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Bill

S 4940

A bill to ensure the continued availability of specialized infant formula regulated by the Food and Drug Administration for preterm babies.

119th Congress Introduced by Joni Ernst

Ensures continued access to FDA-regulated specialized infant formula for preterm and medically vulnerable infants during shortages or disruptions.

Introduced in Senate
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Bill Summary · S 4940

Overview

S. 4940 (119th Congress) aims to ensure the continued availability of specialized infant formula regulated by the Food and Drug Administration (FDA) for preterm babies. Introduced in the Senate and referred to the Judiciary Committee, with Joni Ernst listed as a co-sponsor, the bill seeks to address potential shortages or lapses in access to medically necessary infant formulas used for preterm or otherwise medically underserved infants.

Purpose and Intent

  • Ensure uninterrupted access to FDA-regulated specialized infant formula for preterm and medically vulnerable infants.
  • Provide a legislative mechanism or authority to support continued supply, distribution, and regulatory oversight during shortages or transition periods.
  • Support parents, healthcare providers, and hospitals in delivering appropriate nutrition to preterm infants who rely on specialized formulas.

Key Provisions and Changes

  • The bill would affirm or establish the continued availability of specialized infant formula regulated by the FDA for preterm babies.
  • It may include specific measures to prevent or mitigate shortages, such as facilitating supply chain continuity, enabling continued production, import, or distribution of specialized formulas, and ensuring regulatory flexibility during emergencies or market disruptions.
  • Provisions could prescribe roles for federal agencies (e.g., FDA) and potential coordination with other departments (e.g., Health and Human Services, Treasury) to maintain supply and access.
  • The bill may establish reporting, oversight, or compliance requirements to monitor the availability of these formulas and address gaps promptly.
  • Any funding or appropriations details are not specified in the summary provided, but such measures could be contemplated to support implementation.

Who Would Be Affected

  • Preterm infants and other babies who rely on specialized, FDA-regulated infant formula for nutrition.
  • New parents and caregivers of preterm infants who depend on consistent access to medically necessary formula.
  • Hospitals, neonatal intensive care units (NICUs), pediatricians, and dietitians who prescribe or administer specialized formulas.
  • Manufacturers, distributors, and retailers of specialized infant formula, due to potential regulatory or supply-chain implications.
  • Federal regulatory agencies (primarily the FDA) responsible for oversee­ing infant formula safety and availability.

Procedural and Timeline Aspects

  • Introduced in the Senate and assigned to the Judiciary Committee on June 24, 2026.
  • The bill’s progression will depend on committee action (mark up, amendments) and subsequent floor consideration in the Senate.
  • As a Judiciary Committee referral, primary considerations may include regulatory authority, safety, and related legal implications; however, detailed procedural steps (e.g., hearing dates, reporting deadlines) are not provided in the available information.

Potential Impact and Considerations

  • If enacted, the bill could reduce risk of shortages in specialized infant formulas for preterm infants, potentially improving clinical outcomes and feeding stability in NICUs and home settings.
  • It may create or reinforce pathways for expedited production, importation, or distribution during supply disruptions.
  • The scope and funding mechanisms remain to be clarified; practical effects will hinge on the exact language about regulatory authority, enforcement, and funding.

If you’d like, I can tailor this summary to focus on stakeholders (hospitals, manufacturers, insurers) or compare it to related legislation on infant formula shortages.

Compiled from official sources — confirm details with the bill’s official record.

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