This bill directs the Secretary of Health and Human Services to study and report on preterm infant formula regulations, temporarily prevents states from creating differing requirements, and defines key terms related to preterm infant formula.
Diana Harshbarger
Representative
TN-1
This bill directs the Secretary of Health and Human Services to study the availability, safety, and regulation of preterm infant formula and to report findings to Congress. It also establishes a temporary preemption of state laws that differ from federal requirements for preterm infant formula, while allowing legal actions against manufacturers for willful misconduct that results in death or serious injury. The bill defines key terms such as "preterm infant formula" and "willful misconduct" to clarify the scope and application of the legislation.
New Bill Orders Study on Preterm Infant Formula, Temporarily Halts New State Rules for Two Years
This legislation kicks off a deep dive into preterm infant formula across the country. Specifically, it directs the Secretary of Health and Human Services (HHS), via the FDA, to conduct a comprehensive study looking into everything from how available this specialized formula is, to the patchwork of federal and state laws governing its design, testing, manufacturing, and safety. The study also needs to weigh whether manufacturers should get FDA pre-approval before these formulas hit the market, and if so, what that process should look like. Congress expects a report back within two years.
States on Hold: Federal Rules Rule (Temporarily)
While that study is underway, the bill puts a two-year pause on states creating or enforcing their own rules for preterm infant formula if they differ from or add to existing federal standards under key laws like the Food, Drug, and Cosmetic Act. Think of it as hitting pause on new state-level requirements to potentially create a more uniform national standard down the line. This means, for the next two years, the federal rules are the main playbook for manufacturers regarding labeling, packaging, and safety standards covered by those specific federal acts.
Navigating Liability: The 'Willful Misconduct' Clause
The bill carves out an exception allowing lawsuits against manufacturers if willful misconduct in making the formula leads to death or serious injury. However, proving this won't be simple. The bill defines 'willful misconduct' very specifically: it requires showing an intentional act or omission done deliberately to achieve a wrongful purpose, knowing it was unjustified, and disregarding a known, obvious, and very high risk of harm. Anyone bringing such a case has the burden of proving this high standard with 'clear and convincing evidence,' which is a tougher legal threshold than in many standard civil cases. Furthermore, manufacturers facing these suits in state court can potentially move the case to federal court if they argue the state claim is overridden by this federal law. Any existing lawsuits based on state rules preempted by this bill would be dismissed.