To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.

This bill requires a study on preterm infant formula and temporarily prevents states from adding their own requirements beyond federal law. It also defines key terms and allows certain lawsuits for willful misconduct.

Sec. 1, Study: The Secretary of Health and Human Services, through the FDA Commissioner, must study the availability of preterm infant formula, all federal and state laws related to it, whether the Federal Food, Drug, and Cosmetic Act should require premarket approval for such formula, and if so, a process for that approval. A report to Congress is due within two years of enactment.

Sec. 1, Temporary Preemption: For two years after enactment, no state or local government may create or enforce any requirement for preterm infant formula that is different from or additional to federal laws under the Federal Food, Drug, and Cosmetic Act, the Poison Prevention Packaging Act, or the Fair Packaging and Labeling Act. This covers design, development, testing, manufacturing, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, and safety.

Sec. 1, Exception for Willful Misconduct: The preemption does not block civil or criminal lawsuits against a manufacturer for willful misconduct in manufacturing or production that caused death or serious injury. A manufacturer can move such a state court case to federal court if they claim the law is preempted. The plaintiff must prove willful misconduct by clear and convincing evidence.

Sec. 1, Dismissal of Pending Actions: Any pending civil or criminal action that tries to enforce a requirement preempted by this section must be dismissed.

Sec. 1, Definitions: "Infant formula" is defined by the Federal Food, Drug, and Cosmetic Act. "Manufacturer" means someone who prepares, reconstitutes, changes, packages, or labels preterm infant formula for distribution, but not someone doing so only for an infant in their direct care. "Preterm infant formula" means infant formula exempt under a specific federal law and intended for infants born before 37 weeks or low-birth-weight infants. "Willful misconduct" means an act or omission done intentionally for a wrongful purpose, knowingly without justification, and disregarding a known or obvious risk that harm will likely outweigh benefit.