A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.

According to KFF Health News, when a mother reported that her baby died after using a particular infant formula, the manufacturer closed the case file without informing the FDA. The gap in oversight is striking: while medications face stringent adverse-event reporting requirements, infant formula relies largely on manufacturers to self-report safety concerns to regulators. This creates a system where public safety depends on whether companies choose to flag potential risks — raising questions about accountability when vulnerable infants are at stake.

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