Senate bill dictates infant formula reform

The Senate 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 “FDA Safety and Landmark Advancements (FDASLA) Act.”

“Families need accountability from the FDA and formula manufacturers, and they desperately need nutritional formula — and I try to get it at every opportunity,” said Senator Patty Murray, D-WA, who chairs the assistance committee.

“The legislation we passed today includes several valuable steps from me and my colleagues to address this crisis and ensure that we never face a situation like this again. It requires the FDA to investigate and resolve mailroom issues that have hampered their response, and requires manufacturers to notify The Food and Drug Administration is addressing issues that could disrupt supply, require the Food and Drug Administration (FDA) to present 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, Michigan. The shutdown came when the company began recalling large quantities of infant formula in mid-February after the Food and Drug Administration found five strains of Chronobacter bacteria in the production plant. FDA inspectors have also discovered other food safety issues such as leaking roofs and dirty conditions.

The Food and Drug Administration, through a federal court approval decree, allowed the plant to reopen on June 4 under strict government controls, but the formula shortage is expected to last through July. Abbott Nutrition owns 48 percent of the US infant formula market.

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

The Senate bill would:

  • Requiring the US Food and Drug Administration (FDA) to conduct annual checks for every infant formula manufacturer;
  • Require the FDA, in consultation with the Secretary of Agriculture, to develop and issue a national infant formula strategy within 90 days of its enactment to increase the resilience of the infant formula supply chain, protect against future contamination and other potential causes of shortages, and ensure that parents and caregivers can access the formula and information they need to her ;
  • require manufacturers of infant formula to submit a report to the Food and Drug Administration immediately after initiating a recall, including a plan of actions the manufacturer will take to address the recall;
  • requiring infant formula manufacturers to notify the Food and Drug Administration of discontinuities in manufacturing that could potentially lead to significant disruption to the supply of infant formula;
  • Require the FDA to ensure timely contact with manufacturers after inspection and timely re-examination of facilities;
  • Require the FDA to report to Congress on the development and implementation of new or revised policies and procedures to monitor and ensure the effective receipt, tracking, management and prioritization of complaints;
  • Establishment of the Office of Critical Foods in the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration;
  • Require the FDA to work with other countries to discuss harmonization of infant formula regulatory requirements;
  • Require the FDA to submit an annual report to Congress on infant formula introductions and concentrations;
  • Require the Food and Drug Administration to notify Congress of the recall of infant formula products and to estimate any supply interruptions
  • Imports of infant formula intended during the current shortage are allowed from countries with similar protections such as the United States, as well as import for personal use for a period of 90 days;
  • and more.

Section by section of the FDASLA is here.

Legislative text here.

Modifications passed here.

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