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Preterm infant formula

Specialized baby formula designed for infants born before 37 weeks of pregnancy or those with low birth weight, often exempt from standard infant formula regulations due to their specific needs.

Premarket approval

A process where a product, such as a medical device or drug (or, in this case, potentially infant formula), must receive official clearance from a regulatory agency (like the FDA) before it can be sold to the public.

Preemption

A legal principle where federal law overrides or supersedes state laws on the same subject. In this bill, it means federal rules temporarily take precedence over state rules for preterm infant formula.

Willful misconduct

Actions or failures to act that are done intentionally for a wrongful purpose, knowingly without legal justification, or in disregard of a known risk where harm is highly probable.

Federal Food, Drug, and Cosmetic Act (FDCA)

A foundational federal law that gives the FDA authority to regulate food, drugs, cosmetics, and medical devices to ensure their safety and effectiveness.

Secretary of Health and Human Services (HHS)

The head of the U.S. Department of Health and Human Services, a cabinet-level position responsible for federal health and social services programs.