I 
119TH CONGRESS 
1ST SESSION 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 
MARCH 24, 2025 
Mrs. HARSHBARGER (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-
tives of the United States of America in Congress assembled, 
SECTION 1. PRETERM INFANT FORMULA. 
(a) STUDY.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall study— 
(A) the availability of preterm infant for-
mula in the United States; 
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(B) Federal and State laws, regulations, 
orders, and requirements, including under State 
common law, that relate to preterm infant for-
mula, including with respect to— 
(i) the design, development, clinical 
testing or investigation, formulation, man-
ufacture, distribution, sale, donation, pur-
chase, marketing, promotion, packaging, 
labeling, licensing, and use of preterm in-
fant formula; or 
(ii) any aspect of the safety of 
preterm infant formula; 
(C) whether the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) should be 
amended to require a manufacturer of preterm 
infant formula to obtain premarket approval for 
such formula from the Food and Drug Admin-
istration; and 
(D) if the Secretary recommends such pre-
market approval, a process and corresponding 
requirements for such premarket approval. 
(2) RECOMMENDATIONS.—Not later than two 
years after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall 
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submit to the Congress a report on the results of the 
study under paragraph (1). 
(b) TEMPORARY PREEMPTION.— 
(1) PERIOD
OF
APPLICABILITY.—This sub-
section applies only during the period— 
(A) beginning on the date of enactment of 
this Act; and 
(B) ending on the date that is two years 
after the date of enactment of this Act. 
(2) PREEMPTION.—Except as provided in para-
graph (3), no State or political subdivision of a 
State may establish, implement, or enforce with re-
spect to preterm infant formula any requirement, in-
cluding under any State statute, regulation, order, 
or common law— 
(A) that is different from, or in addition 
to, any requirement applicable to preterm in-
fant formula under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), the 
Poison Prevention Packaging Act of 1970 (15 
U.S.C. 1471 et seq.), or the Fair Packaging 
and Labeling Act (15 U.S.C. 1451 et seq.); and 
(B) that relates to preterm infant formula, 
including— 
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(i) the design, development, clinical 
testing or investigation, formulation, man-
ufacture, distribution, sale, donation, pur-
chase, marketing, promotion, packaging, 
labeling, licensing, and use of preterm in-
fant formula; and 
(ii) any aspect of the safety of 
preterm infant formula. 
(3) EXCEPTION FOR CIVIL AND CRIMINAL AC-
TIONS FOR WILLFUL MISCONDUCT.— 
(A) EXCEPTION.—Paragraph (2) does not 
preempt civil or criminal actions based on a re-
quirement described in paragraph (2) to the ex-
tent such actions are against a manufacturer 
for willful misconduct in the manufacturing or 
production of preterm infant formula that 
caused death or serious physical injury. 
(B) REMOVAL.—In the case of a civil ac-
tion brought in a State court against a manu-
facturer, if that manufacturer alleges that the 
law under which the action is brought is pre-
empted by paragraph (2), such action may be 
removed by the manufacturer to the district 
court of the United States for the district and 
division embracing the place wherein the civil 
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(i) prepares, reconstitutes, or other-
wise changes the physical or chemical char-
acteristics of a preterm infant formula; or 
(ii) packages or labels a preterm in-
fant formula in a container for distribu-
tion; and 
(B) does not include a person taking ac-
tions described in subparagraph (A) exclusively 
for an infant under such person’s direct care. 
(3) The term ‘‘preterm infant formula’’ means 
any infant formula that is exempt under section 
412(h)(1) of the Federal Food Drug, and Cosmetic 
Act (21 U.S.C. 350a(h)) and intended to be admin-
istered to— 
(A) an infant born before 37 weeks of ges-
tation; or 
(B) a low-birth-weight infant. 
(4) The term ‘‘willful misconduct’’ means, ex-
cept as such term is further restricted pursuant to 
subparagraph (B), an act or omission that is 
taken— 
(A) intentionally to achieve a wrongful 
purpose; 
(B) knowingly without legal or factual jus-
tification; and 
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(C) in disregard of a known or obvious risk 
that is so great as to make it highly probable 
that the harm will outweigh the benefit. 
Æ 
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