S. 272, Protect Infant Formula from Contamination Act

S. 272 would require manufacturers of infant formula to notify the Food and Drug Administration (FDA) within one business day of discovering contamination, misbranding, or adulteration of infant formula. The bill would direct the FDA to respond to such notifications within one business day and to assess within 90 days whether the manufacturer has taken appropriate corrective action. The bill would require the FDA to report to the Congress each quarter on the supply chain for infant formula and, within 180 days of enactment, on progress toward implementing a national strategy to ensure those products are safe and available.

The bill also would direct the FDA to engage with the Department of Agriculture, manufacturers, and others to develop evidence-based practices to maximize the supply and safety of infant formula and to describe those practices periodically in reports to the Congress.

Using information about the cost of similar activities, CBO estimates that implementing S. 272 would increase the FDA’s administrative costs by $2 million over the 2026-2031 period; any related spending would be subject to the availability of appropriated funds.

The costs of the legislation fall within budget function 550 (health).

S. 272 would impose private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). The bill would require manufacturers to notify the FDA more quickly and in more detail than under current law upon discovering contamination, misbranding, or adulteration of infant formula. The bill would impose additional responsibilities for responding to contamination involving Cronobacter or Salmonella bacteria. CBO estimates that the cost of the mandate would not exceed the annual private-sector threshold established in UMRA ($214 million in 2026, adjusted annually for inflation).

The CBO staff contacts for this estimate are Ryan Greenfield (for federal costs) and Andrew Laughlin (for mandates). The estimate was reviewed by Chad Chirico, Director of Budget Analysis.