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:
- Routine reporting on and assessments of FDA mailroom activity
- The establishment of the Office of Critical Foods in FDA’s Center for Food Safety and Applied Nutrition (CFSAN)
- Flexibilities for premarket submission requirements in the event of supply disruptions
- Efforts to internationally harmonize formula regulatory requirements
- Reporting on and assessments of FDA’s regulation of formula in the U.S.
- New timelines for FDA responses to formula submissions, reviews of formula nutrient requirements, and manufacturer communication
- Manufacturer requirements for recall reporting, annual inspections, notification of product discontinuance, and risk management plans
- Making information about substitutes for specialty infant formula publicly available in the event of a shortage
- Information-sharing with the Secretary of Agriculture and other relevant regulatory officials in the event of supply disruptions.
The HELP Committee’s focus on infant formula follows nationwide supply shortages precipitated by the fatal foodborne illness outbreak linked to Abbott Nutrition and the subsequent product recall.