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119-hr-2300119th CongressWALLET

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

Sponsored By: Representative Harshbarger, Diana [R-TN-1]

Introduced

Summary

temporary federal preemption and a federal study of preterm infant formula. This bill would require the HHS Secretary, through the FDA Commissioner, to study availability, laws, and safety for preterm infant formula and report to Congress within 2 years, and would bar states from imposing different or additional requirements for 2 years.

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  • Families and clinicians caring for preterm or low-birth-weight infants would see a federal review that could lead to new FDA premarket approval requirements for formulas intended for infants born before 37 weeks.
  • State and local governments would be blocked for 2 years from creating or enforcing requirements about design, labeling, manufacture, sale, or use of preterm infant formula that differ from federal law.
  • Manufacturers would face a federal examination of whether premarket approval should be required, and pending civil or criminal actions enforcing preempted state rules would be dismissed while a narrow exception allows suits for willful misconduct causing death or serious injury if proven by clear and convincing evidence.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 1 benefits, 0 costs, 2 mixed.

FDA study on preterm infant formula

HHS, through FDA, would study preterm infant formula in the United States. The study would look at availability, safety, testing, labeling, and how it is made and sold. It would also review federal and state laws and whether FDA should require premarket approval. If FDA recommends approval, the report would include how that process should work. The report would be due to Congress within two years of enactment.

Two-year limit on state preterm formula rules

For two years after enactment, states would not be able to enforce rules on preterm infant formula that go beyond federal law. This would cover safety, testing, labeling, packaging, marketing, and similar steps. Civil or criminal cases could still go forward only for willful misconduct that caused death or serious injury. Plaintiffs would need to prove that by clear and convincing evidence. Cases based on preempted state rules would be dismissed, and companies could move cases to federal court.

Defines preterm formula and manufacturers

The bill would define what counts as preterm infant formula. It would cover formulas for babies born before 37 weeks or with low birth weight that are already exempt under federal law. It would also define who counts as a manufacturer, including companies that prepare, change, package, or label these products. People doing these steps only for a baby in their direct care would not be treated as manufacturers.

Sponsors & CoSponsors

Sponsor

Harshbarger, Diana [R-TN-1]

TN • R

Cosponsors

  • Rep. Schneider, Bradley Scott [D-IL-10]

    IL • D

    Sponsored 3/24/2025

  • Rep. Carey, Mike [R-OH-15]

    OH • R

    Sponsored 4/24/2025

Roll Call Votes

No roll call votes available for this bill.

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