Summary of HR 2300: Preterm Infant Formula National Uniformity Act

Bill Number: HR 2300

Introduced: March 24, 2025

Status: Introduced in House

Primary Sponsor: Diana Harshbarger

Cosponsors: Bradley Scott Schneider, Mike Carey

Purpose and Intent

The primary aim of HR 2300 is to establish national uniformity regarding the requirements for preterm infant formula in the United States. The bill seeks to ensure that regulations governing the design, manufacture, and safety of preterm infant formula are consistent across federal and state levels, thereby enhancing safety and availability for vulnerable infants.

Key Provisions

Study and Report

• Secretary of Health and Human Services (HHS) Responsibilities:
  • The Secretary, through the Commissioner of Food and Drugs, is mandated to conduct a comprehensive study on:
  • The availability of preterm infant formula in the U.S.
  • Existing federal and state laws related to preterm infant formula.
  • The necessity of amending the Federal Food, Drug, and Cosmetic Act to require premarket approval for preterm infant formula.
  • A report detailing the findings of this study must be submitted to Congress within two years of the bill's enactment.

Preemption of State Laws

• Uniformity Requirement:
  • For a period starting from the enactment of the bill and lasting for two years, no state or local government may enforce laws or regulations regarding preterm infant formula that differ from federal standards.
  • This includes all aspects of preterm infant formula, such as design, testing, manufacturing, and labeling.

Exceptions

• Legal Actions:
  • The bill does not preempt civil or criminal actions against manufacturers for willful misconduct that results in serious injury or death.
  • If a manufacturer claims that a state law is preempted, the case may be moved to federal court.

Definitions

• Key Terms:
  • Preterm Infant Formula: Defined as any infant formula intended for infants born before 37 weeks of gestation or low-birth-weight infants.
  • Manufacturer: Refers to individuals or entities involved in the preparation, packaging, or labeling of preterm infant formula.

Impact

Affected Parties

• Manufacturers: The bill will directly impact manufacturers of preterm infant formula by standardizing regulations and potentially requiring premarket approval.
• States: State governments will have limited authority to impose additional regulations during the specified period.
• Infants and Caregivers: The legislation aims to enhance the safety and availability of preterm infant formula, benefiting infants who require specialized nutrition.

Procedural Aspects

• Legislative Actions: The bill was referred to the House Committee on Energy and Commerce on the same day it was introduced.
• Timeline: The Secretary of HHS is required to report back to Congress within two years of enactment, which will inform any potential amendments to existing laws regarding preterm infant formula.

In summary, HR 2300 seeks to create a more uniform regulatory environment for preterm infant formula, ensuring that safety standards are consistently applied across the nation while also addressing the specific needs of vulnerable infants.