Bill > HR2300

This bill proposes a comprehensive approach to studying and temporarily regulating preterm infant formula in the United States. The Secretary of Health and Human Services is required to conduct a two-year study examining the availability of preterm infant formula, current federal and state laws governing its production and use, and whether the Food and Drug Administration (FDA) should implement a premarket approval process for such formulas. During this two-year period, the bill temporarily preempts states from establishing any additional or different requirements regarding preterm infant formula's design, development, manufacturing, distribution, marketing, packaging, labeling, or safety beyond existing federal regulations. The bill does allow for civil and criminal actions against manufacturers for "willful misconduct" that results in death or serious physical injury, with the plaintiff bearing the burden of proving such misconduct by clear and convincing evidence. The bill provides specific definitions for key terms like "infant formula," "manufacturer," and "preterm infant formula," which generally refers to formula intended for infants born before 37 weeks of gestation or with low birth weight. At the end of the two-year study period, Congress will receive a report with the Secretary's findings and recommendations for potential regulatory changes.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/2300/all-info