To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.
If enacted, HB2300 would temporarily preempt state regulations relating to preterm infant formula, establishing a federal standard for its manufacture and safety. This preemption is framed to last for two years following the bill's enactment and is intended to prevent a scenario where different states could impose varying requirements, potentially complicating compliance for manufacturers. The bill recognizes exceptions for civil and criminal actions based on willful misconduct, ensuring that manufacturers can still be held accountable for severe negligence that leads to harm.
House Bill 2300, introduced in March 2025, is aimed at establishing national uniformity regarding the regulations surrounding preterm infant formula. The bill mandates a study conducted by the Secretary of Health and Human Services to evaluate the current availability and regulation of preterm infant formula in the United States. This study will review existing federal and state laws, including the design, manufacturing, and safety aspects of preterm infant formula, and it may result in recommendations for requiring premarket approval from the Food and Drug Administration (FDA).
One point of contention surrounding HB2300 is the balance between federal oversight and state control over local safety regulations. Proponents argue that the national uniformity will enhance safety and streamline the regulatory process, facilitating better access to safe preterm infant formulas across the country. Conversely, critics may raise concerns about overreaching federal authority, suggesting that local needs and conditions could be overlooked in favor of a one-size-fits-all approach to regulation that might not adequately address specific community concerns.