[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2300 Introduced in House (IH)]
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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 requirements
relating to preterm infant formula, and for other purposes.
Be it enacted by the Senate and House of Representatives 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 formula in
the United States;
(B) Federal and State laws, regulations, orders,
and requirements, including under State common law,
that relate to preterm infant formula, including with
respect to--
(i) the design, development, clinical
testing or investigation, formulation,
manufacture, distribution, sale, donation,
purchase, marketing, promotion, packaging,
labeling, licensing, and use of preterm infant
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 Administration; and
(D) if the Secretary recommends such premarket
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 submit to the Congress a report on the results of
the study under paragraph (1).
(b) Temporary Preemption.--
(1) Period of applicability.--This subsection 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 paragraph (3), no
State or political subdivision of a State may establish,
implement, or enforce with respect to preterm infant formula
any requirement, including under any State statute, regulation,
order, or common law--
(A) that is different from, or in addition to, any
requirement applicable to preterm infant 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--
(i) the design, development, clinical
testing or investigation, formulation,
manufacture, distribution, sale, donation,
purchase, marketing, promotion, packaging,
labeling, licensing, and use of preterm infant
formula; and
(ii) any aspect of the safety of preterm
infant formula.
(3) Exception for civil and criminal actions for willful
misconduct.--
(A) Exception.--Paragraph (2) does not preempt
civil or criminal actions based on a requirement
described in paragraph (2) to the extent 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 action brought
in a State court against a manufacturer, if that
manufacturer alleges that the law under which the
action is brought is preempted 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
action is pending. This subparagraph applies to any
action pending before, on, or after the date of
enactment of this Act, except to the extent that there
is a final judgment from which no appeal may be taken
and no further review may be sought from a court of
last resort, including the Supreme Court of the United
States.
(C) Burden of proof.--In determining whether the
exception in subparagraph (A) applies, the plaintiff
shall have the burden of proving that the criteria
described in subparagraph (A) are met by clear and
convincing evidence.
(4) Dismissal of pending actions.--A civil or criminal
action that is pending as of the date of enactment of this Act
shall be dismissed to the extent such action seeks to implement
or enforce a requirement that is preempted by paragraph (2).
(c) Definitions.--In this section:
(1) The term ``infant formula'' has the meaning given to
such term in section 201(z) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(z)).
(2) The term ``manufacturer''--
(A) means a person who--
(i) prepares, reconstitutes, or otherwise
changes the physical or chemical
characteristics of a preterm infant formula; or
(ii) packages or labels a preterm infant
formula in a container for distribution; and
(B) does not include a person taking actions
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 administered to--
(A) an infant born before 37 weeks of gestation; or
(B) a low-birth-weight infant.
(4) The term ``willful misconduct'' means, except 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
justification; and
(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.
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