I 

118TH CONGRESS 

1ST SESSION H. R. 5316 

To amend section 412 of the Federal Food, Drug, and Cosmetic Act to 

enhance the safeguards applicable with respect to infant formula. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 29, 2023 

Ms. PORTER (for herself and Mrs. MCCLAIN) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend section 412 of the Federal Food, Drug, and Cosmetic Act to enhance the safeguards applicable with respect to infant formula. 

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 ‘‘Safeguarding Kids and 

5 Families from Critical Food Disruptions Act of 2023’’. 

6 SEC. 2. SAFEGUARDING KIDS AND FAMILIES FROM CRIT7 ICAL FOOD DISRUPTIONS. 

8 (a) IN GENERAL.—Subsection (e) of section 412 of 

9 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 350a) is amended to read as follows: 


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1 ‘‘(e)(1) If the manufacturer of an infant formula has 

2 knowledge which reasonably supports the conclusion that 

3 an infant formula which has been processed by the manu4 facturer and which has left an establishment subject to 

5 the control of the manufacturer— 

6 ‘‘(A) may not provide the nutrients required by 

7 subsection (i); or 

8 ‘‘(B) may be otherwise adulterated or mis9 branded, 

10 the manufacturer shall, within 24 hours, notify the Sec11 retary and the Director of the Office of Critical Foods of 

12 such knowledge. 

13 ‘‘(2) If the manufacturer of an infant formula has 

14 knowledge which reasonably supports the conclusion that 

15 an infant formula which has been processed by the manu16 facturer may be adulterated due to pathogen contamina17 tion (such as confirmation of a positive analytical result 

18 from any in-process or finished product testing), the man19 ufacturer shall— 

20 ‘‘(A) within 24 hours, notify the Secretary and 

21 the Director of the Office of Critical Foods of such 

22 knowledge, regardless of whether such infant for23 mula has left an establishment subject to the control 

24 of the manufacturer; and 


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1 ‘‘(B) provide to the Secretary, for the purpose 

2 of sequencing, results and isolates from a positive 

3 sample of such infant formula. 

4 ‘‘(3) In submitting a notification under paragraph (1) 

5 or (2), a manufacturer shall adhere to any submission re6 quirements or procedures specified by the Secretary. 

7 ‘‘(4) If the Secretary determines that an infant for8 mula presents a risk to human health, the manufacturer 

9 shall immediately take all actions necessary to cease dis10 tribution of such infant formula and recall shipments of 

11 such infant formula from all wholesale and retail establish12 ments, consistent with recall regulations and guidelines 

13 issued by the Secretary. 

14 ‘‘(5)(A) Not later than 72 hours after receipt by the 

15 Director of the Office of Critical Foods of a notification 

16 under paragraph (1) or (2), the Director shall contact the 

17 manufacturer of the infant formula, or an affiliate thereof 

18 in the United States, to discuss corrective action. 

19 ‘‘(B) If there is a failure of the Director of the Office 

20 of Critical Foods to act within 72 hours after receipt of 

21 a notification as required by subparagraph (A), the Sec22 retary shall immediately notify the appropriate congres23 sional committees what, if any, accountability mechanisms 

24 were, or will be, invoked for such failure. 

25 ‘‘(6) The Director of the Office of Critical Foods— 


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1 ‘‘(A) not later than 90 days after receipt by the 

2 Director of a notification under paragraph (1) or 

3 (2), shall confirm that the manufacturer submitting 

4 the notification performed, or is performing, appro5 priate corrective action, including a root cause anal6 ysis; 

7 ‘‘(B) in making such confirmation, may collect 

8 documentation during an inspection, electronically, 

9 or by other means; and 

10 ‘‘(C) shall notify the appropriate congressional 

11 committees if the Director is unable to make such 

12 confirmation and what, if any, accountability mecha13 nisms were, or will be, invoked for such failure. 

14 ‘‘(7) Not later than the end of each of calendar years 

15 2024, 2025, and 2026, the Secretary shall submit to the 

16 Congress a report containing— 

17 ‘‘(A) the number of notifications received under 

18 paragraph (1) or (2) during the fiscal year ending 

19 in the respective calendar year; 

20 ‘‘(B) the average number of hours it took the 

21 Director of the Office of Critical Foods to initiate 

22 contact, as required by paragraph (5), in response to 

23 such notifications; 


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1 ‘‘(C) the longest and shortest time it took the 

2 Director of the Office of Critical Foods to so initiate 

3 contact; 

4 ‘‘(D) the average number of days it took the 

5 Director of the Office of Critical Foods to confirm 

6 corrective action, as required by paragraph (6), in 

7 response to such notifications; and 

8 ‘‘(E) the longest and shortest number of days 

9 it took the Director of the Office of Critical Foods 

10 to so confirm corrective action. 

11 ‘‘(8) For purposes of paragraphs (1) and (2), the 

12 term ‘knowledge’ as applied to a manufacturer means— 

13 ‘‘(A) the actual knowledge that the manufac14 turer had; or 

15 ‘‘(B) the knowledge which a reasonable person 

16 would have had under like circumstances or which 

17 would have been obtained upon the exercise of due 

18 care. 

19 ‘‘(9) For purposes of paragraph (2), the term ‘patho20 gen’ means a microorganism of public health signifi21 cance.’’. 

22 (b) TIMING.— 

23 (1) NOTIFICATION REQUIREMENTS.—Para24 graphs (1), (2), (3), (4), (8), and (9) of subsection 

25 (e) of section 412 of the Federal Food, Drug, and 


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1 Cosmetic Act (21 U.S.C. 350a), as amended by sub2 section (a), apply upon the enactment of this Act. 

3 (2) RESPONSE BY SECRETARY.—Not later than 

4 180 days after the date of enactment of this Act, the 

5 Secretary of Health and Human Services, acting 

6 through the Director of the Office of Critical Foods, 

7 shall establish a process for carrying out paragraphs 

8 (5) and (6) of subsection (e) of section 412 of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 350a), as amended by subsection (a), and begin im11 plementation of such process. 

Æ 


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