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Committee adopts report language directing FDA to review authorities to stabilize preterm infant formula supply

3778704 · June 12, 2025

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Summary

The Appropriations committee approved an amendment directing the FDA to review authorities and potential actions to maintain the stability of the market for preterm infant formulas, amid debate about litigation, plant conditions and market concentration.

Representative Julia Letlow of Louisiana offered and the committee approved report language directing the Food and Drug Administration to review its authorities and options to preserve the stability of the preterm infant formula market. Sponsors said litigation and other pressures threaten supply for infants who require specialized formulas.

Supporters, including the subcommittee chair and other members, described preterm infants as a uniquely vulnerable population that requires specialized nutrition and pointed to ongoing lawsuits and the need for FDA follow-up on previously issued consensus statements with CDC and NIH. Opponents warned that the amendment’s language could be read to encourage limited liability protections for manufacturers; several members urged caution and said they would prefer narrower language limited to requesting a report without endorsing protections.

After extended debate and a roll-call vote, the clerk reported the ayes at 34 and the noes at 27 and the amendment was adopted. The committee’s report now urges FDA to assess authorities, regulatory pathways, and possible interventions to ensure continued supply for preterm infants and to report back to the committee.