HR 2300119th CongressIn Committee

To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.

Introduced: Mar 24, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

This bill aims to create national uniformity in how preterm infant formula is regulated and, while that uniformity is being pursued, to temporarily shield states from imposing different rules. Specifically, it requires the Department of Health and Human Services (through the FDA) to study the availability of preterm formula, review existing federal and state laws and requirements related to preterm formula (including safety, labeling, manufacturing, and promotion), and consider whether the FDA should require premarket approval for preterm formula. If the bill is enacted, there would be a two-year period of federal preemption preventing states from enacting or enforcing differing requirements for preterm formula (with limited exceptions). The act also defines key terms and sets out certain procedures for actions already in progress and for handling willful misconduct. In short, the bill seeks to (1) evaluate the need for tighter federal oversight of preterm formula, (2) potentially establish a premarket approval pathway, and (3) temporarily preempt state and local rules to maintain national consistency while the study and any recommended federal changes are developed.

Key Points

1Study and report requirement: The Secretary of Health and Human Services, via the Commissioner of Food and Drugs, must study the availability of preterm infant formula, current federal/state laws and requirements affecting it (covering design, testing, manufacturing, distribution, marketing, labeling, licensing, and safety), and whether the FDA should require premarket approval for preterm formula, including a recommended process if PMA is advised. A report to Congress is due within two years of enactment.
2Temporary federal preemption (two-year window): From enactment until two years after enactment, states and their subdivisions may not establish or enforce requirements for preterm formula that differ from or add to federal law (FD&C Act, Poison Prevention Packaging Act, or Fair Packaging and Labeling Act). This covers broad aspects such as design, development, testing, formulation, manufacturing, distribution, marketing, packaging, labeling, licensing, use, and safety.
3Exceptions to preemption: Civil or criminal actions based on willful misconduct in manufacturing/producing preterm formula that caused death or serious physical injury are not preempted. Actions may be removed to federal court, and the plaintiff bears the burden of proving the exception by clear and convincing evidence.
4Handling pending actions and preemption: Any civil or criminal action pending at enactment seeking enforcement of preempted state requirements shall be dismissed to the extent it seeks to enforce those preempted requirements.
5Definitions: The bill provides precise definitions for terms including infant formula, manufacturer, preterm infant formula (formula exempt under FD&C Act and intended for infants born before 37 weeks or with low birth weight), and willful misconduct (as defined in the bill with specified criteria).

Impact Areas

Primary group/area affected- Manufacturers and suppliers of preterm infant formula (potentially affected by a possible move toward PMA and uniform federal standards).- Federal and state public health and regulatory agencies (FDA and state agencies would align under a temporary national rule and the study’s findings).Secondary group/area affected- Hospitals, NICUs, pediatricians, and other healthcare providers who rely on preterm formula for care of high-risk infants.- Parents and caregivers of preterm or low-birth-weight infants (impacting product availability, labeling, and safety assurances).Additional impacts- States and localities: during the two-year window, limited ability to pursue or enforce state-specific requirements related to preterm formula.- Legal landscape: potential shift toward federal oversight may affect litigation strategy and preemption-related disputes, especially around the willful-misconduct exception and removal to federal court.- Market dynamics: possible changes in time-to-market for preterm formula if PMA is pursued, and potential effects on price, competition, and supply depending on the study’s findings and any subsequent regulatory actions.The bill is introduced and referred to the House Committee on Energy and Commerce. Sponsors include Mrs. Harshbarger and Mr. Schneider.The text relies on the interplay between the FD&C Act, the Poison Prevention Packaging Act, and the Fair Packaging and Labeling Act to define the scope of federal preemption during the temporary window.

Generated by gpt-5-nano on Nov 1, 2025