The Senate’s Health, Education, Labor and Pensions Committee, has voted to approve a bipartisan deal, which includes policies to respond to the nation’s infant formula crisis.

Its title is the “FDA Safety and Landmark Advancements (FDASLA) Act. “

“Families need accountability from FDA and formula manufacturers, and they desperately need formula—and I am pushing to get them both at every opportunity I can,” said Sen. Patty Murray, D-WA, who chairs the HELP Committee.

“The legislation we passed today includes several valuable steps from me and my colleagues to address this crisis and ensure we are never in a situation like this again. It requires FDA to investigate and resolve the mailroom issues that hindered its response, requires manufacturers to notify the FDA of issues that could disrupt supply, requires FDA to put forward a concrete plan to get formula on shelves as soon as possible, and more. “

The infant formula shortage is a direct result of food safety concerns that led to the shutdown of a formula production plant operated by Abbott Nutrition in Sturgis, MI. The shutdown came when the company initiated a massive recall of infant formula in mid-February after the FDA found five strains of cronobacter in the production plant. Other food safety problems such as a leaking roof and filthy conditions were also discovered by FDA inspectors.

The FDA, through a federal court consent decree, allowed the plant to reopen on June 4 under strict government controls, but the formula shortage is expected to last well into July. Abbott Nutrition has 48 percent of the infant formula market in the United States.

The Committee took action to address the formula crisis in Sections 909 and 910 of FDASLA.. 

The Senate bill will:

  • Require FDA to conduct annual inspections of each manufacturer of infant formula;
  • Require FDA, in consultation with the Secretary of Agriculture, to develop and issue within 90 days of enactment a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of shortages, and ensure parents and caregivers have access to formula and information they need;
  • Require infant formula manufacturers to submit a report to FDA promptly after the initiation of a recall, including a plan of actions the manufacturer will take to address the recall;
  • Require infant formula manufacturers to notify FDA of discontinuances in manufacturing that are likely to lead to a meaningful disruption in the supply of infant formula; 
  • Require FDA to ensure timely communication with manufacturers following an inspection and to re-inspect facilities in a timely manner;
  • Require FDA to submit a report to Congress on the development and implementation of new or revised policies and procedures to monitor and ensure the effective receipt, tracking, managing, and prioritization of complaints;
  • Establish the Office of Critical Foods in the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA;
  • Require FDA to work with other countries to discuss harmonizing regulatory requirements for infant formula;
  • Require FDA to submit an annual report to Congress on infant formula submissions and inspections;
  • Require FDA to notify Congress of a recall of infant formula products and an estimate of any disruption in supply
  • Allows importation of specialty infant formula during the current shortage from countries with similar protections as the US, as well as importation for personal use for 90 days;
  • And more. 

Section-by-section of FDASLA HERE. 

Legislative text HERE.

Amendments passed HERE.

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