• The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the FDA Safety and Landmark Advancements Act of 2022 (FDASLA) to introduce policies in response to the infant formula crisis. Sen. Patty Murray (D-WA), who chairs the HELP committee, introduced the bill in May.
  • The HELP Committee added sections 909 and 910 to address the breakdowns that led to a nationwide shortage of infant formula. Specifically, section 909 would require FDA to report to Congress on its mailroom policies and procedures, including quarterly reports on how the agency handles common carrier packages and correspondence. Section 910 would introduce a long list of requirements, including requiring FDA to monitor infant formula manufacturers more closely, increase the resiliency of the formula supply chain, work with other countries to “harmonize regulatory requirements” for formula, and provide flexibility in the infant formula premarket submission process during supply chain disruptions.
  • The formula shortage occurred due to food safety concerns that shut down a formula production plant in mid-February. The plant reopened June 4, but the shortage is expected to continue into the summer.