This bill directs the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to conduct a comprehensive study on preterm infant formula. The study will examine the availability of such formula in the United States, analyze existing federal and state laws and regulations governing its design, manufacturing, and safety, and assess whether premarket approval by the Food and Drug Administration should be required. A report detailing the study's findings and recommendations must be submitted to Congress within two years of the bill's enactment. For a two-year period following enactment, the bill establishes a temporary preemption , prohibiting states or their political subdivisions from imposing requirements on preterm infant formula that are different from or in addition to existing federal laws. This preemption covers various aspects, including the formula's design, manufacturing, distribution, marketing, and safety. However, an important exception allows for civil or criminal actions against a manufacturer for willful misconduct in manufacturing that results in death or serious physical injury. Manufacturers may remove such civil actions to federal court, and the plaintiff bears the burden of proving willful misconduct by clear and convincing evidence. Any pending actions that are preempted by this provision must be dismissed.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.
USA119th CongressHR-2300| House
| Updated: 3/24/2025
This bill directs the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to conduct a comprehensive study on preterm infant formula. The study will examine the availability of such formula in the United States, analyze existing federal and state laws and regulations governing its design, manufacturing, and safety, and assess whether premarket approval by the Food and Drug Administration should be required. A report detailing the study's findings and recommendations must be submitted to Congress within two years of the bill's enactment. For a two-year period following enactment, the bill establishes a temporary preemption , prohibiting states or their political subdivisions from imposing requirements on preterm infant formula that are different from or in addition to existing federal laws. This preemption covers various aspects, including the formula's design, manufacturing, distribution, marketing, and safety. However, an important exception allows for civil or criminal actions against a manufacturer for willful misconduct in manufacturing that results in death or serious physical injury. Manufacturers may remove such civil actions to federal court, and the plaintiff bears the burden of proving willful misconduct by clear and convincing evidence. Any pending actions that are preempted by this provision must be dismissed.