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

Bill Number

H.R. 2300

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-03-24: Referred to the House Committee on Energy and Commerce.

Last Updated

2025-04-25T08:05:27Z

AI-Generated Summary

Purpose of the Legislation

This bill aims to create national uniformity in regulations for preterm infant formula, a specialized product for premature or low-birth-weight babies. It directs a federal study on the formula's regulation and temporarily blocks state or local rules that differ from federal standards, while exploring new federal approval requirements.

Key Provisions

• Federal Study and Report: The Secretary of Health and Human Services (HHS), through the Food and Drug Administration (FDA) Commissioner, must conduct a study on:
• The availability of preterm infant formula in the U.S.
• Existing federal and state laws, rules, and court decisions related to the formula's design, testing, production, distribution, sale, marketing, packaging, labeling, licensing, use, and safety.
• Whether the Federal Food, Drug, and Cosmetic Act (FD&C Act)—the main U.S. law governing food and drug safety—should be updated to require manufacturers to get FDA premarket approval (official permission before selling) for preterm infant formula.
• If premarket approval is recommended, details on the process and rules for it.
• A report with findings and recommendations must be sent to Congress within two years of the bill's enactment.

• Temporary Preemption of State and Local Rules: For two years starting from enactment:
• States and local governments cannot create, apply, or enforce any rules on preterm infant formula that differ from or add to federal laws like the FD&C Act, the Poison Prevention Packaging Act (which requires child-resistant packaging for certain products), or the Fair Packaging and Labeling Act (which sets standards for product labels).
• This covers all aspects of the formula, including its development, manufacturing, safety, and marketing.

• Exceptions and Legal Processes:
• Civil (non-criminal lawsuits) or criminal cases against manufacturers are allowed if they involve "willful misconduct" (intentional wrongful acts or knowing risks that cause death or serious injury during manufacturing). The plaintiff (person suing) must prove this by "clear and convincing evidence" (a high standard, stronger than usual proof in civil cases).
• Manufacturers can move such state court cases to federal court if they claim preemption (federal law overrides state law).
• Any ongoing cases as of enactment that try to enforce preempted state rules must be dismissed.

• Definitions:
• Preterm infant formula: A type of infant formula exempt from standard FDA nutrition rules, meant for babies born before 37 weeks or with low birth weight.
• Manufacturer: Anyone who prepares, changes, packages, or labels the formula for sale or distribution (but not those doing so only for babies in their direct care, like hospitals).
• Infant formula: As defined in the FD&C Act, a food for babies up to 12 months to replace breast milk.
• Willful misconduct: Intentional acts for a wrongful purpose, without justification, ignoring a high risk of harm.

Significant Changes to Existing Law

• Introduces a temporary (two-year) federal override of state and local regulations on preterm infant formula, which previously could vary by location and sometimes impose stricter rules than federal ones.
• Mandates a study that could lead to amending the FD&C Act to require premarket FDA approval, a new step not currently needed for this exempt category of formula (unlike regular infant formula, which has strict federal oversight but no premarket approval).
• Adds specific protections for manufacturers, like easier case removal to federal court and dismissal of conflicting pending lawsuits, shifting more control to federal law during the preemption period.

Potential Impacts

• Government Agencies: The FDA/HHS will need resources for the two-year study and potential new approval processes, increasing federal oversight of infant nutrition products. States may lose flexibility in regulating local safety or access issues temporarily.
• Citizens: Premature or low-birth-weight infants and their families could benefit from uniform national availability and safety standards, reducing confusion from varying state rules. However, the preemption might limit quicker state responses to local concerns, and any new federal approval could affect formula options or prices.
• International Relations: No direct impacts mentioned; the bill focuses on domestic U.S. regulation and does not address imports or foreign manufacturers explicitly.

Main Stakeholders Affected

• Manufacturers: Face temporary protection from diverse state rules but potential future federal premarket approval, which could raise costs for compliance.
• Infants and Families: Premature/low-birth-weight babies and parents/caregivers, who rely on consistent access to specialized formula for health and nutrition.
• Healthcare Providers: Hospitals and doctors using or preparing formula for direct care, unaffected if not distributing commercially.
• States and Local Governments: Temporarily restricted from enforcing unique rules, potentially affecting public health initiatives.
• Federal Agencies: FDA/HHS, responsible for the study and any new regulations.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens federal preemption under the Supremacy Clause (part of the U.S. Constitution that makes federal law override conflicting state law), but carves out exceptions for misconduct cases to balance accountability. The high burden of proof for exceptions and federal court removal could favor manufacturers in lawsuits.
• Constitutional: Raises federalism issues (tension between federal and state powers), as it limits state authority over health and safety—a traditional state area—under the Commerce Clause (federal power to regulate interstate commerce, like formula distribution).
• Political: Promotes national standardization in a sensitive area like infant health, potentially reducing industry burdens but sparking debate over whether it weakens state protections for vulnerable populations. The bipartisan introduction (by Reps. Harshbarger and Schneider) suggests cross-party support for uniformity in medical products.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Harshbarger, Diana [R-TN-1]

Cosponsors (2)

Rep. Schneider, Bradley Scott [D-IL-10], Rep. Carey, Mike [R-OH-15]

Recent Actions

• 2025-03-24: Referred to the House Committee on Energy and Commerce.
• 2025-03-24: Introduced in House
• 2025-03-24: Introduced in House

Bill Versions

• To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes. — issued 2025-03-24 — PDF (7 pages)