FDA gets two years to study preterm formula; states lose safety authority.
H.R. 2300 — To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes. · Filed by Diana Harshbarger (R-TN) · 2 cosponsors · Introduced Mar 24, 2025 · Referred to committee
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What it does
This bill directs the FDA to study preterm infant formula availability and safety requirements across federal and state law, and to recommend whether premarket approval should be required. For two years, it blocks states from imposing their own rules on preterm formula that differ from federal standards—except states can still sue manufacturers for willful misconduct causing death or serious injury. After two years, the preemption expires and states regain authority unless Congress acts.
Why we flagged it
The bill's core mechanism is a two-year suspension of state regulatory authority over preterm infant formula, paired with a federal study to determine future policy. It is neither a pure deregulation nor a pure safety measure—it is a temporary uniformity mandate that trades state flexibility for federal consistency.
What the text implies
- The two-year preemption is temporary, but if Congress does not act, state authority automatically returns—creating uncertainty for manufacturers about long-term regulatory stability.
- The 'willful misconduct' exception requires clear and convincing evidence (a high standard) and applies only to death or serious physical injury, potentially leaving minor harms or design defects outside the exception.
The full analysis lists 4 implications of this text.
Who stands to gain
preterm infant formula manufacturers; medical device/pharmaceutical companies with preterm formula products