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) intro-
duced 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. 
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 ‘‘Baby Food Safety Act 
of 2023’’. 
SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
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‘‘(tt) The term ‘infant and toddler food’— 
‘‘(1) means foods intended for infants and chil-
dren less than two years of age; and 
‘‘(2) includes infant formula.’’. 
SEC. 3. TOXIC ELEMENTS IN INFANT AND TODDLER FOOD. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 425. TOXIC ELEMENTS IN INFANT AND TODDLER 
FOOD. 
‘‘(a) IN GENERAL.—The Secretary, by administrative 
order— 
‘‘(1) shall establish limits for lead, cadmium, 
mercury, and inorganic arsenic in infant and toddler 
food; and 
‘‘(2) if determined by the Secretary to be ap-
propriate upon review of relevant health data and 
other relevant information, may— 
‘‘(A) establish limits for additional toxic 
elements in infant and toddler food; and 
‘‘(B) revise limits established pursuant to 
paragraph (1) or subparagraph (A). 
‘‘(b) PROCEDURE.—In establishing or revising any 
limit under subsection (a), the Secretary shall— 
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‘‘(1) evaluate relevant health data and other 
relevant information; 
‘‘(2) take into account relevant differences 
among infant and toddler food types, groups, or cat-
egories, as appropriate, including— 
‘‘(A) the feasibility of achieving the limit 
based on the food type, group, or category; and 
‘‘(B) the extent to which the level of a 
toxic element in infant and toddler food is as 
low as reasonably achievable; and 
‘‘(3) notwithstanding the requirements of sub-
chapter II of chapter 5 of title 5, United States 
Code, and chapter 6 of title 5, United States Code— 
‘‘(A) publish any administrative order 
under subsection (a) in the Federal Register 
following— 
‘‘(i) publication of a proposed order in 
the Federal Register; and 
‘‘(ii) consideration of comments to a 
public docket open for no fewer than 45 
calendar days; and 
‘‘(B) set forth in any proposed or final ad-
ministrative order under subsection (a) a sub-
stantive summary of the valid scientific evidence 
concerning the proposed or final limit. 
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‘‘(c) TIMEFRAME FOR INITIAL LIMITS.— 
‘‘(1) IN GENERAL.—Subject to the deadlines for 
final orders under paragraph (2), the Secretary shall 
issue orders for limits under subsection (a) as fol-
lows: 
‘‘(A) For each of lead, inorganic arsenic, 
and cadmium, a proposed order not later than 
December 31, 2025, and a final order not later 
than June 30, 2027. 
‘‘(B) For mercury, a proposed order not 
later than April 30, 2029, and a final order not 
later than October 31, 2030. 
‘‘(2) FINAL ORDERS.—The Secretary shall issue 
each final administrative order for a limit estab-
lished pursuant to subparagraph (a)(1) not later 
than the earlier of— 
‘‘(A) the applicable deadline for a final 
order specified in paragraph (1); and 
‘‘(B) 18 months after issuance of the re-
spective proposed order. 
‘‘(d) CRITERIA.—The limits established under this 
section shall represent the level at which the toxic element 
may render the infant and toddler food injurious to health, 
taking into account— 
‘‘(1) the protection of the public health; and 
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‘‘(2) the extent to which the level of the toxic 
element is as low as reasonably achievable. 
‘‘(e) GUIDANCE.—Whenever the Secretary publishes 
a new or revised limit for a toxic element under this sec-
tion, the Secretary shall publish, together with the admin-
istrative order establishing or revising such limit, guidance 
concerning compliance with such limit. 
‘‘(f) PERIODIC REVIEW.—The Secretary shall peri-
odically, or as relevant data is made available, review the 
limits and guidance established under this section to con-
sider whether such limits and guidance should be revised, 
following the applicable procedures and criteria under this 
section.’’. 
SEC. 4. ADULTERATION. 
Section 402 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 342) is amended by adding at the end the 
following new subsection: 
‘‘(j) If it is an article of infant and toddler food in 
final product form that bears or contains any toxic ele-
ment in excess of a limit established under section 425(a) 
taking into consideration variability of the validated meth-
od of analysis.’’. 
SEC. 5. MANDATORY RECALL AUTHORITY. 
Section 423(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350l(a)) is amended by inserting 
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after ‘‘animals,’’ the following: ‘‘or if the Secretary deter-
mines through any means that an article of infant and 
toddler food (other than infant formula) bears or contains 
a toxic element that renders the product adulterated under 
section 402(a)(1) or 402(j),’’. 
Æ 
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