Senate Mandates FDA to Ensure Infant Formula Safety, Supply
On June 12, 2022, the U.S. Senate’s Health, Education, Labor, and Pensions Committee (HELP Committee) passed the “FDA Safety and Landmark Advancements Act” (FDASLA Act), which addresses the current infant formula shortage and safety crises. The FDASLA Act clarifies and advances many FDA activities and regulations, but specifically addresses infant formula in Section 910 of the Act.
The bipartisan Act requires FDA to resolve mailroom issues (Section 909) that negatively affected its response to problems with the U.S. infant formula supply, requires manufacturers to notify FDA of potential formula supply disruptions, and mandates that FDA create a plan to increase the supply of formula in the U.S. as soon as possible. Other solutions featured in the FDASLA Act include: