116TH CONGRESS 

2D SESSION H. R. 2117 

AN ACT 

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, 
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1 SECTION 1. SHORT TITLE. 

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

3 Treatment, Education, and Research Act of 2020’’ or the 

4 ‘‘FASTER Act of 2020’’. 

5 SEC. 2. FOOD ALLERGY SAFETY RECOMMENDATIONS OF 

6 THE NATIONAL ACADEMY OF MEDICINE. 

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

8 Public Health Service Act is amended by inserting before 

9 section 318 of such Act (42 U.S.C. 247c) the following 

10 new section: 

11 ‘‘SEC. 317W. COLLECTION OF FOOD ALLERGY DATA. 

12 ‘‘(a) IN GENERAL.—The Secretary, acting through 

13 the Director of the Centers for Disease Control and Pre14 vention, shall— 

15 ‘‘(1) expand and intensify the collection of in16 formation on the prevalence of food allergies for spe17 cific allergens in the United States, such as through 

18 the National Health and Nutrition Examination 

19 Survey and the National Health Interview Survey; 

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

21 other periodic reporting to the Congress and the 

22 public on other surveillance activities; and 

23 ‘‘(3) encourage research to improve the accu24 racy of food allergy prevalence data. 

25 ‘‘(b) BIOMARKERS.—Any research conducted pursu26 ant to subsection (a)(3) shall include— 
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1 ‘‘(1) the identification of biomarkers and tests 

2 to validate data generated from such research; and 

3 ‘‘(2) the investigation of the use of identified 

4 biomarkers and tests in national surveys conducted 

5 as part of that research.’’. 

6 (b) ALLERGEN LABELING.— 

7 (1) MAJOR FOOD ALLERGEN DEFINITION.— 

8 (A) IN GENERAL.—Section 201(qq)(1) of 

9 the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 321(qq)(1)) is amended by striking 

11 ‘‘and soybeans’’ and inserting ‘‘soybeans, and 

12 sesame’’. 

13 (B) EFFECTIVE DATE.—The amendment 

14 made by subparagraph (A) shall apply with re15 spect to food introduced or delivered for intro16 duction into interstate commerce on or after 

17 January 1, 2022. 

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

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

20 U.S.C. 321(qq)) is amended by adding at the end 

21 the following: 

22 ‘‘(3) Any other food ingredient that the Sec23 retary determines by regulation to be a major food 

24 allergen, based on the scientific criteria determined 

25 by the Secretary (including the prevalence and sever-
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1 ity of allergic reactions to the food ingredient) that 

2 establish that such food ingredient is an allergen of 

3 public health concern.’’. 

4 (3) TECHNICAL CORRECTIONS.—Section 

5 201(qq)(2) of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 321(qq)(2)) is amended by striking 

7 ‘‘paragraph’’ each place it appears and inserting 

8 ‘‘subparagraph’’. 

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

10 DATA ON TREATMENTS FOR PATIENTS WITH 

11 FOOD ALLERGIES. 

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

13 U.S.C. 355 note) is amended— 

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

15 the following: 

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

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

18 ‘‘(b) TREATMENTS FOR PATIENTS WITH FOOD AL19 LERGIES.—Each report under subsection (a) shall include 

20 a synopsis of the use by the Food and Drug Administra21 tion in regulatory decisionmaking of patient experience 
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1 data on products with an indication for the treatment of 

2 a food allergy.’’. 

Passed the House of Representatives November 17, 

2020. 

Attest: 

Clerk. 
116TH CONGRESS 

2D SESSION H. R. 2117 

AN ACT 

To improve the health and safety of Americans livother purposes. eosinophilic gastrointestinal diseases, and for food protein-induced enterocolitis syndrome, and cluding potentially life-threatening anaphylaxis, ing with food allergies and related disorders, in-