# 119-hr-2300: To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.

119-hr-2300, To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes., is a 119th Congress bill sponsored by Rep. Harshbarger, Diana [R-TN-1] (R-TN); status introduced; PRIA reads it as touching household money (as of 2025-12-21).

- Canonical: https://policyrisk.com/legislation/119-hr-2300
- As of: 2025-12-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-2300
- Congress: 119
- Title: To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.
- Status: introduced
- Introduced: 2025-03-24
- Sponsor: Rep. Harshbarger, Diana [R-TN-1] (R-TN)
- Cosponsors: 2
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2025-12-21

## 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. - 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.

## Cosponsors (2)

- Rep. Schneider, Bradley Scott [D-IL-10] (D-IL), 2025-03-24T00:00:00.000Z
- Rep. Carey, Mike [R-OH-15] (R-OH), 2025-04-24T00:00:00.000Z

## Provisions PRIA read

- FDA study on preterm infant formula: benefit, medium. 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 rep…
- Two-year limit on state preterm formula rules: mixed, medium. 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…
- Defines preterm formula and manufacturers: mixed, low. 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 the…

## Related bills

- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-5509: Safe Step Act
- 119-hr-2853: Combating Organized Retail Crime Act of 2025
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025
- 119-hr-3164: Ensuring Community Access to Pharmacist Services Act

## Sources
- [119-hr-2300 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/2300)

## Related
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-5509: Safe Step Act](https://policyrisk.com/legislation/119-hr-5509)
- [119-hr-2853: Combating Organized Retail Crime Act of 2025](https://policyrisk.com/legislation/119-hr-2853)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [119-hr-3164: Ensuring Community Access to Pharmacist Services Act](https://policyrisk.com/legislation/119-hr-3164)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-2300 (as of 2025-12-21).