Preterm Formula Bill Freezes State Safety Rules for Two Years, Mandates Federal Study on Availability

This new legislation takes aim at the highly specialized world of preterm infant formula—the food designed for babies born early or with very low birth weights. The bill’s main goal is to create national uniformity regarding how this formula is regulated, manufactured, and sold.

First, the bill mandates that the Secretary of Health and Human Services (HHS), via the FDA Commissioner, conduct a thorough study. This study needs to dig into the current availability of preterm formula and review every federal and state law that touches on its design, testing, labeling, and safety. A key question the FDA must answer is whether manufacturers should be required to get premarket approval, similar to how new drugs are handled. If they decide approval is necessary, they have to lay out exactly what that process would look like (Sec. 1).

The Two-Year State Rule Freeze

Here’s the part that impacts state-level protections immediately: For two years following enactment, states and local governments are temporarily blocked from enforcing any rules about preterm infant formula that are different from or add to existing federal regulations. This means if your state had a stricter rule about formula labeling or safety testing than the federal standard, that rule is effectively paused for 24 months. The idea is to streamline the supply chain and ensure manufacturers only have one set of rules to follow nationwide, but the practical effect is that any stricter consumer safeguards currently in place at the state level are temporarily suspended (Sec. 1).

Accountability for Catastrophic Harm

While the bill blocks states from enforcing most regulatory laws, it carves out a critical exception for the most serious cases. The temporary freeze does not stop civil lawsuits or criminal charges against a manufacturer if their "willful misconduct" in production caused an infant’s death or serious physical injury. This is a vital provision, ensuring manufacturers can still be held accountable when intentional, egregious actions lead to tragedy.

However, there’s a massive hurdle here: If a parent or guardian sues, they must prove that misconduct by “clear and convincing evidence.” That’s a much higher legal standard than what’s typically required in a civil case. "Willful misconduct" is defined extremely narrowly—it means the manufacturer intentionally acted for a wrong reason, knowing the risk was so high that the resulting harm was almost certain to outweigh any benefit. For busy families, this means that while the door to justice remains technically open for the most catastrophic failures, the burden of proof is set incredibly high, making it difficult to win even if negligence occurred (Sec. 1).

Finally, manufacturers get a procedural advantage: If they are sued in state court over something the federal law now preempts, they have the right to move that case to federal court. This shift could change the legal landscape and costs for plaintiffs, depending on the jurisdiction.