H.R.2300 - To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes. (119th Congress)
Summary
H.R.2300 aims to ensure national uniformity in requirements for preterm infant formula. It mandates a study by the Secretary of Health and Human Services, through the FDA Commissioner, on the availability, regulation, and potential premarket approval process for such formulas. The bill also includes a temporary preemption of state laws regarding preterm infant formula, with an exception for willful misconduct leading to death or serious injury.
Expected Effects
The bill, if enacted, would lead to a standardized national approach to regulating preterm infant formula. This could streamline the manufacturing and distribution process. The temporary preemption of state laws could reduce regulatory burdens on manufacturers, while the study could inform future federal regulations.
Potential Benefits
- National Uniformity: Creates consistent standards for preterm infant formula across states.
- Study and Recommendations: The HHS study could lead to improved safety and availability of preterm infant formula.
- Reduced Regulatory Burden: Temporary preemption may lower compliance costs for manufacturers.
- Focus on Safety: The exception for willful misconduct ensures accountability for manufacturers.
- Potential for Improved Access: Standardized regulations could streamline production and distribution.
Potential Disadvantages
- Limited State Authority: Temporary preemption restricts states' ability to address specific local concerns.
- Potential for Weaker Standards: National standards might be less stringent than some state regulations.
- Delayed Action: The study and report requirement delays any permanent regulatory changes for two years.
- Burden of Proof: The plaintiff bears a high burden of proof (clear and convincing evidence) in cases of willful misconduct.
- Removal of Cases to Federal Court: Shifts legal actions from state to federal court, potentially increasing costs and complexity for plaintiffs.
Constitutional Alignment
The bill's focus on regulating interstate commerce aligns with the Commerce Clause (Article I, Section 8, Clause 3) of the U.S. Constitution, which grants Congress the power to regulate commerce among the states. The preemption of state laws raises federalism concerns, but is permissible under the Supremacy Clause (Article VI, Clause 2) when Congress acts within its constitutional authority. The study mandated by the bill falls under Congress's power to legislate for the general welfare.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).