H.R. 2300 directs the FDA to study preterm infant formula availability and regulations across the country, with a focus on whether the federal government should require manufacturers to get premarket approval before selling these specialized formulas. The bill temporarily prevents states from imposing their own rules on preterm infant formula that go beyond federal standards for two years—the same period during which the FDA must complete its study and submit recommendations to Congress. The preemption does not block state lawsuits against manufacturers for willful misconduct that causes death or serious injury. This legislation aims to create uniform national standards for preterm infant formula, which is specially formulated for babies born prematurely or with low birth weight, rather than allowing a patchwork of different state requirements.
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