I 

118TH CONGRESS 

1ST SESSION H. R. 6756 

To amend the Federal Food, Drug, and Cosmetic Act to establish limits 

on certain toxic elements in infant and toddler food, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 13, 2023 

Mr. KRISHNAMOORTHI (for himself, Mr. CA ́RDENAS, and Mrs. SYKES) introduced the following bill; which was referred to the Committee on Energy 

and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

establish limits on certain toxic elements in infant and 

toddler food, 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 ‘‘Baby Food Safety Act 

5 of 2023’’. 

6 SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD. 

7 Section 201 of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 321) is amended by adding at the end the 

9 following: 


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1 ‘‘(tt) The term ‘infant and toddler food’— 

2 ‘‘(1) means foods intended for infants and chil3 dren less than two years of age; and 

4 ‘‘(2) includes infant formula.’’. 

5 SEC. 3. TOXIC ELEMENTS IN INFANT AND TODDLER FOOD. 

6 Chapter IV of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 341 et seq.) is amended by adding at the 

8 end the following: 

9 ‘‘SEC. 425. TOXIC ELEMENTS IN INFANT AND TODDLER 

10 FOOD. 

11 ‘‘(a) IN GENERAL.—The Secretary, by administrative 

12 order— 

13 ‘‘(1) shall establish limits for lead, cadmium, 

14 mercury, and inorganic arsenic in infant and toddler 

15 food; and 

16 ‘‘(2) if determined by the Secretary to be ap17 propriate upon review of relevant health data and 

18 other relevant information, may— 

19 ‘‘(A) establish limits for additional toxic 

20 elements in infant and toddler food; and 

21 ‘‘(B) revise limits established pursuant to 

22 paragraph (1) or subparagraph (A). 

23 ‘‘(b) PROCEDURE.—In establishing or revising any 

24 limit under subsection (a), the Secretary shall— 


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1 ‘‘(1) evaluate relevant health data and other 

2 relevant information; 

3 ‘‘(2) take into account relevant differences 

4 among infant and toddler food types, groups, or cat5 egories, as appropriate, including— 

6 ‘‘(A) the feasibility of achieving the limit 

7 based on the food type, group, or category; and 

8 ‘‘(B) the extent to which the level of a 

9 toxic element in infant and toddler food is as 

10 low as reasonably achievable; and 

11 ‘‘(3) notwithstanding the requirements of sub12 chapter II of chapter 5 of title 5, United States 

13 Code, and chapter 6 of title 5, United States Code— 

14 ‘‘(A) publish any administrative order 

15 under subsection (a) in the Federal Register 

16 following— 

17 ‘‘(i) publication of a proposed order in 

18 the Federal Register; and 

19 ‘‘(ii) consideration of comments to a 

20 public docket open for no fewer than 45 

21 calendar days; and 

22 ‘‘(B) set forth in any proposed or final ad23 ministrative order under subsection (a) a sub24 stantive summary of the valid scientific evidence 

25 concerning the proposed or final limit. 


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1 ‘‘(c) TIMEFRAME FOR INITIAL LIMITS.— 

2 ‘‘(1) IN GENERAL.—Subject to the deadlines for 

3 final orders under paragraph (2), the Secretary shall 

4 issue orders for limits under subsection (a) as fol5 lows: 

6 ‘‘(A) For each of lead, inorganic arsenic, 

7 and cadmium, a proposed order not later than 

8 December 31, 2025, and a final order not later 

9 than June 30, 2027. 

10 ‘‘(B) For mercury, a proposed order not 

11 later than April 30, 2029, and a final order not 

12 later than October 31, 2030. 

13 ‘‘(2) FINAL ORDERS.—The Secretary shall issue 

14 each final administrative order for a limit estab15 lished pursuant to subparagraph (a)(1) not later 

16 than the earlier of— 

17 ‘‘(A) the applicable deadline for a final 

18 order specified in paragraph (1); and 

19 ‘‘(B) 18 months after issuance of the re20 spective proposed order. 

21 ‘‘(d) CRITERIA.—The limits established under this 

22 section shall represent the level at which the toxic element 

23 may render the infant and toddler food injurious to health, 

24 taking into account— 

25 ‘‘(1) the protection of the public health; and 


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1 ‘‘(2) the extent to which the level of the toxic 

2 element is as low as reasonably achievable. 

3 ‘‘(e) GUIDANCE.—Whenever the Secretary publishes 

4 a new or revised limit for a toxic element under this sec5 tion, the Secretary shall publish, together with the admin6 istrative order establishing or revising such limit, guidance 

7 concerning compliance with such limit. 

8 ‘‘(f) PERIODIC REVIEW.—The Secretary shall peri9 odically, or as relevant data is made available, review the 

10 limits and guidance established under this section to con11 sider whether such limits and guidance should be revised, 

12 following the applicable procedures and criteria under this 

13 section.’’. 

14 SEC. 4. ADULTERATION. 

15 Section 402 of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 342) is amended by adding at the end the 

17 following new subsection: 

18 ‘‘(j) If it is an article of infant and toddler food in 

19 final product form that bears or contains any toxic ele20 ment in excess of a limit established under section 425(a) 

21 taking into consideration variability of the validated meth22 od of analysis.’’. 

23 SEC. 5. MANDATORY RECALL AUTHORITY. 

24 Section 423(a) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 350l(a)) is amended by inserting 


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1 after ‘‘animals,’’ the following: ‘‘or if the Secretary deter2 mines through any means that an article of infant and 

3 toddler food (other than infant formula) bears or contains 

4 a toxic element that renders the product adulterated under 

5 section 402(a)(1) or 402(j),’’. 

Æ 


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