3211(qq)(1)) is amended by adding at the 

2 end the following: 

3 ‘‘(3) Any other food ingredient that the Sec4 retary determines by regulation to be a major food 

5 allergen, based on the prevalence and severity of al6 lergic reactions to the food ingredient.’’. 

7 SEC. 3. REPORT ON USE BY FDA OF PATIENT EXPERIENCE 

8 DATA ON TREATMENTS FOR PATIENTS WITH 

9 FOOD ALLERGIES. 

10 Section 3004 of the 21st Century Cures Act (21 

11 U.S.C. 355 note) is amended— 

12 (1) by striking ‘‘Not later than’’ and inserting 

13 the following: 

14 ‘‘(a) IN GENERAL.—Not later than’’; and 

15 (2) by adding at the end the following: 

16 ‘‘(b) TREATMENTS FOR PATIENTS WITH FOOD AL17 LERGIES.—Each report under subsection (a) shall include 

18 a synopsis of the use by the Food and Drug Administra19 tion in regulatory decisionmaking of patient experience 

20 data on treatments for patients with food allergies.’’. 

21 SEC. 4. STUDY ON ECONOMIC COSTS OF FOOD ALLERGIES. 

22 The Director of the National Institutes of Health 

23 shall seek to enter into an arrangement with the National 

24 Academies of Sciences, Engineering, and Medicine (or if 


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1 the National Academies decline to enter into an arrange2 ment, another appropriate entity) to— 

3 (1) study the economic costs of food allergies in 

4 the United States, both individually and for the food 

5 allergy population overall; and 

6 (2) not later than 1 year after the date of en7 actment of this Act— 

8 (A) complete such study; 

9 (B) submit to the Congress a report on the 

10 results of such study; and 

11 (C) publish such report. 

Æ 


kjohnson on DSK79L0C42 with BILLS