The bill directs the Department of Health and Human Services to study the availability of preterm infant formula and related federal and state requirements. The study must consider whether manufacturers should need FDA premarket approval and, if recommended, how that approval could work. A report is due to Congress within two years of enactment.
For the first two years after enactment, states and local governments could not enforce requirements on preterm infant formula that differ from or add to certain federal requirements. The bill preserves civil and criminal actions against manufacturers for willful misconduct in manufacturing or production that caused death or serious physical injury. Plaintiffs would have to prove the exception applies by clear and convincing evidence. Certain pending actions would be dismissed to the extent they seek to enforce a preempted requirement.
The bill would temporarily limit state and local requirements concerning preterm infant formula. It would also require a federal study and report. The text does not describe how particular families, infants, or manufacturers would be affected.
The bill does not specify expenses or funding for the study.
No publicly available information.
No publicly available information.