119-hr2300

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2300 Introduced in House

    (IH) ]

<DOC>

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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