Protect Infant Formula from Contamination Act
Protect Infant Formula from Contamination Act
Plain Language Summary
# Protect Infant Formula from Contamination Act – Summary **What the Bill Does** This bill strengthens safety requirements for infant formula by requiring manufacturers to report potential contamination problems to the FDA much faster than current law allows. Specifically, manufacturers would have to notify the FDA within one business day if they discover their formula may lack required nutrients or could be contaminated with harmful microorganisms like salmonella. The bill also requires manufacturers to share test results with the FDA and work with the agency on how to properly handle contaminated batches. **Who It Affects and Why** The bill targets infant formula manufacturers and the FDA, ultimately protecting infants and families who depend on safe formula.
Current law only requires manufacturers to report contamination *after* formula has left their control, which can delay the FDA's response to safety issues. This bill aims to catch problems earlier in the manufacturing process, preventing contaminated formula from reaching store shelves and consumers. **Current Status** The bill (S 272) was introduced in the 119th Congress by Senator Gary Peters (D-MI) and is currently in committee, meaning it has not yet been voted on by the full Senate. The bill addresses concerns raised by previous infant formula contamination incidents that affected supply and consumer confidence.
CRS Official Summary
Protect Infant Formula from Contamination ActThis bill imposes certain new requirements on infant formula manufacturers and the Food and Drug Administration (FDA) following the discovery of contaminated, adulterated, or misbranded infant formula. Specifically, the bill requires infant formula manufacturers to report to the FDA within one business day of learning that formula that was processed by the manufacturer but that is no longer within the manufacturer’s control may not provide required nutrients or may be otherwise adulterated or misbranded. Further, if any testing of finished infant formula reveals the presence of specified microorganisms (e.g., salmonella), the manufacturer must notify the FDA within one business day. (Under current law, manufacturers are only required to report contamination to the FDA if the affected formula has left the manufacturer’s control.) The manufacturer must also promptly provide the test results to the FDA and consult with the FDA on proper isolation and disposal of the affected product. The FDA must respond to such a notification and begin discussing proper investigative and corrective action with the manufacturer within one business day. Within 90 days of a report of adulterated, misbranded, or contaminated infant formula, the FDA must determine whether the manufacturer that reported the problem has performed, or is performing, appropriate investigative and corrective action. Finally, the FDA is required to periodically report on the infant formula supply chain and efforts to improve the safety and supply of infant formula, and must consult with other federal agencies and infant formula stakeholders on these issues.
Latest Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.