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H.R. 5316

BillFederalHouseIn Committee
To amend section 412 of the Federal Food, Drug, and Cosmetic Act to enhance the safeguards applicable with respect to infant formula.
About This Bill
Committee
Latest Action · September 1, 2023
Referred to the Subcommittee on Health.
Congress
118th (2023–2025)
Introduced
August 29, 2023
Cosponsors (7)
6D 1R
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Summary

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This bill strengthens safety requirements for infant formula manufacturers by requiring them to notify federal health officials within 24 hours if they discover their formula may lack required nutrients, be contaminated with harmful pathogens, or be otherwise unsafe. Manufacturers must also provide test samples from positive contamination results to the government for analysis. The bill establishes a new Office of Critical Foods within the FDA that must contact manufacturers within 72 hours of receiving a safety notification to discuss corrective actions and must confirm within 90 days that the manufacturer has fixed the problem through a root cause analysis. If the Office of Critical Foods fails to meet these timelines, the Secretary of Health and Human Services must report the failure and any consequences to Congress. The bill takes effect immediately upon enactment, with the FDA required to establish its response process within 180 days, and requires the Secretary to submit annual reports through 2026 documenting the number of safety notifications received and how quickly the government responded to them.

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