“To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.”
No CRS summary available for this bill.
This section requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to study (1) the availability of preterm infant formula in the United States; (2) federal and state laws, regulations, and requirements relating to its design, development, testing, manufacture, distribution, sale, marketing, packaging, labeling, licensing, and use, or its safety; (3) whether the Federal Food, Drug, and Cosmetic Act should be amended to require premarket approval for such formula; and (4) if recommended, a process and requirements for such approval. The Secretary must submit a report on the study to Congress within two years after the date of enactment. This section temporarily preempts, during the two-year period beginning on the date of enactment, any state or local requirement relating to preterm infant formula that differs from or adds to requirements under the Federal Food, Drug, and Cosmetic Act, the Poison Prevention Packaging Act of 1970, or the Fair Packaging and Labeling Act. The preemption does not apply to civil or criminal actions against a manufacturer for willful misconduct in manufacturing or production causing death or serious physical injury (with the plaintiff bearing the burden of proof by clear and convincing evidence); allows removal of such actions to federal district court; and requires dismissal of any pending civil or criminal actions seeking to enforce preempted requirements. (As background, preterm infant formula is exempt from standard infant formula premarket notification requirements under FDCA §412(h)(1) (21 U.S.C. 350a(h)(1)).) This section defines "infant formula" by reference to FDCA §201(z) (21 U.S.C. 321(z)); "manufacturer" as a person who prepares, reconstitutes, changes characteristics of, packages, or labels such formula for distribution (excluding actions exclusively for an infant under direct care); "preterm infant formula" as formula exempt under FDCA §412(h)(1) intended for infants born before 37 weeks gestation or low-birth-weight infants; and "willful misconduct" as an intentional act or omission without justification and in disregard of a known or obvious risk so great as to make harm highly probable.