FDA gets two years to study preterm formula; states lose safety authority.

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.
• Removal of state-court actions to federal court shifts litigation venue and may increase costs for plaintiffs, effectively narrowing access to state-law remedies.
• The bill does not define what constitutes 'premarket approval' or its timeline; the FDA study will recommend a process, but Congress must act to implement it—leaving a gap in authority if the study recommends approval but Congress does not legislate.

Section numbers refer to the bill text the analysis read — linked under Primary records below.

Who it affects

The bill creates a temporary uniform federal floor for preterm formula safety, which may reduce compliance costs and speed market access for manufacturers—potentially benefiting parents through lower prices and wider availability. However, it strips states of authority to impose stricter protections for two years, and the exception for willful misconduct suits places a high burden of proof (clear and convincing evidence) on plaintiffs, which may shield manufacturers from accountability for serio

Who stands to gain

• preterm infant formula manufacturers
• medical device/pharmaceutical companies with preterm formula products

Named in the bill

FDA (Food and Drug Administration), HHS (Department of Health and Human Services), State governments, Preterm infant formula manufacturers, Federal Food, Drug, and Cosmetic Act, Poison Prevention Packaging Act of 1970, Fair Packaging and Labeling Act

Where it stands

2 cosponsors: 1 Democrats, 1 Republicans.

• Mar 24, 2025 — Introduced · Congress.gov: “Introduced in House”
• Mar 24, 2025 — Referred to House Committee on Energy and Commerce · Congress.gov: “Referred to the House Committee on Energy and Commerce”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

6 lobbying clients named this bill on 11 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $5,220,000 in lobbying spend. A filing names 1 bills on average, so that figure is what each filing reported, not a share belonging to this bill.

More lobbying clients named this bill than 82% of bills with at least one filing.

Diana Harshbarger, the sponsor, reported $727,520 in PAC receipts in the 2026 cycle. $10,000 of that came from 1 PAC tied to these lobbying clients.

• American Association for Justice — $3,610,000 on 2 filings
• Abbott Laboratories — $1,150,000 on 1 filing
• Abbott — $120,000 on 2 filings
• Abbott Laboratories — $120,000 on 2 filings
• Prolacta Bioscience, Inc. — $120,000 on 2 filings

Lobbying Disclosure Act filings through Jul 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.