I
119THCONGRESS
1
STSESSION H. R. 2300
To ensure national uniformity with respect to certain requirements relating
to preterm infant formula, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH24, 2025
Mrs. H
ARSHBARGER(for herself and Mr. SCHNEIDER) introduced the
following bill; which was referred to the Committee on Energy and Commerce
A BILL
To ensure national uniformity with respect to certain require-
ments relating to preterm infant formula, and for other
purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. PRETERM INFANT FORMULA. 3
(a) S
TUDY.— 4
(1) I
N GENERAL.—The Secretary of Health and 5
Human Services, acting through the Commissioner 6
of Food and Drugs, shall study— 7
(A) the availability of preterm infant for-8
mula in the United States; 9
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(B) Federal and State laws, regulations, 1
orders, and requirements, including under State 2
common law, that relate to preterm infant for-3
mula, including with respect to— 4
(i) the design, development, clinical 5
testing or investigation, formulation, man-6
ufacture, distribution, sale, donation, pur-7
chase, marketing, promotion, packaging, 8
labeling, licensing, and use of preterm in-9
fant formula; or 10
(ii) any aspect of the safety of 11
preterm infant formula; 12
(C) whether the Federal Food, Drug, and 13
Cosmetic Act (21 U.S.C. 301 et seq.) should be 14
amended to require a manufacturer of preterm 15
infant formula to obtain premarket approval for 16
such formula from the Food and Drug Admin-17
istration; and 18
(D) if the Secretary recommends such pre-19
market approval, a process and corresponding 20
requirements for such premarket approval. 21
(2) R
ECOMMENDATIONS .—Not later than two 22
years after the date of enactment of this Act, the 23
Secretary of Health and Human Services, acting 24
through the Commissioner of Food and Drugs, shall 25
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submit to the Congress a report on the results of the 1
study under paragraph (1). 2
(b) T
EMPORARYPREEMPTION.— 3
(1) P
ERIOD OF APPLICABILITY .—This sub-4
section applies only during the period— 5
(A) beginning on the date of enactment of 6
this Act; and 7
(B) ending on the date that is two years 8
after the date of enactment of this Act. 9
(2) P
REEMPTION.—Except as provided in para-10
graph (3), no State or political subdivision of a 11
State may establish, implement, or enforce with re-12
spect to preterm infant formula any requirement, in-13
cluding under any State statute, regulation, order, 14
or common law— 15
(A) that is different from, or in addition 16
to, any requirement applicable to preterm in-17
fant formula under the Federal Food, Drug, 18
and Cosmetic Act (21 U.S.C. 301 et seq.), the 19
Poison Prevention Packaging Act of 1970 (15 20
U.S.C. 1471 et seq.), or the Fair Packaging 21
and Labeling Act (15 U.S.C. 1451 et seq.); and 22
(B) that relates to preterm infant formula, 23
including— 24
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(i) the design, development, clinical 1
testing or investigation, formulation, man-2
ufacture, distribution, sale, donation, pur-3
chase, marketing, promotion, packaging, 4
labeling, licensing, and use of preterm in-5
fant formula; and 6
(ii) any aspect of the safety of 7
preterm infant formula. 8
(3) E
XCEPTION FOR CIVIL AND CRIMINAL AC -9
TIONS FOR WILLFUL MISCONDUCT .— 10
(A) E
XCEPTION.—Paragraph (2) does not 11
preempt civil or criminal actions based on a re-12
quirement described in paragraph (2) to the ex-13
tent such actions are against a manufacturer 14
for willful misconduct in the manufacturing or 15
production of preterm infant formula that 16
caused death or serious physical injury. 17
(B) R
EMOVAL.—In the case of a civil ac-18
tion brought in a State court against a manu-19
facturer, if that manufacturer alleges that the 20
law under which the action is brought is pre-21
empted by paragraph (2), such action may be 22
removed by the manufacturer to the district 23
court of the United States for the district and 24
division embracing the place wherein the civil 25
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action is pending. This subparagraph applies to 1
any action pending before, on, or after the date 2
of enactment of this Act, except to the extent 3
that there is a final judgment from which no 4
appeal may be taken and no further review may 5
be sought from a court of last resort, including 6
the Supreme Court of the United States. 7
(C) B
URDEN OF PROOF .—In determining 8
whether the exception in subparagraph (A) ap-9
plies, the plaintiff shall have the burden of 10
proving that the criteria described in subpara-11
graph (A) are met by clear and convincing evi-12
dence. 13
(4) D
ISMISSAL OF PENDING ACTIONS .—A civil 14
or criminal action that is pending as of the date of 15
enactment of this Act shall be dismissed to the ex-16
tent such action seeks to implement or enforce a re-17
quirement that is preempted by paragraph (2). 18
(c) D
EFINITIONS.—In this section: 19
(1) The term ‘‘infant formula’’ has the meaning 20
given to such term in section 201(z) of the Federal 21
Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)). 22
(2) The term ‘‘manufacturer’’— 23
(A) means a person who— 24
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(i) prepares, reconstitutes, or other-1
wise changes the physical or chemical char-2
acteristics of a preterm infant formula; or 3
(ii) packages or labels a preterm in-4
fant formula in a container for distribu-5
tion; and 6
(B) does not include a person taking ac-7
tions described in subparagraph (A) exclusively 8
for an infant under such person’s direct care. 9
(3) The term ‘‘preterm infant formula’’ means 10
any infant formula that is exempt under section 11
412(h)(1) of the Federal Food Drug, and Cosmetic 12
Act (21 U.S.C. 350a(h)) and intended to be admin-13
istered to— 14
(A) an infant born before 37 weeks of ges-15
tation; or 16
(B) a low-birth-weight infant. 17
(4) The term ‘‘willful misconduct’’ means, ex-18
cept as such term is further restricted pursuant to 19
subparagraph (B), an act or omission that is 20
taken— 21
(A) intentionally to achieve a wrongful 22
purpose; 23
(B) knowingly without legal or factual jus-24
tification; and 25
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(C) in disregard of a known or obvious risk 1
that is so great as to make it highly probable 2
that the harm will outweigh the benefit. 3
Æ
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